MINRAD DRTS LIGHT SABER SYRINGE

K981140 · Minrad, Inc. · FMF · Jun 25, 1998 · General Hospital

Device Facts

• Record ID: K981140
• Device Name: MINRAD DRTS LIGHT SABER SYRINGE
• Applicant: Minrad, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Jun 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Single use disposable syringe to inject fluids into, or retract fluids from the body. When used with the DRTS™ Laser Alignment System, the Light Saber™ Syringe will provide an accuracy of +/- 3mm from the laser path when using a 10 cm needle.

Device Story

The MINRAD Light Saber™ Syringe is a single-use, disposable syringe designed for fluid injection or aspiration. It is intended for use in conjunction with the DRTS™ Laser Alignment System. The system utilizes laser guidance to assist the clinician in positioning the syringe needle, providing an accuracy of +/- 3mm from the laser path when using a 10 cm needle. The device is operated by healthcare professionals in a clinical setting. By providing visual laser alignment, the device assists the clinician in precise needle placement, potentially improving the accuracy of fluid delivery or withdrawal procedures and reducing risks associated with manual positioning.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single-use disposable syringe. Designed for integration with the DRTS™ Laser Alignment System. Mechanical device for fluid delivery/aspiration.

Indications for Use

Indicated for use as a single-use disposable syringe for the injection or aspiration of fluids in patients requiring such procedures. 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)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 5 1998

Mr. Thomas L. Parker ·Director, Regulatory Affairs MINRAD™ Incorporated 6576 East Quaker Street Orchard Park, New York 14127-2593

Re : K981140 MINRAD DRTS Light Saber™ Syringe Trade Name: Requlatory Class: II Product Code: FMF Dated: March 23, 1998 Received: March 30, 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 legally marketed predicate 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 Pleáse note: concerning your device in the Federal Register. 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.

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## Page 2 - Mr. 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html"

Sincerely yours,

Timothy A. Ulatowski

A. Director

Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## SECTION 5

## INDICATIONS FOR USE

## MINRAD LIGHT SABER™ SYRINGE

"Single use disposable syringe to inject fluids into, or retract fluids from the body"

"When used with the DRTS™ Laser Alignment System, the Light Saber™ Syringe will provide an accuracy of +/- 3mm from the laser path when using a 10 cm needle."

Patricia Cucciate
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devi 510(k) Number K98 1

Prescription use ✓
(Per 21CFR 801.109)