PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES by XIMED/PROSURE/INJECTX

The PercuTx - Injection /Aspiration Needle device is indicated for use as an accessory for currently marketed endoscopes to provide for delivery of injectable materials into tissues during endoscopic procedures.

As with currently marketed endoscopic injection needles, the PercuTx Endoscopic Injection needle device may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials which have received approval for use by the FDA. The type of material to be injected will be dependent on the nature of the endoscopic procedure, but such materials may include for example: delivery of collagen during cystoscopic procedures; delivery of sclerosing agents during esophagoscopic, and gastroscopic procedures; delivery of local anesthetics during cystoscopic or laryngoscopic procedures; or delivery of saline or contrast media during colonoscopic.

Device Description

PercuTxTM Injection/Aspiration Needle Probes with Control Handpiece

AI/ML Overview

It appears the provided document is a 510(k) clearance letter from the FDA for a medical device called "PercuTxTM Injection/Aspiration Needle Probes with Control Handpiece". This type of document does not typically include detailed information about acceptance criteria, study designs, or performance metrics in the way a clinical study report or a premarket approval (PMA) application would.

510(k) clearance is based on demonstrating "substantial equivalence" to a legally marketed predicate device, not necessarily on new clinical performance data that would involve detailed acceptance criteria and studies as requested in the prompt. While some 510(k) submissions might include performance testing, the provided letter itself does not contain that information.

Therefore, I cannot provide the requested information based on the given text. The text only states that the device is "substantially equivalent" to predicate devices and provides its intended use.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 1 2000

Mr. Lee Bui Quality Assurance, Regulatory Manager InjecTx, Inc. 2195 Trade Zone Boulevard San Jose, California 95131

Re: K994151

Trade Name: PercuTxTM Injection/Aspiration Needle Probes with Control Handpiece Regulatory Class: II Product Code: GAA Dated: December 7, 1999 Received: December 9, 1999

Dear Mr. Bui:

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 (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.

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Page 2 - Mr. Lee Bui

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,

Tizvell Suyo

Sur James 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 KNOW): K994151

DEVICE NAME: PercuTx- Injection /Aspiration Needle Probe / Device

INDICATION FOR USE:

Russell Sayer

Division of General Restorative Devices
510(k) Number12994151
DO NOT WRITE BELOW THIS LINE-CONTINUE ON TI

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON THE ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

. . .

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

Regulation Number and Section

§ 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.