Aquilion Lightning, TSX-036A/1, V8.4

K170019 · Toshibamedical Systems Corporation · JAK · Feb 2, 2017 · Radiology

Device Facts

• Record ID: K170019
• Device Name: Aquilion Lightning, TSX-036A/1, V8.4
• Applicant: Toshibamedical Systems Corporation
• Product Code: JAK · Radiology
• Decision Date: Feb 2, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

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

Aquilion Lightning is an 80-row CT system; acquires cross-sectional X-ray volumes of whole body/head. System utilizes PUREVision detector technology; transforms X-ray attenuation data into volumetric images. Operated by trained physicians/technicians in clinical settings. Output consists of diagnostic-quality cross-sectional images; used for clinical decision-making and specialized studies. Device includes workflow-enhancing software applications (e.g., CT Fluoroscopy, Variable Helical Pitch, SURESubtraction). Benefits include improved diagnostic imaging capabilities and workflow efficiency. Healthcare providers interpret images to inform patient diagnosis and treatment planning.

Clinical Evidence

Bench testing only. Performance verified using phantoms to assess spatial resolution, CT number magnitude/uniformity, noise properties, low contrast detectability, and CNR performance. Representative diagnostic images (head, chest, abdomen, pelvis, peripheral) reviewed by an American Board Certified Radiologist confirmed diagnostic quality.

Technological Characteristics

80-row CT system; 896-channel PUREVision detector; max 36kW output (50.4kW option). Gantry rotation 0.75s (0.5s/0.6s options). Features QDS, AIDR 3D, AIDR 3D Enhanced noise reduction, and SEMAR metal artifact reduction. Standards: IEC 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-28, 60601-2-44, 60825-1, 62304, 62366; NEMA PS 3.1-3.18, XR-25, XR-26. Radiation safety per 21 CFR 1010/1020.

Indications for Use

Indicated for acquisition and display of cross-sectional volumes of the whole body, including the head, for use by trained physicians in specialized studies.

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

• Aquilion Lightning, TSX-035A/4 and /5, V7.0 (K153263)
• Aquilion PRIME TSX-303A/F, V6.0 (K141741)

Reference Devices

• CT Cardiac Function Analysis Software (K023760)
• SUREPlaque (K043111)
• ECG-Gating Reconstruction System (K991766)
• Scan Protocol Management (K142465)
• 4D Airways Analysis (K143294)
• Body Perfusion (K090504)

Submission Summary (Full Text)

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

February 2, 2017

Toshiba Medical Systems Corporation % Orlando Tadeo, Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K170019

Trade/Device Name: Aquilion Lightning, TSX-036A/1, V8.4 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: December 30, 2016 Received: January 3, 2017

Dear Mr. Tadeo:

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 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 Industry and Consumer Education at its toll-free 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/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 [phone] or [phone] or at its Internet address

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

Sincerely yours.

Michael D'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

## K170019

Device Name

Aquilion Lightning, TSX-036A/1, V8.4

#### Indications for Use (Describe)

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

The Aquilion Lightning 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.

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

ال Prescription Use (Part 21 CFR 801 Subpart D)

_ 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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Image /page/3/Picture/0 description: The image contains the words "TOSHIBA MEDICAL" in large, bold, red letters. The word "TOSHIBA" is on the top line, and the word "MEDICAL" is on the bottom line. The font is sans-serif and appears to be a blocky, modern style. The background is white.

#### 510(k) SUMMARY

#### 1. SUBMITTER'S NAME:

Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550

#### 2. OFFICIAL CORRESPONDENT:

Akinori Hatanaka Senior Manager, Regulatory Affairs and Vigilance

# 3. ESTABLISHMENT REGISTRATION:

9614698

#### 4. CONTACT PERSON:

Orlando Tadeo, Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive Tustin, CA 92780 [phone]

#### 5. Date Prepared:

January 31, 2017

## 6. TRADE NAME(S):

Aquilion Lightning, TSX-036A/1, V8.4

## 7. COMMON NAME:

System, X-ray, Computed Tomography

#### 8. DEVICE CLASSIFICATION:

Class II (per 21 CFR 892.1750, Computed Tomography X-ray System)

#### 9. PRODUCT CODE / DESCRIPTION:

90JAK / Computed Tomography X-Ray System

#### 10. PERFORMANCE STANDARD:

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

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#### 11. PREDICATE DEVICE:

| Product | Marketed by | Regulation Number | Regulation Name | Product Code | 510(k) Number | Clearance Date |
|---------------------------------------------|---------------------------------|-------------------|----------------------------------|---------------------------------------------------|---------------|-------------------|
| Aquilion Lightning, TSX-035A/4 and /5, V7.0 | Toshiba America Medical Systems | 21 CFR 892.1750 | Computed Tomography X-ray System | JAK:<br>System, X-ray,<br>Tomography,<br>Computed | K151263 | April 1, 2016 |
| Aquilion PRIME TSX-303A/F, V6.0 | Toshiba America Medical Systems | 21 CFR 892.1750 | Computed Tomography X-ray System | JAK:<br>System, X-ray,<br>Tomography,<br>Computed | K141741 | November 26, 2014 |

#### 12. REASON FOR SUBMISSION:

New device

#### 13. DEVICE DESCRIPTION:

The Aquilion Lightning, TSX-036A/1, v8.4 is an 80-row CT System that is intended to acquire and display cross-sectional volumes of the whole body, including the head. This system is based upon the technology and materials of previously marketed Toshiba CT systems.

#### 14. INDICATIONS FOR USE:

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

The Aquilion Lightning 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:

The Aquilion Lightning, TSX-036A/1, v8.4, is substantially equivalent to the Aquilion Lightning, TSX-035A/4 and /5, v7.0, which received premarket clearance under K153263 and the Aquilion PRIME, TSX-303A, V6.0, which received premarket clearance under K141741, both of which are marketed by Toshiba America Medical Systems. The Aquilion Lightning, TSX-036A/1, v8.4, incorporates modifications to the cleared device including implementation of the CT detector previously cleared under K141741 (increases the available detector rows from 16 to 80), a change to the wedge filter and modifications to previously cleared optional software applications in order to realize workflow improvements. These changes do not affect the safety or efficacy of the cleared device, as demonstrated in performance testing. The method of operation and manufacturing process for the Aquilion Lightning remain unchanged from the cleared device. See below for a brief comparison of the technological characteristics between the subject and the predicate devices:

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| Item | Aquilion Lightning,<br>TSX-036A/1, V8.4 | Aquilion PRIME<br>TSX-303A/F, V6.0 | Aquilion Lightning,<br>TSX-035A/4 and /5, V7.0 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| 510(k) Number | This submission | K141741 | K153263 |
| Gantry Rotation | 0.75 sec/rotation | 0.35 sec/rotation | 0.75 sec/rotation |
| Speed (max) | (Option: 0.5 sec/0.6 sec) | | (Option: 0.5 sec/0.6 sec) |
| Detector | 896 channels x 80 rows<br>PUREVision | 896 channels x 80 rows<br>PUREVision | 800 channels × 16 rows<br>PUREVision |
| Slices/rotation | 40 [(Software limits<br>acquisition to 40 slices) 80<br>w/ double slice upgrade]<br>80 (160 w/ double slice<br>and dynamic volume<br>upgrade) | 40 [(Software limits acquisition<br>to 40 slices) 80 w/ double<br>slice upgrade]<br>80 (160 w/ double slice and<br>dynamic volume upgrade) | 16 (32 w/ double slice<br>upgrade) |
| Scan<br>length/rotation | 40 mm | 40 mm | 20 mm |
| FOV (field of view)<br>diameter | 320/500mm | 180/240/320/400/500mm | 180/240/320/390/500mm |
| Wedge filter types | Two types | Three types | Three types |
| X-ray rated output | Max. 36 kW | 60 kW | Max. 36 kW |
| | (Option: Max. 50.4kW) | (Option: Max 72 kW) | (Option: Max. 50.4kW) |
| X-ray tube voltage | 80/100/120/135 kV | 80/100/120/135 kV | 80/100/120/135 kV |
| X-ray tube current | 10-300 mA | 10-300 mA | 10-300 mA |
| | (Option: 10-420 mA) | (Option: 10-420 mA) | (Option: 10-420 mA) |
| X-ray fan angle | 49.2° | 49.2° | 43.9° |
| X-ray cone angle | 3.8° | 3.8° | 1.9° |
| Noise reduction<br>processing | QDS, AIDR 3D , AIDR3D<br>Enhanced | QDS, AIDR 3D , AIDR3D<br>Enhanced | QDS, AIDR 3D , AIDR3D<br>Enhanced |
| Metal Artifact<br>Reduction | SEMAR (Helical and<br>Volume Scan) | SEMAR (Helical and<br>Volume Scan) | SEMAR (Helical Scan) |
| Gantry opening<br>size (diameter) | 780 mm | 780 mm | 780 mm |
| Tilt angle | ±30° | ±30° | ±30° |
| Variable helical | Optional | Optional | Optional |
| pitch | (2 or multi-phase) | (2-phase) | (2-phase) |
| Patient couch | 205kg/300kg | 205kg/300kg | 205kg/300kg |
| Lateral movement<br>kit | Available | Available | Not Available |
| Installation area | Minimum 18.3 m² | Minimum 20 m² | Minimum 17.2m² |
| (Short patient<br>couch) | (15.5 m² ) | (19.5 m² ) | (14.4 m² ) |

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Modifications to previously cleared software options:

| Application | Comment |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CT Fluoroscopy | Workflow improvement: Max speed limit on couch-<br>top movement increased and time from scan<br>completion to start button illumination has been<br>reduced |
| Variable Helical Pitch (vHP) | Workflow improvements: 3-phase vHP available and<br>for ECG-gated helical scan phase, Modulation can be<br>specified and SUREExposure3D is enabled |
| SURESubtraction Ortho | Workflow improvement: positioned matched images<br>can be subtracted |
| Dual Energy System Package | Workflow improvement: DE clinical application can<br>be executed during scanning |

Previously cleared software options being implemented to the modified device:

| CT Cardiac Function Analysis Software | Previously cleared under K023760 |
|---------------------------------------|----------------------------------|
| SUREPlaque | Previously cleared under K043111 |
| ECG-Gating Reconstruction System | Previously cleared under K991766 |
| Scan Protocol Management | Previously cleared under K142465 |
| 4D Airways Analysis | Previously cleared under K143294 |
| Body Perfusion | Previously cleared under K090504 |

## 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 following standards IEC60601-1, IEC60601-1-2, IEC60601-1-3, IEC60601-1-6, IEC60601-2-28, IEC60601-2-44, IEC60825-1, IEC62304, IEC62366, NEMA PS 3.1-3.18, NEMA XR-25 and NEMA XR-26. 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 established specifications for the device have been met. CT image quality metrics were performed, utilizing phantoms, which demonstrated that the subject device is substantially equivalent to the predicate device with regard to spatial resolution, CT number magnitude and uniformity, noise properties, low contrast detectability and CNR performance.

Representative diagnostic images, reviewed by an American Board Certified Radiologist, including head, chest, abdomen, pelvis and peripheral exams were also obtained using the subject device

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which demonstrates that the device produces images of diagnostic quality and; therefore, performs as intended.

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

#### 18. CONCLUSION

The Aquilion Lightning, TSX-036A/1, v8.4, performs in a manner similar to and is intended for the same use as the predicate devices, as indicated in product labeling. Based upon bench testing, successful completion of software validation and application of risk management and design controls, it is concluded that the subject device is substantially equivalent in safety and effectiveness to the predicate devices.