RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE

K032054 · Radionics, A Division of Tyco Healthcare Group LP · HAW · Sep 15, 2003 · Neurology

Device Facts

• Record ID: K032054
• Device Name: RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE
• Applicant: Radionics, A Division of Tyco Healthcare Group LP
• Product Code: HAW · Neurology
• Decision Date: Sep 15, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Indications for Use

The Radionics Nashold Biopsy Needle is intended for single patient use in stereotactic biopsy of brain tumors.

Device Story

The Radionics Nashold Biopsy Needle (NBN-D) is a single-use, dual-cannula device designed for stereotactic brain tumor biopsies. It is used in conjunction with the Radionics CRW stereotactic system. Operation involves inserting the needle into the target site, applying suction via an external syringe to draw tissue into the cannula, and rotating the inner cannula to excise the tissue sample. The device is intended for use by neurosurgeons in a clinical or surgical setting. It provides a mechanical means for tissue acquisition to assist in diagnostic decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dual-cannula biopsy needle; stainless steel construction; manual operation; single-use; designed for integration with the Radionics CRW stereotactic system.

Indications for Use

Indicated for patients requiring stereotactic biopsy of brain tumors.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• MRI Devices Corporation (DAUM CORP.) Daum Neurocut Neurobiopsy Needle (K990278)
• Ad-Tech's Brain Biopsy Needle For Stereotaxic (K924348)
• Elekta Instrument's Leksell Sedan Biopsy Needle

Submission Summary (Full Text)

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K032054

## SEP 1 5 2003

Attachment VII: Summary of Safety and Effectiveness Information [510(k) Summary]

| SUBMITTER: | Radionics, a division of Tyco Healthcare LP<br>22 Terry Ave.<br>Burlington, MA 01803<br>Tel.: [phone]<br>Fax: [phone] |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact: Kevin J. O'Connell<br>Senior Regulatory Associate |
| PROPRIETARY NAME: | Radionics Nashold Biopsy Needle - Single Use (NBN-D) |
| COMMON OR USUAL<br>NAME: | Disposable biopsy needle |
| CLASSIFICATION CODE: | 21 C.F.R. § 882.4560 |
| PREDICATE DEVICES: | MRI Devices Corporation (DAUM CORP.) Daum Neurocut<br>Neurobiopsy Needle, K990278<br>Ad-Tech's Brain Biopsy Needle For Stereotaxic, K924348<br>Elekta Instrument's Leksell Sedan Biopsy Needle, 510(k) unk |
| INTENDED USE: | The Radionics Nashold Biopsy Needle is intended for single<br>patient use in stereotactic biopsy of brain tumors. |
| DESCRIPTION: | The NBN-D is a dual cannula device made from stainless<br>steel hypodermic needles. The device requires suction<br>provided by a syringe to draw the tissue into the needle. The<br>inner cannula is then rotated to cut the tissue. The device is<br>designed to be used with the Radionics CRW system. |

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 5 2003

Mr. Kevin J. O'Connell Senior Regulatory Associate Radionics A Division of Tyco Healthcare LP 22 Terry Avenue Burlington, Massachusetts 01803

Re: K032054

Trade/Device Name: Radionics Nashold Biopsy Needle - Single Use Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: July 1, 2003 Received: July 2, 2003

Dear Mr. O'Connell:

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. Kevin J. O'Connell

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]. 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 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

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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## 2.0 ODE Indications Statement:

Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Radionics Nashold Biopsy Needle – Single Use

, "

The Radionics Nashold Biopsy Needle is intended for single patient use in stereotactic biopsy of brain tumors.

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

PRESCRIPTION USE

OR

Over-The-Counter Use

(Per 21 CFR 801.109

Miriam C. Provost

(Optional Format 1-2-96)

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

510(k) Number K032054