CAVERMAP SURGICAL AID

K041732 · Blue Torch Medical Technologies · FGM · Sep 21, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K041732
• Device Name: CAVERMAP SURGICAL AID
• Applicant: Blue Torch Medical Technologies
• Product Code: FGM · Gastroenterology, Urology
• Decision Date: Sep 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4730
• Device Class: Class 1

Intended Use

The Blue Torch Medical Technologies CaverMap Surgical Aid is intended to provide stimulation to the body to locate and identify nerves and to test their excitability.

Device Story

The CaverMap Surgical Aid Perineal Tip is an accessory electrode for the CaverMap Surgical Aid System. It consists of a surgical stainless steel electrode encapsulated in dielectric insulating tubing, with an exposed tip for nerve stimulation. The device is used by surgeons during perineal radical prostatectomy, prostate brachytherapy, and prostate cryotherapy. The physician uses the probe to deliver electrical stimulation to tissues; the device aids in locating and identifying cavernosal and parasympathetic nerves by testing their excitability. The device is an adjunct to nerve-sparing surgical techniques; it does not replace the surgeon's clinical judgment or expertise in identifying neurovascular bundles. The system includes a reusable control handle for connection to the probe tip. The device provides the same charge density profile as previously marketed electrodes.

Clinical Evidence

Bench testing only. The device relies on design controls and performance testing to demonstrate substantial equivalence to the predicate device. No clinical data was provided.

Technological Characteristics

Materials: Surgical stainless steel electrode, dielectric insulating tubing. Energy: Electrical nerve stimulation. Form factor: Perineal probe tip with graduated length markings. Connectivity: Reusable control handle. Standards: 21 CFR 820, ISO 46001, EN 60601-1, ISO 10993.

Indications for Use

Indicated for stimulation of cavernosal and associated parasympathetic nerves in males during open or laparoscopic prostatectomy, prostate brachytherapy, prostate cryotherapy, and open colorectal procedures. Used as an adjunct to nerve-sparing techniques to aid the physician in nerve location. 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

• Blue Torch Medical Technologies CaverMap Surgical Aid (K970971)

Submission Summary (Full Text)

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K041732
page 1 of 2

# SEP 2 1 2004 510(k) Summary of Safety and Effectiveness Blue Torch Medical Technologies CaverMap Surgical Aid Additional Perineal Tip

## Company Name

Blue Torch Medical Technologies

# Official Contact

Frederick Tobia

## Device Name

| Proprietary Name: | Blue Torch Medical Technologies CaverMap® Surgical Aid Perineal<br>Tip |
|-------------------------|---------------------------------------------------------------------------------------------|
| 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

Blue Torch Medical Technologies CaverMap Surgical Aid K970971

## Intended Use

The Blue Torch Medical Technologies CaverMap Surgical Aid is intended to provide stimulation to the body to locate and identify nerves and to test their excitability.

### Indications for Use

The Blue Torch Medical Technologies CaverMap® Surgical Aid Perineal Tip is an accessory stimulating tip to be used for a perineal approach to nerve stimulation. It is an addition to the Blue Torch Medical Technologies CaverMap® Surgical Aid System. The system is indicated for use in the stimulation of the cavemosal and associated parasympathetic nerves during open or laproscopic prostatectorny, prostate brachytherapy placement, prostate cryotherapy, and open colorectal (surgical) procedures in males. The device aids the physician in locating these nerves. The device is designed as an adjunct to the current open or laproscopic prostatectomy, prostate brachytherapy placement, prostate cryotherapy, and open 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 physician's skill determines whether these nerves are spared regardless of any aid..

PAGE 30 OF 36 510(K) CAVERMAP SURGICAL AID PERINEAL TIP

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K041732
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### Description

The CaverMap Surgical Aid Perineal Tip has been designed specifically for use during perineal radical prostatectomy, prostate brachytherapy, and prostate cryotherapy procedures, where a nerve sparing technique is employed.

The perineal probe tip is designed as a single electrode made from surgical stainless steel. The probe tip is encapsulated in dielectrical insulating tubing, with the exception of the tip which is exposed to deliver the stimulation to the nerves. The tip also includes graduated length markings below the insulating tubing. The surface area of the stimulating (exposed) trocar tip is the same as the current electrodes of the currently marketed probe tip, giving the electrode the same charge density profile as the currently marketed probe tips.

A new reusable control handle was also designed in order to allow for a proper connection to the new probe tip. The materials used to manufacture the new handle are exactly the same as the currently marketed product.

The perineal probe tip functions exactly the same as the existing probe tip. The new tip was designed for use during nerve sparing procedures where a perineal approach to stimulating the cavernosal nerves is indicated.

## Summary of Standards Achieved

FDA Quality Systems Regulation 21 CFR § 820 ISO 46001: Quality System EN 60601-1 ISO 10993

#### Summary

In summary, the Blue Torch Medical Technologies CaverMap Surgical Aid Perineal Tip is substantially equivalent to legally marketed devices. Quality System & Design Controls assure the device is substantially equivalent to the predicate devices with respect to its performance, safety, and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

SEP 2 1 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Frederick Tobia Regulatory Consultant Blue Torch Medical Technologies, Inc. 200 Homer Avenue Ashland Technical Center ASHLAND MA 01721

Re: K041732

Ro41732
Trade/Device Name: Blue Torch Medical Technologies CaverMap Surgical Aid Perineal Probe Tip Regulation Number: 21 CFR §874.1820 Regulation Name: Surgical nerve stimulator/locator Product Code: 77 ETN Regulation Number: 21 CFR §876.4730 Regulation Name: Manual gastroenterology-urology surgical instrument and accessories Product Code: 78 FGM Regulatory Class: II Dated: August 23, 2004 Received: August 25, 2004

Dear Mr. Tobia:

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 (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. 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 (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.

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to obgin maining of substantial equivalence of your device to a legally prematication. The PDF mailing of and in the 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), please If you desire specific advice for your de of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, 101 questions on the process. Also, please note the regulation entitled, "Misbranding Onlice of Complance at (2017 27) 21 11 (21 CFR Part 807.97) you may obtain. Other general by relevence to premarked nonmoution (er the Act may be obtained from the Division of Small Information on your responsionalist and Consumer Assistance at its toll-free number [phone] or Manblacturers, International and Solass
[phone] or at its Internet address http://www.fda.gov/cdch/dsmaldsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Page _

510(k) Number (if known):

K041932

Device Name:

Blue Torch Medical Technologies CaverMap® Surgical Aid Perineal Probe Tip

Indications for Use: The Blue Torch Medical Technologies CaverMap® Surgical Aid Perineal Tip is an accessory stimulating tip to be used for a perineal approach to nerve stimulation. It is an is all accessory of manang Medical Technologies CaverMap® Surgical Aid System. The system is indicated for use in the stimulation of the cavemosal and associated parasympathetic nerves during moreated for are in the outsecures, prostate brachytherapy placement, prostate cryotherapy, and open of laptoseopic producedem), provenles. The device aids the physician in locating these nerves open colored is designed as an adjunct to the current open or laproscopic prostatectomy, prostate I he uctier is deagered as arraste cryotherapy, and open colorectal procedures in which a nerve oracing technique is used. The Surgical Aid is not designed to replace the surgeon's expertise in sparing to the neurovascular bundles. Each physician'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)

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OR

Over-The-Counter Use*_*_

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number: K041737

CAVERMAP SURGICAL AID PERINEAL TIP