The CT Scope option is an addition to the CT Twin and HeliCAT families of CT . scanners. It comprises of hardware and software for initiation and termination of the scan process and for on-line monitoring of the resulting images in the gantry room, in addition to the Operator Console. Exposure is initiated by one of two pedals near the patient table and terminated by releasing the pedal. Partially reconstructed images are displayed at a rate of 6 images/second with a delay of approximately one second and displayed on a monitor in the scanner room. A handle for holding the needle from outside the direct radiation to reduce the dose received by the doctor during the interventional procedure is also included. The optional LaserGuide may be used for marking the entrance point and angle . of needle insertion externally to the gantry opening for convenience.

AI/ML Overview

The provided text (K974344) describes a 510(k) submission for a “CT Scope option for CT scanners.” This submission focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with detailed performance metrics.

Therefore, much of the requested information regarding specific acceptance criteria demonstration and study details is not available within this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated as quantifiable performance metrics. The document emphasizes safety and functional equivalence to predicate devices.	The option's specifications and functional requirements were met.
Potential hazards identified in hazard analysis are controlled.	Software safety assured by company procedures conforming to accepted practices. Quality assurance procedures adhered to.
Adherence to IEC 601-1 standards.	Electrical and Mechanical safety assured by adherence to IEC 601-1 standards.
Compliance with 21 CFR, Subchapter J performance standards.	Radiation safety assured by compliance with 21 CFR, Subchapter J performance standards.
Enables initiation and termination of scan process and on-line monitoring in gantry room.	The CT Scope option enables initiation and termination of the scan process and on-line monitoring of the resulting images in the gantry room.
Reduced X-ray exposure to interventionist (with optional LaserGuide).	The use of the LaserGuide may reduce the X-ray exposure to the interventionist.

Reason for "Not explicitly stated": The document is a 510(k) summary, which typically focuses on demonstrating "substantial equivalence" to a legally marketed predicate device rather than presenting de novo clinical trial data with specific performance endpoints and acceptance criteria in the way a PMA (Premarket Approval) might. The "performance" stated here is about fulfilling system specifications and complying with regulations, not clinical accuracy or diagnostic performance.

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

Not applicable/Not provided.
The document does not describe a "test set" in the context of clinical or performance data for an AI/algorithm-based device. The evaluation is focused on engineering verification and validation (that specs are met) and regulatory compliance.

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

Not applicable/Not provided.
No ground truth establishment for a test set is described.

4. Adjudication method for the test set

Not applicable/Not provided.
No test set adjudication method is described.

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

Not applicable/Not provided.
This document describes a CT system option, not an AI or algorithm-based diagnostic tool that would typically undergo an MRMC study.

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

Not applicable/Not provided.
This is not an AI/algorithm-only device. It's an enhancement for existing CT scanners.

7. The type of ground truth used

Not applicable/Not provided.
No "ground truth" in the context of clinical accuracy or diagnostic performance is mentioned. The ground truth for engineering validation would be the functional specifications and regulatory standards.

8. The sample size for the training set

Not applicable/Not provided.
No training set is mentioned as this is not an AI/machine learning device.

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

Not applicable/Not provided.
No training set ground truth establishment is described.

Summary of the K974344 Document's Approach:

The K974344 submission is a 510(k) Premarket Notification for a CT Scope option. Its primary goal is to demonstrate substantial equivalence to predicate devices already on the market (CT-Twin flash, HeliCAT CT scanner, other interventional CT systems).

The evidence provided focuses on:

Compliance with general controls: GMP practices, International Standards (IEC 601-1), and FDA regulations (21 CFR, Subchapter J performance standards).
Hazard analysis and control: Identifying potential hazards and demonstrating how they are managed (e.g., software assurance procedures, quality assurance).
Functional requirements: Stating that the option's specifications and functional requirements were met during internal testing (though no specific test results or data are presented in the summary).

The FDA's response confirms that the device is substantially equivalent for its stated indications for use (whole body CT applications and interventional procedures), meaning it is considered as safe and effective as the predicate devices without requiring a full clinical trial for novel performance claims.

Summary

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K974344

JUN 3 10008

Summary of Safety and Effectiveness

1. Device Name

CT Scope option for CT scanners

2. Submitter

Elscint Inc., 505 Main Str. Hackensack, NJ 07601

3. Intended Use Of Device and its Main Features

The option is used for whole body computed tomography applications and specifically for interventional procedures that are performed on the CT table.

The CT Scope option is an addition to the CT Twin and HeliCAT families of CT . scanners. It comprises of hardware and software for initiation and termination of the scan process and for on-line monitoring of the resulting images in the gantry room, in addition to the Operator Console. Exposure is initiated by one of two pedals near the patient table and terminated by releasing the pedal. Partially reconstructed images are displayed at a rate of 6 images/second with a delay of approximately one second and displayed on a monitor in the scanner room. A handle for holding the needle from outside the direct radiation to reduce the dose received by the doctor during the interventional procedure is also included.
The optional LaserGuide may be used for marking the entrance point and angle . of needle insertion externally to the gantry opening for convenience.

4. Predicate Devices

CT-Twin flash submitted in "HRSW Option for CT-Twin Flash" K945512.
◆ HeliCAT CT scanner, K930090
Precise Biopsy Localization by Computed Tomography, . Radiology 118:603-607, March 1976
Toshiba America Medical Systems Inc., Real time Reconstruction system option . for Xpress/SX CT System, K950972, cleared on April 15, 1996.
GE-YMS CT ProSpeed Family of CT Systems with ProSpeed Renaissance . Options, K970606, cleared on April 4, 1997.

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5. Safety and Effectiveness

The safety of the option is assured by adherence to GMP practices and to International Standards. Potential hazards are identified in a hazard analysis and controlled in the following manner:

Software safety of the option is assured by the company procedures that conform to accepted practices. Quality assurance procedures were adhered to, and test results demonstrate that the option specifications and functional requirements were met.

Electrical and Mechanical safety is assured by adherence to IEC 601-1 standards.

Radiation safety is assured by compliance with 21 CFR, Subchapter J performance standards.

The CT Scope option enables initiation and termination of the scan process and on-line monitoring of the resulting images in the gantry room, in addition to the Operator of the LaserGuide during the CT Scope procedure may reduce the X-ray exposure to the interventionist by enabling the initial needle insertion under Laser Guide, leaving only the final needle approach to the continuous scanning phase.

6. Substantial Equivalency Statement

Based on the above considerations, it is Elscint's opinion that scanners incorporating the CT Scope and LaserGuide options are substantially equivalent in safety and effectiveness to the predicate devices, CT Twin flash, K945512 and HeliCAT, K930090,

In our opinion they are also substantially equivalent to the interventional procedures using CT that predate the 1976 Medical Device Amendments an example of which is the article "Precise Biopsy Localization by Computed Tomography", Radiology 118:603-607, March 1976.

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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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human profiles or a bird in flight, rendered in black.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 1998 JUN

Steven M. Kay Director, Regulatory Affairs and Quality Assurance Elscint . Inc. Corporate Headquarters 505 Main Street Hackensack, NJ 07601

Re: K974344

CT Scope option for CT Scanners Dated: March 10, 1998 Received: March 11, 1998 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK

Dear Mr. Kay:

We have reviewed your Section 510/2) 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 (Premarket Approval), it may be subject to such additional controls. Existing major resulations 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 (OS) 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 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 (301) 594-4613. 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/odrh/dsmaldsmamain.html".

Sincerely yours,

Kilian Yin

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

Enclosure

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Page 1 of 1

510(k) Number (if known): _ 17 4344

Device Name: CT Scope option for CT Scanners.

Indications For Use:

ಿನ

Whole body Computed Tomography applications and specifically for interventional procedures that are performed on the CT table.

(Please do not write below this line-continue on another page if needed)

(Concurrence of CDRH, office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-the-counter use

Daniel C. Skyman

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, 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.