MICROMARK II TISSUE MARKER,MODEL C1535

K013413 · Ethicon Endo-Surgery, Inc. · NEU · Dec 3, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K013413
• Device Name: MICROMARK II TISSUE MARKER,MODEL C1535
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Dec 3, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended Use

The 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

MicroMark II Tissue Marker is a sterile, single-patient-use device consisting of a stainless steel marker (clip), a disposable introducer, and an applier. Used with imaging guidance (stereotactic and ultrasound) during or after breast biopsy procedures. The introducer features a flexible tube, distal ramp, and lateral port; the applier includes a flexible shaft and deployment mechanism. Designed for use with Ethicon Endo-Surgery MAMMOTOME® Probes. The marker is MR safe at 3.0 Tesla or less, posing no additional risk of movement or heating during MRI. The device allows clinicians to radiographically identify biopsy sites for follow-up or surgical planning.

Clinical Evidence

Bench testing only. Testing demonstrated the device performs as intended in MRI procedures at 3.0 Tesla or less.

Technological Characteristics

Stainless steel marker; disposable introducer and applier; flexible shaft/tube design. MR safe at 3.0 Tesla or less. No software or electronic components.

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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## DEC 0 3 2001 MicroMark™ II Tissue Marker 510(k) Summary of Safety and Effectiveness Information

### Company

K013413

Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242

## Contact

Georgia C. Abernathy, MBA. RAC Senior Regulatory Affairs Associate Telephone: [phone] Fax: [phone] Email: [e-mail]

## Date Prepared

October 12, 2001

#### Device Name

Trade Name: MicroMark™ II Tissue Marker Classification Name: Implantable Staple

#### Predicate Device

MicroMark™ Clip

#### Device Description

The 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 MicroMark II Tissue Marker is used with the currently marketed Ethicon Endo-Surgery MAMMOTOME® Probes which function as standard rigid coaxial introducer needles post biopsy.

The Tissue Marker is used with imaging guidance (stereotactic and ultrasound). The stainless steel marker is Magnetic Resonance (MR) safe at 3.0 Tesla field strength or less. The marker, when present in a patient undergoing an MRI procedure at 3.0 Tesla or less, will not create an additional hazard or risk with respect to magnetic field-related interactions, movement / dislodgment, or heating.

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## Indications for Use

The 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

No design changes have been made to the MicroMark II Tissue Marker. The specification and labeling-modified marker is identical and possesses the same technological characteristics as the currently marketed marker.

## Performance Data

Bench testing was performed to demonstrate that the device will perform as intended in MRI procedures utilizing 3.0 Tesla or less.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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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

DEC 0 3 2001

Re: K013413

Trade/Device Name: MicroMark™ II Tissue Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: October 12, 2001 Received: October 15, 2001

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 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 (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 - 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,

Susan Walker, us

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

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Enclosure

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# Indications for Use Statement

| 510 (k) Number (if known): | K013413 |
|----------------------------|---------|
|----------------------------|---------|

Device Name:

# MicroMark™ II Tissue Marker

Indications for Use:

The MicroMark™ II Tissue Marker is indicated for use to attach to soft breast tissue The Microivials Tissue Marker 16 indical breast biopsy or a percutaneous breast at the surgical site darms an open barger starget 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)

(Optional Format 3-10-98)