GEL MARK IV

K040706 · Senorx, Inc. · NEU · Apr 8, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040706
• Device Name: GEL MARK IV
• Applicant: Senorx, Inc.
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Apr 8, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended Use

The Gel Mark IV is intended to radiographically and sonographically mark breast tissue prior to or during a breast biopsy procedure.

Device Story

Gel Mark IV Tissue Marker; implantable device used to mark breast tissue sites during or prior to biopsy procedures. Provides radiographic and sonographic visibility for subsequent identification of biopsy site. Used by clinicians in clinical settings. Benefits include accurate localization of biopsy site for follow-up or surgical intervention.

Clinical Evidence

No clinical data provided; substantial equivalence based on device description and intended use.

Technological Characteristics

Implantable tissue marker; designed for radiographic and sonographic visibility. Class II device (21 CFR 878.4300).

Indications for Use

Indicated for radiographic and sonographic marking of breast tissue in patients undergoing breast biopsy procedures. Prescription use only.

Regulatory Classification

Identification

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

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract eagle design with three stylized wing segments, symbolizing the department's mission to protect and promote the health and well-being of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national scope.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 8 2004

Ms. Amy Boucly Director, Regulatory Affairs and Quality Assurance SenoRx, Inc. 11 Columbia, Suite A Aliso Viego, California 92656

Re: K040706

Trade/Device Name: Gel Mark IV Tissue Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: March 17, 2004 Received: March 18, 2004

Dear Ms. Boucly:

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 adviscd 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

Page 2 - Ms. Amy Boucly

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Mark H. Milliman

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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known): K040706

Device Name: Gel Mark IV Tissue Marker

Indications For Use:

The Gel Mark IV is intended to radiographically and sonographically mark breast tissue prior to or during a breast biopsy procedure.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Dévice Evaluation (ODE)

K04070

b. Mark A. Mellema

Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number