GEL MARK III BIOPSY SITE MARKER

K031938 · Senorx, Inc. · NEU · Sep 5, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031938
• Device Name: GEL MARK III BIOPSY SITE MARKER
• Applicant: Senorx, Inc.
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Sep 5, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended Use

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

Device Story

Disposable applicator containing resorbable pellets; some pellets contain wireform for long-term marking of biopsy cavity. Used during percutaneous breast biopsy procedures to mark tissue site for radiographic visualization. Operated by clinicians. Output is a radiopaque marker remaining in the breast tissue to assist in future localization or monitoring of the biopsy site.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Implantable marker consisting of resorbable pellets and wireform. Delivered via disposable applicator. Radiopaque for radiographic visualization.

Indications for Use

Indicated for radiographic marking of breast tissue during percutaneous breast biopsy procedures.

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™ Biopsy Site Marker (SenoRx Inc.)
• Gel Mark™ Ultra Biopsy Site Marker (SenoRx Inc.)
• MammoMark™ Biopsy Site Marker (Artemis Medical, Inc.)

Submission Summary (Full Text)

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SenoRx Inc. Premarket Notification Gel Mark III Biopsy Site Marker

2.

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K\$\phi\$31938 (P. 1 of 2)

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92

#### SUBMITTER INFORMATION 1.

| a. Company Name: | SenoRx Inc. |
|-----------------------------|---------------------------------------------------------------------|
| b. Company Address: | 11 Columbia, Suite A |
| c. Telephone:<br>Facsimile: | [phone]<br>[phone] |
| d. Contact Person: | Amy Boucly<br>Director, Regulatory Affairs<br>and Quality Assurance |
| e. Date Summary Prepared: | June 12, 2003 |
| DEVICE IDENTIFICATION | |

| a. Trade/Proprietary Name: | Gel Mark III<br>(Trade Name is to be determined.) |
|----------------------------|---------------------------------------------------|
|----------------------------|---------------------------------------------------|

- Implantable Staple, 21 CFR 878.4750 b. Classification Name:
## IDENTIFICATION OF PREDICATE DEVICES 3.

| Gel Mark™ Biopsy Site<br>Marker | SenoRx Inc. |
|---------------------------------------|-----------------------|
| Gel Mark™ Ultra Biopsy<br>Site Marker | SenoRx Inc. |
| MammoMark™ Biopsy<br>Site Marker | Artemis Medical, Inc. |

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\$\phi\$31938 (P. 2 of 2)

#### DESCRIPTION OF THE DEVICE 4.

The SenoRx Gel Mark III consists of a disposable applicator containing resorbable pellets. Some pellets contain a wireform, which is intended for long-term marking of the biopsy cavity.

### STATEMENT OF INTENDED USE 5.

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

#### 6. COMPARISON WITH PREDICATE DEVICES

The intended use, design, construction, marker material and nominal specifications are similar to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird image.

SEP = 5 2003

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: K031938

Trade/Device Name: Gel Mark III Biopsy Site Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: II Product Code: NEU Dated: June 20, 2003 Received: June 23, 2003

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 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. 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,

Miriam C. Provost

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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#### FDA Indications for Use Page 2

510(k) number (if known): K931938

Device Name: Gel Mark III (Trade/Model Name to be determined.)

Indications for Use: The Gel Mark III is indicated for use to radiographically mark breast tissue during a percutaneous breast biopsy procedure.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

*Miriam C. Provost*
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

K031938

510(k) Number K031938