Medical Device News Update - June 2023

FDA approvals, warning letters and recalls issued during the month of June 2023

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Monthly roundup of FDA approvals, warning letters and recalls issued in June 2023

I. Innovation

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

A. De-Novos

1. DEN220041: Tristel Duo ULT high level disinfectant¹
   Tristel Duo ULT is a high level disinfectant foam for reprocessing endocavity transvaginal and transrectal ultrasound probes, that are first cleaned using a validated cleaning protocol or standard.
   Product Code QWS, Class II, Regulation 21 CFR 880.6886

2. DEN220028: Cue COVID-19 molecular test²
   Cue COVID-19 molecular test is a nucleic acid amplification assay used with the Cue monitoring system (Cue cartridge reader) for rapid, qualitative detection of SARS-CoV-2 nucleic acid in anterior nasal swab samples collected from symptomatic individuals. This test was previously authorized through the Emergency Use Authorization pathway.
   Product Code QWB, Class II, Regulation 21 CFR 866.3984

3. DEN220078: Eroxon non-medicated topical formulation for ED³
   Eroxon is an over-the-counter, non-medicated topical formulation for treatment of erectile dysfunction that works by stimulating the nerve endings by inducing a temperature change.
   Product Code QWW, Class II, Regulation 21 CFR 876.5021

4. DEN220048: Neoasis active noise attenuation system for infant incubators ⁴
   The Neoasis(R) device reduces noise levels inside an infant incubator in the neonatal intensive care unit (NICU) in the noise frequency range of 250 Hz to 1,000 Hz.
   Product Code QWX, Class II, Regulation 21 CFR 880.5405

5. DEN200052: KidneyIntelX.dkd(TM) test for managing type-2 diabetes⁵
   This is an artificial intelligence enabled prognostic testing platform to guide care management for adults with type 2 diabetes and early stage chronic diabetic kidney disease. It combines blood based biomarkers with clinical variables using AI to provide actionable information in guiding care in large, at-risk patient populations.
   Product Code QWZ, Class II

B. Premarket Approvals (PMA) - Original only

1. P220024: LIQUIFIX hernia mesh fixation device⁶
This device is used for fixation of a polypropylene or polyester mesh to the abdominal wall during laparoscopic surgical repair of groin hernias. A clinical study has been completed but no results are posted for public review. A post-approval study is currently in progress. Product Code: PLJ.

2. P220021: DETOUR(TM) stent graft, superficial femoral artery bypass system ⁷
The DETORU(TM system from Endologix is comprised of the ENDOCROSS(TM) device and the TORUS stent graft system to create a percutaneous transmural bypass in the femoral artery to restore blood flow to the legs. It is indicated in patients with symptomatic femoropopliteal lesions from 200mm to 460 mm in length with chronic total occlusions (110mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments.

Figure 1: DETOUR(TM) system. Photo Source: Endologix

In a clinical trial with 220 patients across 36 investigational sites, primary effectiveness endpoint of patency at 12 months post procedure was evaluated. Patency is defined as absence of CD-TLR (clinically driven target lesion revascularization) and absence of recurrent target lesion diameter stenosis > 50% by imaging. 128 of the 188 (68.1%) evaluable patients at 12-month time point achieved the primary endpoint. 60/200 patients had patency failure. The lower 97.5% exact confidence limit of 60.9% exceeded the prespecified 60.4% threshold for null hypothesis.

The frequency and type of most adverse events were judged to be consistent with those expected in the studied patient population and therapeutic area.

3. P220002: TOPS(TM) prosthesis, posterior spine elements system⁸
TOPS(TM) system is intended to stabilize the spine following a lumbar decompression without rigid fixation/fusion. It is an alternative to spinal fusion surgery for patients with moderate to severe lumbar spinal stenosis, degenerative spondylolisthesis and related spinal conditions.

A post-market study is currently in progress.

4. BP220799: RECELL(R) autologous cell harvesting device⁹
The RECELL(R) device is intended for use at point of care for treatment of small and large thermal wounds using a patient’s own regenerative cells. A clinical study showed that it requires significantly less donor skin and promotes faster healing with lower pain level¹⁰.

5. P210025: SurVeil drug coated balloon¹¹
This is a combination product for treatment of peripheral artery disease (PAD) which includes a drug formulation applied on a catheter with an improved process for more uniform coating.

6. P200007: HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads¹²
These disposable, single-use pads are indicated for use with compatible automatic external defibrillator (AED) models on patients over 8 years of age or greater than 55 pounds. These pads are intended for short-term use only.

7. P190033: AAV5 DetectCDx for detection of antibodies to adeno-associated virus¹³
This is a companion diagnostic assay for qualitative detection of total antibodies in human plasma that bind to the adeno-associated virus serotype 5 (AAV5). This assay is indicated as an aid in the selection of adult hemophilia A patients that are anti-AAV5 antibody negative who may be eligible for ROCTAVIAN, a gene-therapy based treatment.

8. P210002: Therascreen(R) PDGFRA RGQ PCR kit¹⁴
This is a real-time qualitative in-vitro assay for the detection of D842V somatic mutation in the PDGFRA gene, used as a companion diagnostic test to aid clinicians in identification of patients with gastrointestinal stromal tumor (GIST) who may be eligible for treatment with AYVAKIT(TM).

9. P220029: Optilume™ BPH Catheter System¹⁵
This is a combination product indicated for the treatment of obstructive urinary symptoms associated with benign prostatic hyperplasia (BPH) in men over 50 years of age. It combines mechanical dilation for immediate symptomatic relief with local drug delivery to maintain urethral patency. See manufacturer’s website¹⁶ for results of a 3-year durability study.

C. Premarket Notifications (510k)

FDA cleared a total of 305 devices through the premarket notification process during June 2023. A majority of these devices (83%) were cleared through the Traditional 510k process.

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

Figure 2: 510(k) summary statistics for June 2023

Here are the key highlights:

• Top 5 medical specialties accounted for 55% of the total 510k (169/305) with median days to decision ranging from 76 to 195 after receipt.

• Orthopedic medical specialty had the highest number of 510k (342/169) with 76 median days to decision after receipt. Top 5 product codes were in the dental, radiology, general and plastics surgery, GI/urology and neurology specialties.

• DZE was the top product code corresponding to endosseous, root form dental implant with 7 501ks.

• In aggregate, days to decision ranged from a minimum of 1 day to a maximum of 1139 days after receipt, with a median of 129 days. 20th percentile of the devices were cleared within 61 days, while the 80th percentile were cleared within 268 days.

• A-Line advanced, an orthodontic ceramic bracket was cleared in just 1 day after receipt (Product Code: NJM, 510k number K231635)

• Tisuthes e-PTFE surgical patch, a surgical mesh for facial implants using plastic surgery was cleared in 1139 days (Product Code: OWR, 510k number K201153)
  

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II. FDA Warning Letters

There was only 1 device related warning letter issued during the month of June 2023.

1. CMS 653455 Vitang Technology LLC¹⁷

   Devices impacted: UniSmile Clear Aligner
   Observations cited: use of unauthorized software iRokOrthoRx 4.0 instead of the originally cleared Orchestrate 3D (K181112) software and not submitting a new 510K for the UniSmile Clear Aligners. Quality system regulation violations related to complaints handling, software validation, purchased product verification, monitoring and control of process parameters, equipment calibration, device history records, management reviews, training.

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III. Medical Device Recalls

In the month of June 2023, FDA published 3 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. Abiomed: Impella 5.5 with SmartAssist¹⁸
   Device use: The Impella 5.5 with SmartAssist system is used to support patients with pumping of the heart chambers (ventricles) for up to 14 days, when there is ongoing cardiogenic shock that occurs less than 48 hours after a severe heart attack, open heart surgery or in cardiomyopathy.
   Reasons for recall: leakage of purge fluid from purge sidearm of the pump.
   Patient safety impact: fluid leak, if not resolved, may result in persistent low purge pressure and purge flow that may lead to pump failure and loss of therapy. Patients may experience further deterioration or worsening of their condition leading to serious injury or death. 179 complaints and three injuries have been reported.

2. BearCare, Inc.: Rechargeable wearable smart thermometer¹⁹
   Device use: This is a reusable thermometer paired with an application on a mobile phone, intended for home use to continuously monitor body temperature of infants and children 0 to 6 years old.
   Reasons for recall: leakage of battery chemicals
   Patient safety impact: exposure to corrosive chemicals could cause skin irritation, burns, other serious injuries or death. 5 complaints have been reported.

3. Teleflex and Arrow International: Arrow endurance extended dwell peripheral catheter system²⁰
   Device use: this catheter system allows healthcare providers to access a patient’s peripheral vascular system for short term use, to sample blood, monitor blood pressure, or administer fluids, blood and blood products.
   Reasons for recall: catheter separation or leakage.
   Patient safety impact: if the separation or leakage occurs while in a blood vessel, catheter fragments could be left in the blood stream and migrate to other parts of the body. This issue may cause serious injury, including blockage of blood vessels, inadequate blood flow, injury to blood vessels, blood clots, blockage of lung arteries, heart attack or death. 83 complaints and 18 related injuries have been reported.

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1. FDA: DEN220041 Reclassification Order

2. FDA: DEN220028 Reclassification Order

3. FDA: DEN220083 Reclassification Order

4. FDA: DEN220048 Reclassification Order

5. Renalytix website announcement

6. P220024 LIQUIFIX hernia mesh fixation device: PMA database entry

7. P220021 DETOUR(TM) system: Summary of safety and effectiveness data

8. P220002 TOPS(TM) system: PMA database entry

9. BP220799 RECELL(R) autologous cell harvesting device: PMA database entry

10. RECELL clinical data summary on manufacturer’s website

11. P210025 SurVeil drug coated balloon: PMA database entry

12. P200007 HeartSync single use AED pads: PMA database entry

13. P190033 AAV5 DetectCDx: PMA database entry

14. P210002 Therascreen PCR kit: PMA database entry

15. P220029 Otihume(R) BPH catheter system: PMA database entry

16. Optilume clinical data at Laborie website

17. FDA: Vitang Technology warning letter

18. FDA: Abiomed Impella 5.5 with SmartAssist recall announcement

19. FDA: BearCare rechargeable wearable smart thermometer recall announcement

20. FDA: Teleflex and Arrow International recall announcement