8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535

K020276 · Ethicon Endo-Surgery, Inc. · NEU · Apr 12, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020276
• Device Name: 8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Apr 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended Use

The 8 Gauge MicroMark II Tissue Marker is indicated for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.

Device Story

The 8 Gauge MicroMark II Tissue Marker is a sterile, single-patient-use device designed to mark biopsy sites in soft breast tissue. It consists of a stainless steel marker (clip), a disposable introducer (flexible tube, distal ramp, lateral port), and an applier (flexible shaft, deployment mechanism, handle). The device is used in conjunction with the Ethicon Endo-Surgery Mammotome Hand-Held 8 Gauge Probe, which acts as a rigid coaxial introducer. Under stereotactic or ultrasound imaging guidance, the clinician deploys the marker into the tissue. The marker remains in the body to provide a radiographic reference point for the biopsy location, assisting clinicians in future clinical decision-making and follow-up procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Implantable stainless steel marker (clip). Introducer consists of a flexible tube, distal ramp, and lateral port. Applier includes a flexible shaft, deployment mechanism, and handle. Designed for use with 8 Gauge rigid coaxial introducers. Sterile, single-patient-use.

Indications for Use

Indicated for patients undergoing open surgical or percutaneous breast biopsy to radiographically mark the biopsy site in soft breast tissue.

Regulatory Classification

Identification

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

Predicate Devices

• MicroMark Clip

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness Information

1020276

| Company | Ethicon Endo-Surgery, Inc.<br>4545 Creek Road<br>Cincinnati, OH 45242 | |
|------------------|--------------------------------------------------------------------------------------------|------------------------|
| Contact | Georgia C. Abernathy, MBA, RAC<br>Senior Regulatory Affairs Associate | |
| | Telephone: | [phone] |
| | Fax: | [phone] |
| | Email: | [e-mail] |
| Date Prepared | January 25, 2002 | |
| Device Name | Trade Name: 8 Gauge MicroMark™ II Tissue Marker<br>Classification Name: Implantable Staple | |
| Predicate Device | MicroMark Clip | |

#### Device Description

The 8 Gauge MicroMark II Tissue Marker is a sterile, single patient use device comprised of a small stainless steel marker (clip) and a disposable Introducer and Applier. The Introducer consists of a flexible tube, a distal ramp, and a lateral port. The applier consists of a flexible shaft, a deployment mechanism and a handle. The marker is located at the distal end of the applier.

The 8 Gauge MicroMark II Tissue Marker is used with the currently marketed Ethicon Endo-Surgery, Inc. Mammotome® Hand-Held 8 Gauge Probe, which functions as a standard rigid coaxial Introducer.

The Tissue Marker is used with imaging guidance (stereotactic and ultrasound).

#### Indications for Use

The 8 Gauge MicroMark II Tissue Marker is indicated for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.

#### Technological Characteristics

Design changes made to the 8 Gauge MicroMark II Tissue Marker are an increase in the diameter of the Introducer. There are no changes to the implantable stainless steel marker (clip); it is identical to the marketed device.

#### Performance Data

Bench testing was performed to demonstrate that the device will perform as intended.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

APR 1 2 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD -20850

Ms. Georgia C. Abernathy, MBA, RAC Senior Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242-2839

Re: K020276

Trade/Device Name: 8 Gauge MicroMark™II Tissue Marker Regulation Number: 878.4750 Regulation Name: Implantable Staple Regulatory Class: II Product Code: NEU Dated: January 25, 2002 Received: January 28, 2002

Dear Ms. Abernathy:

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 mav 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. Georgia C. Abernathy, MBA, RAC

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). 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

for 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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### Indications for Use Statement

K020276 510 (k) Number (if known):

Device Name:

# 8 Gauge MicroMark™ II Tissue Marker

Indications for Use:

The 8 Gauge MicroMark II Tissue Marker is indicated for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost
Division of OM

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

(Optional Format 3-10-98)

510(k) Number K020276