Medical Device News Update - June 2024

FDA approvals, warning letters and Class I recalls issued during June 2024

Jul 31, 2024

Each month, Let’s Talk Risk! (LTR) provides a comprehensive summary of new device approvals or clearances, warning letters, and Class I recall announcements issued by the FDA in the previous month.

As a risk practitioner, it is very important to stay up to date with the latest regulatory developments affecting the medical device industry. A review of latest innovations approved or cleared by the FDA helps in understanding different ways the agency evaluates benefit-risk of medical devices when reviewing their safety and effectiveness. Warning letters and recall announcements are useful to study to build awareness of gaps in quality management system and the risk management process that should be addressed before they are cited by the FDA.

Only publicly available information is curated in this article. Links to relevant sources are provided in the footnotes.

Quick Summary

New device approvals/clearances

A suture system for replacement of the mitral chordae tendineae (De Novo DEN230069).
An external pump system for temporary reduction of Intraocular Pressure during sleep (De Novo DEN230055).
An RT-PCR based detection test for Hepatitis C infection (De Novo DEN240016).
A coronary dilatation catheter to manage the risk of restenosis and improving myocardial perfusion (PMA, Original, P230026).
A pulmonary artery pressure sensing system to help clinicians manage heart failure patients at home, and minimize hospitalizations and more invasive heart failure treatments (PMA, Original, P230040).
A total of 263 devices were cleared through the 510(k) process during June 2024. Days to FDA decision ranged from 14 to 746 days with a median of 146 days. Top 5 medical specialties were Orthopedic (OR), Cardiovascular (CV), General & Plastic Surgery (SU), Radiology (RA) and Gastroenterology & Urology (GU) accounting for 63% (165/263) of devices cleared.

FDA warning letters

AG Essence, Inc.: Marketing of wound care products without FDA authorization, violations of device registration and listing requirements.

Class I recall announcements

Medtronic: Select versions of the StealthStation S8 cranial software due to errors that can lead to serious brain injury, paralysis or death.
Medline Industries, LP.: Endotracheal tubes due to detachment or tearing of the inflation tube from the main tube.
Teleflex/Arrow International: Intra-aortic balloon kits due to a manufacturing error that can cause the balloon to become overtwisted and prevent full inflation.
Getinge: Vaporizer sevoflurane maquet filling for discoloration and corrosion that can cause toxic chemical exposure.
Megadyne: Soft pediatric return electrode pads for risk of serious burns injuries.
Philips Respironics, Inc.: Ventilator inoperative alarm use instructions due to interruptions and/or loss of breathing support therapy.
Zoll Medical Corporation: Missing MRI safety information in ventilator use instructions.
Abbott Medical: HeartMate LVAS monitor correction due to screen issues that may cause unintentional pump stop.

Let us take a closer look.

I. Innovation

Here is a summary of De-Novo decisions, PMA approvals and 510(k) clearances in the month of June 2024. See footnotes for links to additional information.

A. De-Novos

DEN230069: Mi-CHORD System1
The Mi-CHORD is indicated for use in patients on cardiopulmonary bypass, with the heart either arrested or fibrillating, as a surgical replacement of mitral chordae tendineae. These are inelastic cords of fibrous connective tissue connecting the papillary muscles to the tricuspid valve and the mitral valve in the heart. A suture placement device is used to replace these cords using non-absorbable sutures secured with clips or fasteners. The system is indicated for use under direct visualization.
Product Code SBK, Class II, Regulation 21 CFR 870.3490
DEN230055: FSYX™ Ocular Pressure Adjusting Pump System2
This novel device is used to reduce the Intraocular Pressure (IOP) during sleep in adult patients with open-angle glaucoma and IOP of less than or equal to 21 mm of Hg who are currently using or have gone through another IOP-lowering treatment. This system uses hardware and software to create a negative pressure in front of the eye to temporarily reduce the IOP.
Product Code QQJ, Class II, Regulation 21 CFR 886.5000
DEN240016: Xpert HCV; GeneXpert Xpress System3
The Xpert HCV is an RT-PCR test for the qualitative detection of Hepatitis C virus RNA in blood sample collected using a finger stick. It is not intended for monitoring patients undergoing treatment or for use in screening blood, plasma or tissue donors.
Product Code SBP, Class II, Regulation 21 CFR 866.3171

B. Premarket Approvals (PMA) - Original only

1. P230026: Lacrosse NSE ALPHA Coronary Dilatation Catheter4

The Lacrosse NSE ALPHA coronary dilatation catheter is indicated for balloon dilatation of the stenotic portion of the coronary artery to manage the risk of restenosis and improving myocardial perfusion.

Figure 1: Lacrosse NSE ALPHA coronary dilatation catheter. Source: Summary of Safety and Effectiveness data on fda.gov

The catheter balloon has nylon threads, protruding out at 3 locations 120 degrees apart, to focus the dilatation force during inflation. Two radiopaque markers inside the balloon indicate the working length to guide proper positioning around the target lesion. The device is available in 9 diameters ranging from 2.0 to 4.0 mm.

According to the Summary of Safety and Effectiveness Data (SSED)5,

In the EXPANSE-PTCA study, the primary endpoint of procedural success was achieved in 89.8% of subjects, with the lower 95% confidence interval of 85.5%. The EXPANSE-PTCA study thus failed to reject the null hypothesis in favor of the alternative that the proportion of primary endpoint successes was greater than the predetermined performance goal of 87.7%.

However, the failure to meet the predefined primary endpoint was considered to be of limited concern because of known complications that could be mitigated during the procedure.

The safety profile of this device showed acceptable freedom from device-related injury with no device-related perforations or device-related flow-limiting dissections.

FDA approved the PMA on June 6, 2024, with a requirement of a post-approval study.

2. P230040: Cordella Pulmonary Artery Sensor System (CorPASS)6

The Cordella Pulmonary Artery Sensor System is used to measure, record and transmit pulmonary artery pressure (PAP) data in heart failure patients on diuretic drugs and guideline-directed medical therapy (GDMT). This device can help clinicians manage heart failure patients at home, and minimize hospitalizations and more invasive heart failure treatments.

The CorPASS system comprises the following subsystems:

Cordella PA sensor
Cordella delivery system
myCordella handheld patient reader including dock
Cordella calibration equipment (CalEQ)
Cordella data analysis platform (CDAP).

Figure 2: Cordella sensor and delivery system. Source: Summary of Safety and Effectiveness Data on fda.gov

As shown in Figure 2, the CorPASS system consists of the Cordella PA sensor and a delivery system catheter. The sensor is permanently implanted in the patient’s interlobar right pulmonary artery. It is a battery-less capacitive pressure sensor, packaged in a glass body coated with a medical grade silicone. The Sensor implantation takes place during a minimally invasive right heart catheterization (RHC) that typically takes less than an hour.

The sensor changes it resonating frequency in proportion to the PAP, which is transmitted wirelessly to the handheld patient reader as shown in the Figure below.

Figure 3: myCordella reader and how it is used by a patient to read the pulmonary artery pressure (PAP). Source: Summary of Safety and Effectiveness Data on fda.gov

Guided by an app running on the myCordella tablet, a patient places the reader against their chest to record a PAP reading. The reader briefly powers the implanted sensor which allows the data to be transmitted and recorded wirelessly on the tablet. Data is then transmitted to the Cordella Data Analysis Platform (CDAP), a web based application processes the raw data and makes it available to clinicians through the secure myCordella Patient Management Portal (PMP). Changes in PAP can be used in conjunction with vital signs and patient-reported symptoms to guide adjustments to diuretic and other medications.

According to the Summary of Safety and Effectiveness Data (SSED)7:

Given that the upper confidence bound of the observed event rate was less than the performance goal (PG) (0.2106 vs 0.43), the observed rate was significantly lower than PG (0.1589 vs 0.43; p<0.0001), and the observed rate was less than 0.37, all criteria for the primary efficacy were satisfied.

Further;

The study's first primary safety endpoint was the freedom from a Device/System-Related Complication (DSRC) through 6 months. Four adjudicated DSRC events were observed in the ITT population during the follow-up and the probability of being free from a DSRC at 6 months post-implant procedure was 99.2%.

However, none of the DSRCs resulted in permanent subject impairment or death, and all subjects recovered without further complications.

Based on these results, FDA approved the PMA on June 20, 2024 with a requirement of a post-approval study and periodic study progress reports

C. Premarket Notifications (510k)

FDA cleared a total of 263 devices through the premarket notification process during June 2024. A majority of these devices (84%) were cleared through the Traditional 510k process.

Following graphic provides an overview of these 510k’s.

Figure 4: Overview of 510k clearances in June 2024.

Here are the key highlights:

Top 5 medical specialties accounted for 63% of the total 510k (165/263) with median days to decision ranging from 88 to 254 days after receipt.
Orthopedic medical specialty had the highest number of 510k (44/263) with 88 median days to decision after receipt. Top 5 product codes were in the Orthopedic, Radiology and General & Plastic Surgery specialties.
OLO was the top product code corresponding to a Orthopedic stereotaxic instrument in the Orthopedic category with 10 510ks.
In aggregate, days to decision ranged from a minimum of 14 days to a maximum of 746 days after receipt, with a median of 146 days. 20th percentile of the devices were cleared within 62 days, while the 80th percentile were cleared within 266 days.
A safety lancet intended for capillary blood sampling was cleared just 14 days after receipt (K241627, PRO Code: FMK).
It took 746 days for microbial nucleic acid storage and stabilization device, InActiv, Blue to receive 510k clearance (K221547, PRO Code: QBD).

II. FDA Warning Letters

FDA issued 1 warning letter to medical device manufacturers during the month of June 2024.

CMS 678344, AG Essence, Inc.8
1. Devices impacted: Banda-SiL silver wound care gel and Banda-Sil silver liquid gel spray.
2. Observations cited:
  1. Marketing of products without FDA authorization
  2. Products may be regulated by CDER based on claims
  3. UDI labeling violations
  4. Inactive device registration and failure to meet annual listing requirements.

III. Medical Device Recalls

In the month of June 2024, FDA published 8 Class I recalls. This classification reflects the most serious type of recall, where the use of impacted devices may cause serious injuries or death.

Medtronic: StealthStation S8 cranial software9
1. Device use: the StealthStation cranial software is used in the StealthStation system to locate anatomical structures during neurosurgery.
2. Reasons for recall: software errors in select versions result in missing numbers or letters from the displayed text, which can cause errors in estimating distances and locations during navigation with surgical tools.
3. Patient safety impact: incorrect placement of surgical tools during a cranial procedure can cause serious permanent injuries, including brain, nerve or vascular damage, leading to paralysis or death. There have been 28 complaints related to this issue but no injuries or deaths.
Medline Industries, LP: Endotracheal tubes10
1. Device use: these tubes are inserted through the mouth into the windpipe to to provide breathing support to patients.
2. Reasons for recall: detachment or tearing of the tube and other device components from the main tube.
3. Patient safety impact: tube damage can affect the flow of air, result in partial or total airway obstruction or choking. There have been 3 reported injuries but no death.
Teleflex/Arrow International: Intra-aortic balloon catheter kits11
1. Device use: these intra-aortic balloon (IAB) catheter kits are used with a balloon pump on patients undergoing cardiac and non-cardiac surgery for treatment of acute coronary syndrome or complications of heart failure.
2. Reasons for recall: a manufacturing error may cause the catheter’s balloon to become overtwisted, which prevents it from fully inflating resulting in blood backing up in the tube, helium leak, catheter damage or insertion difficulty.
3. Patient safety impact: these malfunctions can cause serious injury, blood loss, artery perforation, unstable blood pressure, ischemia or death. There have 322 complaints, 31 injuries and 3 deaths related to this issue.
Getinge: Vaporizer Sevoflurane Maquet filling12
1. Device use: this filling is part of an anesthesia system used to start and maintain general anesthesia.
2. Reasons for recall: reports of discoloration or corrosion within the vaporizer when used with certain low water content sevoflurane.
3. Patient safety impact: degradation of sevoflurane releases hydrogen fluoride, a hazardous chemical for both users and patients. Inhaling hydrogen fluoride may cause inflammation, lung edema, and hypocalcemia. Skin exposure can cause burns, superficial wounds or hypomagnesemia. There have been reports of 2 incidents but no injuries or deaths related to this issue.
Megadyne: Soft pediatric patient return electrodes13
1. Device use: these electrodes are soft pads used during electrosurgery to manage the electric current flow to reduce the risk of excessive heating.
2. Reasons for recall: complaints of burn injuries to patients.
3. Patient safety impact: burn injuries, including third degree burns, can be especially serious and life-threatening to pediatric patients. There has been 4 reported injuries but no reports of death related to this issue.
Philips Respironics, Inc.: Continuous BiPAP ventilators14
1. Device use: these devices are used to provide breathing support to adults and children.
2. Reasons for recall: revised use instructions needed to handle ventilator inoperative alarms which can cause loss or interruption of therapy.
3. Patient safety impact: loss or interruption in breathing support can cause hyperventilation, hypoxemia, hypercarbia, respiratory failure and death. There are a total of 911 reports, including 894 malfunctions, 10 injuries and 7 deaths related to this issue.
Zoll Medical Corporation: 731 series ventilators15
1. Device use: the 731 series of ventilators are small, portable devices to provide breathing support to infants, children and adults.
2. Reasons for recall: missing information in use instructions for MRI safety that can cause ventilator malfunctions, alarms or unexpected shutdown when used during an MRI exam.
3. Patient safety impact: misuse of ventilators during an MRI can cause serious, life-threatening situations, including lack of oxygen, difficulty in breathing, organ damage or death. There have been no reports of injury or death due to this issue.
Abbott Medical: Thoratec HeartMate system monitor16
1. Device use: these monitors are a part of the HeartMate left ventricular assist system (LVAS) used by patients experiencing heart failure.
2. Reasons for recall: monitors experiencing screen freezing issues, incorrect, missing or overlapping information display.
3. Patient safety impact: missing, incorrect, or unclear information on the monitor can cause mistakes in user settings causing incorrect pump operation. Serious or life-threatening situation can occur for patients such as low blood pressure, pump stop, stroke, brain damage, heart or organ damage and death. There have been 14 reports of injury but no death due to this issue.