LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM

K040884 · Hologic, Inc. · IZH · Apr 23, 2004 · Radiology

Device Facts

• Record ID: K040884
• Device Name: LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM
• Applicant: Hologic, Inc.
• Product Code: IZH · Radiology
• Decision Date: Apr 23, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1710
• Device Class: Class 2

Intended Use

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 add-on to standard x-ray mammography units and stereotactic breast biopsy systems. Input consists of x-ray signals captured by a Charge-Coupled Device (CCD) digital image receptor. The system processes these signals to produce near real-time digital images on a high-resolution flat-panel monitor. Operated by clinicians in a clinical setting, the system allows physicians to visualize suspicious breast lesions to guide fine needle aspiration or core biopsy procedures. Output includes digital images for display and archiving on CD/DVD media. DICOM connectivity enables query/retrieval operations. The device assists in precise lesion targeting, potentially improving biopsy accuracy and patient outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System includes workstation, monitor, trackball, keyboard, computer, and CCD digital image receptor. Imaging area 5.0 cm x 5.0 cm; 512 or 1024 pixel resolution. Intel-based microprocessor. Connectivity via DICOM. Compliance with IEC-601-1, IEC 601-1-x, IEC 601-2-xx, UL 1950, FCC-A, DHHS, CSA-950, and IEC 950 standards.

Indications for Use

Indicated for patients requiring stereotactic lesion localization, fine needle aspiration, or core biopsy of breast lesions identified as suspicious via prior mammographic examination.

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.

Predicate Devices

• Lorad DSM (K921962A)
• Lorad MultiCare Platinum System (K030666)

Submission Summary (Full Text)

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| Summary of Safety and Effectiveness | | |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| K040884 | | APR 2 3 2004 |
| Submitter: | Hologic, Inc.<br>35 Crosby Drive<br>Bedford, MA 01730 | |
| Contact Person: | Gail Yaeker-Daunis<br>Sr. Regulatory Specialist | |
| Date Prepared: | April 1, 2004 | |
| Common Name: | DSM | |
| Proprietary Name: | Digital Spot Mammography System | |
| Predicate Devices: | Lorad DSM K921962A & K030666 | |
| Intended Use: | DSM as part of a standard x-ray mammography unit is part of a<br>stereotactic lesion localization system that has the application of<br>localizing, and then giving a physician the capability of performing<br>fine needle aspiration or core biopsy of lesions determined to be<br>suspicious through prior mammographic examination | |

## Compliance Statement:

The DSM has been designed for certification to International Electrotechnical Commission Standard IEC-601-1, IEC 601-1-x, IEC 601-2-xx

cUL 187, UL 1950, FCC-A, DHHS, CSA-950, IEC 950

A comprehensive Operator's Manual provided with each system is user friendly and comprehensive, thus ensuring safe and effective operation of the DSM.

This information is provided pursuant to the requirements of the Safe Medical Devices Act of 1990 (SMDA).

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#### General Information Section 1.0

Ko4o884

## Introduction 1.1

The purpose of this Special 510(k) is to modify the Lorad Digital Spot Mammography System which was originally cleared for market as 510 (k) # K921962A At that time, DSM was cleared for use on the Lorad Mammography systems and the Lorad StereoGuide Stereotactic Breast Biopsy System for use in localization and stereotactic procedures.

DSM was last modified as part of the Lorad MultiCare Platinum System (formerly StereoGuide) with Digital Spot Mammography as 510 (k) # K030666.

At this time, Lorad wishes to modify DSM to include DICOM capabilities and to provide capability for use with both the MultiCare Platinum Breast Biopsy System and Lorad Mammography Systems.

#### 1.2 Indications for Use

The indications for use of the DSM are the same as submitted in the Lorad MultiCare Platinum System, 510 (k) # K030666, and repeated below:

DSM as part of a standard x-ray mammography unit is part of a stereotactic lession 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.

### 1.3 Substantial Equivalence

The DSM and the predicate device DSM as cleared in MultiCare Platinum 510(k) # K030666 have the same intended use, the same general configuration, the same principles of operation, and similar operating parameters. The DSM is now available for use with both Lorad MultiCare Platinum Breast Biopsy Table System and M-IV Mammography System. The addition of DICOM capability is considered the only significant change to the device.

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DSM is comprised of a workstation, monitor, trackball, keyboard, computer and digital image receptor.

Image /page/2/Picture/3 description: In the image, a computer is sitting on a desk. The computer has a monitor, keyboard, and tower. The desk is made of wood and has a simple design. The computer is likely used for work or school.

Table 1 below compares the current DSM to the predicate DSM cleared on February 27, 2003 as 510(k) # K030666.

| DSM Console | DSM (K030666) Lorad Multicare | DSM |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| | Platinum | |
| Tissue Imaging Area | 5.0 cm x 5.0 cm<br>Operator control of Image contrast &<br>luminance: Choice of 512 or 1024<br>pixel resolution<br>Large 18 in., high resolution, gray<br>scale flat screen monitor | Same |
| Near Real-Time<br>Image Display | 512 Mode - approx. 4 seconds<br>1024 Mode - approx 8 seconds | Same |
| Image Device | Charge-Coupled Device (CCD) | Same |
| Monitor | Flat Panel | Same |
| Display Area | 18 in. diagonal (minimum) 160°<br>viewing angle (minimum) | Same |
| Computer<br>Microprocessor | Intel CPU | Same |
| Archive Media | DVD + R/RW, CD - R/RW | Same |
| Operating System | Operating system will only recognize<br>disks, DVD/CD formatted with DOS,<br>Windows 9X/NT/2000 | Same |
| User Controls | Power, Brightness, Contrast, Picture<br>Tilt, Height Vertical Position,<br>Horizontal Position | Same |

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Section 1.0

| DSM Console | DSM (K030666) Lorad Multicare<br>Platinum | DSM |
|-------------|-------------------------------------------|------|
| Approvals | UL 1950, FCC-A, DHHS, CSA-950,<br>IEC 950 | Same |
| DICOM | DICOM Query/Retrieval Operations | Same |

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 2 3 2004

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

Re: K040884 Trade/Device Name: Lorad Digital Spot Mammography System (DSM) Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: II Product Code: 90 IZH Dated: April 2, 2004 Received: April 6, 2004

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 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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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 one of the following numbers, based on the regulation number at the top of the letter;

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Lorad Digital Spot Mammography System (DSM)

Indications for Use:

DSM as part of a standard x-ray mammography unit is part of a stereotactic lesion Down as part of a standad as the application of localizing, and then giving a physician the location 37 stem that has the uppers aspiration or core biopsy of lesions determined to be suspicious through prior mammographic examination

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V 21 CFR 801.109

OR

Over-the-Counter Use

David h. leppmm

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 14008 510(k) Number