PERFORMA STEREO

K023864 · Instrumentarium Corp. Imaging Division · IZH · Jan 9, 2003 · Radiology

Device Facts

• Record ID: K023864
• Device Name: PERFORMA STEREO
• Applicant: Instrumentarium Corp. Imaging Division
• Product Code: IZH · Radiology
• Decision Date: Jan 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1710
• Device Class: Class 2

Intended Use

Performa Stereo is intended to be used for breast biopsy or lesion marking with the base mammographic system Performa with stereo adapter.

Device Story

Performa Stereo is a breast biopsy and lesion marking accessory for the Performa mammographic system. It consists of a biopsy unit with a motorized Cytoguide needle guide, a breast support table, a ±15° stereo adapter, and a film marker unit. During examination, two X-ray images are captured at ±15° angles on an 18x24 cm film cassette. The user marks the target lesion on both images using a cursor on a film reader. The film marker unit calculates the target's XYZ coordinates. The system then automatically positions the needle holder based on these coordinates and the selected needle length. The clinician inserts the needle into the holder to penetrate the lesion. The device is used in clinical settings by healthcare professionals. It facilitates precise needle targeting for biopsies, potentially improving diagnostic accuracy and patient outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical biopsy unit with motorized needle guide; includes stereo adapter for ±15° imaging. Interfaces mechanically with the Performa mammographic system; no electrical connections. Uses film-based imaging (18x24 cm cassette). Coordinates calculated via film marker unit for automated needle positioning.

Indications for Use

Indicated for breast biopsy (fine needle aspiration, core biopsy, vacuum assisted biopsy) and lesion marking in patients undergoing 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

• Alpha Stereo 4 (K934478)
• GE Stereotix 2 (K941191)
• Siemens Mammomat 3000 Stereo (K884107)

Reference Devices

• Performa mammographic system (K981641)
• Delta 16
• Delta 32

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains a logo with the text "INSTRUMENTARIUM imaging". The logo features a stylized letter "i" with curved lines emanating from the top, resembling radio waves or a signal. The word "INSTRUMENTARIUM" is in a bold, uppercase font above the word "imaging", which is in a smaller, lowercase font. The overall design is simple and modern.

13 November 2002

## 510(K) SUMMARY

# JAN 0 9 2003

#### MANUFACTURER:

Instrumentarium Corp. Imaging Division (Street Address: Nahkelantie 160) P.O.Box 20 FIN-04301 Tuusula, Finland

Phone: [phone] [phone] Fax:

Contact person: Kaija Jokela

#### UNITED STATES SALES REPRESENTATIVE (U. S. DESIGNATED AGENT):

Instrumentarium Imaging Inc. 300 West Edgerton Avenue Milwaukee, Wisconsin 53207

414-747-1030 Phone: Fax: [phone]

#### PRODUCT, CLASSIFICATION NAME

Performa Stereo (Film stereotactic biopsy and lesion marking system)

System, x-ray, mammographic/ IZH

Regulation number: 892.1710

#### SUBSTANTIAL EQUIVALENCE:

We consider this product is similar in design, composition and function to the following devices introduced into commercial distribution after May 28, 1976:

| Alpha Stereo 4 | #K934478 |
|------------------------------|----------|
| GE Stereotix 2 | #K941191 |
| Siemens Mammomat 3000 Stereo | #K884107 |

The comparison of characteristics supports substantial equivalence. The Performa Stereo integrates the features of the predicate device Alpha Stereo 4 to the new platform Performa.

Instrumentarium Imagina

(Nahkelantie 160) P.O. Box 20 • FIN-04301 TUUSULA. Finland • Tel. [phone] • Fax [phone] infalori inctriumantarinon sam .

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Image /page/1/Picture/0 description: The image contains a logo for "Instrumentarium Imaging". The logo features a stylized letter "i" enclosed in a circle with radiating lines, followed by the words "INSTRUMENTARIUM" in a bold, sans-serif font above the word "imaging" in a thinner, sans-serif font. The overall design is clean and professional, suggesting a company involved in technology or imaging-related services.

13 November 2002

## DESCRIPTION:

Performa Stereo is a breast biopsy and lesion marking system in connection with the Performa mammographic system (#K981641). The Performa stereo is especially developed for fine needle aspiration (FNA), core biopsy, vacuum assisted biopsy and lesion marking. The Performa Stereo system consists of a biopsy unit with a needle guide and a breast support table, an adapter unit for making ±15° angles, and a film marker unit. A mechanical docking interface is used for connecting the Performa Stereo's stereo adapter and the biopsy unit together. There are no electrical connections between the biopsy unit and Performa.

The adapter unit is identical to adapter used in the case of Alpha Stereo 4 and Delta 16. The needle guide is a Cytoguide biopsy unit which is the same than used in the case of Delta 32.

In an examination two X-ray images are taken at angles of +15° and -15° degree of the region of interest in the breast. The image capturing will be made by 18x24 cm film cassette and the needle targeting driving will be made with the motorized Cytoguide needle guide unit which are the main functions of the biopsy unit. After making two individual stereotactic X-ray exposures to one film, the corresponding two images are shown side by side on the film reader unit. The user then marks the target point with a cursor on each image. Based on the marking the xyzcoordinates of target are calculated by the film marker unit. The needle holder is then automatically positioned, taking into account the coordinate information and the needle length selected. The tip of the needle, which is then inserted into the holder with correct bushings can now be used to penetrate the lesion area.

#### INTENDED USE:

Performa Stereo is intended to be used for breast biopsy or lesion marking with the base mammographic system Performa with stereo adapter.

Instrumentarium Corp. Imaging Division

Kaija Jokela

Regulatory Affairs tel. + 358 10 3946767, fax [phone] e-mail: kaija.jokela@ fi.instrumentarium.com

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Instrumentarium Corp. Imaging Division % Mr. Brian Broncatti Instrumentarium Imaging, Inc. 300 West Edgerton Avenue MILWAUKEE WI 53207

#### Re: K023864

JAN 0 9 2003

Trade/Device Name: Performa Stereo Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: II Product Code: 90 IZH Dated: November 13, 2002 Received: November 20, 2002

Dear Mr. Broncatti:

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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Image /page/4/Picture/0 description: The image shows the logo for Instrumentarium Imaging. The logo consists of a stylized lowercase "i" with curved lines emanating from the top, enclosed in a circle. To the right of the symbol is the text "INSTRUMENTARIUM" in a bold, uppercase font, stacked above the word "imaging" in a larger, lowercase font. The overall design is simple and modern.

13 November 2002

510(k) Number (if known):

Device Name:

Performa Stereo

Indications for Use:

Performa Stereo is intended to be used for breast biopsy or lesion marking with the base mammographic system Performa with stereo adapter.

Instrumentarium Corp. Imaging Division

Kaija Jokela
Regulatory Affairs

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

Concurence of CDRH, Office of Device Evaulation (ODE)

*Prescription Use*

David A. Leggett

(Optional Format 3-10-98