Medical Device News Update - February, 2023

FDA approvals, warning letters and recalls

Dear colleagues - at the end of each month, I will share with you a summary of FDA approvals, warning letters and recalls from the prior month. My goal is to help you stay on top of these important developments in our industry without having to spend too much time searching for information across multiple sources.

Let me know in your comments below if you find this information useful.

Innovation

Here is a summary of De-Novo decisions, PMA approvals and 510(k) clearances in the month of February 2023. See footnotes for links to additional information.

De-Novos

1. DEN220014: RefleXion Medical Radiotherapy System (RMRS)¹
   This innovative device is indicated for treatment planning and precise delivery of image-guided radiation therapy, while minimizing the exposure to healthy tissue.
   Product Code QVA, Regulation 21 CFR 892.5060

2. DEN220044: Active Anthrax Detect Plus Rapid Test²
   This innovative point-of-care rapid diagnostic test provides visual and rapid qualitative detection of lethal factor of B. anthracis as an aid to diagnosis of inhalation anthrax.
   Product Code QUU, Regulation 21 CFR 866.3046

3. DEN210022: PMD-200³
   PMD-200 with Nociception Level (NOL) Index is used in a clinical setting that requires assessment of changes in nociception levels in adult patients under general anesthesia receiving opioid or opioid-sparring analgesia as part of their care. NOL index provides an objective way to quantify a patient’s physiological pain response (nociception), enabling the clinical team to personalize the pain treatment.
   Product Code QVE, Regulation 21 CFR 868.2200

4. DEN220065: Pill Sense System⁴
   The PillSense System is used for the detection of blood in the upper gastrointestinal tract using a single-use ingestible capsule and a reusable receiver.
   Product Code QUD, Regulation 21 CFR 876.1390

5. DEN220063: Caption Interpretation Automated Ejection Fraction Software⁵
   This innovative software is used to process previously acquired cardiac ultrasound images using artificial intelligence/machine learning (AI/ML) to help the clinicians in a cardiac evaluation.
   Product Code QVD, Regulation 21 CFR 892.2055

Premarket Approvals (PMA) - Original only

P220009: StableVisc(TM ) and TotalVisc(TM) Ophthalmic Viscosurgical Device⁶

This Class III medical device is a transparent viscous liquid used during intraocular surgery when a cataract has to be surgically removed and replaced with a synthetic intraocular lens (IOL). This thick, viscous liquid helps to maintain the space for IOL implantation and prevents damage to the ocular tissue.

There are many others different types of ophthalmic viscosurgical devices (OVDs) available in the market. This specific OVD performed similar to other similar already approved alternatives. As an example, endothelial cell loss after 3 months was 17.5 for every 100 cells compared to 16.9 for every 100 cells for the already approved device⁷.

Premarket Notifications (510k)

FDA cleared a total of 256 devices through the premarket notification process. A majority of these devices (82%) were cleared through the Traditional 510k process.

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

Here are a few key highlights:

• Top 5 medical specialties accounted for 63% of the total 510k (162/256) with median days to decision ranging from 126 to 207 after receipt.

• Radiology had the highest number of 510k (43/256) with 128 median days to decision after receipt. 3 of the top 5 Product Codes belong to the Radiology medical specialty (IYN, LLZ, LNH). These are imaging systems using ultrasound, radiological or nuclear magnetic resonance.

• Top applicants in the Radiology category were Elekta Solutions, Siemens Healthcare and GE Medical.

• In aggregate, days to decision ranged from a minimum of 6 days to a maximum of 832 days after receipt, with a median of 143 days. 20th percentile of the devices were cleared within 63 days, while the 80th percentile were cleared within 270 days.

• 3M VitCal Liner/Base, a dental restoration product was cleared in just 6 days after receipt (K230270⁸)

• An insulin syringe with integrated needle from DLP Medical Products, Corp was cleared in over 800 days after receipt (K203211⁹)
  

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FDA Warning Letters

In the month of February 2023, FDA published 3 warning letters.

1. CMS 643188 MicroVention Costa Rica S.R.L.¹⁰
   Devices impacted: microcatheters and balloon catheters used in intravascular procedures such as infusion of diagnostic/therapeutic devices, infusion of diagnostic agents, vascular occlusion and embolization.
   Observations cited: issues related to process validation especially for safety-related outcomes, software validation, not initiating supplier CAPAs for non-conformances, missing quality data inputs in the CAPA determination process, not investigating root causes of certain non-conformances.

2. CMS 640048 Wintech Medipro LLC¹¹
   Devices impacted: medical and surgical face masks
   Observations cited: distributing surgical masks in the USA without marketing authorization. Observations cited in most major areas of the Quality System such as MDR procedures, complaints handling procedures, design controls, validation, CAPA, nonconformance, acceptance activities and quality audits.

3. CMS 644680 Getsch+Hiller Medizintechnik GmbH¹²
   Devices impacted: Monopolar laparoscopic instruments with disposable and reusable instrument tips
   Observations cited: no design history file, not completing acceptance of incoming materials, not seeking pre-market approval after significant changes or modifications to the device.

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Medical Device Recalls

In the month of February 2023, FDA published 4 announcements related to
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. Smith Medical: CADD system administration sets and cassette reservoirs¹³
   Device use: these are infusion systems used to deliver controlled amount of medications to patients. CADD system administration sets and cassette reservoirs are disposable and intended for use with CADD infusion pumps.
   Reasons for recall: tubing occlusion prevents delivery or causes under-delivery of medication; and a false “no disposable attached (NDA)” alarm prevents pump use.
   Patient safety impact: delay or interruption in therapy, under-delivery of medication have the potential to cause serious patient harm or death.

2. Universal Meditech Inc.: SARS-CoV-2 rapid antigen test kits¹⁴
   Device use: these rapid antigen test kits are used for detection of SARS-CoV-2 virus which causes COVID-19.
   Reasons for recall: test kits were distributed in the US market without authorization, clearance or approval by the FDA.
   Patient safety impact: false positive or false negative results may lead to delayed or incorrect therapy.

3. GE Healthcare: Nuclear medicine 600/800 series systems¹⁵
   Device use: these imaging systems are used to detect or diagnose issues such as cardiovascular disease, neurological disorders and cancer.
   Reasons for recall: risk of a heavy (>1000 lbs) detector falling on a patient due to potential failure of a ball screw that serves as a design mitigation to prevent the detector from falling.
   Patient safety impact: heavy detector can crush or trap a patient resulting in serious injury or death.

4. Philips Respironics: reworked Trilogy 100/200 and Garbin ventilators¹⁶
   Device use: these ventilators are used to provide breathing support to both adult and pediatric patients, generally in critical care.
   Reasons for recall: these ventilators have a silicone sound abatement foam installed to replace the PE-PUR foam, but it may separate from the plastic backing due to adhesive failure, blocking the airway path. In some of the reworked ventilators, residual PE-PUR foam was found that is hazardous to patients.
   Patient safety impact: blockage of airway path reduces available oxygen which may cause difficulty in breathing, asphyxia, hypoventilation or hypoxemia. These are life-threatening conditions. Exposure to residual PE-PUR foam may cause serious injury, permanent impairment and additional medical intervention.

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1. FDA: DEN220014 Classification Order

2. FDA: DEN220044 Classification Order

3. FDA: DEN210022 Classification Order

4. FDA: DEN220065 Classification Order

5. FDA: DEN220063 Classification Order

6. FDA: P220009 Approval Order

7. FDA: Summary of Safety and Effectiveness Data for P220009

8. FDA: K230270 510k Summary

9. FDA: K203211 510k Summary

10. FDA: Warning Letter CMS 643188

11. FDA: Warning Letter CMS 640048

12. FDA: Warning Letter CMS 644680

13. FDA: Smith Medical recall announcement

14. FDA: Universal Meditech recall announcement

15. FDA: GE Healthcare recall announcement

16. FDA: Philips Respironics recall announcement