PCA-8000A, MARK 11, PET / CT SYSTEM

K082244 · Toshiba America Medical Systems, In.C · KPS · Aug 21, 2008 · Radiology

Device Facts

• Record ID: K082244
• Device Name: PCA-8000A, MARK 11, PET / CT SYSTEM
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: KPS · Radiology
• Decision Date: Aug 21, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

This device is intended to acquire PET images of any desired region of the whole body simultaneously with CT images of the same region (to be used for attenuation correction or image fusion), to detect the location of a positron emitting radiopharmaceutical in the body with obtained images. This device is to be used by a trained health care professional to gather metabolic and functional information from the distribution of the radiopharmaceutical in the body for the assessment of metabolic and physiologic functions. This information can assist in the research, diagnosis, therapeutic planning and therapeutic outcome assessment of (but not limited to) cancer, cardiovascular disease and brain dysfunction. Additionally, this device can function independently as a whole body multi-slice CT scanner.

Device Story

Integrated multi-slice CT and PET scanner; acquires PET images simultaneously with CT images. CT data used for attenuation correction of PET images; PET and CT images fused for anatomical localization of radiopharmaceutical activity. System supports all PET tracers and CT contrast agents. Operated by trained healthcare professionals in clinical settings. Output includes anatomical and functional images displayed on integrated graphical system. Assists clinicians in research, diagnosis, therapeutic planning, and outcome assessment. CT component functions as standalone whole-body scanner.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design conformance to safety standards.

Technological Characteristics

Integrated PET/CT system. Materials and processes similar to predicates. Conforms to ISO 60601, IEC 60601-1, IEC 60601-2-28, IEC 60601-2-32, and IEC 60601-2-44. Multi-slice CT architecture. Standalone CT capability. Complies with 21 CFR 1020.30 and 1020.33 (Federal Diagnostic X-ray Equipment Standard).

Indications for Use

Indicated for patients requiring PET/CT imaging for assessment of metabolic and physiologic functions, including cancer, cardiovascular disease, and brain dysfunction. For use by trained healthcare professionals.

Regulatory Classification

Identification

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Predicate Devices

• GE Discovery VCT (K050559)
• Toshiba, TSX-201A, Aquilion LB (K050458)

Submission Summary (Full Text)

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# Toshiba America Medical Systems, Inc. 510(k) Pre-market Notification; PCA-8000A Mark II

### 510(k) Summary

| Date: | August 1, 2008 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive,<br>Tustin, CA 92781-2068 |
| Submitter's Contact: | Paul Biggins, Director Regulatory Affairs<br>[phone] |
| Establishment Registration<br>Number: | 2020563 |
| Device Proprietary Name: | PCA-8000A, Mark II, Pet/CT System |
| Common Name: | Emission Computed Tomography System<br>Scanner, Computed Tomography, X-Ray<br>[Fed. Reg. No. 892.1200, Pro. Code: 90KPS]<br>[Fed. Reg. No. 892.1750, Pro. Code: 90JAK] |
| Regulatory Class: | II |
| Performance Standard: | 21 CFR Subchapter J<br>Federal Diagnostic X-ray Equipment Standard |
| Predicate Device(s): | GE Discovery VCT; K050559<br>Toshiba, TSX-201A, Aquilion LB K050458 |
| Reason for Submission | New Device |

#### Device Description:

The PCA-8000A consists of an integrated multi-slice CT system and a Positron Emission Topography Scanner. This system uses CT images to correct for non-uniform attenuation of the PET images. CT images and PET images are integrated to provide localization of emission activity. This system is capable of imaging with all available PET tracers and CT contrast agents. The system will display anatomical and functional information via the integrated graphical display system. The CT portion of the system can be used as a standalone head and whole body CT system.

### Summary of Intended Uses:

This device is intended to acquire PET images of any desired region of the whole body simultaneously with CT images of the same region (to be used for attenuation correct on or image fusion), to detect the location of a positron emitting radiopharmaceutical in the boody

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### Toshiba America Medical Systems, Inc. 510(k) Pre-market Notification; PCA-8000A Mark II

with obtained images. This device is to be used by a trained health care professional to gather metabolic and functional information from the distribution of the radiopharmaceutical in the body for the assessment of metabolic and physiologic functions. This information can assist in the research, diagnosis, therapeutic planning and therapeutic outcome assessment of (but not limited to) cancer, cardiovascular disease and brain dysfunction. Additionally, this device can function independently as a whole body multislice CT scanner.

#### Technological Characteristics:

This device employs similar materials and processes as found in the predicate device. All portions of this device have been designed and manufactured in accordance with the requirements of the applicable portions of ISO 60601and its collateral standards.

#### Safety and Effectiveness Concerns:

This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR § 1020.30 and 1020.33, that apply to this device, will be met and reported via a an initial report. Additionally this system is in conformance with the applicable parts of the IEC 60601-1 {applicable portions}; IEC 60601-2-28, IEC 60601-2-32, and IEC 60601-2-44. - Medical Device Safety standards.

#### Substantial Equivalence:

This device provides the same indications for use as the predicate device and utilizes technologies and materials that are similar in nature. Toshiba America Medical Systems, Inc. is of the opinion that device is substantially equivalent to those devices already marketed in the United States.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized eagle symbol with three parallel lines extending from its body, resembling wings or feathers.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### AUG 2 1 2008

Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K082244

Trade/Device Name: PCA-8000A Mark II, PET/CT System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: August 7, 2008

Received: August 8, 2008

#### Dear Mr. Job:

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.

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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.

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 to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance pt one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Styall Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html (

Sincerely vours.

Nancy C. Brogdon

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

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## Indications for Use

510(k) Number (if known):

KDP2244

Device Name: PCA-8000A, Mark II, PET/CT System

Indications for Use:

This device is intended to acquire PET images of any desired region of the whole body simultaneously with CT images of the same region (to be used for attenuation correction or image fusion), to detect the location of a positron emitting radiopharmaceutical in the body with obtained images. This device is to be used by a trained health care professional to gather metabolic and functional information from the distribution of the radiopharmaceutical in the body for the assessment of metabolic and physiologic functions. This information can assist in the research, diagnosis, therapeutic planning and therapeutic outcome assessment of (but not limited to) cancer, cardiovascular disease and brain dysfunction. Additionally, this device can function independently as a whole body multi-slice CT scanner.

Prescription Use
(Part 21 CFR 801 Subpart D)
✓

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of *_*_

Angel M. Whay

(Division S Division of Reprodi Radiological Dev 510(k) Numbe