(53 days)
For the percutaneous punture of the abdomen or pelvis for the purpose of removing tissue of the soft tissue organs for microscopic examination, for the purpose of diagnosis of disease. The needle is to be used with the automatic biopsy devices marketed by C.R. Bard and Manan Medical Products.
Automatic Cutting Needle
I apologize, but the provided text from the FDA 510(k) clearance letter for the "Automatic Cutting Biopsy Needle" does not contain specific acceptance criteria, device performance data, details of a study (sample sizes, data provenance, expert qualifications, adjudication methods), or information about ground truth establishment.
This document is a regulatory clearance letter, primarily stating that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It does not typically include the detailed technical and scientific data from performance studies.
To answer your request, I would need a document specifically detailing the performance study, often found in an appendix to the 510(k) submission or a separate technical report.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based solely on the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 1998 NOV
Mr. Joesph E. Harms. President Needle & Infusion Technologies, Inc. 390 Scarlet Boulevard Oldsmar, FL 34677
Re: K983218 N.I.T. Inc. Automatic Cutting Biopsy Needle Dated: September 14,1998 Received: September 14, 1998 Regulatory Class: II 21 CRF 876.1075/Procode: 78 FCG
Dear Mr. Harms,
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 (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 requirements, 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 the Electronic Product 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 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/odrh/dsmaldsmam.html".
Sincerely vours
Lillian Yin, Ph.D.
Director. Division of Reproducti Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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1983218 510(k) Number (if known): _
Device Name: Automatic Cutting Needle
Indications For Use:
For the percutaneous punture of the abdomen or pelvis for the purpose of removing tissue of the soft tissue organs for microscopic examination, for the purpose of diagnosis of disease. The needle is to be used with the automatic biopsy devices marketed by C.R. Bard and Manan Medical Products.
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEBORD)
Coucurrence of CDRH, Office of Device Evaluation (ODE)
Amich. Sgamm
(Division Sign-Off) 0 Division of Reproductive, Abdominal, EN and Radiological Devices 510(k) Number.
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 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.