PLANMED CYTOGUIDE

K973493 · Planmed OY · IZH · Nov 10, 1997 · Radiology

Device Facts

• Record ID: K973493
• Device Name: PLANMED CYTOGUIDE
• Applicant: Planmed OY
• Product Code: IZH · Radiology
• Decision Date: Nov 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1710
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Planmed Cytoguide is a mammography stereotactic biopsy system which is attached to Planmed Sophie Classic mammographic x-ray unit. The Cytoguide system is a removable attachment and is intended for obtaining tissue samples, for delivering localized treatment and for placement of a radio-opaque marking to assist subsequent procedures, especially for breast lesions too small to be palpable.

Device Story

Planmed Cytoguide is a stereotactic biopsy attachment for the Planmed Sophie Classic mammographic X-ray unit. It enables clinicians to perform image-guided tissue sampling, localized treatment, and radio-opaque marker placement for non-palpable breast lesions. The system integrates with the existing mammography unit to provide precise localization of lesions. It is used in clinical settings by radiologists or surgeons to improve diagnostic accuracy and facilitate subsequent surgical or therapeutic procedures. By allowing for the biopsy of small, non-palpable lesions, the device aids in early detection and management of breast abnormalities.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stereotactic biopsy attachment for mammography X-ray units. Mechanical guidance system for needle positioning. Removable design for integration with Planmed Sophie Classic. Class II device (21 CFR 892.1710).

Indications for Use

Indicated for patients requiring breast tissue sampling, localized treatment delivery, or radio-opaque marking for non-palpable breast lesions.

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 10 1997

Lars Moring Regulatory Affairs Manager Planmed Ov c/o Planmed Inc. 362 Balm Court Wood Dale, IL 60191

K973493 Re:

Planmed Cytoguide attached to Planmed Sophie Classic Mammographic X-Ray Unit Dated: September 11, 1997 Received: September 15, 1997 Regulatory class: II 21 CFR 892.1710/Procode: 90 IZH

Dear Mr. Moring:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the intentions for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

William Yu, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ENCLOSURE 11

September 11, 1997/LM

510(k) Notification Mammography Stereotactic Biopsy System Planmed Cytoguide for Planmed Sophie Classic

p. 1(1)

## INDICATIONS FOR USE

The Planmed Cytoguide is a mammography stereotactic biopsy system which is attached to Planmed Sophie Classic mammographic x-ray unit. The Cytoguide system is a removable attachment and is intended for obtaining tissue samples, for delivering localized treatment and for placement of a radio-opaque marking to assist subsequent procedures, especially for breast lesions too small to be palpable.

Luis Leefy

Lars Moring Regulatory Affairs Manager

Date: September 11, 1997

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Division Sign-Off

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**Prescription Use**
(Per 21 CFR 801.109)