(183 days)
Not Found
Not Found
No
The summary describes a mechanical clamp with Doppler functionality for detecting and occluding uterine arteries. There is no mention of AI, ML, or any computational analysis of the Doppler signal that would suggest the use of these technologies.
No
The device is described as being for "detection and temporary occlusion" during surgery, which is an interventional or diagnostic function rather than a therapeutic one designed to treat a condition.
No
The device is described as being for "bilateral detection and temporary occlusion of the uterine arteries," implying an interventional or procedural function, rather than the primary purpose of diagnosing a disease or condition. The "detection" aspect using Doppler is for locating the arteries for occlusion, not for diagnosing pathology.
No
The device description clearly indicates a "Transvaginal Doppler Clamp," which is a physical hardware device used for detection and occlusion. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The Transvaginal Doppler Clamp is described as a device for the "bilateral detection and temporary occlusion of the uterine arteries during conservative gynecological surgery." This is a surgical tool used in vivo (within the living body) during a procedure.
- Lack of Sample Analysis: The description does not mention any analysis of biological samples taken from the patient. The Doppler modality is used for real-time detection of blood flow within the body.
Therefore, the function and intended use of this device clearly place it outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
DXC, ITX, HHM, HDC, JAF
Device Description
Transducer Model Numbers
09-0016-01
09-0016-02
09-0016-03
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterine arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of a human figure with three wavy lines extending from the head, resembling hair or a flowing design.
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 (301) 594-4591. 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
2
Page 3 – Mr. Al Memmolo
Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 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 (301) 443-8262, 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
3
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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