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..

Device 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. 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.

AI/ML Overview

This document does not include acceptance criteria for device performance, nor does it describe a study to demonstrate the device meets any such criteria.

The document is a 510(k) summary for the Blue Torch Medical Technologies CaverMap Surgical Aid with Video Monitor. It focuses on demonstrating substantial equivalence to an existing predicate device (Blue Torch Medical Technologies CaverMap Surgical Aid K970971), rather than establishing performance against defined acceptance criteria through a clinical or performance study.

Here's a breakdown of why the requested information cannot be provided from this document:

No Acceptance Criteria or Performance Claims: The document states that "Quality System & Design Controls assure the device is substantially equivalent to the predicate devices with respect to its performance, safety, and effectiveness." This implies that the device's performance is deemed acceptable because it is similar to a previously cleared device, not because it met specific, quantifiable performance metrics defined for this new device.
Focus on Substantial Equivalence: The core of a 510(k) submission is to show that a new device is "substantially equivalent" to a legally marketed predicate device. This often relies on design comparisons, adherence to recognized standards (like ISO 46001, EN 60601-1, and 21 CFR § 820), and sometimes non-clinical testing to confirm that changes do not raise new questions of safety or effectiveness. It generally does not involve a formal study with acceptance criteria for a device's clinical performance.
Nature of the Device Modification: The submission describes the addition of a video monitor to an existing surgical aid. This is presented as a modification that primarily changes how data is displayed (text and graphical format, tumescence signals, stimulation current, etc.) and not necessarily the fundamental function or accuracy of the nerve stimulation itself. Therefore, a clinical outcome study or a study with stringent performance acceptance criteria might not have been deemed necessary for this type of modification.

In summary, the requested information (performance acceptance criteria, details of a study proving those criteria were met, sample sizes, expert involvement, etc.) is not present in this 510(k) summary because the submission pathway focuses on demonstrating substantial equivalence rather than establishing de novo performance against new acceptance criteria.

Summary

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Image /page/0/Picture/0 description: The image shows a sequence of alphanumeric characters, specifically "KO31527". The characters are handwritten in a dark ink, and they appear to be a combination of uppercase letters and numbers. The characters are written in a clear and legible manner.

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 VideoMonitor
Common Name:	Nerve Stimulator/Locator
Classification Name(s):	21 CFR § 874.1820 Stimulator, Nerve21 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

Description

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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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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol of three stylized human profiles facing right. The profiles are stacked on top of each other, with the top profile being the most complete and the bottom profile being the least complete. The seal is black and white.

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	(301) 594-4592
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:(Per 21 CFR 801.109)	✓	OR	Over-The-Counter Use
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(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number	K031527
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PAGE 38 OF 38 SPECIAL 510(K) CAVERMAP SURGICAL AID WITH VIDEO MONITOR

Regulation Number and Section

§ 876.4730 Manual gastroenterology-urology surgical instrument and accessories.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.