SNT DISPOSABLE BIOPSY NEEDLE

K971247 · Surgical Navigation Technologies, Inc. · HAW · Jun 16, 1997 · Neurology

Device Facts

• Record ID: K971247
• Device Name: SNT DISPOSABLE BIOPSY NEEDLE
• Applicant: Surgical Navigation Technologies, Inc.
• Product Code: HAW · Neurology
• Decision Date: Jun 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The SNT DISPOSABLE BIOPSY NEEDLE is intended to be used for stereotaxic biopsy of brain tissue. This needle is only intended for use with the StealthStation™ Image Guided Surgery System and it's rigid needle guide holder. The biopsy needle is supplied sterile and is intended for single use only.

Device Story

Disposable biopsy needle for stereotaxic brain tissue sampling. Integrates with StealthStation™ Image Guided Surgery System; utilizes LED tracking for navigation rather than traditional headframe-based stereotactic coordinate systems. Used by neurosurgeons in clinical settings to guide needle placement for biopsy procedures. Provides real-time tracking to assist in precise tissue targeting; benefits patient by enabling image-guided surgical access.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable biopsy needle; includes LED for tracking within the StealthStation™ Image Guided Surgery System. Supplied sterile for single use.

Indications for Use

Indicated for stereotaxic biopsy of brain tissue. Intended for use with the StealthStation™ Image Guided Surgery System and its rigid needle guide holder. Single-use only.

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

• Nashold Biopsy Needle Kit (Radionics)

Submission Summary (Full Text)

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K971247
JUN 16 1997

# 510(k) Summary of Safety and Effectiveness

## SNT DISPOSABLE BIOPSY NEEDLE

I. **Company:** Surgical Navigation Technologies, Inc.
530 Compton Street
Broomfield, CO 80020

II. **Product Name:** SNT DISPOSABLE BIOPSY NEEDLE

III. The SNT DISPOSABLE BIOPSY NEEDLE is intended to be used for stereotaxic biopsy of brain tissue. This needle is only intended for use with the StealthStation™ Image Guided Surgery System and it’s rigid needle guide holder.

IV. The SNT DISPOSABLE BIOPSY NEEDLE was claimed to be substantially equivalent to the stereotactic biopsy needle manufactured by RADIONICS and used in their Nashold Biopsy Needle Kit. The only difference is that their device uses stereotactic coordinates that are dialed into a guide holder on a headframe to lead the needle while our device is tracked using an LED that is tracked by the STEALTHSTATION™. In addition, the SNT DISPOSABLE BIOPSY NEEDLE was claimed to be substantially equivalent to several commercially available biopsy needles. A comparison of these needles was supplied in support of establishing equivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. David A. Mire
Clinical and Regulatory Affairs Associate
Surgical Navigation Technologies, Inc.
530 Compton Street
Broomfield, Colorado 80020

Re: *K971247
Trade Name: SNT Disposable Biopsy Needle
Regulatory Class: II
Product Code: 84HAW
Dated: March 14, 1997
Received: April 3, 1997

Dear Mr. Mire:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.

JUN 16 1997

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Page 2 - Mr. David A. Mire

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,

Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular, Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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03/1997 15:00 303-439-9711 SURGICAL NAVIGATION PAGE 13
CONFIDENTIAL
Page 1 of 1

510(k) Number (if known): __

Device Name: SNT Disposable Biopsy Needle

Indications For Use:

The SNT DISPOSABLE BIOPSY NEEDLE is intended to be used for stereotaxic biopsy of brain tissue. This needle is only intended for use with the StealthStation™ Image Guided Surgery System and it's rigid needle guide holder. The biopsy needle is supplied sterile and is intended for single use only.

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

Concurrence of CDRH, Office Of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K971247

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)