The VCS-A Series Clamp with Ultrasound Doppler is a ring handled mechanical surgical instrument with a ratchet closure to adjust the tension required to occlude the target vessel. The Clamp has an integrated Doppler probe, which allows for blood flow monitoring by using a conventional portable Doppler Ultrasound unit. The VCS-A Series Clamp is made of surgical grade stainless steel and is available in various sizes. The clamp is a sterile, single use device. The method of sterilization will be Gamma Radiation with a SAL of 106.

AI/ML Overview

Table of Acceptance Criteria and Reported Device Performance:

The provided document states that "The performance and functional testing demonstrated that the vascular clamp is substantially equivalent to the predicate devices. The VCS-A series Clamp with Ultrasound Doppler does not raise any new safety, effectiveness, or performance issues. Data are on file at Vascular Control Systems, Inc."

Since the document doesn't explicitly list numerical acceptance criteria or specific performance metrics, the table below reflects this general statement of substantial equivalence to predicate devices.

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Overall Performance	Substantial equivalence to predicate devices regarding safety, effectiveness, and performance.	The VCS-A series Clamp with Ultrasound Doppler demonstrated substantial equivalence to predicate devices, raising no new safety, effectiveness, or performance issues.
Functionality	(Implicit: Temporary occlusion of blood vessels and integrated Doppler functionality)	Demonstrated functionality consistent with intended use and predicate devices.
Safety	(Implicit: No new safety concerns compared to predicate devices)	No new safety issues were identified.
Effectiveness	(Implicit: Achieves intended purpose effectively)	No new effectiveness issues were identified.
Biocompatibility	(Implicit: Suitable for contact with blood vessels)	(Not explicitly stated, but implied by regulatory clearance and lack of new safety issues)
Sterilization	Gamma Radiation with SAL of 10-6	Sterilization method (Gamma Radiation with SAL of 10-6) is specified. Performance of this method implies it met acceptance criteria for sterility.
Material Properties	(Implicit: Suitable for surgical use)	(Not explicitly stated, but implied by regulatory clearance and lack of new safety issues)

Sample size used for the test set and the data provenance:

The document states that "Data are on file at Vascular Control Systems, Inc." without providing specific details regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The study focuses on "performance and functional testing" rather than expert-driven ground truth assessment for image interpretation or diagnosis.
Adjudication method for the test set:

This information is not provided in the document.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

An MRMC comparative effectiveness study was not done. The device is a mechanical surgical clamp with an integrated Doppler, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable as the device is a physical surgical instrument, not an algorithm. Therefore, a standalone algorithm-only performance study would not be relevant.
The type of ground truth used:

The "ground truth" for this device would be its ability to physically perform its intended function (temporary occlusion of blood vessels) and the accurate function of the integrated Doppler. This would be assessed through engineering and functional testing rather than expert consensus, pathology, or outcomes data in the traditional sense of a diagnostic device. The performance and functional testing implicitly served as the "ground truth" verification against engineering specifications and predicate device performance.
The sample size for the training set:

This information is not applicable. The VCS-A Series Clamp with Ultrasound Doppler is a mechanical device, not a machine learning or AI algorithm that requires a training set.
How the ground truth for the training set was established:

This is not applicable, as there is no training set for this type of device.

Summary

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FEB 1 5 2002

KO11863

510(k) SUMMARY Vascular Control Systems, Inc. VCS-A Series Clamp with Ultrasound Doppler

1. GENERAL

Submitter:	Vascular Control Systems, Inc.32236-E Paseo AdelantoSan Juan Capistrano, CA 92675
Contact Person:	Al MemmoloV.P. Quality and Regulatory Affairs
Date Prepared:	February 6, 2002

2. DEVICE NAME

Classification name: Vascular Clamp (21 CFR §870.4450) .
Common or usual name: Vascular Clamp .
Trade or proprietary name: VCS-A Series Clamp with Ultrasound Doppler .

3. PREDICATE DEVICES

• 510(k) #	K973080
• Company:	Walter Lorenz Surgical, Inc.
• Device Classification:	Class II
• Device Name:	Surgical Vascular Clamp
• Clearance Date:	Feb 23, 1998
• 510(k) #	K935994
• Company:	Koven Technologies, Inc.
• Device Classification:	Class II
• Device Name:	PW Doppler Vascular Probes
• Clearance Date:	May 11, 1995

4. DEVICE DESCRIPTION

The VCS-A Series Clamp with Ultrasound Doppler is a ring handled mechanical surgical instrument with a ratchet closure to adjust the tension required to occlude the surgical instrument with a wall integrated Doppler probe, which allows for blood targer vesser. "The Claimp has an the available portable Doppler Ultrasound unit. The Itow sching by using a contineretar areas areas and is available in various VCS-A belies claimp 16 mass. The clamp is a sterile, single use device. The method of sterilization will be Gamma Radiation with a SAL of 106.

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510(k) Summary VCS-A Series Vascular Clamp

5. INTENDED USE

The intended use is the temporary occlusion of blood vessels during vascular surgical procedures.

6. SUBSTANTIAL EQUIVALENCE

Vascular Control Systems, Inc. believes the VCS-A Series Clamp with Ultrasound Doppler raises no new questions of safety and efficacy based upon indications for use Doppiel falses no new questions of barber and the VCS-A Series Clamp meets the and device design. Therefore, we concease many to Section 510(k) guidelines.

7. PRODUCT PERFORMANCE TESTING

The performance and functional testing demonstrated that the vascular clamp is The performance and runetional tesing devices. The VCS-A series Clamp with Substantially equivalient to the proving any new safety, effectiveness, or performance issues. Data are on file at Vascular Control Systems, Inc.

8. CONCLUSIONS

Based on the same intended use, similar technological characteristics and Dascu on the Same intended abonent of Systems, Inc. believes the VCS-A Series performatice testing, vuseum. Ochard equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three flowing lines above it, possibly representing the concept of health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 5 2002

Mr. Al Memmolo Vice President of Quality Assurance and Regulatory Affairs Vascular Control Systems, Inc. 32236-E Paseo Adelanto San Juan Capistrano, CA 92675

Re: K011863

Trade Name: VCS-A Series Clamp Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasound Transducer Regulatory Class: II (two) Product Code: 72 DXC and 90 ITX Dated: February 6, 2002 Received: February 8, 2002

Dear Mr. Memmolo:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 910((i) promativalially equivalent (for the referenced above and we nave detemmed the deviles marketed predicate devices marketed in
indications for use stated in the enclosure) to legally marketed in of the Medical De indications for use stated in the choiosaro, to teenactment date of the Medical Device interstate commence pror to May 20, 1970, the end new market the provisions of the Amendments, of to devices mar liave been recurse market the device, subject to Federal Food, Drug, and Cosmetic Act (Act. Tournal) , ontrols spovisions of the Act include the general controls provisions of the Avi. " Previews vonestical volusion in practice, labeling, requirements against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for This determination of Substantials equir premarket notification:

Transducer Model Number

09-0005-01 09-0005-02 09-0005-03 09-0005-04

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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 n may of subject to sadh addiness Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. may puonsh farmer announ's issuance of a substantial equivalence determination does not mean i fouse of actived that I Dristian that your device complies with other requirements of the Act that I Dr Has made a aond regulations administered by other Federal agencies. You must or mry 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 OF It Fat 607); incoming (21 CFR Part 820); and if applicable, the electronic rord in and quality by solide (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 m Ispendix of (enclosed) of af Diagnostic Ultrasound Systems and Transducers." If the special Decking Manteling Orcarantes or wacceptable 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 Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

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Page 3 - Mr. Al Memmolo

If you have any questions regarding the content of this letter, please contact O.D. Hottenstein, Ph.D. at (301) 443-8262.

Sincerely yours,

Da Tell

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

Enclosures

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VASCULAR CONTROL SYSTEMS, INC. 510(k) K011863 VCS-A Series Clamp

510(k) Number (if known):

VCS-A Series Clamp Device Name:

Indications for Use:

The VCS-A Series Clamp is indicated for use in the temporary occlusion of blood vessels during vascular surgical procedures.

(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)

Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________

Division of Cardiovascular & Respiratory Devices
510(k) Number K011863

B-2

Regulation Number and Section

§ 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).