STEREOTACTIC NEEDLE CORE BIOPSY SYSTEM

K973215 · Laurus Medical Corp. · KNW · Nov 6, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K973215
• Device Name: STEREOTACTIC NEEDLE CORE BIOPSY SYSTEM
• Applicant: Laurus Medical Corp.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Nov 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Laurus Medical Stereotactic Needle Core Biopsy System is to be used in conjunction with Stereotactic Imaging Tables to obtain needle core biopsy samples from soft tissue percutaneously.

Device Story

Stereotactic Needle Core Biopsy System designed for percutaneous soft tissue sampling. Device functions in conjunction with stereotactic imaging tables to guide needle placement. Used by clinicians in clinical settings to obtain tissue cores for diagnostic purposes. System facilitates minimally invasive biopsy procedures, reducing patient trauma compared to open surgical biopsy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Percutaneous needle core biopsy system; manual operation; designed for integration with stereotactic imaging tables. Materials and sterilization methods consistent with standard surgical biopsy instrumentation.

Indications for Use

Indicated for percutaneous needle core biopsy of soft tissue in conjunction with stereotactic imaging tables.

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 is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Norman S. Gordon Vice President, Engineering Laurus Medical Corporation 10 Chrysler, Suite B Irvine, California 92618

NOV - 6 1997

Re: K973215

> Trade Name: Stereotactic Needle Core Biopsy Device Regulatory Class: II Product Code: KNW Dated: August 21, 1997 Received: August 27, 1997

Dear Mr. Gordon:

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 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. Norman S. Gordon

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,

Aisles

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}------------------------------------------------

510(k) Submission Stereotactic Needle Core Biopsy System 08/21/97 Page 32

## STATEMENT OF INTENDED USE

Page __ 1

of

1

K973215

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Unassigned at this time

Device Name: Stereotactic Needle Core Biopsy System

Indications for Use: The Laurus Medical Stereotactic Needle Core Biopsy System is to be used in conjunction with Stereotactic Imaging Tables to obtain needle core biopsy samples from soft tissue percutaneously.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Acade

(Division Sign-Off)
Division of General Restorative Devices K973215
510(k) Number

Prescription Use

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)