RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE

K031344 · Ranfac, Corp. · KNW · May 23, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K031344
• Device Name: RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE
• Applicant: Ranfac, Corp.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: May 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Goldenberg SNARECOIL™ Soft Tissue Biopsy (GSS) Needle is intended for obtaining a percutaneous soft tissue biopsy.

Device Story

Sterile, disposable biopsy needle; features stationary stylet for puncture, spring-activated cannula for cutting, and internal SNARECOIL mechanism for tissue capture. Operation: pull ring cocks spring; trigger fires device. Used by clinicians for percutaneous soft tissue biopsy. Captures tissue sample within outer cannula for diagnostic evaluation. Benefits patient by providing minimally invasive method for obtaining tissue specimens.

Clinical Evidence

No clinical data. Performance verification testing (bench testing) demonstrated the device is functionally acceptable.

Technological Characteristics

Sterile, disposable biopsy needle. Components: stationary stylet, spring-activated cannula, internal SNARECOIL tissue capture mechanism. Manual operation via pull ring and trigger. Biocompatible materials.

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.

Predicate Devices

• Ranfac Single Action Biopsy Needle
• Ranfac Goldenberg Bone Marrow Biopsy Needle
• Ethicon Endo-Surgery Inc. Mammotome Hand Held 11 Gauge Biopsy Probe

Submission Summary (Full Text)

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MAY 2 3 2003

## K031 344 510(k) Summary (Page 1 of 2)

| Submitter's Name and Address: | Ranfac Corporation<br>30 Doherty Avenue<br>Avon, MA 02322-0635 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer's Contact Person: | Barry Zimble<br>Executive Vice President<br>Tel: [phone]<br>Fax: [phone] |
| Date Summary Prepared: | April 21, 2003 |
| Device Trade Name: | Goldenberg SNARECOIL™ Soft Tissue Biopsy<br>(GSS) Needle |
| Common name:<br>Classification Name: | Biopsy Needle<br>Biopsy Instrument (21 CFR 876.1075) Product<br>Codes: KNW, FCG |
| Predicate Device(s): | Ranfac Single Action Biopsy Needle<br>Ranfac Goldenberg Bone Marrow Biopsy Needle<br>Ethicon Endo-Surgery Inc. Mammotome Hand Hel<br>11 Gauge Biopsy Probe |
| Device Description: | The subject device is a sterile disposable product<br>featuring a stationary stylet that punctures, a spring activated cannula that cuts and a SNARECOIL that<br>captures tissue. The device functions by pulling<br>back the pull ring until the trigger cocks and<br>pressing the trigger until the device fires. The<br>biopsy is captured by the snare located inside the<br>outer needle cannula. |
| Intended Use: | The Goldenberg SNARECOIL™ Soft Tissue<br>Biopsy (GSS) Needle is intended for obtaining a<br>percutaneous soft tissue biopsy. |

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## 510(k) Summary K031344 (page 2 of 2)

:

| Technological Characteristics: | The proposed device has similar technological<br>characteristics and is similar in design and<br>configuration compared with the predicate devices. |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-Clinical Data: | Performance verification testing demonstrated that<br>the SNARECOIL Soft Tissue Biopsy (GSS) Needle<br>is functionally acceptable. |
| Clinical Data: | Not Applicable |
| Conclusion: | Based on similarities in materials, design, operating<br>principles, biocompatibility and sterilization method<br>between the GSS Biopsy Needle subject of this<br>premarket notification and the predicate devices, the<br>GSS Biopsy Needle has been shown to be<br>substantially equivalent to predicate devices under<br>the Federal Food, Drug and Cosmetic Act. |

:

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Public Health Service

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MAY 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Barry Zimble Executive Vice President Ranfac Corporation 30 Doherty Avenue Avon, Massachusetts 02322-0635

Re: K031344

Trade/Device Name: Goldenberg Snarecoil™ Soft Tissue Biopsy (GSS) Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: April 23, 2003 Received: May 1, 2003

Dear Mr. Zimble:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Barry Zimble

This letter will allow you to begin marketing your device as described in your Section 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), 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

ﺔ ﻣﺪﺗﻤ ﺗﻤ

For 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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K031344 510(k) Number (if known):

## Device Name: Ranfac Goldenberg SNARECOIL™ Soft Tissue Biopsy (GSS) Needle

The GSS Biopsy Needle is intended for obtaining a percutaneous soft tissue biopsy.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

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

510(k) Number K031344

Prescription Use

OR

Over-the -Counter Use (Per 21 CFR 801.109)