BRILLIANCE ICT

K131773 · Philips Healthcare (Cleveland) · JAK · Sep 24, 2013 · Radiology

Device Facts

• Record ID: K131773
• Device Name: BRILLIANCE ICT
• Applicant: Philips Healthcare (Cleveland)
• Product Code: JAK · Radiology
• Decision Date: Sep 24, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The Brilliance iCT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body 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 Story

Brilliance iCT is a whole-body computed tomography (CT) system; utilizes continuously rotating x-ray tube and detector gantry to acquire transmission data. System reconstructs data into cross-sectional images of body at various angles/planes. Includes signal analysis, display equipment, patient supports, and accessories. Operated by trained healthcare professionals in clinical settings. Output consists of diagnostic-quality cross-sectional images used by radiologists for clinical decision-making. Benefits include high-resolution anatomical visualization for diagnostic purposes. Modification involves updated detection array and supporting software.

Clinical Evidence

Bench testing performed to verify conformance with IEC 61223-3-5:2004, including CT number, uniformity, noise, tomographic section thickness, CTDI dose, air dose, spatial resolution, and low contrast detectability. Clinical evaluation confirmed images reconstructed by the modified system are of diagnostic quality as assessed by a radiologist.

Technological Characteristics

Whole-body CT system; rotating x-ray tube and detector gantry; multi-slice capability. Detection array: 672 x 128 detectors. Complies with AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-44, and IEC 61223-3-5. Includes operator station, patient table, and positioning supports. Software-based image reconstruction.

Indications for Use

Indicated for patients requiring cross-sectional imaging of the body via computed tomography. No specific age, gender, or disease state contraindications provided.

Regulatory Classification

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.

Predicate Devices

• Brilliance Volume (K060937)

Submission Summary (Full Text)

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# 510(k) Summary

# Brilliance iCT

# 510(k) Number K131773

# Applicant's Name:

Philips Medical Systems (Cleveland), Inc. 595 Miner Road Cleveland, Ohio 44143

SEP 2 4 2013

### Contact Person:

Catherine M. Connell Requlatory Affairs Specialist Philips Medical Systems (Cleveland), Inc. 595 Miner Road, Cleveland, OH 44143 USA [phone] Tel: [phone] Fax: E-mail: [e-mail]

# Trade Name:

Brilliance iCT

Preparation Date:

July 09, 2013

# Classification:

Name: System, X-Ray, Tomography, Computed Product Code: JAK Regulation No: 21 CFR 892.1750 Class: !! Panel: Radiology

# Device Description:

The Brilliance iCT is a Whole Body Computed Tomography (CT) X-Ray System featuring a continuously rotating x-ray tube and detectors gantry and multi-slice capability. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. This device also includes signal analysis and display equipment; patient and equipment supports; components; and accessories.

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### Intended Use Statement:

The Brilliance iCT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body 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.

### Predicate Device:

Substantial equivalence to the following predicate device is claimed:

| Device Name | 510(k) No. | Date of Clearance |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Brilliance Volume | K060937<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | June 5, 2006 |

### Compliance with Standards:

Brilliance iCT complies with the following standards:

- AAMI / ANSI ES 60601-1:2005/C1:2009 (R)2012, Medical . electrical equipment - Part 1: General requirements for basic safety and essential performance.
- . IEC 60601-1-2:2007 (Ed. 3), Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
- IEC 60601-1-3:2008 (Ed. 2), Medical electrical equipment -. Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment.
- IEC 60601-2-44:2009 (Ed. 3), Medical electrical equipment. . Particular requirements for the basic safety and essential performance of X-rav equipment for computed tomography.
- . IEC 61223-3-5:2004 (Ed. 1), Evaluation and routine testing in medical imaging departments – Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment.

The system complies with performance standards for Computed Tomography (CT) Equipment and Laser products (21 CFR 1020.33 and 21 CFR 1040.10, respectively).

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# Technical characteristics in comparison to predicate:

Both the cleared Brilliance iCT and its predicate device consist of :

- Operator station .
- Gantry .
- Patient table .
- Patient supports (positioning aids) .

The difference between the modified Brilliance iCT and its previously cleared predicate is:

- Modified detection array that maintains the same structure of t . 672 x 128 detectors
# Substantial Equivalence:

The modified Brilliance iCT is a modification of its predicate device, the "Brilliance Volume". Both are Whole Body Computed Tomography (CT) X-Ray Systems, featuring a continuously rotating x-ray tube and detectors gantry and multi-slice capability, to reconstruct cross-sectional images from the acquired x-ray transmission data.

The modified Brilliance iCT and the legally marketed Brilliance iCT have the same intended use and use the same technology as the predicate device. The modifications that were made are to the detection array and in the supporting software. .

The safe and effective performance of the modified Brilliance iCT has been clearly demonstrated by bench tests.

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#### Performance Data:

The following tests demonstrated that the modified Brilliance iCT system continues to conform to IEC 61223-3-5:2004:

- . CT Number, Uniformity, Noise and Tomographic Section Thickness Measurements
- . CTD! Dose Measurements
- Air Dose Measurements .
- Spatial Resolution Measurements .
- Low Contrast Detectability Measurements .

Clinical evaluation demonstrated that images, which are reconstructed by the modified system, have been evaluated by a radiologist as being of diagnostic quality.

### Conclusion:

Philips Medical Systems (Cleveland), Inc. believes that, based on the information provided in this submission, the modified Brilliance iCT is substantially equivalent to its predicate device without raising any new safety and/or effectiveness concerns.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 24, 2013

Philips Medical Systems (Cleveland) Inc. % Ms. Catherine M. Connell Regulatory Affairs Specialist 595 Miner Road CLEVELAND OH 44143

Re: K131773

Trade/Device Name: Brilliance iCT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: August 22, 2013 Received: August 27, 2013

Dear Ms. Connell:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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# Page 2 - Ms. Catherine M. Connell

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sm.h.7).

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K 131773

Device Name: Brilliance iCT

Indications for Use:

The "Brilliance iCT" is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body 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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (Part 21CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

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