The Philips Brilliance CT in the Private Practice CV configuration is a Computed Tomography X-Ray System intended to produce images of the heart, cardiovascular (including Pals, aorta, iliac, and other distal vessels imaged by CT angiography and peripheral vascular systems (including the carotics and pulmonary veins) by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

Device Description

The "Brilliance CT, Private Practice CV configuration" is a Computed Tomography X-Ray System featuring a continuously rotating X-ray tube and detectors, gantry, and multi-slice capability of up to 16 slices simultaneously. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the heart, cardiovascular, and peripheral vascular systems taken at different angles and planes. This device also includes signal analysis and display equipment, patient and equipment supports, components and accessories.

AI/ML Overview

This 510(k) summary for the "Brilliance CT, Private Practice CV configuration" CT Scanner does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

The document is a premarket notification for a new CT scanner, establishing its substantial equivalence to previously cleared devices. It focuses on:

Device Name and Classification: Identifies the device and its regulatory classification.
Device Description: Provides a general overview of the CT scanner's capabilities.
Intended Use: Specifies the medical imaging applications for which the device is designed (cardiovascular and peripheral vascular systems).
Comparison to Predicate Devices: Explicitly states that the new device has "the same technological characteristics such as design, material, and energy source" as its predicates and is "of comparable type and substantially equivalent."
Safety and Effectiveness Considerations: Addresses safety through adherence to GMP practices, international standards (IEC 60601-1, IEC 60625), and radiation safety regulations (21 CFR, Subchapter J). Software safety is mentioned as conforming to accepted practices and demonstrating that "option specifications and functional requirements were met."
Substantial Equivalency Statement: Reaffirms the substantial equivalence to predicate devices (Brilliance CT 40 Slice configuration, K033326 and Mx8000 IDT, K012009).

Here's a breakdown of why the requested information is absent:

Acceptance Criteria and Reported Device Performance: These are not provided. The document focuses on demonstrating substantial equivalence to predicate devices rather than presenting specific performance metrics against pre-defined acceptance criteria. The claim that "option specifications and functional requirements were met" is a general statement and not a detailed table of acceptance criteria and results.
Sample Size, Test Set Data Provenance: Not applicable/not provided. No specific test set for performance evaluation is described, as the submission relies on substantial equivalence.
Number of Experts, Qualifications for Ground Truth: Not applicable/not provided. Ground truth establishment is not discussed as no new performance study is detailed for this 510(k).
Adjudication Method: Not applicable/not provided.
Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: No MRMC study is mentioned.
Standalone Performance Study: No standalone performance study (algorithm only) is described, as the device is a CT scanner, not an AI algorithm.
Type of Ground Truth Used: Not applicable/not provided.
Training Set Sample Size: Not applicable/not provided.
How Ground Truth for Training Set was Established: Not applicable/not provided.

In summary, this 510(k) notification is a declaration of substantial equivalence based on technological similarity and adherence to safety standards, not a detailed report of a performance study with specific acceptance criteria and results for the device itself. The regulatory pathway for this device (a 510(k)) often relies on demonstrating equivalence to existing, legally marketed devices, rather than requiring extensive new clinical performance trials unless there are significant technological differences or new intended uses.

Summary

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K04 2293

SEP - 8 2004

Philips Medical Systems Inc. 510(k) Summary

"Brilliance CT, Private Practice CV configuration" CT Scanner

1. Submitter

Philips Medical Systems (Cleveland), Inc. 595 Miner Road Cleveland, OH 44143 (440) 483-3000

Contact:

Robert L. Turocy Philips Medical Systems 595 Miner Road Cleveland, OH 44143 Telephone: 440 483 3528 440 483 2989 FAX:

Date of Summary: July 12,2004

2. Device Name and Classification

Device Name: "Brilliance CT, Private Practice CV configuration" CT Scanner

Classification Name: Computed Tomography X-Ray System

The FDA has classified the Computed Tomography X-Ray System as Class II in 21 CFR 892.1750 (Product Code 90JAK)

3. Device Description

4. Intended Use Of The Device

The "Brilliance CT, Private Practice CV configuration" is a Computed Tomography X-Ray System intended to produce cross-sectional images of the heart, cardiovascular, and peripheral vascular systems by computer reconstruction of x-ray transmission data taken at different angles and planes.

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5. Comparison to Predicate Devices

The "Brilliance CT, Private Practice CV configuration" CT scanner has the same technological characteristics such as design, material, and energy source as the predicate devices identified. In the opinion of Philips Medical Systems Inc., the "Brilliance CT, Private Practice CV configuration" CT scanner is of comparable type and substantially equivalent to the legally marketed devices currently in commercial distribution, namely:

Brilliance CT (Philips Plus, K033326) .
Mx8000 IDT, K012009 .

6. Safety and Effectiveness Considerations

The safety of the device 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 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.

Material and Construction, as well as Electrical and Mechanical safety is assured by adherence to IEC 60601-1 standards and associated collateral and particular standards.

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

Laser safety is assured by compliance to IEC 60625 standards

7. Substantial Equivalency Statement

Based on the above considerations, it is Philips's opinion that the "Brilliance CT, Private Practice CV configuration" CT scanner is substantially equivalent in safety and effectiveness to the predicate devices, Brilliance CT 40 Slice configuration, K033326 and Mx8000 IDT, K012009.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 8 2004

Philips Medical Systems (Cleveland) % Mr. Tamas Borsai Program Manager, Third Party Review Program TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

Re: K042293

Trade/Device Name: Brilliance CT, Private Practice CV Configuration Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system

Regulatory Class: II Product Code: 90 JAK Dated: August 17, 2004 Received: August 24, 2004

Dear Mr. Borsai:

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) I ms icter will and in you to obgen finding of substantial equivalence of your device to a legally promative notification. "The Presults 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 It you desire specifice at ne 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 Active 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 miorination on Jour respensional 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. Brydon

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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K042293 510(k) Number (if known):

Page 1 of 1

"Brilliance CT, Private Practice CV configuration" Device Name:

Indications for Use:

The Philips Brilliance CT in the Private Practice CV configuration is a Computed Tomography X-Ray System intended to produce images of the heart, Forlography A Ray DJ Steenslammary veins) and peripheral vascular systems Carolovasounar (morading Pals, aorta, iliac, and other distal vessels imaged by (Including the caronics) by computer reconstruction of x-ray transmission allers with on on on planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories

Contraindications for Use:

Configuredions for CTS. f he I millps Drimance that are defined as non-cardiac and non-vascular (including soft tissue and bone).

(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)
OR
Over-The-Counter Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042293

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.