AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT

K032696 · United States Surgical, A Division of Tyco Healthc · GDW · Dec 1, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K032696
• Device Name: AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Dec 1, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Auto Suture* TA* & knifeless GIA* staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomoses, including occlusion of the left atrial appendage in open procedures.

Device Story

Auto Suture TA and GIA staplers are surgical instruments designed to place multiple staggered rows of titanium or stainless steel staples into tissue. Used by surgeons in abdominal, gynecologic, pediatric, and thoracic procedures to perform resection, transection, and creation of anastomoses, including left atrial appendage occlusion. Devices function mechanically to approximate and secure tissue edges. No electronic or software components involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Titanium or stainless steel compliant with ISO Standard #10993-1. Mechanical stapling mechanism. No energy source, software, or connectivity.

Indications for Use

Indicated for patients undergoing abdominal, gynecologic, pediatric, or thoracic surgery requiring resection, transection, or anastomosis, including occlusion of the left atrial appendage in open procedures.

Regulatory Classification

Identification

An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• Auto Suture TA & GIA Staplers (K032696)

Submission Summary (Full Text)

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# DEC - 1 2003

K03 2696

## IX. 510(k) Summary of Safety and Effectiveness

| SUBMITTER: | United States Surgical<br>150 Glover Avenue<br>Norwalk, CT 06856 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Chester McCoy |
| DATE PREPARED: | November 14, 2003 |
| CLASSIFICATION NAME: | Staple, Implantable |
| COMMON NAME: | Staple, Implantable |
| PROPRIETARY NAME: | Auto Suture* TA* & GIA* Staplers |
| PREDICATE DEVICES: | Auto Suture* TA* & GIA* Staplers |
| TECHNOLOGICAL CHARACTERISTICS: | The Auto Suture* TA* & GIA* Staplers are identical to the predicate devices. The only changes are in the indication for use statement. |
| DEVICE DESCRIPTION: | The Auto Suture* TA* & GIA* Staplers are designed to place multiple staggered rows of titanium or stainless steel staples in various types of tissues. |
| INTENDED USE: | The Auto Suture* TA* & knifeless GIA* staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomoses, including occlusion of the left atrial appendage in open procedures. |
| MATERIALS: | All component materials of the Auto Suture TA* & GIA* staplers are comprised of materials which are in accordance with ISO Standard #10993-1 |

United States Surgical *Trademark of United States Surgical

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three wavy lines, which represent the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 1 2003

Mr. Chester McCoy Director of Regulatory Affairs United States Surgical 150 Glover Avenue Norwalk, Connecticut 06856

Re: K032696

Trade/Device Name: Auto Suture TA Surgical Staplers Auto Suture Knifeless GIA Surgical Staplers Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: August 29, 2003 Received: September 2, 2003

Dear Mr. McCoy:

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. Insting 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. FIDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs 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.

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Page 2 - Mr. Chester McCoy

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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# K 032696

### IV. Indications For Use:

510(k) Number (if known): K032696

Name: Auto Suture* TA* Surgical Staplers Auto Suture* Knifeless GIA* Surgical Staplers

#### Indications For Use:

The Auto Suture* TA* & knifeless GIA* staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomoses, including occlusion of the left atrial appendage in open procedures.

(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Evaluation (ODE)

| Prescription Use:<br>(Per 21 CFR §801.109) | OR Over-The-Counter Use: |
|---------------------------------------------|--------------------------|
|---------------------------------------------|--------------------------|

Miriam C. Provost

1. Restorative al Devic

510(k) Number K032696