SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW

K012224 · Ranfac, Corp. · KNW · Aug 22, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K012224
• Device Name: SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW
• Applicant: Ranfac, Corp.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Aug 22, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Ranfac Single Action Biopsy Needle is intended for obtaining a percutaneous soft tissue biopsy.

Device Story

Ranfac Single Action Biopsy Needle is a manual surgical instrument used for percutaneous soft tissue biopsy. Device facilitates tissue sample collection by physician in clinical setting. Operation is purely mechanical; no electronic or automated components. Output is physical tissue specimen for diagnostic analysis. Benefits include minimally invasive access to soft tissue for pathological evaluation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual biopsy needle; mechanical operation; no energy source; no software; sterile, single-use device.

Indications for Use

Indicated for percutaneous soft tissue biopsy in patients requiring tissue sampling.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2001

Mr. George J. Hattub, CQE Director, Quality Assurance/Regulatory Affairs Ranfac Corporation 30 Doherty Avenue Avon, Massachusetts 02322

Re: K012224

Trade/Device Name: Ranfac Single Action Biopsy Needle Regulation Number: 876.1075 Regulatory Class: II Product Code: KNW, FCG Dated: July 12, 2001 Received: July 16, 2001

Dear Mr. Hattub:

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.

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Page 2 - Mr. George J. Hattub, CQE

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 nouticate 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 11 you desire specific a in vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for questions on the promotion and advertising of your device, (201) 59 m 400 ffice of Compliance at [phone]. Also, please note the regulation 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 Information on your responsion.com sumer Assistance at its toll-free number [phone] or Mandractarers Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

R. Marlin N. Melkersen

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ KO12224

Device Name: Ranfac Single Action Biopsy Needle

Indications For Use: The Ranfac Single Action Biopsy Needle is intended for obtaining a percutaneous soft tissue biopsy.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✓ (per 21 CFR 801.109) Over-the-Counter Use

S. Mark N. Milkerson

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K012224