VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-02

K023154 · Vascular Control Systems, Inc. · DXC · Dec 20, 2002 · Cardiovascular

Device Facts

• Record ID: K023154
• Device Name: VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-02
• Applicant: Vascular Control Systems, Inc.
• Product Code: DXC · Cardiovascular
• Decision Date: Dec 20, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

VCS-A Series Clamp is a stainless steel, ring-handled surgical instrument with an integrated 8 MHz pulsed-wave (PWD) Doppler ultrasound sensor. Used during vascular surgery to temporarily occlude blood vessels; the integrated sensor provides audible blood flow feedback. The device connects to a separate, commercially available portable Doppler transceiver box (Vascular Technology, Inc. 8 MHz Selectable Channel). Operated by surgeons in an intraoperative setting. The audible output allows the surgeon to confirm vessel occlusion or patency in real-time, aiding clinical decision-making regarding blood flow management during procedures. Benefits include precise, monitored vessel control.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 for electrical and thermal safety was verified. Acoustic output power measurements were conducted in accordance with FDA guidance for diagnostic ultrasound systems. No clinical data was required or provided.

Technological Characteristics

Stainless steel vascular clamp with integrated 8 MHz pulsed-wave Doppler transducer. Operates via connection to external Doppler transceiver (VTI P/N 108900-40). Electrical/thermal safety per IEC 60601-1. Acoustic output compliant with FDA diagnostic ultrasound guidance.

Indications for Use

Indicated for temporary occlusion of blood vessels during vascular surgical procedures in patients requiring intraoperative vascular flow monitoring.

Regulatory Classification

Identification

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

Predicate Devices

• VCS-A Series Clamp with Doppler Ultrasound (K011863)
• Surgical Vascular Clamp (K973080)
• PW Doppler Vascular Probes (K935994)

Submission Summary (Full Text)

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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.<br>32236-E Paseo Adelanto<br>San Juan Capistrano, CA 92675<br>[phone] |
|----|-----------------|-------------------------------------------------------------------------------------------------------------|
| b. | Contact Person: | Al Memmolo<br>Vice President, Regulatory Affairs/Quality Assurance<br>[phone] 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 Doppler<br>Ultrasound |
|----|-------------------------|----------------------------------------------------------------------------------------------|
| b. | Classification names: | Vascular Clamp / Diagnostic Ultrasound<br>Transducer<br>(21 CFR §870.4450, 21 CFR §892.1570) |

- 3. 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):

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.

#### 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 [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 Assistance at its toll-free number [phone] or at [phone] 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 [phone], 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<br>(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:

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