SUTURING WASHER

K052642 · First Call, Inc. · MAB · Jan 17, 2006 · Cardiovascular

Device Facts

• Record ID: K052642
• Device Name: SUTURING WASHER
• Applicant: First Call, Inc.
• Product Code: MAB · Cardiovascular
• Decision Date: Jan 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2

Intended Use

This single use device is for radiological identification of the aortic anastomosis in coronary artery bypass surgery

Device Story

Suturing washer serves as radiopaque marker for aortic anastomosis sites during coronary artery bypass surgery. Device consists of circular ring (4.5mm outer diameter, 1.5mm inner diameter, 1mm thickness) implanted permanently at surgical site. Surgeon places washer during procedure to facilitate post-operative radiological identification. Device provides visual reference on imaging, aiding clinical assessment of graft site. Single-use, requires sterilization prior to implantation.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Materials: Stainless steel (ASTM F-138) or titanium (ASTM F-136). Dimensions: 4.5mm OD, 1.5mm ID, 1mm thickness. Form factor: Circular ring. Energy source: None (passive implant). Sterilization: Required prior to use.

Indications for Use

Indicated for radiological identification of the aortic anastomosis in patients undergoing coronary artery bypass surgery.

Regulatory Classification

Identification

A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”

Predicate Devices

• Cook® Vein Graft Ring Marker (K864101)

Submission Summary (Full Text)

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

First Call, Inc. 660 E 200 N, Warsaw, IN 46580

K 052642

| SUMMARY PREPARED: | December 28, 2005 |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) SPONSOR/APPLICANT: | First Call, Inc.<br>660 E 200 N, Warsaw IN 46580 |
| 510(k) PREPARER and<br>CONTACT PERSON: | Dina L. Weissman, J.D.<br>P.O. Box 205, Derby CT 06418<br>Telephone: [phone]<br>Email: [e-mail] |
| TRADE NAME: | Suturing Washer |
| COMMON NAME: | Marker, Cardiopulmonary Bypass (Vein Marker) |
| CLASSIFICATION: | unclassified |
| DEVICE PRODUCT CODE: | MAB |
| PREDICATE DEVICE: | Cook® Vein Graft Ring Marker, K864101,<br>Cleared 30 October 1986 |
| DEVICE DESCRIPTION: | This 4.5mm outer diameter suturing washer is<br>manufactured from either stainless steel (ASTM F-138)<br>or titanium (ASTM F-136). It is permanently implanted<br>and must be sterilized prior to use. |
| INTENDED USE: | This single use device is for radiological identification of<br>the aortic anastomosis in coronary artery bypass surgery |
| COMPARISON TO PREDICATES: | The First Call, Inc. Suturing Washer is similar to the<br>listed predicate device in intended use, performance<br>characteristics, materials of construction, manufacturing<br>methods and design. |

# 510(k) Summary of Safety and Effectiveness

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

## PREMARKET NOTIFICATION

## I. DEVICE SPECIFICATIONS

| TRADE NAME: | Suturing Washer |
|----------------------|----------------------------------------------|
| COMMON NAME: | Marker, Cardiopulmonary Bypass (Vein Marker) |
| CLASSIFICATION: | Unclassified |
| DEVICE PRODUCT CODE: | MAB |

#### Narrative Description

The suturing washer is manufactured from stainless steel, conforming to ASTM F-138, or titanium, conforming to ASTM F-136.

This device is for single use and must be sterilized prior to use.

#### Intended Use/Indications for Use

This single use device is for radiological identification of the aortic anastomosis in coronary artery bypass surgery

### Physical Description

The suturing washer is made from a solid piece of stainless steel (conforming to ASTM F-138) or titanium (conforming to ASTM F-136). The circular device has an outer diameter of 4.5mm and an inner diameter of 1.5mm. It is approximately 1mm in thickness.

The part number is provided in Exhibit A.

The engineering drawing is supplied in Exhibit B.

#### Labeling

.

A proposed label and draft instructions for use are included in Exhibit C.

### Predicate Device

There is no clearance letter or 510(k) summary available online for the predicate device, but the printout from the FDA 510(k) premarket notification database and the page from the Foot website are attached in Exhibit D as evidence of the predicate being legally mont the COU predicate is

- Cook® Vein Graft Ring Marker, K864101, cleared 30 October 1986 .
A discussion of the similarities to and difference from these devices is in the Substantial Equivalence section, following the Manufacturing section.

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

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

JAN 1 7 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

First Call, Inc. c/o Ms. Rebecca Kitchens President 660 E 200 N Warsaw, IN 46580

Re: K052642

Trade Name: Suturing Washer Regulation Name: Suturing Washer Regulatory Class: Unclassified Product Code: MAB Dated: December 28, 2005 Received: December 30, 2005

Dear Ms. Kitchens:

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.

{3}------------------------------------------------

Page 2 – Ms. Rebecca Kitchens

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours,

Dana R. Vachner

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

Enclosure

{4}------------------------------------------------

#### Indications for Use

510(k) Number (if known): K052642

Device Name: Suturing Washer

### Indications for Use:

This single use device is for radiological identification of the aortic anastomosis in coronary artery bypass surgery.

Prescription Use XXXXX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dmna R. Vo dner

Division Sign-Off) livision of Cardiovascular Devices

Page 1 of 1

10(k) Number_K いち2ん42