PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP

K992174 · Pilling Weck Surgical · DXC · Mar 23, 2000 · Cardiovascular

Device Facts

• Record ID: K992174
• Device Name: PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP
• Applicant: Pilling Weck Surgical
• Product Code: DXC · Cardiovascular
• Decision Date: Mar 23, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aortic Spoon Jaw Clamp is for use in the coronary bypass operations without application of an aortic clamp. It provides a mechanical means to isolate a 10 x 8mm area of the aortic wall from blood flow.

Device Story

Aortic Spoon-Jaw Clamp is a surgical instrument used during coronary bypass operations. It functions as a mechanical tool to isolate a specific 10 x 8mm area of the aortic wall from blood flow, allowing surgeons to perform procedures without the need for a traditional, full-occlusion aortic clamp. The device is operated by a surgeon in an operating room setting. By providing localized isolation, it aims to reduce the risks associated with total aortic clamping during bypass surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical surgical clamp designed for localized aortic wall isolation (10 x 8mm area). Device is a manual instrument; no energy source, software, or electronic components.

Indications for Use

Indicated for use in coronary bypass operations to isolate a 10 x 8mm area of the aortic wall from blood flow without the application of a traditional aortic clamp.

Regulatory Classification

Identification

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

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus features a staff with two snakes entwined around it, topped with a pair of wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2000

Mr. Richard G. Jones Pilling Weck Surgical 420 Delaware Drive Fort Washington, PA 19034

Re: K992174 Aortic Spoon-Jaw Clamp Requlatory Class: II (two) Product Code: DXC January 21, 2000 Dated: Received: January 24, 2000

Dear Mr. Jones:

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 Regulations, 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 Regulation (QS) for Medical Devices: General requlation (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 Register. Please note: this response to your premarket notification submission does not affect any 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.

{1}------------------------------------------------

## MAR 2 3 2000

## Page 2 - Mr. Richard G. Jones

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" (21 CFR 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,

Sincerely yours,

Chitrmy thita

James E. Dillard III Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

510(K) Number (if known):

Device Name: Aortic Spoon Jaw Clamp

Indications for Use:

The Aortic Spoon Jaw Clamp is for use in the coronary bypass operations without application of an aortic clamp. It provides a mechanical means to isolate a 10 x 8mm area of the aortic wall from blood flow.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chitophem. Hunfor.

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K992174

The-Counter Use

Prescription Use or Over-

(Per 21 CFR 801.1 09)