LIGHT SABER ASPIRATION NEEDLE by MINRAD, INC.

I am sorry, but based on the provided text, there is no information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device called "Light Saber™ Aspiration Needle." It primarily states that the device has been found substantially equivalent to a predicate device and can therefore be marketed.

The letter does not contain details about:

A table of acceptance criteria and reported device performance.
Sample sizes used for any test set or data provenance.
The number or qualifications of experts used to establish ground truth.
Any adjudication methods.
Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
Whether standalone (algorithm only) performance was done.
The type of ground truth used.
The sample size for the training set.
How the ground truth for the training set was established.

Therefore, I cannot fulfill your request with the given input.

Summary

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AUG - 7 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Thomas L. Parker Directory of Regulatory Affairs MINRAD, Inc. 6576 East Quaker Street Orchard Park, New York 14127

Re: K982018

Trade Name: Light Saber™ Aspiration Needle Regulatory Class: II Product Code: FMF Dated: May 30, 1998 Received: June 8, 1998

Dear Mr. Parker:

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 (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 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. Thomas L. Parker

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,

-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

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Kagzoig

Page 12

SECTION 5 INDICATIONS FOR USE

LIGHT SABER ASPIRATION NEEDLE

"Single use disposable aspiration needle to attach to a syringe to inject fluids into, or retract fluids from the body"

A Prescription Use . (Per 21 CFR 801.109)

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198201

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).