CORE NEEDLE BIOPSY

K040266 · Remington Medical, Inc. · KNW · Jul 9, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K040266
• Device Name: CORE NEEDLE BIOPSY
• Applicant: Remington Medical, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Jul 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Remington CenterFire is Intended for use in obtaining biopsies from soft tissue such as liver, kidney, prostate, breast, spleen and various soft tissue turnors. It is not intended for use in the bone.

Device Story

Remington CentreFire Biopsy Instrument; manual soft tissue biopsy device. Used by clinicians to obtain tissue samples from liver, kidney, prostate, breast, spleen, and soft tissue tumors. Device operation involves manual insertion and activation to excise tissue core. Used in clinical settings; provides tissue samples for diagnostic pathology. Benefits include minimally invasive tissue acquisition for disease diagnosis. Not for use in bone.

Technological Characteristics

Manual soft tissue biopsy instrument. Class II device (21 CFR 876.1075). Product code 78 KNW.

Indications for Use

Indicated for obtaining biopsies from soft tissue including liver, kidney, prostate, breast, spleen, and soft tissue tumors. Contraindicated for use in bone.

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

**JUL - 9 2004**

Ms. Maria P. Granito VP Operations Remington Medical, Inc. 6830 Meadowridge Court ALPHARETTA GA 30005

Re: K040266

Trade/Device Name: Remington CentreFire Biopsy Instrument Regulation Number: 21 CFR §876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: 78 KNW Dated: May 24, 2004 Received: June 8, 2004

Dear Ms. Granito:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosate) to regard) the enactment date of the Medical Device Amendments, or to connine.co phor to may 20, 1978) in accordance with the provisions of the Federal Food, Drug, devices that have occh roomssing in avere approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dicioloro, mance and act include requirements for annual registration, listing of general controls provisions or ractice, 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 your acvice is classified (500 acove) and existing major regulations affecting your device can be n may be subject to address againtions, 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 I Tease of advised that I Dr. or beautes a your device complies with other requirements of the Act that I Dri has made a seconneced by other Federal agencies. You must or any I ederal statutes and regarants, including, but not limited to: registration and listing Compry with an the roc requirently Part 801); good manufacturing practice requirements as set (21 CFR Part 007), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quanty by trems (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your devec as described in your Scetion 510(k)
This letter will and the first of the success of your device to a logally This letter will allow you to begin marketing of substantial equivalence of your device to a legally premarket notification - The PITA momy, or saisines by our 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 Park (1), please
r the regulation If you desire spectic advice for your device on our lassing on good on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, Tor questions of the promotion and the regulation entitled, "Masbranding
Office of Compliance at [phone]. Othios of Compliance at [phone]. Fax) 807.97) you may obtain. Other general
by reference to premarket notification" (21CFR Part 807.97) you may obtained from the Divi by reference to premarket notification (21 of It's are a be obtained from the Division of Small
information on your responsibilities under the Act may be its the sumber (800) information on your responsibilities uncer at its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-fremanain http:// Manufacturers, International and Coulsumor rusicience and Courselv/dsma/dsmamain.html.
[phone] or at its Internet address http://www.fda.gov/cdrl/dsmaldsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K040266

Device Name: Remington CentreFire Biopsy Instrument

Indications For Use:

The Remington CenterFire is Intended for use in obtaining biopsies from soft tissue such as liver, kidney, prostate, breast, spleen and various soft tissue turnors. It is not intended for use in the bone.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
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· AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sammy Morris for NCB
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number J

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