(82 days)
Chiba needles are used in a variety of procedures including biopsy, nerve block, pericardiocentesis, transhepatic cholorangiography as well as other applications where injection and/or aspiration of fluids are required.
Chiba Needle
The provided text is a letter from the FDA regarding a 510(k) premarket notification for a device called "Chiba Needle." This letter confirms the device's substantial equivalence to legally marketed predicate devices and permits its marketing.
However, this document does not contain the information required to answer your questions about acceptance criteria, device performance, study details, ground truth, or sample sizes.
The letter is a regulatory approval document and does not include the results of performance studies, details about test sets, expert qualifications, or ground truth establishment. It merely states that the device is substantially equivalent for the stated indications for use.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer any of the specific questions (1-9) based on the input text.
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OCT 1 5 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Loretta F. Luhman ISPG, Inc. 517 Litchfield Road New Milford, Connecticut 06776
Re: K012358
Trade Name: Chiba Needle Regulation Number: 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: FCG Dated: July 17, 2001 Received: July 25, 2001
Dear Ms. Luhman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Loretta Luhman
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Walter, MD
for
Celia M. Witten, Ph.D., MD Director Division of General, Restorative
and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
Ver/ 3 - 4/24/96 ISPG, Inc. Applicant: _ KO12358 510(k) Number (if known): Device Name: Chiba Needle
Indications For Use:
Chiba needles are used in a variety of procedures including biopsy, nerve block, pericardiocentesis, transhepatic cholorangiography as well as other applications where injection and/or aspiration of fluids are required.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109) (Optional Format 1-2-96)
Signature
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K012357
§ 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.