PROSTATE BIOPSY NEEDLE

K982401 · Remington Medical, Inc. · KNW · Sep 8, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K982401
• Device Name: PROSTATE BIOPSY NEEDLE
• Applicant: Remington Medical, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Sep 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

Prostate Biopsy Needles shall be single use only and are to be used by a urologist in a healthcare setting to obtain needle biopsies of the prostate.

Device Story

Prostate Biopsy Needle is a single-use manual instrument used by urologists in clinical settings to collect tissue samples from the prostate. The device functions as a mechanical tool for biopsy procedures. It is operated manually by the physician to penetrate tissue and retrieve a specimen for diagnostic evaluation. The device aids in the clinical decision-making process by providing tissue samples necessary for the diagnosis of prostate conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single-use manual biopsy needle. Mechanical design for tissue sampling. No electronic components, software, or energy sources.

Indications for Use

Indicated for use by urologists in healthcare settings to obtain prostate needle biopsies. Single-use only.

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)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 8 1998

> Mr. Steve Woody Quality Assurance Coordinator Remington Medical, Inc. 6830 Meadowridge Court Alpharetta, Georgia 30005

Re: K982401 Trade Name: Prostate Biopsy Needle Regulatory Class: II Product Code: KNW Dated: July 7, 1998 Received: July 10, 1998

Dear Mr. Woody:

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 Ouality 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. Steve Woody

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 vour 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

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## Remington Medical, Inc.

Ka8240i

## Appendix B

Indication for Use Statement

510(k) Number (if known): Pending 510(k) Request

Device Name: Prostate Biopsy Needle

Indications for Use:

Prostate Biopsy Needles shall be single use only and are to be used by a urologist in a healthcare setting to obtain needle biopsies of the prostate.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature Sign-Off

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K982401

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The Counter Use _