The Aquilion PRIME has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

Device Description

The Aquilion PRIME TSX-303A/2, v5.00 is an 80-row CT System and the TSX-303A/6, v5.00 is a 40-row CT system that is intended to produce axial scans of the whole body to include the head. These systems are based upon the technology and materials of previously marketed Toshiba CT systems.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Toshiba Aquilion PRIME CT system (K130645):

The submission K130645 is for a modification of an already cleared device (Aquilion Prime CT System, K120710). As such, the purpose of the submission is to demonstrate that the modified device is substantially equivalent to the predicate device and that the modifications do not adversely affect its safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of distinct "acceptance criteria" against which a device's performance is strictly measured in a pass/fail manner with specific quantitative thresholds. Instead, it describes a comparative evaluation against a predicate device and relies on an image quality metrics study using phantoms to show substantial equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Safety & Effectiveness (General)	"Based upon bench testing, successful completion of software validation, application of risk management and design controls, it is concluded that the subject device is safe and effective for its intended use." (Section 18) Adherence to various IEC, NEMA, and FDA standards (Section 16).
Functional Equivalence to Predicate (Changes)	The modifications (X-ray tube substitution, smaller gantry, increased gantry tilt, new gantry scan switch, breath-hold indication, optional software) do not change the indications for use or intended use. (Section 18) The method of operation, base software, and manufacturing process remain unchanged from the cleared device. (Section 15)
Image Quality Equivalence to Predicate	"The modified system was also evaluated according to an image quality metrics study, 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." (Section 17)
Software Performance (Moderate Level of Concern)	Software Documentation for a Moderate Level of Concern, per FDA guidance, is included. (Section 17) "successful completion of software validation" (Section 18)
Performance Standard (Radiation Emitting Products)	"This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020]" (Section 10). "This device complies with all applicable requirements of the radiation safety performance standards, as outlined in 21 CFR §1010 and §1020." (Section 16).
Quality System Compliance	"The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards." (Section 16)
Intended Use & Indications for Use Equivalence to Predicate	"The modifications incorporated into the Aquilion PRIME TSX-303A/2 and 303A/6, v5.00 do not change the indications for use or the intended use of the device." (Section 18) "This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head." (Section 14 & Indications for Use page)
Technical Specifications (e.g., X-ray tube, Gantry dimensions/angles)	Performance data matches predicate for X-ray tube capacity, maximum/continuous cooling rates. (Section 15 table) Gantry size is smaller, tilt angle is increased, and new features added as described in the comparison table. These are engineering design changes, and their implementation is covered by the overall safety and effectiveness assessment and testing. (Section 15 table)

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

Sample Size: Not explicitly stated in terms of patient cases. The testing mentioned is an "image quality metrics study, utilizing phantoms." Phantoms are standardized test objects, not patient data.
Data Provenance: Not applicable as patient data was not used for this specific substantial equivalence claim. The testing involved phantoms.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Number of Experts/Qualifications: Not applicable. Ground truth for phantom-based image quality metrics is established by physical measurements and computed reference values within the phantom, not by expert interpretation.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. The "image quality metrics study, utilizing phantoms" involves objective measurements (e.g., spatial resolution, CT number, CNR, noise properties) comparing the modified device to the predicate, rather than human interpretation requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

MRMC Study: No, an MRMC comparative effectiveness study was not performed or mentioned in this submission. This is not a study assessing human reader performance with or without AI assistance. It's a technical modification to a CT scanner.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

Standalone Performance: Not applicable in the context of an algorithm's diagnostic performance. This submission is about a CT hardware and software system, not a diagnostic AI algorithm that operates standalone. The image quality metrics study is a technical performance assessment of the system.

7. The Type of Ground Truth Used:

Ground Truth: For the "image quality metrics study, utilizing phantoms," the ground truth is established by the known physical properties of the phantoms and the expected scientific principles of CT imaging. This allows for objective quantification of spatial resolution, CT number accuracy, contrast-to-noise ratio, and noise properties.

8. The Sample Size for the Training Set:

Training Set Sample Size: Not applicable. This document describes a modification to an existing CT system and its validation through phantom studies and adherence to standards. It does not refer to the development of a machine learning algorithm that would require a distinct "training set" of data.

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

Ground Truth for Training Set: Not applicable, as there is no mention of a training set for a machine learning algorithm.

Summary of the Study:

The primary study mentioned to demonstrate that the device meets implied acceptance criteria is an "image quality metrics study, utilizing phantoms." This study compared the modified Aquilion PRIME CT system to its predicate device (TSX-302A/2, Aquilion Prime CT System) to demonstrate substantial equivalence in key image quality parameters.

Key Findings: The study validated that the subject device is substantially equivalent to the predicate device with regard to:

Spatial resolution
CT number
Contrast-to-noise ratio (CNR)
Noise properties

This type of technical study, along with bench testing, software validation, risk management, and compliance with applicable standards (IEC, NEMA, FDA), was considered sufficient by the manufacturer and the FDA to conclude that the modified device is safe and effective and substantially equivalent to the predicate.

Summary

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K130645
Page 1 of 3

JUN 0 6 2013

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

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

4. CONTACT PERSON:

Paul Biggins Director, Regulatory Affairs (714) 730-5000

1. Date Prepared: March 8, 2013
1. TRADE NAME(S): Aquilion PRIME, TSX-303A/2 and 303A/6, v5.00

7. COMMON NAME: System, X-ray, Computed Tomography

DEVICE CLASSIFICATION: 8.

Class II (per 21 CFR 892.1750)

PRODUCT CODE / DESCRIPTION: 9.

JAK - System, Computed Tomography

10. PERFORMANCE STANDARD:

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

11. PREDICATE DEVICE:

Product	Marketed by	510(k) Number	Clearance Date
TSX-302A/2, AquilionPrime CT System	Toshiba AmericaMedical Systems	K120710	April 6, 2012

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12. REASON FOR SUBMISSION:

Modification of a cleared device

13. DEVICE DESCRIPTION:

14. SUMMARY OF INTENDED USES:

This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head.

The Aquilion Prime has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software, by a trained and qualified physician.

15. SUBSTANTIAL EQUIVALENCE:

This device is substantially equivalent to the TSX-302A/2, Aquilion Prime CT System, K120710, marketed by Toshiba America Medical Systems. The Aquilion PRIME TSX-303A/2 and 303A/6, v5.00, incorporates modifications to the cleared device which include a smaller gantry size, addition of optional software features and new patient couches. The method of operation, base software and manufacturing process remain unchanged from the cleared device.

A complete comparison table is included in this submission. See below for a brief summary of changes from TSX-302A/2, Aquilion Prime CT System:

Item	Aquilion PRIME	TSX-302A/2,
X-ray Tube Substitution	TSX-303A/2 and 303A/6, v5.00	Aquilion Prime CT System
X-ray tube capacityMaximum tube cooling rateContinuous tube cooling rate	7.5 MHU1386 kHU/min1008 kHU/min	7.5 MHU1386 kHU/min1008 kHU/min
Gantry Size	W=2150mm, H=1870mm, D=870mm	W=2430mm, H=2030mm,D=1070mm
Gantry Tilt Angle	$\u00b130\u00b0$	$\u00b122\u00b0$
Gantry Scan Switch	Standard	N/A
Lamp for Indication ofBreathing	Breath-hold time indication added	N/A

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K130645
Page 3 of 3

(Continued)

Item	Aquilion PRIMETSX-303A/2 and 303A/6, v5.00	TSX-302A/2,Aquilion Prime CT System
Helical Shuttle Scan	Optional	N/A
Lung Volume Analysis	Optional(Previously cleared under K113715)	N/A

1. X-ray tube substitution
1. Smaller gantry
ന് Increased gantry tilt angle
1. New gantry scan switch and breath-hold indication

Previously cleared software options are being added

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, IEC60601-1-2, IEC60601-1-3, IEC60601-1-6, IEC60601-1-9, IEC60601-2-28, IEC60601-2-32, IEC60601-2-44, IEC60825-1, IEC62304, IEC62366, NEMA PS 3.1-3.18and NEMA XR-25. 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/validation testing conducted through bench testing are included in this submission which demonstrates that the requirements for the modifications made to the system have been met. The modified system was also evaluated according to an image quality metrics study, utilizing phantoms, which validated that the subject device is substantially equivalent to the predicate device with regard to spatial resolution, CT number and contrast-tonoise ratio and noise properties.

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

18. CONCLUSION

The modifications incorporated into the Aquilion PRIME TSX-303A/2 and 303A/6, v5.00 do not change the indications for use or the intended use of the device. Based upon bench testing, successful completion of software validation, application of risk management and design controls, it is concluded that the subject device is safe and effective for its intended use.

Page 3 of 3

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three arms or lines extending from the body. The figure is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.

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

June 6, 2013

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

Re: K130645

Trade/Device Name: Aquilion PRIME TSX-303A/2 and 303A/6, v5.00 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 8, 2013 Received: March 11, 2013

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 .- Isting 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 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.

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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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm.

Sincerely yours.

Smh.P.

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

for

Enclosure

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Indications for Use

510(k) Number (if known): K130645

Device Name: Aquilion PRIME, TSX-303A/2 and 303A/6, v5.00

Indications for Use:

This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head.

The Aquilion PRIME has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

Prescription

Prescription Use X (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 In Vitro Diagnostics and Radiological Health (OIR) (Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) K130645

Page 1 of 1

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.