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 Description

AI/ML Overview

This document, K971247, is a 510(k) summary for a SNT Disposable Biopsy Needle, which was cleared on June 16, 1997. It describes the device's intended use and claims substantial equivalence to existing devices.

The information provided does not contain acceptance criteria or study data demonstrating device performance in the typical sense of quantitative metrics like sensitivity, specificity, or accuracy. This is a premarket notification for a medical device (a biopsy needle), not a diagnostic algorithm.

Based on the provided text, here’s an analysis of the requested information:

1. Table of acceptance criteria and the reported device performance

This information is not provided in the given text. For mechanical devices like a biopsy needle, acceptance criteria would typically relate to physical properties, sterility, and functional performance (e.g., sharpness, tissue acquisition capability, compatibility with the guided system). The summary focuses on establishing equivalence rather than presenting performance data against specific criteria.

2. Sample size used for the test set and the data provenance

This information is not provided. As this is a biopsy needle, "test set" in the context of diagnostic algorithms does not apply. Testing for a medical device like this would involve mechanical, biocompatibility, and perhaps animal or cadaver studies, but no details of such studies or their sample sizes are mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided and is not applicable to this type of device submission. Ground truth, in the context of diagnostic performance, is not discussed here.

4. Adjudication method for the test set

This information is not provided and is not applicable to this type of device submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided and is not applicable. The device is a physical biopsy needle, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not provided and is not applicable. The device is a physical biopsy needle, not a standalone algorithm.

7. The type of ground truth used

This information is not provided and is not applicable in the context of diagnostic ground truth. For a biopsy needle, relevant "ground truth" might pertain to successful tissue acquisition (verified by pathology) or accurate targeting (verified by imaging/histology), but no such studies are described.

8. The sample size for the training set

This information is not provided and is not applicable to this type of device submission. The concept of a "training set" applies to machine learning algorithms.

9. How the ground truth for the training set was established

This information is not provided and is not applicable.

Summary of Device and Equivalence Claim:

Device Name: SNT DISPOSABLE BIOPSY NEEDLE
Intended Use: Stereotaxic biopsy of brain tissue, only for use with the StealthStation™ Image Guided Surgery System and its rigid needle guide holder. Supplied sterile and single-use.
Predicate Device: Stereotatic biopsy needle manufactured by RADIONICS (used in their Nashold Biopsy Needle Kit).
Key Difference from Predicate: The SNT needle uses an LED tracked by the STEALTHSTATION™ system for guidance, whereas the RADIONICS device uses stereotactic coordinates dialed into a guide holder on a headframe.
Equivalence Claim: The SNT DISPOSABLE BIOPSY NEEDLE was claimed to be substantially equivalent to the RADIONICS needle and several other commercially available biopsy needles. A comparison was provided to support this claim.

Conclusion:

The provided 510(k) summary focuses on establishing substantial equivalence for a physical medical device (a biopsy needle) by comparing its features and intended use to existing, legally marketed devices. It does not include performance data or acceptance criteria that would typically be found in submissions for diagnostic AI algorithms, which are the context of the questions asked. Therefore, most of the requested information is not present in this document.

Summary

{0}------------------------------------------------

K971247

JUN 16 1997

510(k) Summary of Safety and Effectiveness

SNT DISPOSABLE BIOPSY NEEDLE

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

II. Product Name: SNT DISPOSABLE BIOPSY NEEDLE
The SNT DISPOSABLE BIOPSY NEEDLE is intended to be used for III. 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 SNT DISPOSABLE BIOPSY NEEDLE was claimed to be substantially IV. equivalent to the stereotatic 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.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 16 1997

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

Re: *K971247 SNT Disposable Biopsy Needle Trade Name: Requlatory 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 Requlations, 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 Failure to comply with the GMP regulation may result in assumptions. 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.

{2}------------------------------------------------

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

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

Enclosure

{3}------------------------------------------------

CONFIDENTIAL

Page __ 1 __ of __ 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use: :在

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

STATUTE AND STATUTE AND PROPERTY CONSULTION OF CHARACT OF CHEARTH OF CHEARTH A	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
		Concurrence of CDRH, Office Of Device Evaluation (ODE)

Division Sign Off

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

Image /page/3/Picture/14 description: The image shows the words "Prescription Use" in bold font. Below this text, the words "(Per 21 CFR 801 109)" are printed in a smaller font size. There is a large "X" that crosses out the words "Prescription Use".

Over-The-Counter Use_

(Optional Format 1-2-96)

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
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.(b)
Classification. Class II (performance standards).