AUTO SUTUR ENDO GIA STAPLERS

K061095 · United States Surgical, A Division of Tyco Healthc · GDW · May 31, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061095
• Device Name: AUTO SUTUR ENDO GIA STAPLERS
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: GDW · General, Plastic Surgery
• Decision Date: May 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Auto Suture™ ENDO GIA™ Staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomoses. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.

Device Story

ENDO GIA™ Stapler is a surgical instrument used for tissue resection, transection, and anastomosis. Device places two, triple-staggered rows of titanium staples while simultaneously dividing tissue between rows. Staple size is determined by selection of single-use loading unit (SULU) (2.0 mm, 2.5 mm, 3.5 mm, or 4.8 mm). SULU lengths available in 30 mm, 45 mm, and 60 mm. Used in abdominal, gynecologic, pediatric, and thoracic surgery, including liver procedures. Operated by surgeons in clinical settings. Provides mechanical tissue closure and division, facilitating surgical procedures and potentially reducing operative time.

Clinical Evidence

Evidence includes in-vivo animal testing and a clinical literature search to support the resection and transection of liver substance, hepatic vasculature, and biliary structures.

Technological Characteristics

Mechanical surgical stapler. Components comply with ISO 10993-1. Uses titanium staples. Available in multiple SULU sizes (2.0-4.8 mm) and lengths (30-60 mm). Manual operation.

Indications for Use

Indicated for patients undergoing abdominal, gynecologic, pediatric, or thoracic surgery requiring resection, transection, or anastomosis, including resection/transection of liver substance, hepatic vasculature, and biliary structures.

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™ ENDO GIA™ Stapler (K061095)

Submission Summary (Full Text)

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510(k) Summary of Safety and Effectiveness

| SUBMITTER: | United States Surgical, a division of Tyco Healthcare Group LP<br>150 Glover Avenue<br>Norwalk, CT 06856<br>Tel. No.: [phone]<br>MAY 31 2006 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Frank Gianelli<br>Senior Associate, Regulatory Affairs |
| DATE PREPARED: | April 17, 2006 |
| TRADE/PROPRIETARY NAME: | Auto Suture™ ENDO GIA™ Stapler |
| COMMON/USUAL NAME: | Staple, Implantable |
| CLASSIFICATION NAME: | Staple, Implantable |
| PREDICATE DEVICE(S): | Auto Suture™ ENDO GIA™ Stapler |
| DEVICE DESCRIPTION: | The Auto Suture™ ENDO GIA™ Stapler places two, triple-<br>staggered rows of titanium staples and simultaneously divides<br>the tissue between the two, triple-staggered rows. The size of<br>the staples is determined by the selection of the 2.0 mm, 2.5<br>mm, 3.5 mm or 4.8 mm single-use loading unit (SULU). The<br>ENDO GIA™ Stapler will accommodate any of the single-use<br>loading units that are available in 30 mm, 45 mm and 60 mm<br>sizes. |
| INTENDED USE: | The Auto Suture™ ENDO GIA™ Staplers have applications in<br>abdominal, gynecologic, pediatric and thoracic surgery for<br>resection, transection, and creation of anastomoses. It may be<br>used for transection and resection of liver substance, hepatic<br>vasculature and biliary structures. |
| TECHNOLOGICAL<br>CHARACTERISTICS: | The Auto Suture™ ENDO GIA™ Stapler is identical to the<br>predicate device. The only change is the inclusion of a specific<br>indication concerning the device's use on liver tissue as a<br>subset of the general indication for the Auto Suture™ ENDO<br>GIA™ Stapler. |
| MATERIALS: | All components of the Auto Suture™ ENDO GIA™ Stapler are<br>comprised of materials which are in accordance with ISO<br>Standard 10993-1. |
| PERFORMANCE DATA: | In-vivo animal tests were performed to support the inclusion of<br>a specific indication as a subset of the general indication for<br>the Auto Suture™ ENDO GIA™ Stapler. A clinical literature<br>search was also performed to demonstrate and support the<br>clinical application of the device for the resection and<br>transection of liver. |

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 1 2006

United States Surgical % Mr. Frank Gianelli Senior Associate, Regulatory Affairs 150 Glover Avenue Norwalk, Connecticut 06856

Re: K061095

Trade/Device Name: Auto Suture™ ENDO GIA™ Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW & GAG Dated: April 17, 2006 Received: April 19, 2006

Dear Mr. Gianelli:

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.

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

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## Page 2 - Mr. Frank Gianelli

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) remarket 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,

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Auto Suture™ ENDO GIA™ Surgical Stapler

## Indications For Use

510(k) Number (if known): _K061095

Device Name: Auto Suture™ ENDO GIA™ Stapler

Indications For Use:

The Auto Suture™ ENDO GIA™ Staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomoses. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.

Prescription Use × (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|---------------------|--|

Division of General, Restorative,
and Neurological Devices

| 510(k) Number | K061095 |
|---------------|---------|
|---------------|---------|

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