(56 days)
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.
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.
I am sorry, but the provided text from the FDA 510(k) notification for the Planmed Cytoguide does not contain information on the acceptance criteria, device performance study details, or ground truth establishment. The document is primarily a notification of substantial equivalence and outlines the intended use of the device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this input.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
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 (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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Image /page/1/Picture/0 description: The image shows a logo with the letters 'i' and 'P' stacked on top of each other. The 'i' has a circular dot above it, and the 'P' is stylized with a curved top. Below the logo, the word 'Planmed' is written in a bold, sans-serif font. The logo appears to be for a company named Planmed.
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
Yhmid h. de zum
Division Sign-Off
vision it Reproductive, Abdominal, ENT, I Padiological Devices (k) Number
Prescription Use
(Per 21 CFR 801.109)
§ 892.1710 Mammographic x-ray system.
(a)
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.(b)
Classification. Class II.