TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03

K031812 · Vascular Control Systems, Inc. · DXC · Dec 12, 2003 · Cardiovascular

Device Facts

• Record ID: K031812
• Device Name: TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03
• Applicant: Vascular Control Systems, Inc.
• Product Code: DXC · Cardiovascular
• Decision Date: Dec 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Transvaginal Doppler Clamp is intended for bilateral detection and temporary occlusion of the uterine arteries during conservative gynecological surgery such as laparoscopic myomectomy.

Device Story

Transvaginal Doppler Clamp facilitates bilateral detection and temporary occlusion of uterine arteries during laparoscopic myomectomy. Device integrates with Vascular Technology, Inc. Doppler Transceiver (8 MHz Selectable Channel). Operates by providing ultrasonic Doppler monitoring to locate uterine arteries, followed by mechanical clamping for temporary occlusion. Used in clinical surgical settings by gynecological surgeons. Output consists of Doppler signals for artery identification and mechanical occlusion for blood flow control. Benefits include improved surgical precision and hemorrhage control during myomectomy procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence determination based on technological characteristics and intended use.

Technological Characteristics

Transducer models 09-0016-01, 09-0016-02, 09-0016-03. Operates at 8 MHz. Designed for use with Vascular Technology, Inc. Doppler Transceiver. Combines ultrasonic Doppler sensing with mechanical clamping mechanism. Class II device under 21 CFR 870.4450, 892.1570, 884.4530, and 892.1540.

Indications for Use

Indicated for patients undergoing conservative gynecological surgery, specifically laparoscopic myomectomy, requiring bilateral detection and temporary occlusion of uterine arteries.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Reference Devices

• Vascular Technology, Inc. Doppler Transceiver, 8 MHz Selectable Channel, Part number 108900

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 2 2003

Vascular Control Systems, Inc. c/o Mr. Al Memmolo Vice President, Clinical and Regulatory Affairs 32236 Paseo Adelanto, Suite E San Juan Capistrano, CA 92675

Re: K031812 Transvaginal Doppler Clamp Regulation Number: 21 CFR 870.4450, 892.1570, 884.4530, and 892.1540 Regulation Name: Vascular Clamp, Transducer, Ultrasound, diagnostic for, Sound and Tenaculum, Nonfetal Ultrasonic Monitor Regulatory Class: Class II (two) Product Code: DXC, ITX, HHM, HDC, and JAF Dated: September 16, 2003 Received: September 17, 2003

Dear Mr. Memmolo:

We have reviewed your Section 510(k) premarket 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.

This determination of substantial equivalence applies to the following transducers intended for use with the Vascular Technology, Inc. Doppler Transceiver, 8 MHz Selectable Channel, Part number 108900, as described in your premarket notification:

Transducer Model Numbers

09-0016-01 09-0016-02 09-0016-03

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your 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 market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer

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Page 3 – Mr. Al Memmolo

Assistance at its toll-free number [phone] or at [phone] or at its Internet address
"http://www.fda.gov/odrb/damamain.cl/a.dii "http://www.fda.gov/cdrh/dsmamain.html"?

If you have any questions regarding the content of this letter, please contact CDR O.D. Hottenstein, Ph.D. at [phone], extension 163.

Sincerely yours,

Ashley B. Burris

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K 031812

Device Name: Transvaginal Doppler Clamp

Indications For Use:

The Transvaginal Doppler Clamp is intended for bilateral detection and temporary occlusion of the uterine arteries during conservative gynecological surgery such as laparoscopic myomectomy.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ashley B. Boan

Division Sinn-

510/10 Number

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