URO MED NERVE STIMULATOR

K970971 · Uromed Corp. · ETN · Oct 27, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K970971
• Device Name: URO MED NERVE STIMULATOR
• Applicant: Uromed Corp.
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Oct 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

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.

Device Story

Urovations Nerve Stimulator is an electrical nerve stimulator used during open prostatectomy procedures. Surgeon operates device to apply biphasic current pulses to cavernosal nerves. Device provides variable amplitude (1-20mA), constant pulse width (800μsec/phase), and constant frequency (16Hz). Output elicits visible/measurable tumescence response, confirming nerve location and excitability. Used in surgical setting to assist surgeons in nerve-sparing techniques. Benefits include improved identification of nerves during surgery, potentially reducing nerve damage risk.

Clinical Evidence

Clinical study conducted during radical prostatectomy procedures. Results demonstrated the device successfully provides electrical stimulation to cavernosal nerves, eliciting visible and measurable tumescence. No adverse events reported.

Technological Characteristics

Biphasic current pulse generator; amplitude 1-20mA; pulse width 800μsec/phase; frequency 16Hz. Meets UL-544, AAMI ES1-1993, and IEC-601 standards. Biocompatible materials used for patient-contact components.

Indications for Use

Indicated for stimulation of cavernosal nerves during open prostatectomy procedures to aid surgeons in nerve location. Adjunct to nerve-sparing techniques; not intended to replace surgeon expertise in mapping vascular bundles.

Regulatory Classification

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.

Predicate Devices

• Grass Nerve Stimulator (K844216)
• Brown Nocturnal Penile Tumescence Monitor (K830221)

Submission Summary (Full Text)

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142

# 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

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.

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k970971
2012

## 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 800μsec/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.

## 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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

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

Dear Ms. MacDonald:

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 Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, 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 prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or 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 the Electronic Product 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 vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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:

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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: ☑ (Per 21 CFR 801.109)
OR
Over-The-Counter Use ☐

(Division Sign-Off)
*Dolev R. Sathig 1*
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K970971