AUTO SUTURE SURGICAL STAPLES

K013860 · United States Surgical, A Division of Tyco Healthc · GDW · Dec 19, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K013860
• Device Name: AUTO SUTURE SURGICAL STAPLES
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Dec 19, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Auto Suture Surgical Staples are intended to be used with the currently marketed Auto Suture TA Stapler and Single Use Loading Unit (SULU), Auto Suture GIA Stapler and SULU, and Auto Suture EEA Stapler and SULU.

Device Story

Auto Suture Surgical Staples are implantable fasteners designed for use with specific Auto Suture stapling devices (TA, GIA, and EEA models) and their corresponding Single Use Loading Units (SULU). The staples are used by surgeons during surgical procedures to join tissues. The device functions as a mechanical fastener; it is loaded into the stapler/SULU, which then deploys the staple to secure tissue. The staples are intended for prescription use only.

Clinical Evidence

In vitro and in vivo testing performed to verify compatibility with Auto Suture TA, GIA, and EEA staplers and SULUs.

Technological Characteristics

Material: Titanium, compliant with ISO Standard #10993-1. Form factor: Implantable surgical staples. Energy source: None (mechanical).

Indications for Use

Indicated for use with Auto Suture TA, GIA, and EEA staplers and their respective Single Use Loading Units (SULU) for surgical stapling 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 Modified Surgical Staples (K855047)

Submission Summary (Full Text)

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K013860

## Summary of Safety and Effectiveness IX.

DEC 1 9 2001

United States Surgical SUBMITTER: A division of Tyco Healthcare Group, LP 150 Glover Avenue Norwalk, CT 06856

Chester McCoy CONTACT PERSON:

DATE PREPARED: November 20, 2001

Implantable Staple CLASSIFICATION NAME:

Implantable Staple, General and Plastic Surgery COMMON NAME:

Auto Suture* Surgical Staples PROPRIETARY NAME:

Auto Suture* Modified Surgical Staples (K855047). PREDICATE DEVICES:

The Auto Suture Surgical Staples are intended to be used INTENDED USE: with the currently marketed Auto Suture TA Stapler and Single Use Loading Unit (SULU), Auto Suture GIA Stapler and SULU, and Auto Suture EEA Stapler and SULU.

MATERIALS:

Titanium – The staples are comprised of a material which is in compliance to ISO Standard #10993-1

PERFORMANCE DATA: In vitro and in vivo testing was performed to verify that the Auto Suture* Surgical Staples can be used with the Auto Suture TA Stapler and Single Use Loading Unit (SULU), Auto Suture GIA Stapler and SULU, and Auto Suture EEA Stapler and SULU.

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Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2001

Chester McCoy Program Manager Regulatory Affairs United States Surgical 150 Glover Avenue Norwalk, Connecticut 06856

Re: K013860

Trade Name: Auto Suture Surgical Staples Regulation Number: 878.4750 Regulation Name: Implantable Staple Regulatory Class: II Product Code: GDW Dated: November 20, 2001 Received: November 21, 2001

Dear Mr. McCoy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, (Trefore, market the device, subject to the general controls provisions of the Act. The general therefore, mainions of the Act include requirements for annual registration, listing of devices, controls provisions or actice, 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 If your device 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 that + Drederal 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) This icher will anow you to ogen maing of substantial equivalence of your device to a legally prematication. The PDF micing of casification 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 and IT you desire specific acrise for you invitro diagnostic devices), please contact the Office of additionally 21 OF ICT at 659. Additionally, for questions on the promotion and advertising of Compinatee at (301) of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). I centrion children, "Nilocranisms on responsibilities under the Act may be obtained from the Outcr general informational 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,

Neil R.l. Ogden
Celia M. Witten, Ph.D., M.D. for

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

Enclosure

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Indications for Use V. 013860 510(k) Number (if known): Auto Suture Surgical Staples Device Name:

Indications For Use:

The Auto Suture Surgical Staples are intended to be used with the currently marketed Auto The Auto Suture Burgles areastes areastes in over and Suture GIA Stapler and SULU, and Auto Suture EEA Stapler and SULU.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Prescription Use: | X |
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| | OR Over-The-Counter |
| Use:<br>(Per 21 CFR 801.109) | |

Mo farcmw

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

510(k) Number K013860