PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS

K992476 · Pilling Weck Surgical · MWS · Sep 13, 2000 · Cardiovascular

Device Facts

• Record ID: K992476
• Device Name: PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS
• Applicant: Pilling Weck Surgical
• Product Code: MWS · Cardiovascular
• Decision Date: Sep 13, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4500
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Heart Stabilizer Pad is used on an appropriate heart stabilizer unit for coronary bypass surgery. It provides a mechanical means for immobilization of the anastomotic site on a beating heart and provides coronary artery isolation and occlusion by compression.

Device Story

The Heart Stabilizer Removable Pad is a surgical accessory designed for use with a heart stabilizer unit during coronary artery bypass graft (CABG) surgery. The pad attaches to the stabilizer device to provide a mechanical interface with the epicardial surface. By applying localized compression, the pad immobilizes the specific anastomotic site on the beating heart and facilitates coronary artery isolation and occlusion. This allows the surgeon to perform bypass procedures on a beating heart. The device is intended for use in an operating room setting by qualified cardiovascular surgeons.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical surgical accessory; pad form factor; designed for attachment to heart stabilizer units; non-powered; manual operation.

Indications for Use

Indicated for use during coronary bypass surgery to immobilize the anastomotic site on a beating heart and provide coronary artery isolation and occlusion via compression.

Regulatory Classification

Identification

Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.

Submission Summary (Full Text)

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

Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle's head and neck, with three curved lines representing the body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

SEP 1 3 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Mosaddeq Hossain Regulatory Affairs/Quality Assurance Pilling Weck Surgical 420 Delaware Drive Fort Washington, PA 19034 .

K992476 Re: Pilling Weck Surgical Stabilizer Removable Pads Trade Name: Regulatory Class: I (one) Product Code: MMS Dated: June 13, 2000 Received: June 15, 2000

Dear Mr. Hossain:

We have reviewed your Section 510(k) notification of intent to market the we have reviewed your boose. The determined the device is device referenced above and we nate accessions for use stated in the substantially equivalenc (for the endress marketed in interstate enclosure) to legally marketed produce ment date of the Medical Device commerce prior to May 20, 1970, che character in accordance with Amendments, of to devices chat have book and Cosmetic Act (Act) . You
the provisions of the Federal Food, Drug, and Cosmetic controle the provisions of the reacturies, subject to the general controls may, therefore, market the device, canfrols provisions of the Act, provisions of the Act. The general consisted plasting of devices, good include requirements for annual regiording, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special If your device Is Classifica (boo aboroval), it may be subject to such Controls) of Class III (Fremaries opproventions affecting your device additional controls. Extreme major boysations, Title 21, Parts 800 to e found in the oodeuivalent determination assumes compliance with 895. 895. A substantially equivalence active requirements, as set forth in the the Current Good Manufacturing Fracesses al copices: General regulation Quarity System Regulacion (20) 2021 periodic QS inspections, the Food and (21 CFR Parc 820) and that, chrough pouch assumptions. Failure to comply
Drug Administration (FDA) will verify such assumption - In addition Drug Administration (result in regulatory action. In addition,
with the GMP regulation may result in regulatory device in the with the GMF regulation may reserved to concerning your device in the For may publicity . Please note: this response to your premarket rederal Register. Frease not affect any obligation you might have noctricacion basis of the Act for devices under the under sections 551 through 312 or other Federal laws or requlations.

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

This letter will allow you to begin marketing your device as described in Inis leccer will arrow you se-blash. The FDA finding of substantial your Jro(k) premail.or not to a legally marketed predicate device results equivalence or 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 (Zi Crk rate oor and addression fire of Compliance at [phone]. additionally, for questions on the promotion and advertising of your Audicionally, for quoberne to compliance at [phone]. Also, alease note the regulation entitled, "Misbranding by reference to Other general information on premarket notification" (21CFR 807.97). premarked notification (Eroste act may be obtained from the Division of your responsibilities and its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

. Sincerely yours,

James E. Dillard III

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

Enclosure

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

510(K) Number (if known):

Device Name: Pilling Weck Surgical Heart Stabilizer Removable Pads

K992476

Indications for Use:

The Heart Stabilizer Pad is used on an appropriate heart stabilizer unit for coronary bypass surgery. It provides a mechanical means for immobilization of the anastomotic site on a beating heart and provides coronary artery isolation and occlusion by compression.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kathi Miller

(Division Sign. Division of Cardiovascular, Respiratory, and Neurological De 510(k) Number

Prescription Use _X

**The-Counter Use-**\$\times\$

(Per 21 CFR 801.1 09)

or Over-