COSGROVE CLAMP

K974769 · Allegiance Healthcare Corp. · DXC · Jun 12, 1998 · Cardiovascular

Device Facts

• Record ID: K974769
• Device Name: COSGROVE CLAMP
• Applicant: Allegiance Healthcare Corp.
• Product Code: DXC · Cardiovascular
• Decision Date: Jun 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Allegiance Cosgrove™ Clamp is intended to be used for the temporary occlusion of blood vessels and other delicate vessels during surgerv. Surqical applications include pulmonary and gastrointestinal procedures, peripheral clamping, minimally invasive and standard open cardiovascular and cardiothoracic procedures such as occlusion of the aorta and vena cava, cross-clamping of the aorta, etc.

Device Story

The Cosgrove™ Clamp is a reusable surgical instrument featuring a stainless steel handle, flexible shaft, and jaws. It is designed for use with various inserts that provide atraumatic occlusion of blood vessels. The device is operated by surgeons in clinical settings (OR) during cardiovascular, cardiothoracic, pulmonary, and gastrointestinal procedures. The flexible shaft allows the surgeon to bend the device out of the way after clamping to improve visualization and access to the operative field. By providing temporary, atraumatic vessel occlusion, the device assists in managing blood flow during surgery, potentially reducing tissue trauma and improving surgical site access.

Clinical Evidence

Bench testing only. All materials were subjected to performance and physical tests to evaluate safety, effectiveness, and reliability. All test results were acceptable.

Technological Characteristics

Reusable surgical clamp; stainless steel handle; flexible shaft; jaws designed for use with inserts for atraumatic occlusion. Mechanical device; no energy source or software.

Indications for Use

Indicated for temporary occlusion of blood vessels and other delicate vessels during pulmonary, gastrointestinal, and cardiovascular procedures, including minimally invasive and standard open surgeries. Used for peripheral clamping and clamping over indwelling catheters.

Regulatory Classification

Identification

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

Predicate Devices

• Allegiance Fogarty-Hydragrip® Surgical Clamp (K951413)
• Applied Vascular Atraumax™ Surgical Clamps

Submission Summary (Full Text)

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Ka74769

Image /page/0/Picture/1 description: The image shows the word "Allegiance" in a bold, stylized font. To the left of the word is a symbol resembling a plus sign, but it is made up of many small squares. The word "Allegiance" is written in a slightly slanted, cursive-like style, with the letters connected to each other. The overall impression is that of a logo or brand name.

Allegiance Healthcare corporation

JUN 1 2 1998

1500 Waukegan Road McGaw Park, IL 60085 847 473 1500 FAX: [phone]

## SUMMARY OF SAFETY AND EFFECTIVENESS Appendix F

Manufacturer:

Allegiance Healthcare Corporation V. Mueller Business Unit 1435 Lake Cook Road Deerfield, IL 60015

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

[phone]

December 19, 1997

Cosgrove™ Clamp

Vascular Clamp

Vascular Clamp

Allegiance Fogarty-Hydragrip® Surgical Clamp

The Allegiance Cosgrove™ Clamp is a reusable device which features a stainless steel handle, flexible shaft and jaws. The Cosgrove™ 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.

Telephone:

Date Summary Prepared:

Regulatory Affairs Contact

Product Trade Name:

Common Name: 游--

Classification:

Predicate Device: (K951413)

Description:

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The Allegiance Cosgrove™ Clamp is intended Intended Use: to be used for the temporary occlusion of blood vessels and other delicate vessels during surgerv. Surqical applications include pulmonary and gastrointestinal procedures, peripheral clamping, minimally invasive and standard open cardiovascular and cardiothoracic procedures such as occlusion of the aorta and vena cava, cross-clamping of the aorta, etc. Substantial Equivalence: The Allegiance Cosgrove™ Clamp is substantially equivalent to the Fogarty-Hydragrip® Surgical Clamps and the Applied Vascular Atraumax™ Surgical Clamps in that: Intended use is the same ● Performance attributes are the same ● Atraumatic Jaw design characteristic is the . same Summary of Testing: All materials used in the composition of the Cosgrove™ Clamp were subjected to performance and physical tests to evaluate the safety, effectiveness and reliability of the device. All test results were acceptable.

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## Public Health Service

JUN 1 2 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Patricia Sharpe-Gregg Manager, Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukeqan Road, Bldg. MPWM McGaw Park, IL 60085

Re: K974769 Trade Name: Cosgrove Clamp Requlatory Class: II Product Code: DXC Dated: May 30, 1998 Received: June 14, 1998

Dear Ms. Sharpe-Gregg:

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 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 (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Ms. Sharpe-Gregg

obligation you might have under sections 531 through 542 of the Act for devices 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. Callahan, Ph.D. Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085 USA 847-473-1500 FAX: [phone]

510(k) Notification Cosgrove™ Clamp V. Mueller Business Unit Page 1 of 1

510(k) Number (if known):

Unknown

Device Name:

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.

Allegiance Cosgrove™ Clamp

Tatt

(Division Sign-Off) Division of Cardiovascular, Respira and Neurological Devices 510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

or

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________