The device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT component produces crosssectional images of the body by computer reconstruction of x-ray transmission data. The PET component images the distribution of PBT radiopharmaceuticals in the patient body. The PET component utilizes CT images for attenuation correction and anatomical reference in the fused PET and CT 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 evaluation, detection, diagnosis, therapeutic planning and therapeutic outcome assessment of {but not limited to) cancer, cardiovascular disease and brain dysfunction. Additionally, this device can be operated independently as a whole body multi-slice CT scanner.

Device Description

Celesteion, PCA-9000A, is a large bore, TOF, PET-CT system, which combines a high-end CT system with a high-throughput PET system. The high-end CT system is a multi-slice helical CT scanner with a gantry aperture of 900 mm and a maximum scanning field of 700 mm. The high-throughput PET system has a time of flight (TOF) detector with temporal resolution of 450 ps. Celesteion, PCA-9000A, is intended to acquire PET images of any desired region of the whole body and CT images of the same region (to be used for attenuation correction or image fusion), to detect the location of positron emitting radiopharmaceuticals in the body with the obtained images. This device is used to gather the metabolic and functional information from the distribution of radiopharmaceuticals in the body for the assessment of metabolic and physiologic functions. This information can assist research, diagnosis, therapeutic planning, and therapeutic outcome assessment. This device can also function independently as a whole body multi-slice CT scanner.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Celesteion, PCA-9000A/2 device, based on the provided text:

Acceptance Criteria and Device Performance

The provided text details performance specifications for the Celesteion, PCA-9000A/2, and explicitly states that it met established specifications through phantom testing. Although the document doesn't explicitly list "acceptance criteria" as a separate table, it compares the device's measured performance against the predicate device (Gemini Raptor). We can infer that meeting comparable or improved performance to the predicate device, or meeting specified technical thresholds, constitutes the acceptance criteria.

Table of Acceptance Criteria (Inferred from Predicate Comparison and "Established Specifications") and Reported Device Performance:

Item	Acceptance Criteria (Implied / Predicate Value)	Reported Device Performance (Celesteion PCA-9000A/2)	Notes
PET Specifications
Sensitivity (cps/kBq)	6.6 (Gemini Raptor)	≥ 3.6	The Celesteion is lower in sensitivity, which the document implicitly acknowledges by stating "the Celesteion requires a longer imaging duration (user selectable) to obtain equivalent data and image quality as compared to the predicate device." This suggests they have an acceptable trade-off for other features or image quality.
Count rate maximum NECR (kcps)	90 (Gemini Raptor)	61 ± 10	The Celesteion is lower in maximum NECR. This also likely contributes to the need for longer imaging duration.
System energy resolution (%)	11.7% (Gemini Raptor)	≤ 13.7%	The Celesteion's energy resolution is higher (worse) than the predicate device.
System timing resolution (ps)	495 ps (Gemini Raptor)	≤ 450 ps	The Celesteion's timing resolution is better than the predicate device.
Scatter fraction (%)	26 (Gemini Raptor)	≤ 42.7	The Celesteion's scatter fraction is higher (worse) than the predicate device.
Spatial Resolution FWHM at 1cm	4.7 (Gemini Raptor)	≤ 5.1	The Celesteion's spatial resolution is higher (worse) than the predicate device.
CT Specifications
CT scan FOV	60 cm (Gemini Raptor)	70 cm	The Celesteion has a larger FOV, which is generally an improvement.
CT Detection System	16 row Solid State Detector (Gemini Raptor)	16 row Solid State Detector	Equivalent to predicate.
Output capacity	60 kW (Gemini Raptor)	72 kW (max)	The Celesteion has a higher output capacity, indicating potentially more powerful X-ray generation.
X-ray Tube Voltage	90, 120, 140 kVp (Gemini Raptor)	80, 100, 120 and 135 kV	Different ranges for Celesteion, with a 135 kV option not present in the Gemini Raptor. Compared to Aquilion LB Triton, it's equivalent.
X-ray Tube Current	20-500 mA (Gemini Raptor)	10 mA to 600 mA	The Celesteion has a wider range, including lower minimum and higher maximum current.
X-ray Tube Heat Capacity	8 MHU (Gemini Raptor)	7.5 MHU	The Celesteion has a slightly lower heat capacity.
X-ray Tube Cooling Rate	1,608 kHU/min (max) (Gemini Raptor)	1,386 kHU/min (max) / 1,008kHU/min (actual)	The Celesteion has a lower maximum cooling rate.
Focal Spot Size (IEC)	0.5mm x 1.0mm (small) / 1.0mm x 1.0mm (large)	0.09mm x 0.8mm (small) / 1.6mm x 1.4 mm (large)	Different focal spot sizes for the Celesteion, indicating different X-ray beam characteristics. Compared to Aquilion LB Triton, it's equivalent.
Lowest couch height	Not available (Gemini Raptor)	475 mm (includes moving base)	Provided for Celesteion.
Couch-top stroke	Not available (Gemini Raptor)	2390 mm	Provided for Celesteion.
Other Performance Specifications
Scan Regions	Whole body	Whole body	Equivalent.
Scan System	CT: 360° continuous rotate/rotate	CT: 360° continuous rotate/rotate	Equivalent.
CT Image Quality Metrics	Substantially equivalent to predicate	Validated as substantially equivalent to predicate	Spatial resolution, CT number, contrast-to-noise ratio, and noise properties were validated through phantom testing to be substantially equivalent to the predicate device (Aquilion LB Triton).
PET Image Quality Metrics	Met established specifications	Met established specifications	Spatial resolution, sensitivity, NECR, energy/timing resolution, and PET/CT alignment were validated through phantom testing to meet established specifications.

Study Details

The provided text describes the testing done to support the 510(k) submission, focusing on technical performance verification.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a numerical sample size for "test sets" in terms of cases or patient data. Instead, it mentions that studies were performed using phantoms.
- Data Provenance: The studies were phantom-based bench testing and are implicitly prospective in nature as they were conducted as part of the device's premarket submission. No information about country of origin of patient data is relevant as patient data was not used for this specific testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of human experts to establish ground truth for the test sets. The testing involved objective measurements of physical properties (e.g., spatial resolution, sensitivity) using phantoms, rather than subjective interpretation of diagnostic images by clinicians.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None (Not applicable): Since the described testing involved objective phantom measurements and did not use human interpretation or ground truth derived from expert consensus, an adjudication method for human readers is not relevant.
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:
- No, an MRMC comparative effectiveness study was not done. The submission focuses on the technical performance of the combined PET-CT system itself, not on a human-in-the-loop AI assistance tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in the context of device performance metrics. The testing described ("CT image quality metrics were performed, utilizing phantoms," and "PET image quality metrics were performed") assesses the inherent performance characteristics of the imaging device (the algorithm/hardware combined) in a standalone manner. It evaluates how well the system itself performs its core functions of image acquisition and reconstruction in terms of physical parameters. It's not an "algorithm" in the sense of a separate AI diagnostic tool, but the performance of the integrated imaging system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Phantom-based physical measurements: The ground truth for the technical performance metrics (e.g., spatial resolution, energy resolution, sensitivity) was established using known physical properties of phantoms and standardized measurement protocols (e.g., NEMA standards implicitly for PET metrics).
The sample size for the training set:
- Not applicable / Not specified. The document does not describe any machine learning or AI algorithm development that would involve a "training set" in the traditional sense. The device is a PET-CT imaging system, not a diagnostic AI software tool that requires training on a dataset of images to learn patterns.
How the ground truth for the training set was established:
- Not applicable. As no training set for an AI algorithm is mentioned, the method for establishing its ground truth is irrelevant to this submission.

Summary

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K.140651
Page 1 of 4

TOSHIBA AMERICA MEDICAL BYBTEMS, INC. 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 730-5000

JUN 1 1 2014

510(k) SUMMARY

1. SUBMITTER'S NAME: Toshiba America Medical Systems, Inc.
1. ADDRESS: 2441 Michelle Drive Tustin, CA 92780-2068
1. ESTABLISHMENT REGISTRATION: 2020563
1. CONTACT PERSON: Paul Biggins Director, Regulatory Affairs (714) 730-5000
1. Date Prepared: March 12, 2014

1. TRADE NAME(S): Celesteion, PCA-9000A/2
1. COMMON NAME: System, X-ray, Computed Tomography System, Positron Emission Tomography
1. DEVICE CLASSIFICATION: Class II (per 21 CFR §892.1750 and 21 CFR §892.1200)

9. PRODUCT CODE / DESCRIPTION:

JAK - System, Computed Tomography KPS - System, Positron Emission Tomography

10. PERFORMANCE STANDARD:

This device conforms to applicable Performance Standards for lonizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020]

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11. PREDICATE DEVICE:

Product	Marketed by	510(k) Number	Clearance Date
Aquilion LB Triton, V4.91	Toshiba America Medical Systems	K123500	May 2, 2013
Gemini Raptor	Philips Healthcare	K052640	October 7, 2005

12. REASON FOR SUBMISSION:

New device

13. DEVICE DESCRIPTION:

14. INDICATIONS FOR USE:

The device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT component produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET component images the distribution of PET radiopharmaceuticals in the patient body. The PET component utilizes CT images for attenuation correction and anatomical reference in the fused PET and CT 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 evaluation, detection, diagnosis, therapeutic planning and therapeutic outcome assessment of (but not limited to) cancer, cardiovascular disease and brain dysfunction. Additionally, this device can be operated independently as a whole body multi-slice CT scanner.

15. SUBSTANTIAL EQUIVALENCE:

Celesteion, PCA-9000A/2, is substantially equivalent to the Gemini Raptor which was cleared via Pre-Market Notification 510(k), K052640, marketed by Philips Healthcare as Gemini TF Big Bore.

The CT portion of the Celesteion, PCA-9000A/2, is substantially equivalent to the Aquilion LB Triton system which received 510(k) clearance on May 2, 2013, per K123500. Some minor differences include the use of a moving table base and longer couch top in order to allow scanning in both CT and PET portions and the use of two consoles, one for scanning and one for display, instead of one console that performs both functions. The imaging chain including but not limited to the X-ray tube, detector and data acquisition system of the CT portion is identical to that of the Aquilion LB Triton.

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The PET portions of the Celesteion and the Gemini Raptor operate on the same principles and basic technologies. Both systems acquire PET images and use their respective CT portions for attenuation correction. Additionally, both systems can combine PET and CT images as fused PET/CT images. The main difference between the systems is that the Celesteion requires a longer imaging duration (user selectable) to obtain equivalent data and image quality as compared to the predicate device.

Item	CelesteionPCA-9000A/2	Gemini Raptor	Aquilion LB Triton,V4.91
510(k) Number	This submission	K052640	K123500
PET Specifications
Sensitivity (cps/kBq)	$\u2265$ 3.6	6.6	N/A
Count rate maximum NECR	61 $\u00b1$ 10 kcps	90	N/A
System energy resolution	$\u2264$ 13.7%	11.7%	N/A
System timing resolution	$\u2264$ 450 ps	495 ps	N/A
Scatter fraction (%)	$\u2264$ 42.7	26	N/A
Spatial Resolution FWHM at 1cm	$\u2264$ 5.1	4.7	N/A
Performance Specifications
Scan Regions	Whole body	Whole body	Whole body
CT scan FOV	70 cm	60 cm	70 cm
Scan System	CT: 360°continuous rotate/rotate	CT: 360°continuous rotate/rotate	CT: 360°continuous rotate/rotate
CT Specifications
CT Detection System	16 rowSolid State Detector	16 rowSolid State Detector	16 rowSolid State Detector
Output capacity	72 kW (max)	60 kW	72 kW (max)
X-ray Tube Voltage	80, 100, 120 and 135 kV	90, 120, 140 kVp	80, 100, 120 and 135 kV
X-ray Tube Current	10 mA to 600 mA	20-500 mA	10 mA to 600 mA
X-ray Tube Heat Capacity	7.5 MHU	8 MHU(Anode storage capacity)	7.5 MHU
X-ray Tube cooling rate	1,386 kHU/min (max)1,008kHU/min (actual)	1,608 kHU/min (max)	1,386 kHU/min (max)1,008kHU/min (actual)
Focal Spot Size (IEC)	0.09mm x 0.8mm (small)1.6mm x 1.4 mm (large)	0.5mm x 1.0mm (small)1.0mm x 1.0mm (large)	0.09mm x 0.8mm (small)1.6mm x 1.4 mm (large)
Lowest couch height	475 mm(includes moving base)	Not available	312 mm (312 mm)
Couch-top stroke	2390 mm	Not available	2190 mm (1890 mm)

A complete comparison table is included in this submission. See below for a brief comparison of the technological characteristics between the subject and the predicate devices:

16. SAFETY:

The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC60601-1, IEC60601-1-2, IEC60601-1-3, IEC60601-1-6, IEC60601-2-28, IEC60601-2-44, IEC60825-1, IEC62304, IEC62366, IEC61223, NEMA PS 3.1-3.18, NEMA XR-25, NEMA XR-26 and NEMA NU2.

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K140651
Page 4 of 4

Additionally, this device complies with all applicable requirements of the radiation safety performance standards, as outlined in 21 CFR §1010 and §1020.

17. TESTING

Risk analysis and verification testing conducted through bench testing are included in this submission which demonstrates that the established specifications for the device have been met. CT image quality metrics were performed, utilizing phantoms, which validated that the subject device is substantially equivalent to the predicate device with regard to spatial resolution, CT number and contrast-to-noise ratio and noise properties. Additionally, PET image quality metrics were performed which validated that the subject device met established specifications for spatial resolution, sensitivity, NECR, energy/timing resolution and PET/CT alignment.

Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission.

Additionally, testing of the system was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices and CT Systems.

18. CONCLUSION

Celesteion, PCA-9000A/2, performs in a manner that is similar to and is intended for the same use as the predicate devices, as indicated in product labeling. Based upon this information, conformance to standards, successful completion of software validation, application of risk management and design controls and the performance data presented in this submission it is concluded that the subject device is substantially equivalent in safety and effectiveness to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.

Public Health Service

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

June 11, 2014

Toshiba Medical Systems Corporation % Mr. Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K140651

Trade/Device Name: Celesteion, PCA-9000A/2 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: March 12, 2014 Received: March 13, 2014

Dear Mr. Biggins:

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 comply with all the Act's reguirements, 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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/default.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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

ﺮ ﺗ .

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K140651

Device Name

Celesteion, PCA-9000A/2

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

كا Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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.