Medical Device News Update - July 2024

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

Monthly roundup of FDA approvals, warning letters and recalls issued in July 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. Absorbable implant for repair and closure of fistula-in-ano (De Novo DEN240007).

2. A magnetic compression device used to create a side-to-side duodeno-ileal anastomoses (De Novo DEN240013).

3. A self-contained biological indicator for monitoring steam sterilization (De Novo DEN220042).

4. An RT-PCR based assay for detection of C. auris fungal infection (De Novo DEN230092).

5. A hydrogel used to create a physical barrier around a peripheral nerve in patients with trauma or amputation (De Novo DEN230061).

6. An integrated C3F8 ophthalmic gas delivery system for treatment of retinal detachment (PMA, Original, P220030).

7. A blood-based colorectal cancer screening test (PMA, Original, P230009).

8. A total of 251 devices were cleared through the 510(k) process during July 2024. Days to FDA decision ranged from 17 to 1073 days with a median of 115 days. Top 5 medical specialties were General & Plastic Surgery (SU), Orthopedic (OR), Radiology (RA), Dental (DE), and Gastroenterology & Urology (GU) accounting for 62% (155/251) of devices cleared.

FDA warning letters

1. Jiangsu Shenli Medical Production Co., Ltd.: Failure to establish and maintain design control procedure, and device master records

2. Jiangsu Caina Medical Co., Ltd: Quality data not used in CAPA, no investigations, failure to conduct adequate design validation and risk analysis.

3. Globus Medical, Inc.: Failure to analyze quality data for CAPA, complaints handling and MDR reporting issues.

4. Criticare Technologies, Inc.: Inadequate procedures for design controls, risk analysis, CAPA, purchasing controls, non-conforming product

Class I recall announcements

1. Philips North America LLC: correction of use instructions for RF coils used in MR scanners for risk of thermal injury due to overheating.

2. Inspire Medical Systems, Inc.: removal of an implantable pulse generator used to stimulate the hypoglossal nerve for treatment of sleep apnea.

3. Hamilton Medical: correction of software issues that may cause the ventilator failure to restart.

4. Megadyne: Soft pediatric return electrode pads for risk of serious burn injuries.

5. Baxter: Ventilator system due to insufficient charging or loss of charge due to battery dongle failure.

6. Bausch + Lomb/Synergetics Inc.: I-Pack ocular injection kits due to potential non-sterility.

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 July 2024. See footnotes for links to additional information.

A. De-Novos

1. DEN240007: BioHealx Anal Fistula Device¹
   The BioHealx device is a single synthetic, absorbable implant in the shape of a helical coil used to repair and close fistula-in-ano, generally caused by an infection in the anal area.

   Product Code QML, Class II, Regulation 21 CFR 878.4835

2. DEN240013: GT Metabolic MagDI System²
   This novel device uses magnetic compression to create a side-to-side duodeno-ileal anastomoses (SADI) in minimally invasive and laparoscopic surgery. Two magnets are placed in an incisionless procedure at target locations in the upper part of the small intestine to create a slowly forming anastomoses. The magnets are cleared through the GI tract once the anastomoses is formed with sufficient strength.
   Product Code SAH, Class II, Regulation 21 CFR 878.4816

3. DEN220042: Terragene Bionova Photon Biological Indicator³
   This device is a self-contained biological indicator (SCBI) intended for routine monitoring of the efficacy of steam sterilization process.
   Product Code QVB, Class II, Regulation 21 CFR 880.2806

4. DEN230092: Simplexa C. auris Direct Assay⁴
   This device is a RT-PCR based assay intended for use with the LIAISON MDX instrument for detecting C. auris colonization, a fungal infection that can be transmitted in a healthcare setting and can cause serious illness.
   Product Code SBT, Class II, Regulation 21 CFR 866.3967

5. DEN230061: Allay Nerve Cap⁵
   This device is uses a hydrogel as a physical barrier to create a separation between the peripheral nerve end and the surrounding environment to reduce the risk of symptomatic neuroma, a condition that can occur after trauma or amputation.
   Product Code SBG, Class II, Regulation 21 CFR 882.5260

B. Premarket Approvals (PMA) - Original only

1. P220030: UNIPURE C3F8 Ophthalmic Gas and Delivery System⁶

The UNIPURE C3F8 Ophthalmic Gas is used in the UNIFEYE Gas Delivery System for intraocular injection into the eye to treat uncomplicated retinal detachments. This approval also includes the use of C3F8 in the UNIPEXY Gas Delivery System.

Figure 1: UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System. Source: Summary of Safety and Effectiveness Data on fda.gov.

C3F8 is a colorless, odorless, non-toxic and non-flammable gas under room conditions. In the integrated gas delivery system, it is used in a non-sterile, undiluted liquified state.

According to the Summary of Safety and Effectiveness Data (SSED)⁷, a systematic review of clinical literature was used to establish reasonable assurance of safety and effectiveness:

The overall primary retinal reattachment rate reported 3-months, or later, postoperatively in the analyzed studies was 81.9% (95% CI: 76.4%, 86.3%), which exceeds the prespecified threshold of 72%.

Analysis of clinical literature also showed tolerable side-effects profile with an acceptable rate of adverse events.

FDA approved the PMA on July 2, 2024.

2. P230009: Blood Based Qualitative Colorectal Cancer Screening Test (Shield) ⁸

The Shield test is used for the qualitative detection of colorectal cancer in cell-free DNA from blood using the Guardant Shield Blood Collection Kit. It is intended for use in individuals 45 years or older at average risk of disease, and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.

The Shield test system comprises the following subsystems:

1. Shield blood collection kit

2. Shield assay

3. Instrumentation

4. Software

Figure 2: The Shield CRC screening test. Source: Guardant.com

According to the Summary of Safety and Effectiveness Data (SSED)⁹:

The pivotal clinical study established Shield sensitivity for CRC of 83.1% (95% CI 72.2% to 90.3%), and a specificity for AN of 89.6% (95% CI 88.8% to 90.3%) in average risk population for colorectal cancer.

Based on these results, FDA approved the PMA on July 26, 2024.

C. Premarket Notifications (510k)

FDA cleared a total of 251 devices through the premarket notification process during July 2024. A majority of these devices (78%) were cleared through the Traditional 510k process.

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

Figure 3: Overview of 510k clearances in July 2024.

Here are the key highlights:

• Top 5 medical specialties accounted for 62% of the total 510k (155/251) with median days to decision ranging from 76 to 132 days after receipt.

• General & Plastic Surgery medical specialty had the highest number of 510k (39/251) with 132 median days to decision after receipt. Top 5 product codes were in the Radiology, General & Plastic Surgery, Orthopedic and Gastroenterology & Urology medical specialties.

• LLZ was the top product code corresponding to an image processing system in the Radiology category with 6 510ks.

• In aggregate, days to decision ranged from a minimum of 17 days to a maximum of 1073 days after receipt, with a median of 115 days. 20th percentile of the devices were cleared within 51 days, while the 80th percentile were cleared within 219 days.

• A bone void filler was cleared just 17 days after receipt (K242050, PRO Code: MQV).

• It took 1073 days for wound dressing to receive 510k clearance (K212521, PRO Code: FRO).

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II. FDA Warning Letters

FDA issued 4 warning letters to medical device manufacturers during the month of July 2024.

1. CMS 687035, Jiangsu Shenli Medical Production Co., Ltd.¹⁰

   1. Devices impacted: Non-sterile syringes (private label).

   2. Observations cited:

      1. No design control procedures.

      2. Failure to establish and maintain device master records.

2. CMS 687033, Jiangsu Caina Medical Co., Ltd¹¹

   1. Devices impacted: Sterile luer lock syringes without needles and sterile enteral syringes.

   2. Observations cited:

      1. Quality data not analyzed to identify existing and potential causes of nonconformities in CAPA, no CAPA investigation.

      2. Failure to establish and maintain procedures for design validation and risk analysis

3. CMS 685606, Globus Medical, Inc.¹²

   1. Devices impacted: Surgical robotic system

   2. Observations cited:

      1. Quality data not analyzed using appropriate statistical techniques for CAPA.

      2. Failure to review, evaluate and investigate complaints.

      3. MDR reporting issues.

4. CMS 686915, Criticare Technologies, Inc.¹³

   1. Devices impacted: Patient monitors

   2. Observations cited:

      1. Inadequate CAPA procedure - not enough details to identify quality issues, conduct investigations and taking actions. Repeat deficiency from a 2017 warning letter.

      2. Inadequate design control procedures, including risk analysis.

      3. Inadequate purchasing controls, non-conforming procedures

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III. Medical Device Recalls

In the month of July 2024, FDA published 6 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. Philips North America LLC: RF coils correction¹⁴

   1. Device use: the SENSE XL Torso (1.5T and 3.0T) Coils are used for imaging of torso and abdomen with 1.5T or 3.0T MR scanners.

   2. Reasons for recall: overheating of coils during MRI scan.

   3. Patient safety impact: patients may experience thermal injury including serious burns and death. There have been 12 reported injuries but no deaths.

2. Inspire Medical Systems, Inc.: Implantable nerve stimulator¹⁵

   1. Device use: Inspire IV Implantable Pulse Generator (IPG) is used for electrical stimulation of the hypoglossal nerve for treatment of sleep apnea.

   2. Reasons for recall: a manufacturing defect leading to electrical leakage in the sensing circuit resulting in malfunction.

   3. Patient safety impact: under or loss of stimulation due to battery depletion, pain, shock or death. There have been no reports of injuries or death.

3. Hamilton Medical: Hamilton-C6 medical ventilators¹⁶

   1. Device use: these ventilators are used to provide breathing support for pediatric and adult patients.

   2. Reasons for recall: software issues may cause ventilator to restart if it enters fail mode.

   3. Patient safety impact: most vulnerable patients may experience slow, shallow breathing, stopped breathing, low blood oxygen, slow heart rate, CO2 build-up, increased intracranial pressure and death. There have 1 reported injury and no deaths related to this issue.

4. Megadyne: Soft pediatric patient return electrodes¹⁷

   1. Device use: Megadyne soft patient return electrodes are used as return electrodes during electrosurgery.

   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 15 reported injuries but no reports of death related to this issue.

5. Baxter: Life2000 ventilators¹⁸

   1. Device use: these devices are used to provide continuous or intermittent breathing support.

   2. Reasons for recall: a potential failure of the battery charging dongle can prevent the system from charging or only allow for intermittent charging.

   3. Patient safety impact: loss or interruption in breathing support can cause hyperventilation, hypoxemia, hypercarbia, respiratory failure and death. There is a report of 1 injury and no deaths related to this issue.

6. Bausch + Lomb/Synergetics Inc.: I-Pack injection kits¹⁹

   1. Device use: I-Pack injection kit is used to deliver medication into the eye.

   2. Reasons for recall: unable to verify sterility of injection kits.

   3. Patient safety impact: use of potentially non-sterile kits can cause serious eye infections, vision loss or organ loss and death. There have been no reports of injury or death due to this issue.

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1. FDA: DEN240007 De Novo database entry.

2. FDA: DEN240013 De Novo database entry.

3. FDA: DEN220042 De Novo database entry.

4. FDA: DEN230092 De Novo database entry.

5. FDA: DEN230061 De Novo database entry.

6. FDA: P22030 LUNIPURE C3F8 Ophthalmic Gas and Delivery System PMA database entry.

7. FDA: P220030 Summary of Safety and Effectiveness Data.

8. FDA: P230009 Blood based colorectal cancer screening test PMA database entry.

9. FDA: P230009 Summary of Safety and Effectiveness Data.

10. FDA: Jiangsu Shenli Medical Production Co., Ltd. Warning Letter.

11. FDA: Jiangsu Caina Medical Co., Ltd Warning Letter.

12. FDA: Globus Medical, Warning Letter.

13. FDA: Criticare Technologies, Inc. Warning Letter.

14. FDA: Philips RF coil recall announcement.

15. FDA: Inspire Medical recall announcement.

16. FDA: Hamilton Medical recall announcement.

17. FDA: Megadyne recall announcement.

18. FDA: Baxter recall announcement.

19. FDA: Bausch + Lomb Medical recall announcement.