LIGHT SABER BONE BIOPSY NEEDLE

K982735 · Minrad, Inc. · KNW · Sep 9, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K982735
• Device Name: LIGHT SABER BONE BIOPSY NEEDLE
• Applicant: Minrad, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Sep 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

Disposable needle for obtaining biopsies from Bone and Bone Marrow.

Device Story

Light Saber Bone Biopsy Needle is a disposable device used by clinicians to extract bone and bone marrow samples. The needle is inserted into the target site to collect tissue specimens for diagnostic purposes. It is intended for use in a clinical setting under prescription. The device facilitates minimally invasive tissue acquisition, aiding in the diagnosis of bone-related pathologies.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable needle design; intended for bone and bone marrow biopsy. Specific materials and dimensions not detailed in the provided text.

Indications for Use

Indicated for patients requiring bone or bone marrow biopsy procedures.

Regulatory Classification

Identification

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an abstract bird-like figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

0 1008 SEP

Mr. Thomas L. Parker Director, Regulatory Affairs MINRAD, Inc. 6576 E. Quaker Street Orchard Park, New York 14127

Re: K982735

Trade Name: Light Saber TM Bone Biopsy Needle Regulatory Class: II Product Code: KNW Dated: July 30, 1998 Received: August 5, 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 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 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 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

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

19822735

Page 12

## SECTION 5

## INDICATIONS FOR USE

## LIGHT SABER™ BONE BIOPSY NEEDLE

"Disposable needle for obtaining biopsies from Bone and Bone Marrow."

(Division Sign-Off) Gastroenterology-urology Division

510(k) Number __

colls

Prescription Use 21 CFR 801.109

(Division Sign-Off) Division of General Restorative Devices 510(k) Number