FLEXIBLE VASCULAR CLAMP, VERSION 2

K991589 · Allegiance Healthcare Corp. · DXC · May 18, 1999 · Cardiovascular

Device Facts

• Record ID: K991589
• Device Name: FLEXIBLE VASCULAR CLAMP, VERSION 2
• Applicant: Allegiance Healthcare Corp.
• Product Code: DXC · Cardiovascular
• Decision Date: May 18, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Allegiance Flexible Vascular Clamp, Version 2 is intended to be used for the temporary occlusion of blood vessels and other delicate vessels during surgery. Surgical applications include pulmonary and gastrointestinal procedures, peripheral clamping, minimally invasive and standard open cardiovascular and cardio-thoracic procedures such as occlusion of the aorta and vena cava, cross-clamping of the aorta, etc.

Device Story

Reusable vascular clamp featuring stainless steel handle, flexible shaft, and jaws; used with various inserts for atraumatic vessel occlusion. Operated by surgeons in OR settings during cardiovascular, thoracic, pulmonary, or gastrointestinal procedures. Flexible shaft allows bending to improve visualization and access to operative field. Device provides temporary vessel occlusion; benefits include enhanced surgical access and atraumatic vessel handling.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Reusable stainless steel construction; flexible shaft and jaw mechanism; utilizes interchangeable inserts for atraumatic occlusion. No electronic components or software.

Indications for Use

Indicated for temporary occlusion of blood vessels and other delicate vessels during surgery, including pulmonary, gastrointestinal, and standard open or minimally invasive cardiovascular/cardio-thoracic procedures. Can be used to clamp over indwelling catheters.

Regulatory Classification

Identification

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

Predicate Devices

• Cosgrove™ Clamp (K974769)

Submission Summary (Full Text)

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MAY 1 8 1999

Image /page/0/Picture/2 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a graphic of a plus sign made up of small circles. The word is in black and the background is white.

Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, IL 60085

847.473.1500 FAX: [phone]

## SUMMARY OF SAFETY AND EFFECTIVENESS Attachment E

Manufacturer:

Allegiance Healthcare Corporation V. Mueller Business Unit 1430 Waukegan Road McGaw Park, IL 60085

Patricia Sharpe-Gregg Regulatory Affairs Contact 1500 Waukegan Road McGaw Park, Illinois 60085

Telephone:

Date Summary Prepared:

Product Trade Name:

Common Name:

Classification:

Predicate Device: (K974769)

Description:

[phone]

April 9, 1999

Flexible Vascular Clamp, Version 2

Vascular Clamp

Vascular Clamp

Cosgrove™ Clamp

The Allegiance Flexible Vascular Clamp, Version 2 is a reusable device which features a stainless steel handle, flexible shaft and jaws. This clamp is designed to be used with a variety of inserts which gently surround blood vessels and offer differing degrees of atraumatic occlusion. Following the clamping of the blood vessel, the shaft of the device can be bent out of the way to enhance visualization of and access to the operative field.

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| Intended Use: | The Allegiance Flexible Vascular Clamp,<br>Version 2 is intended to be used for the<br>temporary occlusion of blood vessels and<br>other delicate vessels during surgery. Surgical<br>applications include pulmonary and<br>gastrointestinal procedures, peripheral<br>clamping, minimally invasive and standard<br>open cardiovascular and cardio-thoracic<br>procedures such as occlusion of the aorta and<br>vena cava, cross-clamping of the aorta, etc. |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence: | The Allegiance Flexible Vascular Clamp,<br>Version 2 is substantially equivalent to the<br>Allegiance Cosgrove™ Clamp in that: |
| | Intended use is the same Performance attributes are the same Atraumatic Jaw design characteristic is the same Materials are the same |
| Summary of Testing: | All materials used in the composition of the<br>Flexible Vascular Clamp, Version 2 were<br>subjected to performance and physical tests to<br>evaluate the safety, effectiveness and |
| Common Name: | Vascular Clamp |
| Classification: | Vascular Clamp |
| Predicate Device:<br>(K974769) | Cosgrove™ Clamp |
| Description: | The Allegiance Flexible Vascular Clamp,<br>Version 2 is a reusable device which features<br>a stainless steel handle, flexible shaft and<br>jaws. This clamp is designed to be used with a<br>variety of inserts which gently surround blood<br>vessels and offer differing degrees of<br>atraumatic occlusion. Following the clamping<br>of the blood vessel, the shaft of the device can<br>be bent out of the way to enhance visualization<br>of and access to the operative field. |

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 18 1999

Ms. Patricia Sharpe-Gregg Manager, Requlatory Affairs Allegiance Healthcare Corporation V. Mueller Business Unit 1430 Waukegan Road McGaw Park, IL ୧୦୦୫ ମ

K991589 Re: Flexible Vascular Clamp, Version 2 Trade Name: Requlatory Class: II Product Code: DXC May 6, 1999 Dated: Received: May 7, 1999

Dear Ms. Sharpe-Greqq:

We have reviewed your Section 510(k) 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 reqistration, listinq 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Please note: this response to your premarket Federal Reqister. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices

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Paqe 2 - Ms. Patricia Sharpe-Gregg

under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callaha Director Division of Cardiovascular, Respiratory and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/1 description: The image shows the word "Allegiance" in a bold, sans-serif font. The word is black and slightly slanted to the right. To the left of the word is a symbol that looks like a plus sign made up of small dots. The dots are arranged in a grid-like pattern, with the center dot being the largest and the surrounding dots decreasing in size as they move away from the center.

Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085 USA FAX: [phone]-3636

> Special 510(k) Device Modification: Flexible Vascular Clamp, Version 2 V. Mueller Business Unit Page 1 of 1

510(k) Number (if known):

Unknown

Device Name:

Flexible Vascular Clamp, Version 2

Indications For Use:

Used to occlude a blood vessel temporarily. Used in pulmonary and gastrointestinal procedures and can be used to clamp over indwelling catheters. Also used in minimally invasive and standard open cardiovascular procedures for temporary occlusion of a blood vessel.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

or

Over-The Counter Use

tolem. Re-for TJC

vision Sign=Off) Division of Cardiovascular, Respiratory, and Neurological Dev

510(k) Number