VCS-A SERIES CLAMP

K011863 · Vascular Control Systems, Inc. · DXC · Feb 15, 2002 · Cardiovascular

Device Facts

• Record ID: K011863
• Device Name: VCS-A SERIES CLAMP
• Applicant: Vascular Control Systems, Inc.
• Product Code: DXC · Cardiovascular
• Decision Date: Feb 15, 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 indicated for use in the temporary occlusion of blood vessels during vascular surgical procedures.

Device Story

VCS-A Series Clamp is a ring-handled mechanical surgical instrument with a ratchet closure mechanism; integrates a Doppler ultrasound probe to allow for blood flow monitoring in target vessels. Device is used by surgeons in vascular surgical procedures to temporarily occlude vessels. The integrated Doppler probe connects to a portable ultrasound unit to provide real-time feedback on vessel patency during occlusion. The device is sterile and single-use. By providing both mechanical occlusion and integrated flow monitoring, the device assists the surgeon in managing blood flow during surgery, potentially reducing complications associated with vessel occlusion.

Clinical Evidence

Bench testing only. Performance and functional testing demonstrated the device is equivalent to predicate devices. No clinical data provided.

Technological Characteristics

Mechanical ring-handled clamp with ratchet closure; integrated Doppler ultrasound transducer. Sterilized via Gamma Radiation (SAL 10^-6). Connectivity via external portable Doppler ultrasound unit.

Indications for Use

Indicated for temporary occlusion of blood vessels during vascular surgical procedures in patients requiring such intervention.

Regulatory Classification

Identification

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

Predicate Devices

• Surgical Vascular Clamp (K973080)
• PW Doppler Vascular Probes (K935994)

Submission Summary (Full Text)

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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.<br>32236-E Paseo Adelanto<br>San Juan Capistrano, CA 92675 |
|-----------------|-------------------------------------------------------------------------------------------|
| Contact Person: | Al Memmolo<br>V.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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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 [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].

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)

OR

Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________

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

B-2