CAVERMAP SURGICAL AID

K993436 · Uromed Corp. · FGM · Feb 11, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K993436
• Device Name: CAVERMAP SURGICAL AID
• Applicant: Uromed Corp.
• Product Code: FGM · Gastroenterology, Urology
• Decision Date: Feb 11, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4730
• Device Class: Class 1

Intended Use

The UroMed CaverMap Surgical Aid is currently intended to provide stimulation to the body to locate and identify nerves and to test their excitability.

Device Story

Device combines nerve stimulator and penile rigidity (tumescence) monitor into single unit. Used during open prostatectomy and colorectal surgery to identify exposed cavernosal and sacral nerves. Surgeon applies electrical stimulation to tissue; device monitors resulting penile tumescence. Output provides real-time feedback to surgeon regarding nerve location and excitability. Assists surgeon in identifying nerves to facilitate nerve-sparing techniques, potentially reducing post-operative erectile dysfunction. Operated by surgeon in OR setting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Integrated nerve stimulator and penile rigidity monitor. Complies with ISO 46001, ISO 10993-1, UL 544/A, and IEC 601 standards. Electrical stimulation principle. Standalone unit.

Indications for Use

Indicated for stimulation of cavernosal and associated parasympathetic nerves in males during open prostatectomy and colorectal surgical procedures to aid surgeons in nerve location. Designed as an adjunct to nerve-sparing techniques; not intended to replace surgeon expertise in mapping neurovascular bundles.

Regulatory Classification

Identification

A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop. A manual surgical instrument that is intended specifically for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures are classified under § 884.4910 of this chapter.

Predicate Devices

• UroMed CaverMap Surgical Aid (K970971)

Submission Summary (Full Text)

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# FEB 1 1 2000

### 510(k) Summary of Safety and Effectiveness UroMed® Needle Holder Friday, October 08, 1999

# Company Name

UroMed® Corporation 1400 Providence Highway Norwood, MA 02062

#### Official Contact

Frederick Tobia Director, Regulatory, Quality and Clinical Affairs

# Device Name

| Proprietary Name: | UroMed CaverMap® Surgical Aid |
|-------------------------|---------------------------------------------------------------------------------------------|
| Common Name: | Nerve Stimulator/Locator |
| Classification Name(s): | 21 CFR § 874.1820 Stimulator, Nerve<br>21 CFR § 876.4730 Probe And Director, Gastro-Urology |

# Predicate Devices used for Substantial Equivalence

K970971 UroMed CaverMap Surgical Aid

#### Intended Use

The UroMed CaverMap Surgical Aid is currently intended to provide stimulation to the body to locate and identify nerves and to test their excitability.

#### Indications for Use

The UroMed CaverMap® Surgical Aid is indicated for use in the stimulation of the cavernosal and associated parasympathetic nerves during open prostatectomy and colorectal (surgical) procedures in males respectively. The device aids the surgeon in locating these nerves. The device is designed as an adjunct to the current open prostatectomy and colorectal procedures in which a nerve sparing technique is used. The Surgical Aid is not designed to replace the surgeon's expertise in mapping out the neurovascular bundles. Each surgeon's skill determines whether these nerves are spared regardless of any aid.

#### Description

The UroMed CaverMap Surgical Aid combines the technologies of two devices into one contained unit. The CaverMap Surgical Aid incorporates a nerve stimulator and a penile rigidity (tumescence) monitor into a single unit. The device is designed for identifying exposed nerves during open prostatectorny and colorectal surgical procedures. The device aid's the surgeon in locating the cavernosal and sacral nerves, which both effect tumescence.

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# Summary of Standards Achieved

FDA Quality Systems Regulation 21 CFR § 820 ISO 46001: Quality System ISO 10993-1: Biological Evaluation of Medical Devices UL 544/A IEC 601

# Summary

In summary, the UroMed CaverMap Surgical Aid is substantially equivalent to legally marketed devices. Quality System Controls assure the device is substantially equivalent to the predicate devices with respect to its performance, safety, and effectiveness.

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Image /page/2/Picture/0 description: The image shows a circular logo for the Department of Health & Human Services (HHS) of the United States of America. The logo features the HHS symbol, which is a stylized representation of a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol in a circular fashion.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2000

Mr. Frederick Tobia Director, Regulatory, Quality and Clinical Affairs UroMed Corporation 1400 Providence Highway, Building 2 Norwood, MA 02062

Re: K993436

UroMed CaverMap® Surgical Aid Dated: January 25, 2000 Received: January 27, 2000 Requlatory Class: Il 21 CFR §874.1820/Procode: 77 ETN 21 CFR §876.4730/Procode: 78 FGM

Dear Mr. Tobia:

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 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 (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 requirements, 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 requlatory 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting 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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Page of

#### K993436 510(k) Number (if known):

Device Name:

UroMed CaverMap® Surgical Aid

The UroMed CaverMap® Surgical Aid is indicated for use in the Indications for Use: stimulation of the cavernosal and associated parasympathetic nerves during open prostatectomy and colorectal (surgical) procedures in males. The device aids the surgeon in locating these nerves. The device is designed as an adjunct to the current open prostatectomy and colorectal procedures in which a nerve sparing technique is used. The Surgical Aid is not designed to replace the surgeon's expertise in mapping out the neurovascular 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 _________________________________________________________________________________________________________________________________________________________

David A. Bergman
Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices 902436 510(k) Number.

UroMed Corporation K993436

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