Medical Device News Update - September 2024

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

Monthly roundup of FDA approvals, warning letters and recalls issued in September 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 in building 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.

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Quick Summary

New device approvals/clearances

1. A hearing aid feature mobile app from Apple (De Novo DEN230081).

2. A leaflet splitting device to treat patients at risk of coronary obstruction undergoing valve-in-valve TAVR (De Novo DEN240017).

3. An externally applied cooling device for temporary pain relief to the eye in an ophthalmic procedure (De Novo DEN230011).

4. A silicone gel-filled breast implant for primary breast augmentation or revision augmentation PMA (PMA, Original, P230005).

5. A total of 230 devices were cleared through the 510(k) pathway during September 2024. Days to FDA decision ranged from 7 to 1281 days with a median of 138 days. Top 5 medical specialties were Orthopedic (OR), Radiology (RA), General & Plastic Surgery (SU), Cardiovascular (CV), and Dental (DE) accounting for 62% (142/230) of devices cleared.

FDA warning letters

There were no warning letters issued to medical device manufacturers during September 2024.

Class I recall announcements

1. Baxter Healthcare: disconnection risk for certain components used in a ventilator system.

2. Medtronic: risk of battery instability and overheating in MAC video laryngoscopes.

3. Breas Medical: risk of short-term formaldehyde exposure from emissions in Vivo 45 LS ventilators.

4. Abbott Diabetes Care: risk of inaccurate glucose readings from a small number of FreeStyle Libre 3 sensors.

5. Fresenius Kabi USA: risk of medication overdose due to a manufacturing defect in the administration set used in an infusion system.

6. B. Braun Medical, Inc.: risk of pump stopping in an infusion system due to false occlusion alarms.

7. Smiths Medical: risk of tracheostomy displacement or decannulation due to a manufacturing defect.

8. Smiths Medical: risk of loosening or disconnection of the patient outlet connector in certain emergency and transport ventilators.

9. Baxter Healthcare: contamination risk due to particulate matter in primary packaging of some components used in a pharmacy compounding device.

10. Smiths Medical: risk of inadvertent movement of the tidal volume knob in certain emergency and transport ventilators.

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 September 2024. See footnotes for links to additional information.

A. De-Novos

1. DEN230081: Hearing Aid Feature¹
   The Hearing Aid Feature from Apple, is a mobile app intended to be used with a compatible wearable electronic product. It amplifies sound, utilizing a self-fitting approach without the assistance of a hearing healthcare professional.

   Product Code SCR, Class II, Regulation 21 CFR 874.3335

2. DEN240017: ShortCut leaflet splitting device for valve-in-valve procedures²
   This percutaneous catheter is used for splitting bioprosthetic aortic valve leaflets to facilitate valve-in-valve procedures.
   Product Code SCZ, Class II, Regulation 21 CFR 870.1254

3. DEN230011: OcuCool ophthalmic cooling device³
   OcuCool is an externally cooling device applied to the conjunctiva and sclera for temporary reduction of pain associated with intravitreal injections.
   Product Code QZQ, Class II, Regulation 21 CFR 886.4190

B. Premarket Approvals (PMA) - Original only

1. P230005: Motiva silicone gel-filled breast implants⁴

These silicone gel-filled breast implants are intended for breast augmentation as well as revision surgery to correct or improve the results of a previous augmentation. These devices are covered by regulation 21 CFR 878.3540 and classified under product code FTR.

The summary of safety and effectiveness data (SSED) is currently not available.

C. Premarket Notifications (510k)

FDA cleared a total of 230 devices through the premarket notification process during September 2024. A majority of these devices (87%) were cleared through the Traditional 510k process.

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

Figure 1: Overview of 510ks cleared during September 2024.

Here are the key highlights:

• Top 5 medical specialties accounted for 62% of the total 510k (142/230) with median days to decision ranging from 94 to 234 days after receipt.

• Orthopedic (OR) medical specialty had the highest number of 510k (37/230) with 94 median days to decision after receipt. Top 5 product codes were in the Orthopedic, Radiology and General & Plastic Surgery medical specialties.

• MAX was the top product code corresponding to a fusion device with bone graft in the Orthopedic category with 10 510ks.

• In aggregate, days to decision ranged from a minimum of 7 days to a maximum of 1281 days after receipt, with a median of 138 days. 20th percentile of the devices were cleared within 83 days, while the 80th percentile were cleared within 263 days.

• A vena cava filter system for prevention of recurrent pulmonary embolism was cleared just 7 days after receipt (K242612, PRO Code: DTK).

• It took 1281 days for a biochemistry analyzer device for quantitative testing of venous blood samples to receive 510k clearance as a Class II device (K210933, PRO Code: CGA).

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II. FDA Warning Letters

There were no warning letters to medical device manufacturers during the month of September 2024.

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III. Medical Device Recalls

In the month of September 2024, FDA published 10 Class I recalls. This classification reflects the most serious type of recall, where the use of impacted devices may cause serious injuries or death.

1. Baxter Healthcare: Volara System Single Patient Use Circuit and Blue Ventilator Adapter⁵

   1. Device use: these components are used in ventilators to provide breathing support to patients.

   2. Reasons for recall: risk of disconnection from the nebulizer port on the blue ventilator adapter. If the plug is disconnected, the ventilator may not provide enough ventilation to the patient.

   3. Patient safety impact: patients may experience serious adverse health consequences as a result of decreased oxygen levels, including brain injury, heart attack, respiratory failure and death. There has been no reports of injury or death.

2. Medtronic: MAC video laryngoscopes⁶

   1. Device use: these devices are used to visualize the trachea during a medical procedure.

   2. Reasons for recall: battery may deplete below its designed threshold, increasing the risk of battery instability and overheating leading to a potential explosion.

   3. Patient safety impact: this issue may cause serious adverse health consequences, including burns, cuts, scarring, tooth loss, eye injury, hearing impairment, respiratory failure, hypoxia and death. There have 1 reported injury but no deaths related to this issue.

3. Breas Medical: Vivo 45 LS ventilator correction⁷

   1. Device use: the Vivo 45 LS ventilator is used to provide continuous or intermittent breathing support to pediatric and adult patients.

   2. Reasons for recall: potential for short-term exposure to formaldehyde emissions.

   3. Patient safety impact: exposure to formaldehyde can cause serious health consequences, especially in pediatric patients. These include temporary airway irritation or inflammation leading to other issues such as asthma and death. There have no reported injuries or death.

4. Abbott Diabetes Care: FreeStyle Libre 3 CGM sensors⁸

   1. Device use: the FreeStyle Libre 3 continuous glucose monitoring system is used for continuous monitoring of glucose levels for diabetes management.

   2. Reasons for recall: inaccurate glucose readings from a small number of CGM sensors.

   3. Patient safety impact: inaccurate results may affect the ability to take timely action and may lead to hypoglycemia, loss of consciousness, seizures, coma, brain damage and death. There has been 2 reported injuries but no reports of death related to this issue.

5. Fresenius Kabi USA: Ivenix large volume pump administration sets⁹

   1. Device use: The Ivenix large volume pump is a primary component of the Ivenix infusion system. It is compatible only with specific sterile, single-use disposable administration sets.

   2. Reasons for recall: manufacturing defect that can cause uncontrolled medication flow in the Ivenix infusion system.

   3. Patient safety impact: use of affected products may lead to medication overdose and death. There is a report of 2 injuries but no deaths related to this issue.

6. B. Braun Medical, Inc.: Infusomat system/large volume pumps and battery packs¹⁰

   1. Device use: these pump systems are used for controlled delivery of medications and fluids to pediatric and adult patients.

   2. Reasons for recall: false occlusion alarms leading to pump stopping.

   3. Patient safety impact: use of affected infusion systems may cause serious health consequences including abnormal or unstable blood pressure and death. There have been 1 reported injury and 1 death due to this issue.

7. Smiths Medical: Bivona neonatal/pediatric and adult tracheostomy tubes¹¹

   1. Device use: these tracheostomy tubes are used to provide direct airway access up to 29 days in patients with a tracheostomy.

   2. Reasons for recall: disconnection of the securement flange due to a manufacturing defect.

   3. Patient safety impact: serious and life threatening injuries including improper ventilation, loss of protected airway and death may occur. There have been 35 reports of injuries and 2 deaths due to this issue.

8. Smiths Medical: ParaPAC plus ventilators¹²

   1. Device use: these devices are gas powered emergency and transport portable ventilators suitable for emergency use at an accident site and air transport to a hospital.

   2. Reasons for recall: loosening or disconnection of the patient outlet connector.

   3. Patient safety impact: serious and life threatening injuries including hypoxia, irregular heart beat, low blood pressure, respiratory arrest and death may occur. There have been 1 reported of injury and 1 death due to this issue.

9. Baxter Healthcare: ExactaMix automated compounding device inlets¹³

   1. Device use: these inlets are disposable parts of the ExactaMix compounding devices used in pharmacies to mix medicinal ingredients into the final forumlation.

   2. Reasons for recall: risk of contamination due to particulate matter found within the inlet primary packaging components.

   3. Patient safety impact: patients may experience serious adverse health consequences including blood clots in lungs, stroke, damage to small blood vessels and organs, other serious injuries and death. There has been no reports of injury or death.

10. Smiths Medical: ParaPAC plus ventilators¹⁴

    1. Device use: these devices are gas powered emergency and transport portable ventilators suitable for emergency use at an accident site and air transport to a hospital.

    2. Reasons for recall: risk of inadvertent movement of the device’s tidal volume knob.

    3. Patient safety impact: serious and life threatening injuries including injury from air pressure, hyperventilation, hypoventilation, CO2 build up, acidosis, hypoxia, irregular heart beat, low blood pressure, cardiorespiratory arrest and death may occur. There have been no reports of injury or death due to this issue.

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1. FDA: DEN230081 De Novo database entry.

2. FDA: DEN240017 De Novo database entry.

3. FDA: DEN230011 De Novo database entry.

4. FDA: P230005 Motiva silicone gel-filled breast implants PMA database entry.

5. FDA: Baxter Healthcare recall announcement.

6. FDA: Medtronic recall announcement.

7. FDA: Breas Medical recall announcement.

8. FDA: Abbott Diabetes Care recall announcement.

9. FDA: Fresenius Kabi USA recall announcement.

10. FDA: B. Braun Medical, Inc. recall announcement.

11. FDA: Smiths Medical recall announcement.

12. FDA: Smiths Medical recall announcement.

13. FDA: Baxter Healthcare recall announcement.

14. FDA: Smiths Medical recall announcement.