SURESUBTRACTION ORTHO

K130960 · Toshibamedical Systems Corporation · JAK · Aug 20, 2013 · Radiology

Device Facts

• Record ID: K130960
• Device Name: SURESUBTRACTION ORTHO
• Applicant: Toshibamedical Systems Corporation
• Product Code: JAK · Radiology
• Decision Date: Aug 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

suRESubtraction Ortho software is intended to generate subtraction images and improve the visualization of contrast enhancement. The system can load two or more CT images with and without contrast enhancement. When used by a qualified physician, a potential application is to determine the course of treatment.

Device Story

SURESubtraction Ortho is post-processing software for CT systems. It takes two or more CT image datasets (one contrast-enhanced, one non-contrast) as input. The software uses registration algorithms to align the datasets and subtracts intensity values to isolate bone and contrast-enhanced structures. The output is a subtraction image that improves visualization of contrast enhancement. Used in clinical settings by physicians to aid in diagnosis and treatment planning. The device benefits patients by providing clearer visualization of anatomical structures and contrast-enhanced areas compared to standard CT images.

Clinical Evidence

Bench testing only. Performance studies compared original CT images processed with SURESubtraction Ortho versus the predicate software. Results demonstrated that the subject device successfully visualized calculated enhanced edema in varying positions and rotations and provided improved visualization of contrast enhancement compared to the predicate.

Technological Characteristics

Post-processing software for CT systems. Operates via image registration and pixel-intensity subtraction. Conforms to IEC 62304 (software lifecycle) and IEC 62366 (usability). Designed under 21 CFR 820 and ISO 13485 quality standards.

Indications for Use

Indicated for use by qualified physicians to generate subtraction images from CT datasets (with and without contrast) to improve visualization of contrast enhancement and assist in determining treatment courses for any body region containing bone.

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

• SURESubtraction, CKOS-001A (K051833)
• Aquilion ONE Vision, TSX-301c/1, v4.90 (K122109)

Submission Summary (Full Text)

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K130960

: |

# ГОВНІВА AMERICA MEDICAL БУSTEMS, INC.

2441 Michelle Drive, Tustin, CA 92780 Phone: [phone]

## 510(k) - SUMMARY OF SAFETY AND EFFECTIVENESS

## 1. SUBMITTER'S NAME: Toshiba America Medical Systems, Inc.

- 2. ADDRESS: 2441 Michelle Drive Tustin, CA. 92780-2068
- 3. ESTABLISHMENT REGISTRATION: 2020563

AUG 2 0 2013

- 4. CONTACT PERSON: Paul Biggins Director, Regulatory Affairs [phone]
- 5. DATE PREPARED: July 25, 2013
- 6. TRADE NAME(S): suRESubtraction Ortho, CSSO-001A

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

- 8. DEVICE CLASSIFICATION: Class II (per 21 CFR 892.1750)
- 9. PRODUCT CODE / DESCRIPTION: 90JAK - System, Computed Tomography
- 10. PERFORMANCE STANDARD: None

#### 11. PREDICATE DEVICE:

| Product | Marketed by | 510(k) Number | Clearance Date |
|-------------------------------------------|------------------------------------|---------------|--------------------|
| Aquilion ONE Vision,<br>TSX-301c/1, v4.90 | Toshiba America<br>Medical Systems | K122109 | September 21, 2012 |

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# 12. REASON FOR SUBMISSION:

Modification to an accessory software

## 13. DEVICE DESCRIPTION:

The SURESubtraction Ortho, CSSO-001A is a post-processing software that subtracts image information by comparison of two data sets, one of which is contrast enhanced. Registration software is used to match the two independent studies. This registration software has been used on Toshiba CT systems for a number of years with no adverse events reported.

## 14. INDICATIONS FOR USE:

suRESubtraction Ortho software is intended to generate subtraction images and improve the visualization of contrast enhancement. The system can load two or more CT images with and without contrast enhancement. When used by a qualified physician, a potential application is to determine the course of treatment.

## 15. SUBSTANTIAL EQUIVALENCE:

This device is substantially equivalent to SURESubtraction, the subtraction tool used for Orbital Synchronized Scan System, CKOS-001A, which was originally cleared under the premarket notification for TSX-101A/H, /i, Aquilion 64/32 SP CT Scanner 510(k), K051833. Since this clearance all Toshiba CT systems have incorporated this post processing software; the latest clearance being on the Aquilion ONE Vision, TSX-301c/1, v4.90, K122109.

sureSubtraction Ortho includes modifications to the predicate software which improves on the anatomical region with which the software can be used. This post processing software performs in a manner similar to the predicate device in that subtraction images are created which aid in diagnosis. Additionally, this software includes modifications that improve upon the visualization of contrast enhancement as demonstrated in the performance studies included in this submission.

| | SURESubtraction,<br>CKOS-001A | SURESubtraction Ortho,<br>CSSO-001A |
|-----------------------------------------|-------------------------------|-------------------------------------|
| | Predicate device | Subject Device |
| Anatomical Region<br>(CT Field Of View) | Head and neck region | Any body region containing<br>bone |

A summary of the changes is included below and in more detail within this submission.

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| | SURESubtraction,<br>CKOS-001A | SURESubtraction Ortho,<br>CSSO-001A |
|---------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| | Predicate device | Subject Device |
| Target<br>For Subtraction | Bone and<br>calcifications close to<br>vasculature | Bone |
| Subtraction<br>Algorithm | Subtraction of intensity<br>values of registered<br>contrast-enhanced and<br>non-contrasted pixels | Subtraction of intensity<br>values of registered<br>contrast-enhanced and<br>non-contrasted pixels |

#### 16. SAFETY:

This 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 IEC62304 and IEC62366 standards. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR §1020, that apply to this device, will be met and reported via product report.

#### 17. TESTING

Risk analysis and performance testing conducted through bench testing are included in this submission. Performance studies demonstrated that resultant subtraction images produced by the software can be used to successfully visualize calculated enhanced edema in varying positions and rotations and that in comparing original CT images processed with SURESubtraction Ortho versus the predicate software, the resultant images demonstrate improved visualization.

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.

## 18. CONCLUSION

SURESubtraction Ortho, CSSO-001A, performs in a manner similar to the predicate device in that subtraction images are created which aid in diagnosis. Based upon the data presented in this submission including conformance to standards, application of design controls and performance data, Toshiba America Medical Systems, believes that SURESubtraction Ortho, CSSO-001A, is substantially equivalent in safety and effectiveness to the predicate device.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

August 20, 2013

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

- Re: K130960/S001
Trade/Device Name: SURESubtraction Ortho CSSO-001A Regulation Number: 21 CFR 892.1750 Regulation Name: Commuter Tomography X-ray System Regulatory Class: Class II Product Code: JAK Dated: July 25, 2013 Received: July 26, 2013

Dear Mr. Paul 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

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#### Page 2 - Mr. Paul Biggins

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.

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 [phone] or [phone] 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address 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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# Indications for Use

510(k) Number (if known): K130960 SURESubtraction Ortho_CSSO-001A

Device Name:

Indications For Use:

suRESubtraction Ortho software is intended to generate subtraction images and improve the visualization of contrast enhancement. The system can load two or more CT images with and without contrast enhancement. When used by a qualified physician, a potential application is to determine the course of treatment.

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

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510(k): K130960

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