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 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.

AI/ML Overview

The provided text is a 510(k) Pre-market Notification for the Toshiba America Medical Systems, Inc. PCA-8000A Mark II PET/CT System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study. As such, much of the requested information about acceptance criteria and study details is not present in this document.

Here's a breakdown of what can and cannot be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria or provide a table of reported device performance metrics against such criteria. The submission focuses on demonstrating substantial equivalence to predicate devices. The "performance" discussed is primarily about meeting general safety standards and having similar technological characteristics and intended uses.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical study or a test set of data (e.g., patient scans) used to evaluate the device's performance against specific acceptance criteria. Therefore, information on sample size and data provenance is not available.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Since no specific performance study on a test set is described, there's no mention of experts establishing ground truth or their qualifications.

4. Adjudication Method

As no specific performance study is detailed, an adjudication method is not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not describe a MRMC comparative effectiveness study, nor does it discuss the effect size of human readers improving with AI vs. without AI assistance. This device is a PET/CT scanner, not an AI-assisted diagnostic tool in the sense of a standalone algorithm for interpretation.

6. Standalone (Algorithm Only) Performance Study

The document does not describe a standalone performance study for an algorithm without human-in-the-loop performance. The device is a medical imaging system that produces images for human interpretation.

7. Type of Ground Truth Used

No ground truth is explicitly mentioned as being used for performance evaluation, as no specific performance study is detailed with quantitative outcomes.

8. Sample Size for the Training Set

The document does not refer to a "training set" in the context of an algorithm's development. This is a medical imaging device, and the focus is on hardware and integrated software capabilities, not on a machine learning algorithm trained on a specific dataset.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned, the method for establishing its ground truth is also not applicable or present in this document.

Summary of what the document does state regarding acceptance or equivalence:

Conformance to Standards: "All portions of this device have been designed and manufactured in accordance with the requirements of the applicable portions of ISO 60601 and its collateral standards." and "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... 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: The primary "proof" relies on demonstrating that the PCA-8000A Mark II has "the same indications for use as the predicate device and utilizes technologies and materials that are similar in nature." The predicate devices are listed as GE Discovery VCT (K050559) and Toshiba, TSX-201A, Aquilion LB (K050458).

Essentially, this 510(k) submission establishes that the new device is safe and effective by showing that it is fundamentally the same as devices already legally marketed, in terms of technology, intended use, and adherence to relevant safety standards, rather than presenting a novel performance study against specific clinical acceptance criteria.

Summary

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KORZZYY

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,Tustin, CA 92781-2068
Submitter's Contact:	Paul Biggins, Director Regulatory Affairs(714)730-5000
Establishment RegistrationNumber:	2020563
Device Proprietary Name:	PCA-8000A, Mark II, Pet/CT System
Common Name:	Emission Computed Tomography SystemScanner, Computed Tomography, X-Ray[Fed. Reg. No. 892.1200, Pro. Code: 90KPS][Fed. Reg. No. 892.1750, Pro. Code: 90JAK]
Regulatory Class:	II
Performance Standard:	21 CFR Subchapter JFederal Diagnostic X-ray Equipment Standard
Predicate Device(s):	GE Discovery VCT; K050559Toshiba, TSX-201A, Aquilion LB K050458
Reason for Submission	New Device

Device Description:

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 (800) 638-2011 or (240) 276-3150 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:

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

Regulation Number and Section

§ 892.1200 Emission computed tomography system.

(a)
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.(b)
Classification. Class II.