The CT BiopsyView option is intended to be used for instant display of CT images during interventional procedures. The instant display of images allows the operating physician to watch the placement of an interventional instrument in real-time.

CT BiopsyView is an option to the TOMOSCAN family of CT systems. TOMOSCAN systems are whole body Computed Tomography (CT) systems which are diagnostic X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission of data from the same axial plane taken at different angles. They includes signal analysis and display equipment, patient and equipment supports, component parts and accessories which are used in combination with signal and image processing software to facilitate the relative localization of anatomy with gray-scale representation of density relative to water utilizing Houndsfield indices with or without contrast mediums. They are used for the display, storage and analysis of digital diagnostic CT images. They are intended for use by a physician in the diagnosis and planning phases of patient conditions and treatment.

The CT BiopsyView option extends the intended use of a TOMOSCAN CT system to include its use by a physician in the interventional phases of patient conditions and treatment.

Device Description

CT BiopsyView is a software option to the Philips TOMOSCAN product family of computed tomography systems.

The TOMOSCAN products are whole body scanners. These systems are already provided with the RapidView Reconstructor (512 x 512 image matrix) option which allows the reconstruction of one image per second.

The CT BiopsyView option provides real-time CT fluoroscopy (6 images per second) for a TOMOSCAN CT system equipped with the RapidView reconstructor. The scan parameters are imited to 15. 25. 50 and 75 mA and 120 and 140 KV. The maximum exposure time is 100 seconds and the remaining time is displayed on the monitor for quick reference.

The CT BiopsyView option is used for interventional procedures, such as biopsy, drainage procedures, therapy control and functional studies.

AI/ML Overview

This submission (K983140) describes the Philips CT BiopsyView, a software option that provides real-time CT fluoroscopy for interventional procedures. The document, however, does not contain information related to specific acceptance criteria or a dedicated study proving the device meets said criteria as would be expected for an AI/ML device submission.

Instead, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices and addressing safety information related to the overall CT system and radiation control. The information provided is characteristic of a submission for a traditional medical device software option that extends the functionality of an existing, cleared hardware system rather than a new AI/ML-driven diagnostic or assistive device that requires performance validation through studies against a ground truth.

Therefore, many of the requested elements for an AI/ML study (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) are not present in this document.

Here is a breakdown of what can be extracted and what is missing based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/ML component. The "acceptance criteria" for this device appear to be primarily focused on functionality and safety equivalence to predicate devices.
- Functional Criteria (Implied): Provides real-time CT fluoroscopy (6 images per second) for a TOMOSCAN CT system equipped with the RapidView reconstructor. Scan parameters are limited to 15, 25, 50, and 75 mA and 120 and 140 KV. Maximum exposure time is 100 seconds.
- Safety Criteria (Implied): Introduces no new safety issues beyond existing TOMOSCAN systems, compliance with Radiation Control for Health and Safety Act, Federal X-ray Performance standards (21 CFR 1020.30, 1020.33), UL-2601/UL-187, and IEC601-1. Hazard analysis indicates a minor level of concern.
Reported Device Performance:
- Image Reconstruction Speed: 6 images per second (for CT BiopsyView), in contrast to the RapidView Reconstructor's 1 image per second.
- Scan Parameters: 15, 25, 50, 75 mA; 120, 140 KV.
- Max Exposure Time: 100 seconds (with remaining time displayed).
- Safety: Device classified as "minor level of concern" based on hazard analysis.

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

Not applicable / Not provided. This document does not describe a clinical performance study using a test set of patient data to validate the performance of an AI/ML algorithm. The "testing" implied is functional verification and validation of the software's ability to display images at a certain speed and within specified parameters, and its compliance with safety standards, rather than performance in a diagnostic or interventional context that would require a patient data test set.

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

Not applicable / Not provided. As there's no clinical performance study on a test set, there is no mention of experts establishing ground truth.

4. Adjudication method for the test set:

Not applicable / Not provided.

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:

No. This is not an AI-assisted diagnostic or assistive device that would typically undergo an MRMC study. It is a real-time imaging display tool.

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

Not applicable / Not provided. This device is an imaging option for a CT system, not a standalone algorithm. Its function is to facilitate real-time image display for physician-led interventional procedures.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable / Not provided. For a functional device like this, "ground truth" would relate to the accuracy of image reconstruction and display according to engineering specifications, rather than clinical outcomes or diagnostic categories.

8. The sample size for the training set:

Not applicable / Not provided. This device is described as a software option for real-time image reconstruction and display. It is not an AI/ML device that would typically involve a "training set" in the sense of machine learning.

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

Not applicable / Not provided.

Summary of the Study that "Proves" Device Meets Criteria:

The "study" or justification for this device's safety and effectiveness, as described in the 510(k) submission, relies primarily on:

Substantial Equivalence: The primary method for proving the device meets criteria is by demonstrating its substantial equivalence to two predicate devices already cleared by the FDA:
- Real-Time Reconstruction System option for the Toshiba Xpress/SX CT System (K950972)
- C.A.R.E. Vision option to the Siemens SOMOTOM Plus 4 CT System (K965004)
  The argument is that since these predicate devices perform similar real-time CT fluoroscopy functions and have been deemed safe and effective, the CT BiopsyView, with its similar technological characteristics and intended use, is also safe and effective.
Compliance with Standards and Regulations: The document states compliance with:
- Radiation Control for Health and Safety Act.
- Federal X-ray Performance standards 21CFR 1020.30, 1020.33.
- UL-2601 or UL-187 (Underwriters Laboratories standards for medical electrical/X-ray equipment).
- IEC601-1 (Medical Electrical Equipment).
Hazard Analysis: A hazard analysis was conducted, which concluded the device is of "minor level of concern," indicating that potential risks were identified and mitigated.
Functional Specifications: The device's ability to reconstruct 6 images per second and operate within specified scan parameters (mA, KV, exposure time) indicates it meets its functional design requirements.

In essence, this is a traditional 510(k) summary focused on hardware/software feature addition and regulatory compliance through substantial equivalence, not an AI/ML performance study as implied by the detailed questions.

Summary

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K983140

Philips Medical Systems

510(K) Summary

In accordance with the requirements of the Safe Medical Device Act, Philips Medical Systems North America Compary herewith submits a 510(K) summary of safety and effectiveness for the following device

SUBMITTER NAME / ADDRESS:	Philips Medical Systems North America Company710 Bridgeport AvenueShelton. CT 06484-0917
CONTACT PERSON / TEL NO:	Peter Altman Director of Regulatory AffairsTel No. (203) 926-7031
DATE SUMMARY PREPARED:	September 4 1998
ESTABLISHMENT NO.:	1217116
CLASSIFICATION NAME:	Computed Tomography X-ray System(21 CFR 892.1750: Class II: Tier 2: 90JAK)
COMMON/USUAL NAME:	Option for CT X-ray System
TRADE/PROPRIETARY NAME:	CT BiopsyView
PREDICATE DEVICE(S):	(1) Real-Time Reconstruction System option for Xpress/SXCT System Toshiba America Medical Systems, Inc.(2) C.A.R.E. Vision option to the SOMOTOM Plus 4 CTSystem; Siemens Medical Systems, Inc.

DEVICE DESCRIPTION:

CT BiopsyView is a software option to the Philips TOMOSCAN product family of computed tomography systems.

The CT BiopsyView option is used for interventional procedures, such as biopsy, drainage procedures, therapy control and functional studies.

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INTENDED USE:

The CT BiopsyView option is intended to be used for instant display of CT images during rterventional procedures The instant display of images allows the operating physician to watch the clacement of an interventional instrument in real-time.

CT Bropsylview is an option to the TOMOSCAN family of CT systems. TOMOSCAN systems are whole body Computed Tomography (CT) systems which are diagnostic X-ray systems intended to produce cross-sectional mages of the body by computer reconstruction of x-ray transmission of data from the same axial plane taken at different angles They includes signal analysis and display equipment. patient and equipment supports. component parts and accessories which are used in combination with signal and image processing software to facilitate the relative localization of anatomy with gray-scale representation of density relative to water utilizing Houndsfield indices with or without contrast mediums. They are used for the display storage and analysis of digital diagnostic CT images. They are intended for use by a physician in the diagnosis and planning phases of patient conditions and treatment.

The CT BiopsyView option extends the intended use of a TOMOSCAN CT system to include ts use by a physician in the interventional phases of patient conditions and treatment.

SUBSTANTIAL EQUIVALENCE INFORMATION:

The CT BiopsyView option is considered comparable and substantially equivalent to the following predicate devices:

· Real-Time Reconstruction System option for the Toshiba Xpress/SX CT System (ref: K950972;
· C A.R.E. Vision option to the Siemens SOMOTOM Plus 4 CT System (ref: K965004)

Each predicate device has been cleared for commercial distribution via its referenced 510 × submission.

SAFETY INFORMATION:

The CT BiopsyView option introduces no new safety issues to the TOMOSCAN family of CT systems other then those already known with the TOMOSCAN system in which this option is used. Computed tomography is a mature technology with which industry and users have many years of experience. These devices must comply with the appropriate sections of the Radiation Control for Health and Safety Act. The CT BiopsyView option as part of the TOMOSCAN system and its associated labeling complies with the applicable requirements of the Federal X-ray Performance standards 21CFR 1020.30, 1020.33.

The Philips TOMOSCAN family of CT systems with which the CT BiopsyView option is used are designed to comply with the requirements of Underwriters Laboratories (UL) Standard for Safety of Medical Electrical Equipment (UL-2601) or UL Standard for Safety of X-ray Equipment (UL-187) and be classified by Underwriters Laboratories or an equivalent test laboratory. They are also designed to comply with the requirements of IEC601-1 (Medical Electrical Equipment).

The results of the hazard analysis, combined with the appropriate preventive measures taken ndicate that the device is of minor level of concern as per the August 29, 1991 issue of the "Reviewer's Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review"

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Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Re:

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 1998 NOV

Frank Gianelli Senior of Regulatory Affairs Specialist Philips Medical Systems 710 Bridgeport Avenue Shelton, CT 06484

K983140 BiopsyView CT Option Dated: September 4, 1998 Received: September 8, 1998 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK

Dear Mr. Gianelli:

We have reviewed your Section 510(k) notification of intent to markets the 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 pror 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 Fecteral 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 (QS) 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 vitn 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/cdrh/dsmaldsmamain.html".

Sincerely yours,

William Yi

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

Enclosure

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510(k) Number (if known):

Philips CT BiopsyView Device Name :

Indications For Use :

The CT BiopsyView option extends the intended use of a TOMOSCAN CT system to include its use by a physician in the interventional phases of patient conditions and treatment.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Chid le. leym

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

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Prescription Use
( Per 21 CFR 801.109 )

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

N/A