AUTO SUTURE SITE MARKER CLIP

K983400 · United States Surgical, A Division of Tyco Healthc · GDW · Feb 10, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K983400
• Device Name: AUTO SUTURE SITE MARKER CLIP
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Feb 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2

Intended Use

The Auto Suture* Site Marker** staple is intended for use in soft tissue during an open or percutaneous biopsy procedure to radiographically mark the location.

Device Story

The Auto Suture Site Marker staple is a single-use, disposable, non-absorbable staple designed for radiographic visibility. It is deployed into soft tissue during open or percutaneous biopsy procedures using a manual stapler. The device serves as a permanent marker to identify the biopsy site for subsequent radiographic imaging. It is intended for use by clinicians in a surgical or clinical setting.

Clinical Evidence

Bench testing only. Materials comply with ISO Standard #10993-1.

Technological Characteristics

Single-use, disposable, non-absorbable staple. Radiopaque for radiographic visibility. Materials comply with ISO Standard #10993-1. Manual deployment mechanism.

Indications for Use

Indicated for use in soft tissue during open or percutaneous biopsy procedures to radiographically mark the biopsy location.

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

• MicroMark™ clip (K970817)

Submission Summary (Full Text)

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K9 83400

## Auto Suture* Site Marker** staple

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

SUBMITTER:

United States Surgical Corporation 150 Glover Avenue Norwalk, CT 06856

Christopher A. Graham CONTACT PERSON:

September 22, 1998 DATE PREPARED:

CLASSIFICATION NAME: Implantable Staple

COMMON NAME: Implantable Staple

Auto Suture* Site Marker** staple PROPRIETARY NAME:

PREDICATE DEVICES: MicroMark™ clip (K970817)

DEVICE DESCRIPTION:

The Auto Suture* Site Marker** staple, is a single use disposable staple, which consists of a non-absorbable material that is clearly visible on a radiograph. The staple is deployed into soft tissue during open or percutaneous procedures to mark a surgical location for radiograph by a manual stapler.

The Auto Suture* Site Marker** staple is intended for use INTENDED USE: in soft tissue during an open or percutaneous biopsy procedure to radiographically mark the location.

MATERIALS: All component materials of the Auto Suture* Site Marker** staple are comprised of materials which are in accordance with ISO Standard # 10993-1.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 1999

Christopher A. Graham Associate, Regulatory Affairs United States Surgical Corporation 150 Glover Avenue Norwalk, CT 06856

Re:

K983400 Auto Suture Site Marker Staple Dated: January 6, 1999 Received: January 7, 1999 Regulatory class: II 21 CFR 878.4750/Procode: 90 GDW

Dear Mr. Graham:

We have reviewed your Section 510(k) 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 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Auto Suture* Site Marker** staple

IV. Indications For Use:

510(k) Number (if known):

Name: Auto Suture* Site Marker**

Indications For Use:

mancations For Ose.
The Auto Suture* Site Marker** staple is intended for use in soft tissue during an open or The Auto Datare " The Maniforn to radiographically mark the biopsy location.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Evaluation (ODE)

Prescription Use: (Per 21 CFR §801.109) OR Over-The-Counter Use:_

Daniel G. Segran

(Division Sign-Off) Division of Reproductive, Abdominal, B and Radiological Dey 510(k) Number

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number

510(k) Premarket Notification

United States Surgical Corporation * Trademark of United States Surgical Corporation ** Trademark name not yet determined