MAMMOPATH

K021113 · Fischer Imaging Corp. · MWP · Jun 13, 2002 · Radiology

Device Facts

• Record ID: K021113
• Device Name: MAMMOPATH
• Applicant: Fischer Imaging Corp.
• Product Code: MWP · Radiology
• Decision Date: Jun 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The MammoPath can be used with Mammotest® (K861692). Mammotest is a breast biopsy system manufactured by Fischer Imaging, Inc., a dedicated Mammographic device for stereotactically - guided needle biopsy of the breast. Mammotest allows the operator to visualize suspicious breast lesions under Mammographic X-Ray and to guide various tissue acquisition devices to the lesion for tissue harvesting. The Mammopath would then be used for digital imaging of the harvested specimen to provide rapid verification that the correct tissue has been excised during biopsy. The MammoPath can also be used as a stand-alone unit (without Fischer's Mammotest) and would be used to verify correct tissue sampling any given harvested specimen. Doing the verification directly in the same room enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit number of patient recalls.

Device Story

MammoPath is a digital specimen radiography system used to verify breast tissue samples harvested during stereotactic needle biopsies. It functions either integrated with the Fischer Mammotest biopsy system or as a standalone unit. The device captures X-ray images of excised tissue specimens, allowing clinicians to immediately confirm that the target lesion has been successfully sampled. By enabling rapid, point-of-care verification within the biopsy room, the device reduces procedure time and minimizes the need for patient recalls. The output is a digital image reviewed by the physician to guide clinical decision-making regarding the adequacy of the biopsy sample.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital specimen radiography system; stationary X-ray system (21 CFR 892.1680). Designed for integration with stereotactic biopsy systems or standalone operation. Provides digital imaging of harvested tissue specimens.

Indications for Use

Indicated for digital imaging of harvested breast tissue specimens to verify correct tissue sampling during biopsy procedures. Intended for use in clinical settings to confirm excision of suspicious lesions.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Mammotest (K861692)

Submission Summary (Full Text)

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Public Health Service

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## JUN 1 3 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Samir B. Paliwal Director. Regulatory Affairs and Ouality Assurance Fischer Imaging Corporation 12300 North Grant Street DENVER CO 80241

Re: K021113

Trade/Device Name: Mammopath™M Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: 90 MWP Dated: March 31, 2002 Received: April 5, 2002

Dear Mr. Paliwal:

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 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 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 this 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" (21 CFR Part 807.97). 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. Snogdon

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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## ATTACHMENT A

## 510(k) Number: K021113 Product: Mammopath

## INDICATIONS FOR USE

The MammoPath can be used with Mammotest® (K861692). Mammotest is a breast biopsy system manufactured by Fischer Imaging, Inc., a dedicated Mammographic device for stereotactically - guided needle biopsy of the breast. Mammotest allows the operator to visualize suspicious breast lesions under Mammographic X-Ray and to guide various tissue acquisition devices to the lesion for tissue harvesting. The Mammopath would then be used for digital imaging of the harvested specimen to provide rapid verification that the correct tissue has been excised during biopsy.

The MammoPath can also be used as a stand-alone unit (without Fischer's Mammotest) and would be used to verify correct tissue sampling any given harvested specimen.

Doing the verification directly in the same room enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit number of patient recalls.

*Prescription Use*

David A. Severson