The Revi™ System is an implanted tibial electrical urinary continence device that wirelessly receives power from a non-implanted external wearable unit to provide electrical stimulation of the tibial nerve in proximity to the ankle. The device is intended for the treatment of urge urinary incontinence, alone or in combination with urinary urgency. The implantable device is implanted in the vicinity of the tibial neurovascular bundle. The treatment effect of the system is achieved by the implantable wireless neurostimulation component, which sends pulses to the tibial nerve when energized by the wearable unit transmitted power. The electrical pulses stimulate the nerve along the leg, reaching the sacral plexus and entering the spinal cord. This stimulation has the power to modulate nerve function, relieving symptoms.

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding the Revi™ System, a medical device for treating urgency incontinence. It outlines the FDA's determination of substantial equivalence to a predicate device and includes a 510(k) summary with device specifications and a discussion of performance testing.

However, the document does not contain the detailed information required to answer your specific questions concerning acceptance criteria, device performance, sample size, ground truth establishment, expert qualifications, or MRMC studies. The "Discussion of the Performance Testing" section is very brief and only mentions non-clinical benchtop testing for verification, not clinical studies with human participants that would generate performance metrics against specific acceptance criteria.

Therefore, I cannot populate the requested table or answer most of your questions based solely on the provided text. The document refers to "verification testing to ensure identical specification to predicate," which implies that the acceptance criteria for this 510(k) may have been tied to demonstrating that the new device (v4.3 software) performs comparably to the predicate device (v4.1.2.5 software) in bench tests.

Here's what I can extract, recognizing the limitations:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Specific Acceptance Criteria (Not explicitly stated, inferred from verification testing)	Reported Device Performance (Summary)
Stimulation Frequency Control	Compliance with range and accuracy specifications.	Verified to comply with specifications.
Charging Mode Protection	Protection operates in compliance with specifications.	Verified to comply with specifications.
System Performance	Compliance with technical specifications.	Verified to comply with technical specifications.
Software Verification	Requirements met, including cybersecurity.	Verified, including cybersecurity testing.
Human Factors/Usability	No new critical tasks introduced by v4.3 software compared to predicate.	No new critical tasks introduced.

2. Sample size used for the test set and the data provenance:

The document only mentions "non-clinical benchtop testing." It does not specify a human "test set" and therefore no sample size, country of origin, or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as no human test set or ground truth establishment by experts for performance evaluation is described in the provided text. The testing mentioned is for device specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable as no human test set or adjudication process is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This device is an implanted neurostimulation system, not an AI-assisted diagnostic tool. Therefore, an MRMC study and effects on human readers are not relevant and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The performance described is essentially standalone in the sense that it's benchtop testing of the device's technical specifications. There's no "human-in-the-loop performance" described in the context of accepting the device's efficacy, only human factors/usability analysis to ensure no new critical tasks were introduced.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the verification testing appears to be the defined technical specifications of the device and its predicate, rather than clinical outcomes or expert consensus on a disease state.

8. The sample size for the training set:

Not applicable. This document describes verification testing, not the development or training of an AI model.

9. How the ground truth for the training set was established:

Not applicable.

In summary, the provided document focuses on demonstrating substantial equivalence through benchtop verification testing for a software update to an implanted medical device, not on clinical performance studies involving a test set, ground truth, or an AI algorithm.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it.

May 2, 2024

BlueWind Medical Ltd. Jason Woehrle Director Regulatory Affairs 6 Maskit Street Herzliya, 4614002 ISRAEL

Re: K240037

Trade/Device Name: Revi™ System Regulation Number: 21 CFR 876.5305 Regulation Name: Implanted Tibial Electrical Urinary Continence Device Regulatory Class: II Product Code: QXM Dated: January 4, 2024 Received: January 5, 2024

Dear Jason Woehrle:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See

{2}------------------------------------------------

the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Sharon M. Andrews -S

Sharon M. Andrews Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use

Submission Number (if known)

K240037

Device Name

Revi™ System

Indications for Use (Describe)

The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Blue Wind Medical. The logo consists of the words "Blue Wind" stacked on top of each other, with the word "MEDICAL" underneath. To the right of the text is a curved line of blue circles that get progressively smaller.

510(k) Summary

I. Company: BlueWind Medical Ltd. 6 Maskit Street Herzliya, 4614002 Israel
- Jason Woehrle (Primary) Contact: Director, Regulatory Affairs Telephone Number: (1) 952-240-2229 Email:Jason.Woehrle@bluewindmedical.com

Roni Diaz (Alternate) VP Regulatorv and Clinical Affairs Telephone Number: (1) 888-715-2080 Email: roni.diaz(a)bluewindmedical.com

Date Prepared: May 1, 2024

II. Proprietary Trade Name: Revi™ System
III. Common or Usual Name: Implantable tibial electrical urinary continence device
Classification Name: Implantable tibial electrical urinary continence device (21 CFR IV. 876.5305)
Classification: Class II V.
VI. Product Code: QXM

VII. Product Description:

VIII. Indications for Use

The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Blue Wind Medical. The logo features the words "Blue Wind" in a bold, sans-serif font, with "Blue" stacked above "Wind". Below "Wind" and slightly offset to the left is the word "MEDICAL" in a smaller font. Above and below the words "Blue Wind" are a series of blue dots arranged in a curved line, creating a visual representation of wind or movement.

Description	Subject DeviceRevi System with v4.3 software(K240037)	Predicate DeviceReviSystem with v4.1.2.5software(DEN220073)
Indications for Use	The Revi System is indicated for thetreatment of patients with symptomsof urgency incontinence alone or incombination with urinary urgency.	The Revi System isindicated for thetreatment of patientswith symptoms ofurgency incontinencealone or in combinationwith urinary urgency.
Principles of Operation	Implanted device received powerfrom non- implanted externalwearable device providing electricalstimulation to tibial nerve inproximity to ankle.	Implanted devicereceived power fromnon- implanted externalwearable deviceproviding electricalstimulation to tibial nervein proximity to ankle.
Treatment Programs	Ability to store up to 4 treatmentprograms	Ability to store up to 2treatment programs

Summary of the Technological Characteristics IX.

The modified Revi System with v4.3 software is identical to the predicate Revi System with v4.1.2.5 software in terms of indications for use, intended use, operational principle, design and is equivalent in terms of software function. The differences between the modified Revi System and predicate device do not raise different questions of safety and effectiveness.

Identification of Legally Marketed Devices X.

Revi System (DEN220073) Note: The predicate device has not been subject to a design-related recall.

XI. Discussion of the Performance Testing
Non-clinical benchtop testing was conducted to evaluate the performance characteristics of the modified Revi System.

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for Blue Wind Medical. The logo features the words "Blue Wind" in a bold, sans-serif font, with the word "Blue" in a darker shade than the word "Wind." Below "Blue Wind" is the word "MEDICAL" in a smaller, sans-serif font. To the right of the text is a curved line of blue circles, starting with larger circles and gradually decreasing in size.

Verification testing to ensure identical specification to predicate included the following:

stimulation frequency control to ensure range and accuracy compliance with ● specification
charging mode protection to ensure protection operates in compliance with . specification
system performance to ensure system performance in compliance with technical . specification
software verification to verify software requirements, including cybersecurity ● testing

A human factors/usability evaluation of the Revi™ System with v4.3 software and a gap analysis with the predicate device found that no new critical tasks were introduced by the subject device.

Conclusion XII.

The Revi™ System with v4.3 software has been shown through testing and comparison to be substantially equivalent to the identified predicate device.

Regulation Number and Section

N/A