LIGHT SABER ASPIRATION NEEDLE

K982018 · Minrad, Inc. · FMF · Aug 7, 1998 · General Hospital

Device Facts

• Record ID: K982018
• Device Name: LIGHT SABER ASPIRATION NEEDLE
• Applicant: Minrad, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Aug 7, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Indications for Use

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

Device Story

Light Saber Aspiration Needle is a single-use, disposable medical device designed for attachment to a syringe. It functions as a conduit for the injection of fluids into the body or the aspiration (retraction) of fluids from the body. Used in clinical settings by healthcare professionals, the device facilitates fluid management procedures. It provides a mechanical interface between a syringe and the patient's tissue, enabling targeted fluid delivery or collection. The device is intended for prescription use only.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single-use, disposable aspiration needle. Designed for attachment to standard syringes. Mechanical device; no energy source, software, or electronic components.

Indications for Use

Indicated for use as a single-use disposable aspiration needle for the injection of fluids into or the retraction of fluids from the body. Prescription use only.

Regulatory Classification

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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context.

Image /page/0/Picture/11 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle-like symbol with three profiles facing right, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the symbol.

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.

{1}------------------------------------------------

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone].

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 [phone] or [phone] 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}------------------------------------------------

## 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)

basello

198201