MICS INTERVENTION AID, CATALOG # MICS-MIA AND MICS-MIAS

K020289 · Machnet BV · LNH · Apr 24, 2002 · Radiology

Device Facts

• Record ID: K020289
• Device Name: MICS INTERVENTION AID, CATALOG # MICS-MIA AND MICS-MIAS
• Applicant: Machnet BV
• Product Code: LNH · Radiology
• Decision Date: Apr 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

For use in conjunction with a Magnetic Resonance Scanner and the Machnet Bilateral Open Breast Coil to localize lesions in female breasts and perform needle biopsies accurately. For use by a trained physician.

Device Story

MICS Intervention Aid (MICS-MIA/MIAS) is a stereotactic localization accessory for MRI-guided breast biopsies. Device consists of a transparent acrylic plate with ~600 puncture holes, a frame with MR fiduciary markers, a sliding locator plate, and a sterilizable needle guide. Used in conjunction with Machnet Bilateral Open Breast Coil to position and compress breast tissue. Physician inputs lesion coordinates and fiduciary marker locations from MR images into the provided PC software. Software calculates optimal puncture hole and needle depth. System assists physician in accurate needle placement for biopsy. Used in clinical MRI settings by trained physicians.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified through internal company procedures to ensure design intent is met.

Technological Characteristics

Transparent acrylic plate with ~600 puncture holes (4mm diameter); MR fiduciary markers; sterilizable needle guide; PC-based software for coordinate calculation; compatible with MRI scanners; non-electronic mechanical accessory.

Indications for Use

Indicated for female patients requiring breast lesion localization and needle biopsy using an MRI scanner and Machnet Bilateral Open Breast Coil. For use by trained physicians.

Regulatory Classification

Identification

A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

Special Controls

*Classification.* Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device 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

• Philips Medical Systems Stereotactic Localization Device (SLD) (K000832)
• MRI Devices Corp Model MR-Biopsy 160 (K010570)
• Siemens Medical Systems MR Breast Biopsy Device (K010773)

Submission Summary (Full Text)

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K020289

## APR 2 4 2002

EXHIBIT 2 MACHNET BV PO BOX 85444 NL-3508 AK UTRECHT THE NETHERLANDS

AMERSFOORTSEWEG 24 A NL-3951 LB MAARN PHONE [phone] FAX [phone] Contact: Abe van der Werf, President January 25, 2002 510(k) Summary of Safety and Effectiveness

- 1. Identification of the Device: Proprietary-Trade Name: "MICS INTERVENTION AID (MICS-MIA and MICS-MIAS)." Classification Name: Accessory to Magnetic Resonance Diagnostic Device Product Code LNH, Stereotactic Localization Device Common/Usual Name: Accessory to MRI Device
- 2. Equivalent legally marketed device: This device is similar in design and identical in function to the Philips Medical Systems Stereotactic Localization Device (SLD) K000832 and MRI Devices Corp Model MR-Biopsy 160, K010570, and Siemens Medical Systems MR Breast Biopsy Device K010773
- 3. Indications for Use (intended use) .. For use in conjunction with a Magnetic Resonance Scanner and the Machnet Bilateral Open Breast Coil to localize lesions in female breasts and perform needle biopsies accurately. For use by a trained physician.
- 4. Description of the device: The MR-Mammography Intervention Aid basically consists of a transparent acrylic plate containing about 600 puncture holes of 4 mm in diameter, held in a frame containing a set of MR fiduciary markers. The device can easily and firmly be attached to the Bilateral Open Breast Coil, thereby positioning and compressing the breast against a Breast Support Pad. The device comes with a (blue) Sliding Locator Plate for easy eyeretrieval of the software-established puncture hole, a detachable Fiduciary Marker Plate and sterilizable Needle Guide. The Mammography Intervention Aid comes with a PC-software package for supporting the calculation of the location and depth of puncturing. Information regarding the coordinates of a lesion and of the MR fiduciary markers should be retrieved from a relevant MR image and are input to the MICS software package. The software may calculate which hole to puncture through and how deep. A notebook PC with MIA Software Package installed is a system option

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### Photo of Machnet Product

Image /page/1/Picture/1 description: The image shows a close-up of a piece of equipment, possibly a machine or electronic device. The equipment has a dark, perforated panel with a grid of circular holes. The panel is positioned beneath a flat surface with a circular opening, suggesting a functional or ventilation purpose. The overall image is somewhat grainy and lacks fine detail.

- 5. Safety and Effectiveness, comparison to predicate device:

| Comparison Areas | Philips Medical Systems<br>Stereotactic Localization<br>Device (SLD) K000832 and<br>MRI Devices Corp Model<br>MR-Biopsy 160, K010570,<br>and Siemens Medical<br>Systems MR Breast Biopsy<br>Device K010773 | MICS INTERVENTION<br>AID (MICS-MIA and<br>MICS-MIAS |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Indications for use | For use in conjunction with<br>a Magnetic Resonance<br>Scanner to localize lesions<br>in female breasts and<br>perform needle biopsies<br>accurately | SAME |
| Use with MRI Model | Philips, GE, Siemens<br>GE Signa® :(3X-LX) 1.5T,<br>1.0T. 0.5T MR scanners | GE Signa :(3X-LX) 1.5T,<br>1.0T, 0.5T MR scanners |

- Testing information and Conclusion 6.
In all material respects, the "MICS INTERVENTION AID (MICS-MIA and MICS-MIAS) is substantially equivalent to Philips Medical Systems Stereotactic Localization Device (SLD) K000832 and MRI Devices Corp Model MR-Biopsy 160, K010570, and Siemens Medical Systems MR Breast Biopsy Device K010773. Testing was performed according to internal company procedures. Test results support the conclusion that actual device performance satisfies the design intent.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three distinct segments, representing the department's focus on health, human services, and the well-being of the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

#### Public Health Service

od and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

# APR 2 4 2002

Machnet BV % Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates PO Box 7007 DEERFIELD IL 60015

Re: K020289

Trade/Device Name: MICS Intervention Aid, Catalog # MICS-MIA and MICS-MIAS Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: March 18, 2002 Received: March 19, 2002

Dear Mr. Kamm:

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 (OS) 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 predication. The I Dr I 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 If you desire specific at 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 Other or Comphares an (rotification" (21 CFR Part 807.97). Other general information on of felection to promative 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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## j) Indications for Use

510(k) Number K020289

The "MICS INTERVENTION AID (MICS-MIA and MICS-MIAS)" is for use in conjunction with a Magnetic Resonance Scanner and the Machnet Bilateral Open Breast Coil to localize lesions in female breasts and perform needle biopsies accurately. For use by a trained physician.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V OR Over the Counter Use (Per 21 CFR 801.109)

Nancy C brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K020289

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