MODIFICATION TO CAVERMAP SURGICAL AID

K031527 · Blue Torch Medical Technologies · FGM · Jun 5, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K031527
• Device Name: MODIFICATION TO CAVERMAP SURGICAL AID
• Applicant: Blue Torch Medical Technologies
• Product Code: FGM · Gastroenterology, Urology
• Decision Date: Jun 5, 2003
• Decision: SESE
• Submission Type: Special
• 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 with Video Monitor is an accessory to the CaverMap Surgical Aid System. It consists of an IBM-compatible computer with an integrated liquid plasma video screen. The monitor connects to the CaverMap Surgical Aid Control Unit via a standard RS-232 port to receive unidirectional data. The device displays tumescence signals (baseline and threshold), stimulation current, status, and time/seconds counter in text and graphical formats. It is used in the operating room by surgeons during prostatectomy or colorectal procedures to assist in nerve localization. The visual output provides real-time feedback to the surgeon, aiding in the identification of nerves to facilitate nerve-sparing techniques, potentially improving patient outcomes by reducing nerve damage.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System consists of an IBM-compatible computer with an integrated liquid plasma video screen. Connectivity via standard RS-232 port for unidirectional data transfer. Complies with EN 60601-1 and ISO 46001 standards. Operates as an adjunct to the existing CaverMap Surgical Aid Control Unit.

Indications for Use

Indicated for stimulation of cavernosal and associated parasympathetic nerves in males during open or laparoscopic prostatectomy and open colorectal surgical procedures. Used 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

• Blue Torch Medical Technologies CaverMap Surgical Aid (K970971)

Submission Summary (Full Text)

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# JUN - 5 2003

# 510(k) Summary of Safety and Effectiveness Blue Torch Medical Technologies® CaverMap Surgical Aid With Video Monitor

### Company Name

Blue Torch Medical Technologies® Corporation

### Official Contact

Frederick Tobia Director, Regulatory Affairs and Quality Assurance

### Device Name

| Proprietary Name: | Blue Torch Medical Technologies CaverMap® Surgical Aid with Video<br>Monitor |
|-------------------------|---------------------------------------------------------------------------------------------|
| 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 Video Monitor is a modification to the Blue Torch Medical Technologies CaverMap® Surgical Aid System is indicated for use in the stimulation of the cavernosal and associated parasympathetic nerves during open or laproscopic prostatectomy and open 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 or laproscopic prostatectomy 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 surgeon's skill determines whether these nerves are spared regardless of any aid..

## Description

The CaverMap Surgical Aid Monitor consists of a self contained IBM compatible computer system with an integrated liquid plasma video screen. The integrated video display unit will be connected to the CaverMap Surgical Aid Control unit by a standard RS-232 port.

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The CaverMap Surgical Aid Monitor reads data directly from the CaverMap Surgical Aid Control Unit through a RS232 port, which will be a modification to the current control unit design. The video monitor displays the data to the video screen in text and graphical format. Communication between the CaverMap Surgical Aid and the CaverMap Surgical aid Monitor is unidirectional.

The information displayed is:

- Tumescence Signal
- Baseline and Threshold Tumescence Signals ●
- Status Indication
- Stimulation Current.
- Time and Seconds Counter
- Error Messages

### Summary of Standards Achieved

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

#### Summary

In summary, the Blue Torch Medical Technologies CaverMap Surgical Aid Video Monitor 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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ر Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Blue Torch Medical Technologies, Inc. c/o Mr. Frederick Tobia Director, RA/ QA CareStat 180 Wells Avenue NEWTON MA 02459

Re: K031527

Trade/Device Name: CaverMap® Surgical Aid with Video Monitor Regulation Number: 21 CFR §874.1820 Regulation Name: Surgical nerve stimulator/locator Regulatory Class: II Product Code: 77 ETN Regulation Number: 21 CFR §876.4730 Regulation Name: Manual gastroenterology-urology surgical instrument and accessories Regulatory Class: I Product Code: 78 FGM Dated: May 8, 2003 Received: May 21, 2003

JUN - 5 2003

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. Iisting 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 (OS) 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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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/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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#### 1 _ of _ 1 _ Page _

K03 510(k) Number (if known):

Device Name:

Blue Torch Medical Technologies CaverMap® Surgical Aid

Indications for Use: The Blue Torch Medical Technologies CaverMap® Surgical Aid Video Monitor is a modification to the Blue Torch Medical Technologies CaverMap® Surgical Aid System. The system is indicated for use in the stimulation of the cavernosal and associated parasympathetic nerves during open or laproscopic prostatectomy and open 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 or laproscopic prostatectorny 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 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:<br>(Per 21 CFR 801.109) | <span style="text-decoration: overline;">✓</span> | OR | Over-The-Counter Use <span style="text-decoration: overline;"> </span> |
|-------------------------------------------|---------------------------------------------------|----|------------------------------------------------------------------------|
|-------------------------------------------|---------------------------------------------------|----|------------------------------------------------------------------------|

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

| 510(k) Number | K031527 |
|---------------|---------|
|---------------|---------|

PAGE 38 OF 38 SPECIAL 510(K) CAVERMAP SURGICAL AID WITH VIDEO MONITOR