(545 days)
The PunctureNeedle device is intended for use in puncturing precise anatomical locations (including but not limited to cysts, lesions, fluid spaces, etc.) and aspirating or injecting various fluids or contents. The device may be utilized under MRI guidance.
The PunctureNeedle is a standard needle to puncture precise anatomical locations and inject or aspirate various fluids or contents. The proposed device is different than many needles in that the PunctureNeedle device has components manufactured of titanium alloy, which yields less artifact than stainless steel when utilized under magnetic resonance conditions.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, a study, or any of the other specific details requested in your prompt regarding a study that proves a device meets acceptance criteria.
The documents are a 510(k) summary for the "PunctureNeedle" device and the FDA's clearance letter for it. They describe the device, its intended use, technological characteristics, and its substantial equivalence to predicate devices, particularly highlighting its titanium alloy components for reduced MRI artifact. However, there is no mention of a clinical or technical study proving specific performance metrics against defined acceptance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given information.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for Ferguson Medical. The logo consists of a stylized letter "M" on the left, followed by the words "FERGUSON" and "MEDICAL" stacked on top of each other on the right. The logo is black and white and has a bold, modern look.
916-342-4133 FAX: 916-343-4541
MAR 19 1998
01 September 1996
510(k) SUMMARY
The 510(k) summary information required by 21 CFR 807.92 is as follows:
- Classification name: Needle, aspiration and A. injection, disposable, or biopsy instrument, gastroenterology-urology.
- Aspiration needle, puncture Common/usual name: needle, probe needle, irrigation needle, injection needle, etc.
Proprietary name: PunctureNeedle
- Terumo (K760775), Substantial equivalence: B. Wilson-Cook (K851953, K851957), Daum (K961185), and others.
- The PunctureNeedle is a C. Device description: standard needle to puncture precise anatomical locations and inject or aspirate various fluids or contents.
- The PunctureNeedle is intended for Intended use: D. use in puncturing precise anatomical locations (including but not limited to cysts, lesions, fluid spaces, etc.) and aspirating or injecting various fluids or contents. The
3407 Bay Avenue · Chico, California 95973 · USA
{1}------------------------------------------------
device may be utilized under MRI guidance.
- Technological characteristics: The PunctureNeedle E. is similar to predicate devices in its design, function, and intended use.
proposed device is different than many The needles in that the PunctureNeedle device has components components manufactured of titanium alloy, which yields less artifact than
stainless steel when utilized under magnetic resonance conditions.
Submitted, FERGUSON MEDICAL Establishment Registration Number 2937794
Frank Fear
Frank Ferguson Official Correspondent
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem featuring a stylized caduceus, a symbol often associated with healthcare and medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 19 1998
Mr. Frank Ferquson Ferguson Medical 3407 Bay Avenue Chico, California 95973
Re: K963794 Trade Name: PunctureNeedle Regulatory Class: II Product Code: KNW Dated: December 27, 1997 Received: January 5, 1998
Dear Mr. Ferquson:
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 The general controls provisions of the Act 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. ਬੋ 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 (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 requlations.
{3}------------------------------------------------
Page 2 - Mr. Ferguson
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Stepten Roberts
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Page 1 of 1
PunctureNeedle Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The PunctureNeedle device is intended for use in puncturing precise anatomical locations (including but not limited to cysts, lesions, fluid spaces, etc.) and aspirating or injecting various fluids or contents. The device may be utilized under MRI guidance.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stephen Rhodes
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K963794
Prescription Use X
(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.