VITALCOR FEATHERWEIGHT VASCULAR CLAMPS

K070661 · Vitalcor, Inc. · DXC · Aug 29, 2007 · Cardiovascular

Device Facts

• Record ID: K070661
• Device Name: VITALCOR FEATHERWEIGHT VASCULAR CLAMPS
• Applicant: Vitalcor, Inc.
• Product Code: DXC · Cardiovascular
• Decision Date: Aug 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These titanium clamps are used for temporarily occlusion of blood vessels during surgery.

Device Story

Vitalcor Featherweight Vascular Clamps are manual surgical instruments used for temporary occlusion of blood vessels during surgery. Constructed from Grade 5 titanium, these multi-use clamps are calibrated to exert a specific clamping pressure (15g/mm²) to minimize vessel damage. The device is available in six sizes, each designed for a specific vessel diameter range (0.4mm to 5mm). Used by surgeons in an operating room setting, the clamps provide a mechanical means to occlude vessels during procedures such as microvascular anastomosis. The titanium construction makes the device non-magnetic, offering an advantage over stainless steel alternatives. The clamps are sterilized via steam autoclave. By providing controlled, atraumatic occlusion, the device facilitates surgical access and vessel management, potentially reducing the risk of vessel trauma during complex vascular procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility verification and validation of steam autoclave sterilization by an independent laboratory.

Technological Characteristics

Material: Grade 5 titanium. Sensing/Actuation: Mechanical spring-loaded clamping. Energy Source: None (manual). Dimensions: Six sizes covering vessel ranges from 0.4mm to 5mm. Connectivity: None. Sterilization: Steam autoclave. Software: None.

Indications for Use

Indicated for temporary atraumatic vascular occlusion of blood vessels during surgery in patients requiring microvascular procedures.

Regulatory Classification

Identification

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

Predicate Devices

• S&T Micro Anastomosis Clamp (K022754)

Submission Summary (Full Text)

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AUG 2 9 2007

510(k) Summary Vitalcor. Inc 100 E. Chestnut Ave Westmont, IL 60559 [phone] 630-325-5500 Fax [phone] Contact: R Gregory Huck, President Prepared July 21, 2007

## 1. Identification of the Device:

Proprietary-Trade Name: Vitalcor Featherweight Vascular Clamps Classification Name/Product Codes: DXC Common/Usual Name: Vascular Clamp

- 2. Equivalent legally marketed devices: S&T Micro Anastomosis Clamp, K022754
- 3. Indications for Use (intended use) : These titanium clamps are used for temporarily occlusion of blood vessels during surgery.
- 4. Description of the Device: Vitalcor Featherweight clamps are made from Grade 5 titanium, Vitalcor Featherweight clamps are calibrated to have a clamping pressure that will minimize the possibility of vessel damage. As a guide, the following Vitalcor Featherweight sizes should be used for the vessels size range indicated.
- VA079-06 0.4mm-1.0mm .
- . VA115−09 0.6mm−1.5mm
- VA140-09 1mm-2mm .
- VA240-18 1.5mm-3mm .
- VA300-24 2mm-4mm .
- VA375-30 3mm-5mm .
- 5. Comparison to predicate device. The results of non-clinical and bench testing indicates that the new device is completely comparable to the predicate devices. Biocompatibility and sterilization studies were successfully completed.

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## 6. Substantial Equivalence Chart

| Item | Predicate S&T, K022754 | Vitalcor Featherweight |
|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Indications | The S&T Micro<br>Anastomosis Clamp is a<br>hand held surgical<br>instrument that is designed to<br>be used in Microvascular<br>Surgery to either temporarily<br>occlude or approximate<br>blood vessels during the<br>anastomosis process. The<br>clamps are used to facilitate<br>surgical procedures that are<br>typically called "free flaps"<br>or replants. Once the micro<br>anastomosis has been<br>completed the micro clamp is<br>removed from the patient. | These titanium clamps are<br>used for temporarily<br>atraumatic vascular<br>occlusion of blood vessels<br>during surgery. |
| Vessel size range | The clamps are available in<br>three different size ranges and<br>are to be used on vessels that<br>range in size from 0.4mm to<br>2.25mm. | VA079-06 0.4mm-1.0mm<br>VA115-09 0.6mm-1.5mm<br>VA140-09 1mm-2mm<br>VA240-18 1.5mm-3mm<br>VA300-24 2mm-4mm<br>VA375-30 3mm-5mm |
| Material<br>employed | Stainless steel (multi-use)<br>Plastic (single use) | Titanium only, multi-use |
| Appearance | Image: Predicate S&T clamp | Image: Vitalcor Featherweight clamp |
| Range of<br>pressure on<br>vessel<br>(Maximum<br>recommended in<br>literature is<br>30g/mm²) | 15g/mm² | 15g/mm² |
| Magnetic | Yes (stainless steel) | No (Titanium) |
| Sterilization | Autoclave presumed | Steam autoclave. |

- 7. Conclusion: After analyzing bench and non-clinical testing data, it is the conclusion of Vitalcor that the Featherweight Vascular Clamps are comparable to the predicate device in form and function, have few technological differences, and have no new indications for use, thus rendering them substantially equivalent to the predicate device. The ability to steam autoclave these clamps was validated by an independent laboratory. Biocompatibility verified by independent lab.

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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 stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

AUG 2 9 2007

Vitalcor, Inc. c/o Mr. Daniel Kamm Kamm & Associates P.O. Box 7007 Deerfield, IL 60015

Re: K070661

Vitalcor Featherweight Vascular Clamps Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: August 21, 2007 Received: August 24, 2007

Dear Mr. Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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.

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.

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## Page 2 -- Mr. Daniel Kamm

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 letter will allow you to begin marketing your device as described in your Section 510(k) 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 the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

R. Vachner

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

Enclosure

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## Indications for Use

510(k) Number (if known): ___K070661 ________

Vitalcor Featherweight Vascular Clamps Device Name:

Indications For Use:

These titanium clamps are used for temporarily occlusion of blood vessels during surgery.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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)

suma R.Vachmes

(Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number_603066

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