SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM

K072913 · Suros Surgical Systems, Inc. A Hologic Company · NEU · Jan 4, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K072913
• Device Name: SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM
• Applicant: Suros Surgical Systems, Inc. A Hologic Company
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Jan 4, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended Use

The Tissue Site Marking System is indicated for the permanent radiographic marking of sites in soft tissue.

Device Story

SeCurMark Biopsy Site Identification System consists of an implantable marker and a manual deployment device. The implantable component contains both bioabsorbable and permanent materials. The device is used to mark biopsy sites in soft tissue for subsequent identification under ultrasound, x-ray, magnetic resonance, or direct visualization. It is intended for single-patient use.

Clinical Evidence

No clinical data; substantial equivalence supported by verification and validation testing.

Technological Characteristics

System comprises a manual deployment device and an implantable marker containing bioabsorbable and permanent components. Designed for use under ultrasound, x-ray, magnetic resonance, and direct visualization. Single-patient use.

Indications for Use

Indicated for permanent radiographic marking of biopsy sites in soft 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

• Tissue Site Marking System (K062528)
• BiomarC (K042296)

Submission Summary (Full Text)

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K072913 Page 1/2

Hologic, Inc.

6100 Technology Center Drive, Indianapolis, IN 46278 USA Main: +1.800.650.2169 Fax: [phone]

## 510(k) Summary

Senior Quality & Regulatory Consultant

Hologic, Inc. – Suros Division 6100 Technology Center Drive

Indianapolis, IN 46278 Phone: [phone]

### OWNER/OPERATOR:

| Firm: | Hologic, Inc. - Suros Division |
|-----------------|--------------------------------------------------------|
| Address: | 6100 Technology Center Drive<br>Indianapolis, IN 46278 |
| Phone #: | 317-344-7500 |
| Fax #: | 317-344-7697 |
| Registration #: | 3003862400 |
| CONTACT: | Paula A. Gray |

JAN - 4 2008

DATE: 12/06/2007

#### DEVICE NAME:

| Classification Name: | Marker, Implantable Radiographic |
|-----------------------|-------------------------------------------------|
| Common/Usual Name: | Tissue Site Marking System |
| Proprietary Name: | SeCurMark Biopsy Site Identification System |
| Device Class: | Class II |
| Description | Implantable Clip |
| Number | NEU |
| 21 CFR Ref. | 878.4300 |
| Performance Standards | No applicable performance standards established |

#### PREDICATE DEVICES:

| 510(k)-Number | Device Name | Device Manufacturer | Location |
|---------------|-------------------------------|--------------------------------------|---------------|
| K062528<br>IN | Tissue Site Marking<br>System | Hologic, Inc. – Suros Division | Indianapolis, |
| K042296 | BiomarC | Carbon Medical<br>Technologies, Inc. | St. Paul, MN |

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Image /page/0/Picture/13 description: The image shows the word "HOLOGIC" in all caps. The letters are bold and black. The background is white.

Image /page/0/Picture/14 description: The image shows the text "Clarity of Vision" in a simple, sans-serif font. The text is black and appears to be printed on a white background. To the left of the text, there is a partial, abstract graphic, also in black, that adds a visual element to the composition.

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6100 Technology Center Drive, Indianapolis, IN 46278 U Main: +1.800.650.2169 Fax: [phone]

#### DEVICE DESCRIPTION AND CHARACTERISTICS:

The SeCurMark family of Tissue Site Marking Systems is composed of two components:

- . an implantable component, composed of a bioabsorbable and permanent component, and
- a deployment device utilized for placement of the implantable component at the site of . interest.

Hologic, Inc.

This family of devices is intended for use with the manual method of deployment under the following imaging modalities: ultrasound, x-ray, magnetic resonance, and direct visualization. The device is intended for single patient use only.

#### INTENDED USE:

The Tissue Site Marking System is indicated for the permanent radiographic marking of sites in soft tissue.

#### SUBSTANTIAL EQUIVALENCE:

Verification and validation testing has been conducted as part of the Suros divisions design control process and has proven that the SeCurMark family of devices is substantially equivalent to the predicates devices and is safe and effective for use.

#### CONCLUSION:

Based on the information presented in this 510(k) submission, the SeCurMark Biopsy Site Identification System is substantially equivalent to the presently marketed predicate devices. No new safety or efficacy questions or risks are raised with the SeCurMark Biopsy System.

Image /page/1/Picture/13 description: The image shows the word "HOLOGIC" in bold, black letters. The letters are evenly spaced and appear to be a sans-serif font. The word is horizontally oriented and fills most of the frame.

Image /page/1/Picture/14 description: The image contains the text "Clarity of Vision" in a bold, sans-serif font. The text is arranged horizontally, with "Clarity of" appearing above "Vision". The overall impression is clean and straightforward, suggesting a focus on clear and distinct visual perception.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.

Public Health Service

JAN - 4 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Suros Surgical Systems, Inc. % Ms. Paula A. Gray Senior Quality & Regulatory Consultant 6100 Technology Center Drive Indianapolis, Indiana 46278

Re: K072913

Trade/Device Name: SeCurMark Biopsy Site Identification System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: December 6, 2007 Received: December 7, 2007

Dear Ms. Gray:

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

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Page 2 - Ms. Paula A. Gray

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.

If 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 Protmarket, 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 vours.

Mark N Milhusan

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

Enclosure

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# Indications for Use

510(k) Number (if known): K072913

Device Name: SeCurMark Biopsy Site Identification System

Indications for Use:

The SeCurMark Tissue Site Marking System is indicated for the permanent radiographic marking of sites in soft tissue.

Prescription Use X (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)

Page 1 of 1

Kimbay H. Bley FOR M.MEIERSON

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

K072913 510(k) Number

(Posted November 13, 2003)