AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER

K024275 · United States Surgical, A Division of Tyco Healthc · GDW · Mar 14, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K024275
• Device Name: AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Mar 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Auto Suture* Auto Suture* Premium Plus CEEA* Disposable Stapler has applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries, including bariatric surgery.

Device Story

Single-patient-use disposable stapler; places double staggered row of titanium staples; integrated knife blade resects excess tissue immediately after staple formation; creates circular anastomosis. Used in open and laparoscopic alimentary tract surgeries, including bariatric procedures. Operated by surgeons. Device facilitates tissue joining and resection, reducing surgical time and complexity compared to manual suturing.

Technological Characteristics

Mechanical stapler; titanium staples; materials compliant with ISO 10993-1. Single-patient-use disposable form factor.

Indications for Use

Indicated for patients undergoing open or laparoscopic alimentary tract surgery, including bariatric surgery, requiring the creation of end-to-end, end-to-side, or side-to-side anastomoses.

Regulatory Classification

Identification

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

Submission Summary (Full Text)

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KΨ24275

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

| SUBMITTER: | United States Surgical<br>150 Glover Avenue<br>Norwalk, CT 06856<br>MAR 1 4 2003 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Sarah Hubeny |
| DATE PREPARED: | December 20, 2002 |
| CLASSIFICATION NAME: | Staple, Implantable |
| COMMON NAME: | Staple, Implantable |
| PROPRIETARY NAME: | Auto Suture* PREMIUM PLUS CEEA*<br>Disposable Stapler |
| DEVICE DESCRIPTION: | The Auto Suture* PREMIUM PLUS CEEA* Disposable<br>Stapler is a single patient use device which places a double<br>staggered row of titanium staples. Immediately after staple<br>formation, the instrument's knife blade resects the excess<br>tissue, creating a circular anastomosis. |
| INTENDED USE: | The Auto Suture* Auto Suture* Premium Plus CEEA*<br>Disposable Stapler has applications throughout the<br>alimentary tract for the creation of end-to-end, end-to-side<br>and side-to-side anastomoses in both open and laparoscopic<br>surgeries, including bariatric surgery. |
| MATERIALS: | All component materials of the Auto Suture* Premium Plus<br>CEEA* Disposable Stapler are comprised of materials<br>which are in accordance with ISO Standard #10993-1. |

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Image /page/1/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

MAR 1 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sarah Hubeny Regulatory Affairs Associate United States Surgical, a division of Tyco Healthcare Group, LP 150 Glover Avenue Norwalk, Connecticut 06856

Re: K024275

Trade/Device Name: Auto Suture*Premium Plus CEEA* Disposable Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: December 20, 2002 Received: December 23, 2002

Dear Ms. Hubeny:

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. Iisting 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 forth in the quality systems (OS) 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 - Ms. Sarah Hubeny

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]. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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

W 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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IV. Indications For Use: 424275 510(k) Number (if known):

Name: Auto Suture* PREMIUM PLUS CEEA* Disposable Stapler

Indications For Use:

The Auto Suture* Premium Plus CEEA* Disposable Stapler has applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries, including bariatric surgery.

(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Evaluation (ODE) OR Over-The-Counter Use: Prescription Use: (Per 21 CFR §801.109)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K024275