Aquilion Lightning, TSX-035A/4 and /5, V7.0
Device Facts
| Record ID | K153263 |
|---|---|
| Device Name | Aquilion Lightning, TSX-035A/4 and /5, V7.0 |
| Applicant | Toshibamedical Systems Corporation |
| Product Code | JAK · Radiology |
| Decision Date | Apr 1, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1750 |
| Device Class | Class 2 |
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/hardware, by a trained and qualified physician.
Device Story
16-row CT system; acquires cross-sectional X-ray images of whole body/head. Transforms X-ray attenuation data into volumetric image sets via reconstruction algorithms. Operated by trained physicians/technicians in clinical settings. Includes noise reduction (AIDR 3D, QDS) and metal artifact reduction (SEMAR). Output viewed on workstation for diagnostic interpretation; aids clinical decision-making by providing anatomical visualization. Benefits include diagnostic imaging capabilities for various patient conditions.
Clinical Evidence
Bench testing only. No clinical data. Verification and validation testing confirmed performance specifications for modified X-ray generator, rotation speed, patient couch, and software applications.
Technological Characteristics
16-row CT system; 800 channels; 780mm gantry aperture; 0.5-0.75s rotation speed; max 50.4kW generator output. Materials/design per ISO 13485, IEC 60601-1, IEC 60601-2-44, NEMA XR-25/26. Includes QDS, AIDR 3D, and SEMAR processing. Connectivity via NEMA PS 3.1-3.18 (DICOM).
Indications for Use
Indicated for acquisition and display of cross-sectional whole-body volumes, including 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/2 (K151833)
Reference Devices
- CT Cardiac Function Analysis Software (K023760)
- Sure Plaque (K043111)
- ECG-Gating Reconstruction System (K991766)
- Scan Protocol Management (K142465)
- 4D Airways Analysis (K143294)
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
April 1, 2016
Toshiba Medical Systems Corporation % Orlando Tadeo, Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K153263
Trade/Device Name: Aquilion Lightning, TSX-035A/4 and /5, V7.0 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 2, 2016 Received: March 3, 2016
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
# K153263
Device Name
Aquilion Lightning, TSX-035A/4 and /5, V7.0
#### 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)
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#### FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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#### TOSHIBA AMERICA MEDICAL SYSTEMS, INC
2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 730-5000
#### 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 (714) 669-7459
#### 5. Date Prepared:
March 2, 2016
# 6. TRADE NAME(S): Aquilion Lightning, TSX-035A/4 and /5, V7.0
- 7. COMMON NAME: System, X-ray, Computed Tomography
- 8. DEVICE CLASSIFICATION (Regulatory Class, CFR Reference, Name): Class II (per 21 CFR 892.1750, Computed Tomography X-ray System)
# 9. PRODUCT CODE / DESCRIPTION:
JAK / 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 | Regulation | Regulation | Product Code | 510(k) | Clearance |
|--------------------------------------|------------------------------------------|--------------------|----------------------------------------|---------------------------------------------------|---------|--------------------|
| | by | Number | Name | | Number | Date |
| Aquilion<br>Lightning,<br>TSX-035A/2 | Toshiba<br>America<br>Medical<br>Systems | 21 CFR<br>892.1750 | Computed<br>Tomography<br>X-ray System | JAK:<br>System, X-ray,<br>Tomography,<br>Computed | K151833 | October 9,<br>2015 |
### 12. REASON FOR SUBMISSION:
Modification to an existing device.
# 13. DEVICE DESCRIPTION:
The Aquilion Lightning, TSX-035A/4 and /5, v7.0 is a 16-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-035A/4 and /5, v7.0, is substantially equivalent to the Aquilion Lightning, TSX-035A/2, that received premarket clearance under K151833 and is marketed by Toshiba America Medical Systems. The Indications for Use for the subject device are identical to those of the predicate device. See below for a brief comparison of the technological characteristics between the subject and the predicate devices:
| Item | Aquilion Lightning, TSX-035A/4 and /5 | Aquilion Lightning, TSX-035A/2 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| 510(k) Number | This submission | K151833 |
| Gantry Rotation<br>Speed | 0.75 sec/rotation<br>Options:<br>• 0.6 sec (Available when 0.6s Fast Scan Kit,<br>CGS-61A, is installed)<br>• 0.5 sec (Available when 0.5s Fast Scan Kit,<br>CGS-67A, is installed) | 0.75 sec/rotation<br>Option:<br>• 0.6 sec (Available when 0.6s<br>Fast Scan Kit, CGS-61A, is<br>installed) |
| Detector | 800 channels × 16 rows | 800 channels × 16 rows |
| FOV (field of view) | 180/240/320/390/500 mm | 180/240/320/390/500 mm |
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| X-ray rated output | Max. 36 kW<br>Option:<br>• Max. 50.4kW when X-ray Power-Up Kit,<br>CSGS-016A is installed | | | | Max. 36 kW | |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------|-----------|------------|------------|--------------------------------|------------|
| X-ray tube voltage<br>X-ray tube current | 80/100/120/135 kV<br>10-300 mA<br>Option:<br>• 10-420 mA when X-ray Power-Up Kit,<br>CSGS-016A is installed | | | | 80/100/120/135 kV<br>10-300 mA | |
| X-ray fan angle | 43.9° | | | | 43.9° | |
| Patient Couch | Long Type | Long Type | Short Type | Short Type | Long Type | Short Type |
| • Couch-top stroke | 2190mm | 2390mm | 1890mm | 1890mm | 2190mm | 1890mm |
| • Scan permissible range<br>(Conventional) | 1830mm | 2030mm | 1530mm | 1530mm | 1830mm | 1530mm |
| • Scan permissible range (Helical) | 1780mm | 1980mm | 1480mm | 1480mm | 1780mm | 1480mm |
| • Max. guaranteed weight | 205kg | 300 kg | 205kg | 300 kg | 205kg | 205kg |
| Noise reduction processing | QDS, AIDR 3D , AIDR3D Enhanced | | | | QDS, AIDR 3D , AIDR3D Enhanced | |
| Metal Artifact Reduction | SEMAR (Helical Scan) | | | | SEMAR (Helical Scan) | |
| Gantry opening size (diameter) | 780 mm | | | | 780 mm | |
| Tilt angle | ±30° | | | | ±30° | |
| Installation area<br>(Short patient couch) | Minimum 17.2m²<br>(14.4 m² ) | | | | Minimum 17.1m²<br>(14.3 m² ) | |
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| CT Cardiac Function Analysis Software | Previously cleared under K023760 |
|---------------------------------------|----------------------------------|
| Sure Plaque | 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 |
Previously cleared software options being implemented to the modified device:
# 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
This submission includes summary tables detailing the risk analysis and verification/validation testing conducted through bench testing which demonstrates that the requirements for the modifications made to the system have been met. Evaluation of the modified device included, but was not limited to, confirmation that the associated performance specifications related to the increased X-ray generator output, increase of the rotation speed, implementation of a new patient couch and application software previously cleared on other Toshiba CT systems, were met.
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-035A/4 and /5, v7.0, performs in a manner similar to and is intended for the same use as the predicate device, 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 device.
