Medical Device News Update - April, 2023

FDA approvals, warning letters and recalls

May 31, 2023

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 April 2023. See footnotes for links to additional information.

A. De-Novos

DEN210055: N-SWEAT Patch - Skin patch for treatment of hyperhidrosis1
A prescription topical patch that utilizes a chemical reaction to generate thermal therapy in situ for treatment of hyperhidrosis. Hyperhidrosis is excessive sweating that is not always related to heat or exercise. It can be a sign of a serious condition, which may require surgical intervention.
Product Code QVX, Class II, Regulation 21 CFR 878.4425
DEN220033: MISHA(TM) knee system2
A medical knee “shock absorber” implanted outside of the knee capsule to reduce loads on the joint surface and to alleviate the symptoms of osteoarthritis. It is intended for patients with medial compartment knee osteoarthritis that have failed to find relief in surgical and/or non-surgical treatments and are still experiencing pain that interferes with daily activities. They are unwilling or unable to undergo total knee replacement.
Product Code QVV, Class II, Regulation 21 CFR 888.3610
DEN220059: NTX100 tonic motor activation system3
This device is intended to reduce symptoms of primary moderate to severe restless leg syndrome and to improve sleep quality in adults refractory to medications. It is an external lower extremity nerve simulator that uses external electrical stimulators and subcutaneous electrodes. Restless leg syndrome is a condition that causes an uncontrollable urge to move the legs because of an uncomfortable sensation. It received a breakthrough device designation in 2020.
Product Code QWD, Class II, Regulation 21 CFR 882.5887
DEN220082: Bateman(TM) bottle breast implant suction retrieval system4
This is a single-patient, single use suction device used to assist in the removal of one intracapsular ruptured breast implant. It uses vacuum to assist the removal and containment of a ruptured silicone breast implant. It is not intended to remove residual silicone or be applied directly to the tissue.
Product Code QVS, Class II, Regulation 21 CFR 878.4675

B. Premarket Approvals (PMA) - Original only

1. P220020: Lava(TM) liquid embolic system (Lava LES) and Lava mixing kit5

The Lava(TM) Liquid Embolic System (Lava LES) is used for embolization of arterial hemorrhage in the peripheral vasculature6. This system consists of the Lava LES kit and the Lava mixing kit.

Figure 1: LAVA(TM) LES 6 mL kit and Lava Mixing Kit (Source: FDA)

The embolic agent is an injectable, non-adhesive liquid comprising a mixture of ethylene vinyl alcohol copolymer dissolved in dimethyl sulfoxide (DMSO) and suspended micronized tantalum powder to provide contrast for visualization under fluoroscopy. It is first mixed using the Lava mixing kit and then delivered to the target anatomy via a DMSO compatible microcatheter.

A multicenter, prospective, single arm trial of 113 patients at 19 investigational sites provided safety and effectiveness data. Primary endpoint for clinical success was defined as absence of bleeding in the treated target lesion after embolization without the need for intervention through 30 days after the procedure. Safety was evaluated by assessing major adverse events (MAE) in 30 days using a composite endpoint that included complications at the catheter incision site, along the pathway for access to target arteries and the site of treatment. Non-target arterial beds where embolic agent is inadvertently administered were also included.

101 of the 113 subjects were available for evaluation at 30-days follow up. None had any MAE but there were other procedure-related secondary adverse events including 8 deaths. Overall, the primary safety endpoint was met in these patients.

The primary effectiveness endpoint was achieved in 94.3% of lesions (133 out of 141 lesions in 113 evaluable patients).

Benefit-risk was considered to be favorable as arterial hemorrhage is a life-threatening condition clinical study data demonstrated effectiveness without any additional risks or serious complications.

2. P220007: Precision 7(TM) series extended wear soft contact lenses7
Precision 7 (TM) series of soft contact lenses for extended wear includes spherical, toric, multifocal and multifocal toric lenses based on the serafilcon A formulation. The serafilcon A material is a mixture of silicone-based copolymers, a hydrophilic monomer and a cross-linker. It also contains a blue dye and UV blocking monomers.

Figure 2: Precision 7 (TM) (serafilcon A) contact lens (Source: FDA)

These soft contact lenses are prescribed for extended wear up to 6 continuous nights with removal for disposal, or cleaning and disinfection prior to reinsertion.

A prospective, multi-center, parallel-group, randomized, double-blinded primary clinical study was conducted with 608 patients (1216 eyes). A total of 581 patients were dispensed the study lenses during the clinical trial.

The primary safety endpoint was based on the difference in proportion of ocular serious and non-serious adverse events between the serafilcon A (study) and comfilcon A (control) lenses. The primary effectiveness endpoint was high contrast distance visual acuity (VA) with study lenses. VA was converted to the log10 of the minimum angle of resolution (LogMAR).

Ulcerative keratitis (serious adverse event) was seen in 3 patients in the control group with Comfilcon A lenses. Significant non-serious adverse events observed included corneal infiltrates, giant papillary conjunctivitis and ulcerative keratitis. Overall statistical analysis supported the primary safety endpoint at the predetermined criteria of 5% difference in proportion of serious adverse events.

Overall, the distribution of VA with study lenses was similar between test and control eyes. LogMAR performance indicated visual comparable outcomes for both types of lenes. Additional supporting information related to effectiveness was collected using an eDiary.

Overall conclusion about benefit-risk was favorable in demonstrating safety and effectiveness.

3. P210011: xT CDx, next generation sequencing oncology panel8

xT-CDx from Tempus Labs is a next generation sequencing lab test to detect genetic mutations in a patient previously diagnosed with solid malignant tumors to evaluate the benefit of a specific personalized treatment of colorectal cancer.

Figure 3: xT-CDx Next Generation Sequcing Oncology Panel (Source:FDA)

This test is designed to detect mutations in 648 genes using DNA isolated from the tumor tissue specimens and DNA isolated from matched normal blood and saliva samples. If the test detects no changes in specific genes, then a personalized treatment plan using 2 specific drugs may be appropriate for these patients.

xT-CDx uses the Illumina NovaSeq 6000 sequencer, a high throughput sequencing system employing sequencing-by-synthesis chemistry.

Effectiveness was demonstrated using non-inferiority statistical testing approach compared to previously approved CDx tests. Risks to safety are similar to other in-vitro diagnostic tests (IVD). Incorrect results and/or incorrect interpretation leads to inappropriate patient management decisions in cancer treatment.

Data from the analytical validation and clinical concordance studies support the reasonable assurance of safety and effectiveness.

C. Premarket Notifications (510k)

FDA cleared a total of 235 devices through the premarket notification process during April 2023. A majority of these devices (77%) 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 64% of the total 510k (151/235) with median days to decision ranging from 97 to 141 after receipt.
Cardiovascular medical specialty had the highest number of 510k (37/235) with 139 median days to decision after receipt. Top 5 product codes were mainly in the radiology, dental and general & plastic surgery specialties.
LLZ was the top product code corresponding to radiological image processing systems.
In aggregate, days to decision ranged from a minimum of 15 days to a maximum of 1211 days after receipt, with a median of 136 days. 20th percentile of the devices were cleared within 56 days, while the 80th percentile were cleared within 271days.
SPOTFIRE RSP positive and negative controls for a clinical microbiology assay, was cleared in just 15 days after receipt (Product Code: PMN, 510k number K2308689)
AUCTION MAX AX-4060 urinalysis system for testing several analytes used in the evaluation of kidney, urinary liver or other metabolic disorders was cleared in 1211 days (510k number K19351410)

II. FDA Warning Letters

There were no device related warning letters issued during the month of April 2023.

III. Medical Device Recalls

In the month of April 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.

Abbott: FreeStyle Libre reader devices11
Device use: FreeStyle Libre glucose monitoring systems are used for continuous monitoring of glucose levels using a wearable sensor and an external reader device.
Reasons for recall: rechargeable lithium-ion batteries used in the reader devices may get extremely hot, spark or catch on fire if not properly stored, charged or used with a manufacturer approved USB cable and power adapter.
Patient safety impact: user is exposed to extreme heat and/or fire which can cause serious injury or death. There have been 88 incidents including at least 7 reports of fire, one injury and no deaths involving this issue.
Philips/Respironics: CPAP, BiPAP machines12
Device use: Philips/Respironics DreamStation devices help people with breathing conditions keep breathing at a regular rhythm. These devices include both continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines.
Reasons for recall: certain reworked devices were assigned incorrect or duplicate serial numbers during initial programming.
Patient safety impact: Incorrect or duplicate serial numbers on machines can cause therapy to be delivered using the wrong prescription or factory default settings. There is no warning or indication to the user that the DreamStation machine is not working as prescribed. Incorrect therapy or therapy failure may lead to severe conditions such as respiratory failure, heart failure, serious injury, and death. Manufacturer has received 43 complaints about this issue. There are currently no reported injuries or deaths.
Fresenius Kabi USA: Ivenix infusion system13
Device use: this infusion system is used in hospitals or other health care facilities to give fluids to patients in precisely controlled amounts and rates. The system delivers blood or blood products, drugs, and other fluid mixtures through blood vessels, the back/spine (epidural), or beneath the skin (subcutaneous) in large volume applications.
Reasons for recall: leak in the system allows fluid to access the electronic circuitry, which may damage the electrical system leading to loss of power and failure of the system’s ID sensor. It can delay or interrupt treatments.
Patient safety impact: interruption, delay or under-infusion of life-critical fluids may cause serious injury or death to patients. Manufacturer has received 14 complaints related to this issue. There are currently no reported injuries or deaths.