The CTG 2000sa system is a stereotactic accessory for Computed Tomography (CT) systems. It displays the simulated image of a rigid interventional instrument, such as a biopsy needle or an aspiration needle, on a computer monitor screen that also shows the CT image of the target organs and the projected future path of the interventional instrument, compensating for respiratory movements of the patient.

The device is intended to be used in clinical applications and for anatomical structures where computed tomography is currently used for visualizing such procedures.

Device Description

The CTG 2000sa provides visual enhancement of the interventional needle by overlaying the image of the insertion device and its predicted future path on the CT image of the internal organs, all displayed on the monitor of a personal computer.

The device uses magnetic transmitters and receivers, sold under the trade name "PC Birds," to determine the location and orientation of the interventional needle. These devices have been used on medical devices cleared by the FDA. The positions and orientations of the interventional device, and the video of the CT image, are transmitted to a Personal Computer, which makes the necessary calculations to provide the overlay of the video image and the interventional device.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the UltraGuide CTG 2000sa device:

Based on the provided text, the device does not have explicitly stated acceptance criteria or a detailed study proving its direct performance against such criteria. The submission relies heavily on substantial equivalence to a predicate device and a lack of necessity for a clinical test due to using the same technology.

Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document. The submission focuses on substantial equivalence and safety/efficacy relative to a predicate device.	The device underwent "Accuracy tests ... in phantoms." No specific metrics or thresholds for accuracy are provided.

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

Sample Size: Not applicable. No dedicated "test set" for a clinical study is described. The "accuracy tests" were performed in phantoms, but no sample size for these phantom studies is mentioned.
Data Provenance: Not applicable. No human data (retrospective or prospective) is mentioned in the context of device performance testing.

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

Not applicable. No human test set or ground truth establishment by experts is described for this device's performance evaluation.

4. Adjudication Method for the Test Set

Not applicable. No human test set or adjudication process is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was it done?: No. The document explicitly states: "Since this system uses the same technology as the predicate device, a clinical test is not necessary."
Effect Size: Not applicable, as no MRMC study was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Was it done?: Yes, to some extent, in the form of "Accuracy tests ... in phantoms." However, the details of these tests, including specific metrics, performance thresholds, and a statistical analysis, are not provided. The device's primary function is to provide visual enhancement and guidance for a human operator, so a purely standalone performance would be about the accuracy of its display.

7. Type of Ground Truth Used

For "Accuracy tests in phantoms": The ground truth would likely be the known, precisely measured positions and paths within the phantoms.
Overall: The submission relies on the established safety and efficacy of the predicate device, CT-Guide 1010 (K002258).

8. Sample Size for the Training Set

Not applicable. This device is a visualization and guidance system based on physical tracking technology and computational overlay, not a machine learning or AI algorithm that requires a "training set" in the conventional sense.

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

Not applicable, as there is no mention of a training set for a machine learning model.

Summary

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K022354

UltraGuide Ltd.

510(k) Summary

CTG 2000sa

I. Submitter Information

A. Name: UltraGuide Ltd.
Yogne'am, New Industrial Park, B. Address: 7b Hayezira st., Israel UltraGuide P.O.B 570 Yokneam Illit 20692
C. Contact Person: Dr. George Myers, 201-727-1703, Fax 201-727-1708
D. Date of preparation: July 3, 2002

II. Device Data

A. Trade Name: CTG 2000sa

B. Common Name: Visualization Enhancement System of Interventional Needles under imaging by computed tomography

C. Classification Name: System, X-Ray, Tomography, Computed
III. Legally-marketed predicate devices.

A. CT- Guide 1010, K002258

IV. Description

V. Intended Use

The CTG 2000sa system is a stereotactic accessory for Computed Tomography (CT) systems. It displays the simulated image of a rigid interventional instrument, such as a

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biopsy needle or an aspiration needle, on a computer monitor screen that also shows the CT image of the target organs and the projected future path of the interventional instrument, compensating for respiratory movements of the patient.

The device is intended to be used in clinical applications and for anatomical structures where computed tomography is currently used for visualizing such procedures.

VI. Technological characteristics

VII. Testing

A. Non-clinical tests

The CTG 2000sa has undergone extensive bench tests for electrical safety and electromagnetic compatibility. The major components (the computer, ultrasound system, and PC Birds) are all commercial devices with published environmental and physical specifications.

Accuracy tests were done in phantoms.

B. Clinical Test

Since this system uses the same technology as the predicate device, a clinical test is not necessary.

VIII. Conclusion

The tests show that the UltraGuide CTG 2000sa is equivalent to the predicate devices in safety and efficacy.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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, with three stylized wing-like shapes.

Public Health Service

ood and Drug Administration 00 Corporate Boulevard ockville MD 20850

AUG 13 2002

UltraGuide, Ltd. % Dr. George Myers Official Correspondent Medsys. Inc. 377 Route 17 South HASBROUCK HEIGHTS NJ 07604

Re: K022354

Trade/Device Name: UltraGuide CTG 2000sa Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II

Product Code: 90 JAK Dated: July 10, 2002 Received: July 19, 2002

Dear Dr. Myers:

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. Iisting 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 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

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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Snogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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UltraGuide Ltd. CTG 2000sa

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J10(k) Number (if known): KO22 35

Device Name: CTG 2000sa

Indications for Use:

The device is intended to be used in clinical applications and for anatomical structures where computed tomography is currently used for visualizing such procedures.

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Prescription Use

David A. Ingram

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number .

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.