DIGITAL SPOT MAMMOGRAPHY SYSTEM

K100692 · Hologic, Inc. · IZH · Apr 6, 2010 · Radiology

Device Facts

• Record ID: K100692
• Device Name: DIGITAL SPOT MAMMOGRAPHY SYSTEM
• Applicant: Hologic, Inc.
• Product Code: IZH · Radiology
• Decision Date: Apr 6, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1710
• Device Class: Class 2

Intended Use

The DSM as part of a standard x-ray mammography unit is part of a stereotactic lesion localization system that has the application of localizing, and then giving a physician the capability of performing fine needle aspiration or core biopsy of lesions determined to be suspicious through prior mammographic examination.

Device Story

Digital Spot Mammography (DSM) system functions as an accessory to standard x-ray mammography units; integrated into stereotactic lesion localization systems. Input: x-ray imaging data of breast tissue. Operation: facilitates precise localization of suspicious lesions identified via prior mammography. Output: visual guidance for physician-performed fine needle aspiration or core biopsy. Used in clinical settings by physicians. Benefit: enables minimally invasive tissue sampling for diagnostic confirmation of suspicious breast lesions.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use as a component of a stereotactic lesion localization system.

Technological Characteristics

Component of a stereotactic lesion localization system; utilizes x-ray mammography imaging technology. Class II device under 21 CFR 892.1710 (Mammographic x-ray system).

Indications for Use

Indicated for use in patients requiring localization and biopsy (fine needle aspiration or core biopsy) of suspicious lesions identified during prior mammographic examination. For use by physicians in a clinical setting.

Regulatory Classification

Identification

A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

APR - 6 2010

Ms. Gail Yaeker-Daunis Senior Regulatory Affairs Specialist Hologic, Inc. 36 Apple Ridge Road DANBURY CT 06810

Re: K100692

Trade/Device Name: Digital Spot Mammography System (DSM) Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: II Product Code: IZH Dated: March 9, 2010 Received: March 10, 2010

Dear Ms. Yaeker-Daunis:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to pareny aket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

Donald J. Trump

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

## Premarket Notification: Digital Spot Mammography (DSM) System

### 510(k) No. (k)100692

Device Name: Digital Spot Mammography System (DSM)

### Indications For Use

The DSM as part of a standard x-ray mammography unit is part of a stereotactic lesion localization system that has the application of localizing, and then giving a physician the capability of performing fine needle aspiration or core biopsy of lesions determined to be suspicious through prior mammographic examination.

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use<br>(21 CFR 807 Subpart C) |
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(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

| 510(k) Number | K100692 |
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