(18 days)
To obtain percutaneous core biopsy samples from soft tissue 10 obtain perculations core bropsy surves, kidney, prostate, and culturs of sach organs as awnen used for breast blopsy, the product is for diagnosis only.
Automated Core Biopsy Device
The provided text is an FDA 510(k) clearance letter for the "Automated Core Biopsy Device" and does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
The letter primarily states that the device has been found substantially equivalent to legally marketed predicate devices and can therefore be marketed. It discusses regulatory matters such as general controls, manufacturing practices, and labeling, but does not include technical details about the device's validation or performance.
Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance based on the provided input.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 7 2000
Mr. Joseph L. Mark Vice President Promex. Inc. 3049 Hudson Street Franklin, Indiana 46131
Re: K994272 Trade Name: Automated Core Biopsy Device Regulatory Class: II Product Code: KNW Dated: December 10, 1999 Received: December 20, 1999
Dear Mr. Mark:
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 indications for use stated in the enclosure) 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, 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 (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 (OS) 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 – Mr. Joseph L. Mark
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) 594-4595. Additionally, for questions on the promotion 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,
ames E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Automated Core Biopsy Device
Indications For Use:
To obtain percutaneous core biopsy samples from soft tissue 10 obtain perculations core bropsy surves, kidney, prostate, and culturs of sach organs as awnen used for breast blopsy, the product is for diagnosis only.
(PLEASE DO NOT WRITE BELOW-THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General Restorative Devices K994272 510(k) Number.
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
..
(Optional Formal 1-2-96)
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.