Medical Device News Update - March, 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.

I. Innovation

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

A. De-Novos

1. DEN220039: Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set)¹
   A lateral flow immunofluorescent sandwich assay intended to be used as an aid in the diagnosis of COVID-19 by qualitative detection of the SARS-CoV-2 N-protein antigen in samples collected from symptomatic individuals when tested at least twice over three days with at least 48h between tests.
   Product Code QVF, Regulation 21 CFR 866.3982

2. DEN220030: RemeOs(TM) Screw LAG Solid²
   An absorbable implant intended for use in traumatic and orthopedic surgery for the fixation of bone fractures and for the correction of deformities and misalignment. It serves as temporary fixation and stabilization by osteosynthesis of bone fractures and osteotomies until bony fusion has occurred.
   Product Code QJD, Regulation 21 CFR 888.3041

3. DEN210039: SNOO Smart Sleeper³
   This device is intended to help infants sleep in a supine position who are not yet able to consistently roll over on their own.
   Product Code QTG, Regulation 21 CFR 880.5690

4. DEN210033: Lenire(R) Tinnitus Treatment Using Bimodal Neuromodulation⁴
   This device applies sound and electrical stimulation of the tongue to reduce symptoms of tinnitus. Tinnitus is a perception of sound when there is no external source. It is intended to be used in patients 18 years of age or older suffering from at least moderate tinnitus as defined by the Tinnitus Handicap Inventory.
   Product Code QVN, Regulation 21 CFR 8874.3410

B. Premarket Approvals (PMA) - Original only

1. P120003: iCast(TM) Covered Stent System⁵

Source: iCast (TM) Stent System Summary of Safety and Effectiveness Data

The iCast(TM) stent system consists of a balloon expandable ePTFE covered stainless steel stent and an over-the-wire delivery system. This device is indicated for used to improve luminal diameter in patients with symptomatic atherosclerotic disease⁶ (i.e. plaque build up) of the native common and/or external iliac arteries⁷. This device has been marketed outside the US since 2002 under the name of Advanta V12 PTFE Covered Stent.

A single-arm clinical study provided safety and effectiveness data. The study enrolled 165 patients in the USA and Germany across 25 investigational sites. Data was collected at baseline, and follow up at 30-days, 6 months, 9 months (primary endpoint), 12 months, 24 months and 36 months post-procedure.

Effectiveness was assessed based on a composite primary endpoint of the occurrence of death within 30 days, target site revascularization (TSR) within 9 months, or restenosis at 9 months post-procedure. Based on published literature, an occurrence rate of less than 16.57% for the composite endpoint was defined as the performance goal. The observed rate for the primary endpoint was 8.1% with the upper 95% confidence interval at 13.4%, which satisfied the performance criteria.

Rate of serious adverse events of any type was approximately 27% within 9 months and 52% within 36 months for all enrolled subjects. There were a total of 13 deaths in the intent to treat group of 153 subjects over the study duration, but none within the first 30 days after the procedure. The primary benefits of improvement or restoration of the blood flow in the iliac arteries were maintained in a majority of patients up to 36 months after the procedure.

Overall, the benefit-risk was assessed to be consistent with other similarly approved iliac artery devices.

2. P170029: CACIVIS Imaging System⁸
This combination product is intended to be used by dental healthcare professionals on patients, 6 years and older, with or at risk of developing demineralization associated with caries lesions (e.g. cavities), on accessible coronal tooth surfaces.

Source: CALCIVIS Imaging System Summary of Safety and Effectiveness Data

This device consists of an imaging camera system integrated with an applicator used to apply a photoprotein onto the tooth surface for visualizing the caries lesion. The mechanism of action of the photoprotein renders areas of calcium loss visible using the specialized intraoral camera system, and the luminescence images acquired help with the assessment of demineralization. This device is CE marked and has been marketed in the UK since 2018.

Safety and effectiveness data from a primary clinical study included 111 patients across 4 investigational sites. The study assessed the agreement between the CALCIVIS imaging system and dentist rating from captured images of suitable teeth. Samples included both “no visible lesions - sound” and “active lesions”. Successful performance outcome was based on a statistically significant agreement between the two ratings at 97.5% confidence level compared to chance agreement (50%) for each tooth status population.

Effectiveness was evaluated based on 90 images sound teeth and 86 images of active teeth. A negative percentage agreement of 97.8% was achieved out of the 90 images of sound teeth. The lower bound of the 97.5% confidence interval was 92.2%, which is higher than the study goal of 50%.

A positive agreement of 90.7% was achieved out of the 86 teeth that were considered to be “active”. The lower bound on the 97.5% confidence interval was 82.9%, which is higher than the study goal of 50%.

There were no patient related adverse events reported for the study.

Overall, the benefit-risk for the intended use was assessed to be positive.

3. P200018: NeuRx Diaphragm Pacing System (DPS)⁹

The NeuRX DPS(R) is intended for use in patients with stable, high spinal cord injuries who lack control of their diaphragms but can be stimulated with this device to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day.

Source: NeuRX DPS(R) Summary of Safety and Effectiveness Data

Four intramuscular electrodes are surgically implanted into the patient’s diaphragm using a laparoscopic procedure. These electrodes are connected to an external pulse generator (EPG) that controls the timing and level of diaphragm pacing stimulation.

This device has been previously approved in the USA under the Humanitarian Device Exemption (HDE). It is approved for distribution in Europe, Japan, and several other countries. To date, over 2000 NeuRX DPS(R) devices have been implanted worldwide.

Safety and effectiveness data was generated in a single-arm pivotal clinical study with a total of 196 patients in 3 different cohorts. Based on FDA agreement, a performance goal of at least 45% of patients not requiring mechanical ventilation was established.

96.2% of the 53 subjects in the primary cohort achieved the primary endpoint of not requiring the mechanical ventilation for breathing support. Similarly in the other two cohorts, 89.6% (95 out of 106) and 92.2% (180/196) of subjects achieved the primary endpoint. 50-60% of the subjects were able to breathe for 24 hours without the support of mechanical ventilation.

There were no significant adverse events reported and none of the subjects needed to return to the operating room for device repair.

Overall, the benefit-risk for the intended use was assessed to be positive.

4. P210037: Prospera Spinal Cord Stimulation (SCS) System¹⁰

The Prospera Spinal Cord Stimulation (SCS) System is indicated as an aid in the management of chronic, intractable pain in the trunk and/or limbs, which may include unilateral or bilateral pain, resulting from several injuries.

Source: Prospera SCS System Summary of Safety and Effectiveness Data

A rechargeable pulse generator (IPG) is implanted to provide stimulation to the neural tissue of the spinal cord through two 8-contact lead port connections. A trial stimulator is used during the surgical procedure to perform intraoperative testing. An off-the-shelf tablet is used with a proprietary software as the clinician programmer (CP) to provide stimulation parameters for the pulse generator. The CP can be used in a clinical setting or from a remote location. A patient programmer allows the patient to make system adjustments within clinician programmed limits, and to receive remotely transmitted programs. A charger allows the patient to transcutaneously recharge the IPG battery. A Neuro Service Center provides secure data connectivity between the clinician and patient programmers for enabling the HomeStream Remote Management functionality. Several accessories are also included in this system for different purposes.

Safety and effectiveness data was provided based on a systematic review of a total of 19 published clinical studies that evaluated other commercially available similar SCS systems. Effectiveness was evaluated based on clinically significant reduction in a validated patient-reported assessment of pain, for example, Visual Analog Scale (VAS), Numerical Rating Scale (NRS) and Patient-reported Pain Relief (PRP). The improvement in pain across all conditions/pain locations for the 15/18 studies was clinically significant at success rates of greater than 50%.

Safety was evaluated based on reported rates of complications related to the SCS system in the literature.

Overall, the benefit-risk for the intended use was assessed to be positive.

C. Premarket Notifications (510k)

FDA cleared a total of 322 devices through the premarket notification process during March 2023. A majority of these devices (82%) were cleared through the Traditional 510k process.

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

Here are the key highlights:

• Top 5 medical specialties accounted for 61% of the total 510k (197/322) with median days to decision ranging from 98 to 180 after receipt.

• Orthopedic medical specialty had the highest number of 510k (54/322) with 98 median days to decision after receipt. Top 5 product codes were evenly distributed across the top 5 medical specialties.

• LLZ was the top product code corresponding to radiological image processing systems. Applicants included GE Healthcare, Siemens, Advantis Medical Imaging, Imaging Wave, LLC, Mediso Medical Imaging Systems, Perspectum and Translational MRI, LLC.

• In aggregate, days to decision ranged from a minimum of 2 days to a maximum of 1136 days after receipt, with a median of 167 days. 20th percentile of the devices were cleared within 78 days, while the 80th percentile were cleared within 276 days.

• Smart MTA Capsule, a root canal filling resin from Sprig Oral Health Technologies, Inc., was cleared in just 2 days after receipt (Product Code: KIF, 510k number K230797¹¹)

• A monitor for opioid induced impairment of oxygenation, Masimo SafetyNet from Masimo Corporation was cleared through the de novo process in 1136 days (Product Code: QVT, DEN200011¹²)
  

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II. FDA Warning Letters

In the month of March 2023, FDA published 1 warning letter to a medical device manufacturer.

1. CMS 654013 Olympus Medical Systems Corp.¹³
   Devices impacted: Single-Use Distal Covers for Duodenoscopes and Single-Use Suction Valve Accessories for Bronchoscopes.
   Observations cited: not initiating a CAPA when complaints of distal end covers “dropping out” were above the expected levels; not including reportable complaints as inputs for CAPA decision, releasing non-conforming product with seal defects that could compromise device sterility, inadequate validation or re-validation of the process after making changes, inadequate investigation of complaints, inadequate MDR reporting procedure.

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III. Medical Device Recalls

In the month of March 2023, FDA published 2 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. Datascope/Getinge: Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABB)¹⁴
   Device use: these intra-aortic balloon pumps (IABP) are electromechanical systems used to inflate and deflate intra-aortic balloons. Once the balloon is placed in the aorta, the pump is set to work synchronously with the electrocardiogram or arterial pressure waveform to inflate and deflate the balloon at the right time during the cardiac cycle. The system provides temporary support to the left ventricle through counter pulsation for patients affected by acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure in a healthcare facility.
   Reasons for recall: the coiled cable connecting the display and the base may fail in some units causing an unexpected shutdown.
   Patient safety impact: an unexpected shutdown or interruption to therapy can lead to unstable blood flow, organ damage and/or death, especially in critically ill patients.

2. Datascope/Getinge: Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABB)¹⁵
   Device use: see above. This is a second recall for a different issue summarized below.
   Reasons for recall: potential for unexpected shutdown due to communication loss between the executive printed circuit board assembly (PCBA) and the video generator.
   Patient safety impact: false positive or false negative results may lead to delayed or incorrect therapy.

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1. FDA: DEN220039 Classification Order

2. FDA: DEN220030 Classification Order

3. FDA: DEN210039 Classification Order

4. FDA: DEN210033 Classification Order

5. P120003 iCast Covered Stent System: Summary of Safety and Effectiveness Data

6. Atherosclerosis is a common condition that develops when a sticky substance called plaque builds up in the artery (source: NIH)

7. Iliac arteries: a set of two major blood vessels that carry blood to the lower part of the body, including the pelvis, reproductive organs, and legs (source: NIH)

8. P170029 CALCIVIS Imaging System: Summary of Safety and Effectiveness Data

9. P200018 NeuRX DPS: Summary of Safety and Effectiveness Data

10. P210037 Prospera SCS System: Summary of Safety and Effectiveness Data

11. K230797: SmartMTA Capsule

12. DEN200011: Masimo SafetyNet

13. FDA: Warning Letter CMS 654013

14. FDA: Datascope/Getinge recall announcement

15. FDA: Datascope/Getinge 2nd recall announcement