(88 days)
The Injection/ Aspiration probes and devices are to be used independently or with commercially available rigid and flexible endoscopes, including laparoscopes, hysteroscopes, cystoscopes, resectoscopes, and suction/irrigation systems. These devices can be used for laparoscopic, hysteroscopic, cystoscopic, and other endoscopic and open surgical procedures designed for injection and aspiration of fluids and solutions in the tissue or body. This device is not intended for injection of drugs.
Injection/Aspiration Needles Probes/Devices
The provided text is a decision letter from the FDA regarding a 510(k) premarket notification for "Injection/Aspiration Needle Probes/Devices." It states that the devices are substantially equivalent to legally marketed predicate devices.
However, the document does not contain any information regarding acceptance criteria, device performance, sample sizes used for testing, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth used, or training set details.
Therefore, I cannot extract the requested information from the provided text. The document's purpose is to grant market clearance based on substantial equivalence, not to detail the performance study results.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Brug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1 1998
Mr. Ashvin Desai President Ximed Medical/Prosurg, Incorporated 2193 Trade Zone Boulevard San Jose, California 95131
Re: K983200 Trade Name: Injection/Aspiration Needle Probes/Devices Regulatory Class: II Product Code: GAA Dated: October 19, 1998 Received: October 23, 1998
Dear Mr. Desai:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 devices 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.
{1}------------------------------------------------
Page 2 - Mr. Ashvin Desai
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, 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,
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
{2}------------------------------------------------
510 (k) NUMBER (IF KNOWN) : K983200
Injection/Aspiration Needles Probes/Devices DEVICE NAME: INDICATIONS FOR USE:
The Injection/ Aspiration probes and devices are to be used independently or with commercially available rigid and flexible endoscopes, including laparoscopes, hysteroscopes, cystoscopes, resectoscopes, and suction/irrigation systems. These devices can be used for laparoscopic, hysteroscopic, cystoscopic, and other endoscopic and open surgical procedures designed for injection and aspiration of fluids and solutions in the tissue or body. This device is not intended for injection of drugs.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE -----
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over - The - Counter - Use (Optional Format 1-2-96)
pcose
(Division Sign-Off) Division of General Restorative Devices 510(k) Number
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.