(62 days)
Adaptation for use on the Mammotest® System tables when the clinician wishes to use the Auto Suture ABBI* System for large core biopsy.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "Mammotest® Adapter Driver." It acknowledges that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, ground truth establishment, or any of the other specific study-related information requested in the prompt.
The letter is a regulatory approval, not a technical report or a study summary. It confirms the device's clearance for marketing based on substantial equivalence, but it does not detail the technical performance studies that might have been submitted to support that claim.
Therefore, I cannot provide the requested table and study information based solely on the provided text. To answer your questions, I would need a different document, such as a summary of safety and effectiveness (SSE) or the full 510(k) submission, which would contain the technical data and study details.
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Re:
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Samuella D. Emrich Director of Regulatory of Affairs Quality Assurance Fischer Imaging Corporation 12300 North Grant St. Denver, CO 80241
K973400 Mammotest® Adapter Driver Dated: August 1, 1997 Received: September 9, 1997 Regulatory class: II 21 CFR 892.1710/Procode: 90 IZH
NOV 10 1997
Dear Mr. Emrich:
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 interestone) to 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). You may, therefore, 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 equivation 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 QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, 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.
N'Kiau Yu
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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Initial 510(k)
Mammotest® Adapter Driver Device Name:
Adaptation for use on the Mammotest® System tables when the Indications for Use: clinician wishes to use the Auto Suture ABBI* System for large core biopsy.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________
David L. Ingram
(Division Sign-Off)
OR
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K973400
§ 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.