GEL MARK V

K050090 · Senorx, Inc. · NEU · Feb 7, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050090
• Device Name: GEL MARK V
• Applicant: Senorx, Inc.
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Feb 7, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended Use

The Gel Mark V is intended to radiographically and sonographically mark breast tissue during a percutaneous breast biopsy procedure.

Device Story

Gel Mark V Biopsy Site Marker is an implantable device used to mark biopsy sites in breast tissue. It is deployed during percutaneous breast biopsy procedures. The marker is designed to be visible under both radiographic and sonographic imaging, allowing clinicians to accurately locate the biopsy site for follow-up monitoring or surgical planning. The device is used in a clinical setting by physicians performing breast biopsies. By providing a permanent, localized marker, it assists in the longitudinal management of patients who have undergone breast tissue sampling.

Clinical Evidence

Bench testing only.

Technological Characteristics

Implantable clip/marker designed for radiographic and sonographic visibility. Device is intended for permanent placement in breast tissue. No specific materials or software algorithms described.

Indications for Use

Indicated for marking breast tissue during percutaneous breast biopsy procedures for radiographic and sonographic visualization.

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

• Gel Mark V Biopsy Site Marker (K030090)

Submission Summary (Full Text)

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Public Health Service

FEB = 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050090

Trade/Device Name: Gel Mark V Biopsy Site Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: January 13, 2005 Received: January 14, 2004

Dear Ms. Boucly:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becared the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encrease in the enactment date of the Medical Device Amendments, or to conninered pror to they 2013 773) in accordance with the provisions of the Federal Food, Drug, de rices that have boon require approval of a premarket approval application (PMA). and Cosmeter Free (110) has the device, subject to the general controls provisions of the Act. The r ou may, ater sever in one 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 If your device is exassinou 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 f 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 or any I 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 (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. 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/industry/support/index.html.

Sincerely yours,

Mark N Millman

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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SenoRx Inc. Special 510(k) Device Modification Gel Mark™ V Biopsy Site Marker

## Indications for Use Statement

| 510(k) Number (if known) | K030090 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Gel Mark V Biopsy Site Marker |
| Indications for Use | The Gel Mark V is intended to radiographically and sonographically mark breast tissue during a percutaneous breast biopsy procedure. |

Prescription Use X (Per 21 CFR 801. 109)

OR

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation

Mark A Wilkerson

(Division Sign-Off) Division of General, Restoration 2011 Neurological Devices

510(k) Number K050096

January 13, 2005