TARGOBEAM by FERGUSON MEDICAL | FDA 510(k) Summary

TarqoBeam is an aiming device intended to be used to verify and control correct angulation of interventional -----devices such as needles used in CT- or MRI-quided punctures, biopsies, and related procedures.

Device Description

The TargoBeam is an aiming device which utilizes lasers to precisely place the correct angulation and position on interventional device such as a biopsy an needle.

AI/ML Overview

Here's an analysis of the provided text regarding the TargoBeam device's acceptance criteria and study information.

It's important to note that the provided documents are a 510(k) summary and an FDA clearance letter from 1997. These documents are primarily focused on demonstrating substantial equivalence to pre-existing devices, rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics in the way modern device submissions often do.

Based on the provided text, the specific details regarding acceptance criteria and a structured study proving device performance are not explicitly available in the format requested. The documents emphasize substantial equivalence to predicate devices rather than meeting a pre-defined performance threshold through a dedicated study.

However, I can extract the available information and highlight what is missing based on your request.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Explicitly Stated in Document)	Reported Device Performance (Explicitly Stated in Document)
Substantial Equivalence to Predicate Devices	The TargoBeam is "similar to predicate devices, and existent methodologies in its intended use." (Implied performance is similar to predicates, but no specific metrics are given.)
Intended Use: "verify and control correct angulation of interventional devices such as needles used in CT- or MRI-guided punctures, biopsies, and related procedures."	The device is an "aiming device which utilizes lasers to precisely place the correct angulation and position on interventional device such as a biopsy an needle." (This is a description of its capability, not a measured performance against specific criteria).
Non-invasive	"The TargoBeam is entirely noninvasive"
Suitable for use under MRI	"suitable for use under MRI."

Missing Information: There are no quantitative acceptance criteria (e.g., accuracy +/- X degrees, success rate > Y%) or quantified performance metrics (e.g., "The device achieved an average angular deviation of 0.5 degrees, meeting the acceptance criterion of < 1 degree"). The assessment is qualitative and comparative.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set: Not specified. The document does not describe a formal "test set" in the context of a clinical performance study.
Data Provenance: Not specified. There is no mention of a study involving patient data, either retrospective or prospective, or country of origin. The submission relies on a comparison to predicate devices and a description of the device's technical characteristics and intended use.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified.
As no formal test set or ground truth establishment process is described for performance, experts for this purpose are not mentioned. The "experts" involved would likely be the FDA reviewers assessing the substantial equivalence.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No test set requiring expert adjudication for ground truth is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study is not mentioned or implied in the provided documents. The focus is on device features and comparison to predicates.
Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable. The TargoBeam is a physical aiming device, not an AI-assisted diagnostic or interventional tool for image interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance Study: Not applicable. The TargoBeam is an aiming device that inherently requires human interaction for its use in guiding interventional procedures. It is not an "algorithm only" device.

7. The Type of Ground Truth Used

Type of Ground Truth: Not explicitly defined or used in the context of a performance study in these documents. The "ground truth" for the submission is primarily the established performance and safety of the predicate devices and the technical specifications of the TargoBeam itself.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. As the TargoBeam is a physical device and not an AI/machine learning model, there is no "training set" in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device.

Summary of what's provided vs. requested:

The provided documents are a regulatory submission for substantial equivalence for a physical medical device from 1997. The requirements for such submissions at that time, and for this type of device, differ significantly from the detailed clinical performance studies, AI model validation, and specific quantitative acceptance criteria that are often expected for newer, more complex devices, especially those incorporating AI or novel clinical pathways.

The "study" that proves the device meets the acceptance criteria in this context is the 510(k) submission itself, which argues that the TargoBeam is functionally equivalent, equally safe, and equally effective to legally marketed predicate devices, and therefore acceptable for market. No specific standalone clinical trial data with defined acceptance criteria and performance results are presented in these particular documents.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Ferguson Medical. The logo consists of a stylized letter "M" on the left, followed by the words "FERGUSON" and "MEDICAL" stacked on top of each other on the right. The logo is in black and white.

916-342-4133 FAX: 916-343-4541

K970819

JUL 1 4 1997

05 February 1997

510(k) SUMMARY

The 510(k) summary information required by 21 CFR 807.92 is as follows:

Unknown Classification name: A .
Laser needle positioner, Common/usual name: stereotactic needle guide, needle guide, etc.

Proprietary name: TargoBeam

Blunt Needle Hawkins Substantial equivalence: B. Access System (Medical Device Technologies), SiteRite II Vascular Access Guidance System ColorMark (EchoCath, (Dymax Corporation), Interventional AccuPlace (Medtronic Inc. ) . . Radiology).
The TargoBeam is an aiming C. Device description: device which utilizes lasers to precisely place the correct angulation and position on interventional device such as a biopsy an needle.
The TargoBeam is intended to be D. Intended use: used to verify and control correct angulation of interventional devices such as needles used in CT- or MRI-guided punctures, biopsies, and

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related procedures.

Technological characteristics: The TargoBeam E. device is similar to predicate devices, and existent methodologies in its intended use.
The proposed device is different than many needles in that the TargoBeam is entirely noninvasive, and suitable for use under MRI.

Submitted, FERGUSON MEDICAL Establishment Registration Number 2937794

Frank Lau

Frank Ferguson Official Correspondent

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that suggest wings and a body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Frank Ferguson Official Correspondent Ferguson Medical 3407 Bay Avenue Chico, California 95926

Re: K970819

TargoBeam (Laser Needle Positioner) Dated: June 20, 1.997 ... .......................................... JUL 1 4 1997 Received: June 27, 1997 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK

Dear Mr. Ferguson:

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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begine as described in your 5100k) 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 (301) 594-4613. Additionally, for question 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.fdu.gov/odrh/dsmamain.html".

Sincerely yours

W. Hiau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (If known): K 970819

Device Name: TarqoBeam

Indications`For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ra. Philly

(Division Sign-Off)

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

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

OR

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.