ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY

K974158 · Ortho Development Corp. · KNW · Dec 9, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K974158
• Device Name: ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY
• Applicant: Ortho Development Corp.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Dec 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Orion Medical Disposable Brain Biopsy Needle is a fine aspiration biopsy needle to remove and sample tissue within the brain in coniunction with a sterotactic head frame. Indications include: (1) to sample brain turnor or to extract brain tissue samples to deternine tissue abnormality or any deviation from healthy brain tissue; (2) The cannula is removed and the tissue sample is placed on a glass slide or sample dish, which is sent to anatomical pathology for smear analysis to determine tissue type; (3) to be used in conjunction with a sterotactic frame with a center-of-the-arc of 21cm. The needles are 21cm from the hub of the needle to the sharp front cutting edge.

Device Story

Disposable 14G/18G brain biopsy needle; used with stereotactic head frame for CT-guided tissue sampling. Physician inserts needle through burr hole to target; uses syringe to aspirate tissue through cannula. Needle removed; sample expelled onto slide for pathological analysis. Facilitates diagnosis of brain tumors or tissue abnormalities. Benefits patient by enabling minimally invasive, precise tissue acquisition for diagnostic evaluation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Three-piece disposable aspiration biopsy needle; 14G and 18G sizes; 21cm length. Manual operation; used with stereotactic head frame. No energy source or software components.

Indications for Use

Indicated for patients requiring stereotactic brain biopsy to sample tissue or determine abnormalities/deviations from healthy brain tissue. Used with 14G or 18G needles in conjunction with a stereotactic head frame (21cm center-of-the-arc).

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

• Ad-Tech's Brain Biopsy Needle (K924348)
• Field-Lee Brain Biopsy Needle (K801760)
• NBN Brain Biopsy Needle
• BioTac Brain Biopsy Needle

Submission Summary (Full Text)

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K974158

## 510(k) Summary

Orion Medical, Inc. 12187 South Business Park Drive, Suite 300 Draper, UT 84020

Fax [phone] [phone]

Contact Name: Carol Freasier, Regulatory Affairs/QA

This submisson was prepared on October 29, 1997.

| Proprietary Name: | Orion Medical Inc. Disposable Brain Biopsy Needle for stereotactic guided biopsy |
|----------------------|----------------------------------------------------------------------------------|
| Classification Name: | 84 HAW, Disposable Brain Biopsy Needle |
| Common Name: | Disposable Brain Biopsy Needle |
| Regulatory Class: | Class II (882.4560) |

Establishment Registration Number: 1723550

### intended Use:

The Orion Medical Disposable Brain Biopsy Needle is a fine aspiration biopsy needle to remove and sample tissue within the brain in coniunction with a sterotactic head frame. Indications include: (1) to sample brain turnor or to extract brain tissue samples to deternine tissue abnormality or any deviation from healthy brain tissue; (2) The cannula is removed and the tissue sample is placed on a glass slide or sample dish, which is sent to anatomical pathology for smear analysis to determine tissue type; (3) to be used in conjunction with a sterotactic frame with a center-of-the-arc of 21cm. The needles are 21cm from the hub of the needle to the sharp front cutting edge.

## Equivalen Devices:

| Ad-Tech's Brain Biopsy Needle | (Ad-Tech Medical Instrument Corporation) | K924348 |
|-------------------------------|------------------------------------------|---------|
| Field-Lee Brain Biopsy Needle | (V. Mueller) | K801760 |
| NBN Brain Biopsy Needle | (Radionics, Inc.) | |
| BioTac Brain Biopsy Needle | (Progress Mankind Technology) | |

### Summary Statement:

The Orion Medical Inc. three piece disposable Brain Biopsy Needle for sampling brain tissue is to be used in conjunction with a sterotactic head frame. The Orion Medical disposable Brain Biopsy Needle is inserted in the brain through a burr hole via a sterotactic head frame to a desired target that is obtained by a CT image. Tissue samples are obtained by aspirating through the Orion Medical disposable Brain Biopsy Needle is then removed from the brain and the sterotactic system and the sample is expelled from the brain biopsy needle onto a slide for analysis. The Orion Medical disposable Brain Biopsy Needle is similar in geometry, safety, function, and intended use as currently available brain biopsy needles.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 9 1997

Orion Medical Incorporated ·C/O Ms. Carol Freasier Regulatory Affairs/Quality Assurance Ortho Development Corporation 106 West 12200 South Draper, Utah 84020

Re: K974158

Trade Name: Orion Medical Inc. Disposable Brain Biopsy Needle for Sterotactic Guided Biopsy Regulatory Class: II Product Code: KNW Dated: October 29, 1997 Received: November 3, 1997

Dear Ms. Freasier:

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 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

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devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 your 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,

Sincerely yours,

[signature]

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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K974158

# Indications for Use

The Orion Medical Disposable Brain Biopsy Needle is an aspiration biopsy needle to remove and sample tissue within the brain in conjunction with a sterotactic head frame. The following statement describes the indications for use of Orion Medical's 14 gauge, and 18 gauge sterotactic disposable brain biopsy needle:

- Sterotactic biopsy needle used to sample brain tissue or to extract brain tissue samples to . determine tissue abnormality or any deviation from healthy brain tissue.
- . Tissue samples are extracted via the cannula using a syringe to aspirate. The cannula is then removed and the tissue sample is placed on a glass slide or sample dish, which is sent to anatomical pathology for smear analysis to determine tissue type.
- . Needle to be used in conjunction with a sterotactic frame with a center-of-the-arc of 21cm. The needles are 21cm from the hub of the needle to the sharp front cutting edge.

Acosta

General Restorative D 51000 Number

**Prescription Use**
(Per 21 CFR 801.109)