The VCS-A Series Clamp is a ring-handled instrument with integrated Doppler sensor, which allows temporary occlusion of blood vessels. The Doppler sensor allows audible sensing of blood flow by connecting to a commercially available portable transceiver box. The VCS-A series Clamp is manufactured from stainless steel.

AI/ML Overview

The provided 510(k) summary for the VCS-A Series Clamp with Doppler Ultrasound is for a device that detects blood flow via Doppler ultrasound, intended for temporary blood vessel occlusion during surgery. It is a submission for substantial equivalence to a predicate device, and as such, the focus of the documentation is on demonstrating that the modified device does not introduce new questions of safety or effectiveness.

Therefore, the document does not contain information typically found in an AI/ML device submission, such as explicit acceptance criteria for model performance, details of a study proving those criteria were met, sample sizes for test and training sets, details on ground truth establishment by experts, or MRMC studies.

Instead, the "acceptance criteria" for this device are its compliance with general electrical and thermal safety standards (IEC 60601-1) and acoustic output power measurements (FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers"). The "study" proving these criteria are met is the performance of these non-clinical tests.

Below is a summary of the requested information based on the provided document, highlighting the absence of AI/ML-specific details.

Acceptance Criteria and Device Performance Study (VCS-A Series Clamp with Doppler Ultrasound)

The provided 510(k) summary focuses on demonstrating substantial equivalence of a modified medical device to a predicate device. As such, it does not detail performance metrics typical of AI/ML device evaluations. The "acceptance criteria" are related to non-clinical safety and performance standards for the hardware, and the "study" is the execution of these non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Compliance with IEC 60601-1	Designed and tested to comply with IEC 60601-1 for electrical and thermal safety.
Compliance with FDA Acoustic Output Guidance	Acoustic output power measurements performed in accordance with FDA guidance.
Reliable Performance (General)	Test results indicate reliable performance when the device is used in accordance with the Instructions for Use.
No new issues of safety/effectiveness/performance compared to predicate product	The modified VCS-A Series Clamp does not raise new issues of safety, effectiveness, or performance of the product.

2. Sample Size for the Test Set and Data Provenance

This information is not applicable as the device is a hardware product and not an AI/ML diagnostic tool evaluated on a clinical test set. The testing described is non-clinical (electrical, thermal, acoustic output).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable. Ground truth establishment by clinical experts is not relevant for the non-clinical hardware testing described.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are typically used for clinical data interpretation in AI/ML studies, not for hardware safety and performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable to this hardware device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a physical vascular clamp with an integrated Doppler sensor, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed relates to engineering specifications, regulatory standards, and physical measurements. For example, the "ground truth" for electrical safety would be defined by the specified limits in IEC 60601-1, and the "ground truth" for acoustic output would be the acceptable power levels specified in FDA guidance.

8. The Sample Size for the Training Set

This information is not applicable. The device is a hardware product, and the concept of a "training set" for an algorithm is not relevant.

9. How the Ground Truth for the Training Set was Established

This information is not applicable. As there is no training set for an algorithm, the method for establishing its ground truth is irrelevant.

Summary

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DEC 2 0 2002

K023/54

Confidential

510(k)

Vascular Control Systems, Inc. VCS-A Series Clamp with Doppler Ultrasound

SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA and 21 CFR 807.92.

Submitter's name, address, telephone number, contact person, and date summary 1. prepared:

a.	Submitter:	Vascular Control Systems, Inc.32236-E Paseo AdelantoSan Juan Capistrano, CA 92675(949) 488-8700
b.	Contact Person:	Al MemmoloVice President, Regulatory Affairs/Quality Assurance(949) 488-8700 ext. 108

Date Summary Prepared: September 20, 2002 C.

Name of device, including trade name and classification name: 2.

a.	Trade/Proprietary Name:	VCS-A Series Vascular Clamp with DopplerUltrasound
b.	Classification names:	Vascular Clamp / Diagnostic UltrasoundTransducer(21 CFR §870.4450, 21 CFR §892.1570)

1. Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:

A. 510(k) #:	K011863
Company:	Vascular Control Systems, Inc.
Device Classification:	Class II
Device Name:	VCS-A Series Clamp with Doppler Ultrasound
Clearance Date:	February 15, 2002
B. 510(k) #:	K973080
Company:	Walter Lorenz Surgical, Inc.
Device Classification:	Class II
Device Name:	Surgical Vascular Clamp
Clearance Date:	February 23, 1998
C. 510(k) #:	K935994
Company:	Koven Technologies, Inc.
Device Classification:	Class II
Device Name:	PW Doppler Vascular Probes
Clearance Date:	May 11, 1995

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4. A description of the device that is the subject of the 510(k), including explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):

Statement of intended use: 5.

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

Statement of how the technological characteristics of the device compare to those of 6. the predicate or legally marketed device.

The modified VCS-A Series Clamp and the predicate device are both intended for temporary occlusion of blood vessels using an 8 MHz pulsed-wave Doppler sensor. The modifications to the VCS-A Series Clamp do not affect the intended use or scientific technology of the device.

Brief summary of nonclinical tests and results: 7.

The VCS-A Series Clamp has been designed and tested to comply with the requirements of IEC 60601-1 for electrical and thermal safety. Acoustic output power measurements were performed in accordance with the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers. Test results indicate reliable performance when the device is used in accordance with the Instructions for Use. The modified VCS-A Series Clamp does not raise new issues of safety, effectiveness, or performance of the product.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 20. 2002

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

Re: K023154

VCS-A Series Clamp Regulation Number: 21 CFR 870.4450 and 892.1570 Regulation Name: Vascular clamp and Diagnostic ultrasound transducer Regulatory Class: II Product Code: 72 DXC and 90 ITX Dated: September 20, 2002 Received: September 23, 2002

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.

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Page 2 - Mr. Al Memmolo

This determination of substantial equivalence applies to the following transducers intended for use with the Vascular Technology (VTI) Doppler Transceiver, 8 MHz Selectable Channel REF 108900-40, as described in your premarket notification:

Transducer Model Number

09-0007-01 09-0007-02 09-0008-01 09-0008-02 .

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.

In this notification, you have provided 510(k) special reports, dated September 20, 2002 and October 18, 2002, for the four subject devices specified above.

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, extension 163.

Sincerely yours,

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

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Indications for Use Statement

K023154

Page 1 of 1

510(k) Number (if known):

Device Name: .

VCS-A-Series Clamp with Doppler Ultrasound

Indications for Use:

The VCS-A Series Clamp is intended 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)

(Division Sign-Off)
Division	Cardiovascular Devices
510(k) Number	K023154

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter-Use
------------------------------------------	----	----------------------

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Vascular Control Systems, Inc. 510(k) K023154 -- Amendment 1 VCS-A Series Clamp with Doppler Ultrasound

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of he human body as follows:


Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(specify)Vascular				P
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal Superficial
Other (specify)

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments: VCS-A Series Clamp with Doppler Ultrasound, Model 09-0008-01

The transducer is specified for use with the Vascular Technology, Inc. Doppler Transceiver,

8 MHz Selectable Channel, VTI P/N 108900-40.

(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)

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Vascular Control Systems, Inc. 510(k) K023154 .- Amendment 1 VCS-A Series Clamp with Doppler Ultrasound

Diagnostic Ultrasound Indications for Use Fo

Fill out one form for each ultrasound system and each transducer.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of he human body as follows:

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(specify)Vascular				P
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments: YCS-A Series Clamp with Doppler Ultrasound, Model 09-0008-02

The transducer is specified for use with the Vascular Technology, Inc. Doppler Transceiver,

8 MHz Selectable Channel, VTI P/N 108900-40.

(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)

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).