The Philips Medical Systems CT Brain Perfusion Option is intended to assist the user by providing a diagnostic patient imaging tool to be included on a CT workspace. It is intended to assist the user-selected area of interest to generate qualitative and quantitative information about changes in image intensity over time. It supports the analysis of dynamic/serial CT after injection of contrast, by calculating the parameters related to brain perfusion and displays the results as a composite (single image that is calculated from a set of time course images at a single location) images. This software runs on the Philips Medical Systems Brilliance TM Workspace of a CT System.

The Brain Perfusion Option is used in a Philips Medical Systems Brilliance ™ Workspace of a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.

Device Description

AI/ML Overview

The Philips Medical Systems CT Brain Perfusion Option is intended to assist the user by providing a diagnostic patient imaging tool to be included on a CT workspace to generate qualitative and quantitative information about changes in image intensity over time. It supports the analysis of dynamic/serial CT after injection of contrast, by calculating the parameters related to brain perfusion and displays the results as composite images.

Based on the provided text, the submission does not contain a detailed study with specific acceptance criteria and performance metrics. Instead, the focus is on establishing substantial equivalence to previously marketed predicate devices (Image Processing Function on the Select CT/SP in CDRH Document Control No K961464 and K012009, and the Mx8000IDT).

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance

The provided text does not include a table of acceptance criteria or reported device performance metrics for the Brain Perfusion Option. The submission relies on demonstrating substantial equivalence to predicate devices rather than presenting a performance study against predefined criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. No specific test set or data provenance is mentioned as there isn't a stand-alone performance study described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. Since there is no described test set or ground truth establishment process, details about experts are absent.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. No adjudication method is mentioned as there is no described test set.

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

There is no mention of an MRMC comparative effectiveness study in the provided text. The document focuses on the device's functional capabilities and substantial equivalence, not on human reader improvement with AI assistance. The device is referred to as "intended to assist the user," but no study is presented to quantify this assistance.

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

A standalone performance study of the algorithm is not explicitly described in the document. The submission emphasizes the device's functional specifications and how it "assists the user," suggesting a human-in-the-loop context, but no specific performance metrics are offered for the algorithm itself.

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

This information is not provided in the document. As no performance study with a test set is outlined, the type of ground truth used is not specified.

8. The sample size for the training set

This information is not provided in the document. Details about algorithm training are not included.

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

This information is not provided in the document. The process of establishing ground truth for any potential training set is not detailed.

Summary of the Study (as inferred from the document):

The "study" described in the provided text is primarily a substantial equivalence review rather than a performance study. Philips Medical Systems (Cleveland), Inc. asserts that the Brain Perfusion Option is "of comparable type and substantially equivalent to the legally marketed devices currently in commercial distribution, namely the Image Processing Function on the Select CT/SP in CDRH Document Control No K961464 and K012009 and the Mx8000IDT."

The basis for this claim is that the devices "comply with the same or equivalent standards and have the same or equivalent intended uses." The document highlights the functional specifications and operator's instructions (Appendices "B" and "C", which are not provided) to support this comparison. It also states that the device adheres to FDA GMPs, 21 CFR 1020.30-33, and voluntary standards for safety/effectiveness (UL 2601) to minimize hazards.

Therefore, the "study" that proves the device meets the acceptance criteria is an argument for substantial equivalence based on comparable intended use, technology, and adherence to regulatory and safety standards, rather than a clinical performance trial with predefined acceptance criteria and measured outcomes against a ground truth.

Summary

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FEB 2 0 2004

Brain Perfusion Option

K033 677 Pine 1/2

The following information is being supplied in accordance with 21CFR 807.92(a).

1. Submitter

Submitter:	Philips Medical Systems (Cleveland), Inc.595 Miner RoadCleveland, OH 44143(440) 483-3000
Contact	Robert L. TurocyPhilips Medical Systems (Cleveland), Inc.595 Miner RoadCleveland, OH 44143Telephone: 440 483 3528FAX: 440 483 2989
Date of Summary:	November 24, 2003

2. Device Name

(Proprietary Name):	Brain Perfusion Option
Classification Name:	Computed Tomography X-Ray System
Common Name:	Computed Tomography X-Ray System

The FDA has classified the Brain Perfusion Option as Class II in 21 CFR 892.1750 (Product Code 90JAK)

3. Intended Use

The Philips Medical Systems CT Brain Perfusion Option is intended to assist the user by providing a diagnostic patient imaging tool to be included on a CT workspace. It is intended to assist the user-selected area of interest to generate qualitative and quantitative information about changes in image intensity over time. It supports the analysis of dynamic/serial CT after injection of contrast, by calculating the parameters related to hrain perfusion and displays the results as a composite (single image that is calculated from a set of time course images at a single location) images. This software runs on the Philips Medical Systems Brilliance TM Workspace of a CT System.

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4. Predicate Device

K033677
Rogerofz

In the opinion of Philips Medical Systems (Cleveland) Inc., the Brain Perfusion Option is of comparable type and substantially equivalent to the legally marketed devices currently in commercial distribution, namely the Image Processing Function on the Select CT/SP in CDRH Document Control No K961464 and K012009. Sce Appendix "G", Equivalent Device Comparison Matrix. This opinion is based on the fact that comparing the Image Processing Function on the Select CT/SP with the Brain Perfusion Option reveals that the devices comply with the same or equivalent standards and have the same or equivalent intended uses.

Functional specifications and operator's instructions (preliminary) are included in the Appendixes "B" and "C".

Safety and Effectiveness

Philips Medical Systems (Cleveland), Inc. adhercs to FDA GMPs, 21 CFR 1020.30-33, and voluntary standards for safety/effectiveness (UL 2601) all of which mandate that components are tested to minimize hazards (electrical, mechanical, and radiation). The Brain Perfusion Option is under the control of health care professionals who are trained and responsible for computed tomography examinations.

Philips has reviewed known information available and performed an investigation as to the causes of safety and effectiveness concerning the Brain Perfusion Option.

6. Substantial Equivalence Statement

The Brain Perfusion Option is substantially equivalent to legally marketed devices. The Brain Perfusion Option will be certified to comply with Federal Diagnostic X-Ray Performance Standards. Labeling (Product Specification and Operator's Manual) will be provided to the user of the equipment.

This opinion is based on the fact that comparing the Image Processing Function on the Select CT/SP and the Mx8000IDT to the Brain Perfusion Option reveals that the devices comply with the same or equivalent standards and have the same or equivalent intended uses.

The Brain Perfusion Option and the Image Processing Function on the Select CT/SP and Mx8000IDT CT Systems 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.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 9 2004

Mr. Robert L. Turocy Regulatory Affairs Manager Philips Medical Systems (Cleveland), Inc. 595 Miner Road CLEVELAND OH 44143

Re: K033677

Trade/Device Name: Brain Perfusion Option Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: November 24, 2003 Received: November 24, 2003

Dear Mr. Turocy:

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, 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 (PMA), 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 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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This letter will allow you to begin marketing your device as described in your Section 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

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 the letter:

8xx. Ixxx	(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" (21CFR Part 807.97) you may obtain. 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. Brogdon

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

Enclosure

Page 2

to proceed to the market.

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KO33677 510(k) Number (if known):

Brain Perfusion Option Device Name:

The Philips Medical Systems CT Brain Perfusion Option Indications for Use: is intended to assist the user by providing a diagnostic patient imaging tool to be included on a CT workspace. It is intended to assist the user-selected area of interest to generate qualitative and quantitative information about changes in image intensity over time. It supports the analysis of dynamic/serial CT after injection of contrast, by calculating the parameters related to brain perfusion and displays the results as a composite (single image that is calculated from a set of time course images at a single location) images. This software runs on the Philips Medical Systems Brilliance TM Workspace of a CT System.

(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

(Optional Format 1-2-96)

David R. Symm

(Division Sign-Off)

Brain Perfusion Option 510(k)

and Radiological Devices 510(k) Number.

Division of Reproductive, Abdominal.

11/24/03

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.