The Urovations Nerve Stimulator is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.

The Urovations Nerve Stimulator is indicated for use in the stimulation of the cavernosal nerves during open prostatectomy (surgical) procedures, aiding the surgeon in locating these nerves. The device is designed as an adjunct to current open prostatectomy procedures in which a nerve sparing technique is used. The Nerve Stimulator is not designed to replace the surgeon's expertise in mapping out the vascular bundles. Each surgeon's skill determines whether these nerves are spared regardless of any aid.

Device Description

The Urovations Nerve Stimulator is a electrical Nerve Stimulator designed for use during open prostatectomy (surgical) procedures. The stimulator provides a biphasic current pulse with variable amplitude between 1 - 20mA, a constant pulse width of 800usec/phase, and a constant frequency of 16Hz. The stimulation is applied to the body by the surgeon in order to locate and test the excitability of the cavernosal nerves.

AI/ML Overview

Here's an analysis of the provided text regarding the Urovations Nerve Stimulator, focusing on acceptance criteria and supporting studies:

It's important to note that the provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against pre-defined acceptance criteria in the same way a de novo or PMA submission might. Therefore, the "acceptance criteria" here are implicitly tied to the performance characteristics of the predicate devices and general safety/effectiveness standards for the device type.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Predicate Equivalence and Test Summary)	Reported Device Performance (from "Pre-clinical and Clinical Testing" and "Summary")
A. Safety:
1. Electrical Safety Standards Conformance	Meets UL-544, AAMI ES1-1993, and IEC-601 standards.
2. Biocompatibility	Extensive biocompatibility testing conducted; materials demonstrated to be biocompatible, suitable, and safe for intended use.
3. Absence of Adverse Events	"No reported adverse events were associated with device use" in the clinical study.
B. Effectiveness/Functionality:
1. Provides Electrical Stimulation	Provides a biphasic current pulse with variable amplitude (1-20mA), constant pulse width (800usec/phase), and constant frequency (16Hz).
2. Locates and Identifies Nerves	Clinical study indicates the device "provides an electrical charge to stimulate the cavernosal nerves."
3. Tests Nerve Excitability	Clinical study indicates the device "elicits a visible and measurable response in tumescence."
4. Substantial Equivalence to Predicate Devices	"Substantially equivalent to legally marketed devices" and "substantially equivalent to these devices with respect to its performance, safety and effectiveness."

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text. The clinical study is mentioned in the singular, implying a single cohort, but the number of patients/procedures is not given.
- Data Provenance: The document is a 510(k) summary submitted to the FDA in the USA, so the study was likely conducted in the USA. It is a prospective clinical study, as it "was conducted to determine if the Urovations Nerve Stimulator provides electrical stimulation..."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The study focused on the device's ability to stimulate nerves and elicit a response, which would likely be observed intra-operatively by the operating surgeon. The "ground truth" here is the physical response to electrical stimulation rather than an interpretation of an image or signal by an expert off-line.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided. Given the nature of observing a direct physiological response during surgery, formal adjudication methods like 2+1 or 3+1 are typically not applicable. The surgeon observing the response acts as the primary "interpreter."
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a nerve stimulator, not an AI-powered diagnostic tool, so "human readers" and "AI assistance" are not relevant concepts in this context. The study focused on the device's ability to directly stimulate nerves and elicit a physiological response during surgery.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the clinical study essentially functions as a standalone performance assessment of the device (not an algorithm) in its intended use. The device directly stimulates nerves, and its performance is measured by its ability to achieve this and elicit a response. While a surgeon operates the device, the study aims to show the device's inherent capability to perform its function.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth was based on direct physiological response/observation during surgery. The text states the study indicated the device "provides an electrical charge to stimulate the cavernosal nerves and elicits a visible and measurable response in tumescence." This visible and measurable response serves as the ground truth for successful nerve stimulation.
The sample size for the training set:
- This device is an electromechanical nerve stimulator, not an AI/machine learning model. Therefore, there is no "training set" in the context of an algorithm.
How the ground truth for the training set was established:
- As there is no AI/machine learning component, there is no training set ground truth to establish.

Summary

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A o T
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510(k) Summary of Safety and Effectiveness Urovations Nerve Stimulator

OCT 27 1997

Company Name

Urovations Inc. 64 A Street Needham, MA 02194

Official Contact

Frederick Tobia Director, Clinical and Regulatory Affairs

Device Name

Proprietary Name:	Urovations Nerve Stimulator
Common Name:	Nerve Stimulator/Locator
Classification Name(s):	21 CFR § 874.1820 Surgical Nerve Stimulator/Locator

Predicate Devices used for Substantial Equivalence

Grass Nerve Stimulator K844216 Brown Nocturnal Penile Tumescence Monitor K830221

Intended Use

The Urovations Nerve Stimulator is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.

Indications for Use

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Description

Summary of Standards Achieved

The Urovations Nerve Stimulator meets UL-544 specifications for electronic medical devices, conforms to AAMI ES1-1993 Safe Current Limits, and meets IEC-601 standards for electronic medical devices.

Pre-clinical and Clinical Testing

A variety of physical tests were conducted on the Urovations Nerve Stimulator to characterize its physical properties, safety margins, and failure modes, as part of a failure modes and effects analysis. In addition, extensive biocompatibility testing was conducted on the materials which will have human contact to demonstrate that the materials are biocompatible, suitable and safe for their intended use.

A clinical study was conducted to determine if the Urovations Nerve Stimulator provides electrical stimulation to the cavernosal nerves during radical prostatectomy procedures. The results of the study indicate the Urovations Nerve Stimulator provides an electrical charge to stimulate the cavernosal nerves and elicits a visible and measurable response in tumescence. No reported adverse events were associated with device use.

Summary

In summary, the Urovations Nerve Stimulator is substantially equivalent to legally marketed devices. Furthermore, based on the results of preclinical and clinical testing, the nerve stimulator is substantially equivalent to these devices with respect to its performance, safety and effectiveness.

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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with the profiles overlapping each other. The profiles are arranged in a way that they also resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Nancy C. MacDonald Manager, Clinical & Regulatory Affairs UroMed Corporation 64 A Street Needham, Massachusetts 02194

Dear Ms. MacDonald:

Re: K970971

Urovations Nerve Stimulator Dated: September 22, 1997 Received: September 23, 1997 Regulatory class: II 21 CFR §874.1820/Product code: 77 ETN 21 CFR §876.4730/Product code: 78 FGM OCT 27 1997

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and probibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation of titled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

William Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K970971

Device Name: Urovations Nerve Stimulator

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: レ (Per 21 CFR 801.109)

Over-The-Counter Use

Peter D. Rathbun
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K970921

Regulation Number and Section

§ 874.1820 Surgical nerve stimulator/locator.

(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.