SURGICAL STAPLE MARKER DEVICE (MODIFY)

K963015 · Biopsys Medical, Inc. · GDW · Oct 7, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K963015
• Device Name: SURGICAL STAPLE MARKER DEVICE (MODIFY)
• Applicant: Biopsys Medical, Inc.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Oct 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2

Intended Use

The Surgical Staple Marker's intended use is to be applied to soft tissue during open or percutaneous procedures and radiographically mark the surgical location.

Device Story

Surgical Staple Marker; non-absorbable, radiopaque staple; applied to soft tissue during open or percutaneous procedures; deployed via manual appliers or surgical instruments; provides radiographic visualization of surgical site; assists clinicians in post-operative localization of tissue; benefits patient by enabling precise follow-up imaging or secondary interventions.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Non-absorbable, radiopaque material; manual deployment via surgical instruments; form factor designed for soft tissue application; compatible with standard radiographic imaging.

Indications for Use

Indicated for patients undergoing open or percutaneous surgical procedures requiring radiographic marking of soft tissue locations.

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

• BMI Surgical Staple Marker
• Ethicon Titanium Staple
• Ethicon Multifeed Stapler (Endopath EMS)
• Ethicon LIGACLIP

Submission Summary (Full Text)

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OCT -7 1996
K963015

# APPENDIX V

## Summary of Safety and Effectiveness

## DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The BMI Surgical Staple Marker is substantially equivalent to many staple/marker devices including the BMI Surgical Staple Marker and Ethicons' Titanium Staple, Stapler (Endopath EMS), and LIGACLIP. The BMI device has the same intended use as the marketed predicate devices; these devices' intended use are to be applied to soft tissue during open or percutaneous procedures and radiographically mark the surgical location. The BMI Surgical Staple Marker has technologic characteristics which are substantially equivalent to the BMI and Ethicon predicate devices.

## COMPANY AND CONTACT PERSON

Biopsys Medical, Inc. (BMI)
3 Morgan
Irvine, CA 92618

Mark A. Cole, Ph.D.
714-460-7800

## DEVICE NAME

Surgical Staple Marker

## NAME OF PREDICATE OR LEGALLY MARKETED DEVICE

1. BMI Surgical Staple Marker
2. Ethicon Surgical Staplers (Titanium Staples, Multifeed Stapler, LIGACLIP)

## STATEMENT OF INTENDED USE

The Surgical Staple Marker's intended use is to be applied to soft tissue during open or percutaneous procedures and radiographically mark the surgical location.

## STATEMENT OF INTENDED USE OF PREDICATE/MARKETED DEVICES

1. The BMI Surgical Staple Marker's intended use is to be applied to soft tissue during open or percutaneous procedures; the staple may be used to radiographically mark the surgical location.
2. The Ethicon Staple/Clip's intended use is to be applied to soft tissue during open or percutaneous procedures; the staple may be used to radiographically mark the surgical location.

510(k) Notification
Biopsys Medical, Inc.
July 24, 1996
CONFIDENTIAL
Page 34

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K 963015 (P. 2 OF 2)

# STATEMENT OF COMPARISON OF TECHNOLOGIC CHARACTERISTICS BETWEEN DEVICE AND PREDICATE DEVICE

The design, construction, materials, nominal specifications are either identical or substantially equivalent to the marketed predicate devices. The devices consist of a non absorbable material compatible with X-ray, i.e., clearly visible on a radiograph; the staple/markers are deployed with manual appliers or surgical instruments.

510(k) Notification
Blopsys Medical, Inc.
July 24, 1996
CONFIDENTIAL
Page 35