STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS

K081085 · Senorx, Inc. · NEU · Aug 1, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K081085
• Device Name: STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS
• Applicant: Senorx, Inc.
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Aug 1, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended Use

The StarchMark Biopsy Site Marker is intended to radiographically mark breast tissue during a percutaneous breast biopsy procedure.

Device Story

StarchMark is a sterile, disposable biopsy site marker used to radiographically identify biopsy sites in breast tissue. The device consists of an applicator containing four resorbable polysaccharide (starch) pellets and one polylactic/polyglycolic acid (PLA/PGA) copolymer pellet with an embedded radiopaque wireform. During a percutaneous breast biopsy, the clinician deploys the pellets into the biopsy site. The radiopaque wireform allows for subsequent visualization via imaging, while the starch pellets assist in the cessation of bleeding. The device is intended for use by physicians in clinical settings.

Clinical Evidence

No human clinical data provided. Evidence includes in vitro laboratory bench testing and a porcine study evaluating bleeding control, which demonstrated superiority in cessation of bleeding time compared to the control group. Biocompatibility testing confirmed compliance with ISO 10993-1.

Technological Characteristics

Implantable clip (biopsy site marker). Materials: resorbable polysaccharide (starch) pellets and PLA/PGA copolymer pellet with embedded radiopaque wireform. Sterile, disposable applicator. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for radiographic marking of breast tissue in patients undergoing 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 III Biopsy Site Marker (K031938)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the word "SENORx" in a stylized font. The letters are black and bold. In the middle of the word, there is a ribbon symbol made up of smaller words.

Kog 1085 リズ

AUG - 1 2008

## 5. 510(K) SUMMARY

| Date prepared | April 14, 2008 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | SenoRx, Inc.<br>11 Columbia<br>Aliso Viejo, CA 92656<br>T. 949.362.4800; F. 949.362.0300 |
| Contact person | Eben Gordon<br>Vice President, RA/QA<br>SenoRx, Inc.<br>T. 949.362.4800; F. 949.362.0300 |
| Device name | StarchMark |
| Common name | Biopsy site marker |
| Classification name | Implantable Clip |
| Classification regulation | 878.4300 NEU |
| Predicate devices | K031938; Gel Mark III Biopsy Site Marker; Clearance date: 9/5/2003 |
| Description | The StarchMark Biopsy Site Marker is a sterile, disposable applicator<br>containing 4 resorbable polysaccharide (starch) pellets and a<br>polylactic/polyglycolic acid-based co-polymer (PLA/PGA) pellet with an<br>embedded radiopaque wireform. |
| Indications for use | The StarchMark Biopsy Site Marker is intended to radiographically mark breast<br>tissue during a percutaneous breast biopsy procedure. |
| Summary of substantial<br>equivalence | Preclinical studies conducted included <i>in vitro</i> laboratory studies to demonstrate<br>that the StarchMark Biopsy Site Marker performed as intended under simulated<br>use conditions. Biocompatibility testing was performed to demonstrate that the<br>starch pellet meet ISO 10993-1 requirements. In a porcine study designed to<br>evaluate the control of bleeding, the StarchMark marker demonstrated<br>superiority over the control group in the cessation of bleeding time.<br><br>The StarchMark marker has the following similarities to the previously cleared<br>predicate device: |
| | • Same indications for use; |
| | • Same intended use; |
| | • Same intended treatment site; |
| | • Same operating principle; |
| | • Same technological characteristics; |

- Same packaging; and
:

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

- . Same sterilization method.
In summary, the StarchMark Biopsy Site Marker as described in this submission is substantially equivalent to the predicate device.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 1 2008

SenorRx, Inc. % Mr. Eben Gordon VP, Regulatory Affairs & Quality Assurance 11 Columbia Aliso Viejo, California 92656

Re: K081085

Trade/Device Name: StarchMark Biopsy Site Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: July 29, 2008 Received: July 30, 2008

Dear Mr. Gordon:

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

{3}------------------------------------------------

Page 2 - Mr. Eben Gordon

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.

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.

lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 M Mulhearn

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications for Use

510(k) Number (if known): K081085

Device Name: StarchMark Biopsy Site Marker

Indications for Use:

The StarchMark Biopsy Site Marker is intended to radiographically mark breast tissue during a percutaneous breast biopsy procedure.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over the Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Millerson

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

510(k) Number

Page 1 of _1_