MYOPERFUSION

K132523 · Toshibamedical Systems Corporation · JAK · Dec 12, 2013 · Radiology

Device Facts

• Record ID: K132523
• Device Name: MYOPERFUSION
• Applicant: Toshibamedical Systems Corporation
• Product Code: JAK · Radiology
• Decision Date: Dec 12, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

This software is intended to be used for the visualization of non-reversible perfusion defects (hypo/hyper dense areas) in patients with angina or with a previous myocardial infarct. Included software tools may aid a trained user in monitoring the disease state and treatment over time. This software provides maps and the values used to generate the maps. The information provided is intended to be qualitative in nature and when used by a qualified physician may aid in the identification of myocardial enhancement defects and the follow up of such findings.

Device Story

MyoPerfusion, CSMP-001A is accessory software for CT systems; processes ECG-gated contrast-enhanced cardiac scan data. Transforms CT values into polar maps, Perfusion Index (PI) maps, and Transmural Perfusion Ratio (TPR) maps. PI calculated as ratio of mean myocardial CT value to LV blood pool CT value; TPR calculated as ratio of endocardial CT value to mean epicardial CT value. Used by qualified physicians in clinical settings to identify myocardial enhancement defects and monitor disease progression. Output provides qualitative visualization and quantitative ratios to aid clinical decision-making regarding myocardial perfusion status.

Clinical Evidence

Bench testing only. Includes hazard analysis, verification, and validation testing. Performance testing confirmed that perfusion map calculation and auto-segmentation algorithms function as intended to provide visualization tools for physician analysis.

Technological Characteristics

Software-based post-processing tool for CT angiography data. Features auto-segmentation and perfusion map generation (polar, PI, TPR). Operates on ECG-gated cardiac scan data. Software level of concern: Moderate.

Indications for Use

Indicated for patients with angina or previous myocardial infarct to visualize non-reversible perfusion defects (hypo/hyper dense areas) and monitor disease state/treatment over time.

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

• Vitrea® CT Myocardial Analysis (K112531)
• CardIQ Xpress 2.0 (K073138)
• syngo.CT Cardiac Function (K110366)

Submission Summary (Full Text)

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K132523
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TOSHIBA AMERICA MEDICAL BYBTEMS, INC.

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

## 510(k) - SUMMARY

TOSHIBA

- 1. SUBMITTER'S NAME: Toshiba America Medical Systems, Inc.
- 2. ADDRESS: 2441 Michelle Drive Tustin, CA. 92780-2068
- 3. ESTABLISHMENT REGISTRATION: 2020563
- 4. CONTACT PERSON: Paul Biggins Director, Regulatory Affairs [phone]
- 5. DATE PREPARED: August 9, 2013
- 6. TRADE NAME(S): MyoPerfusion, CSMP-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

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#### 11. PREDICATE DEVICES:

| Device Name | Vitrea® CT<br>Myocardial Analysis | CardIQ Xpress 2.0 | syngo.CT Cardiac<br>Function |
|----------------------------|-----------------------------------|--------------------|------------------------------------|
| Marketed By | Vital Images, Inc. | GE Medical Systems | Siemens Medical<br>Solutions, Inc. |
| 510(k) Clearance<br>Number | K112531 | K073138 | K110366 |
| Clearance Date | November 18, 2011 | February 26, 2008 | April 12, 2011 |

#### 12. REASON FOR SUBMISSION:

New accessory software

### 13. DEVICE DESCRIPTION:

This device processes ECG-gated contrast enhanced cardiac scan data using MPR generated images according to the cardiac axis. The software generates polar maps, perfusion index (PI) map and Transmural Perfusion Ration (TPR) maps based upon the measured CT values of the tissue within the specified region of interest. The software displays the values associated with the generation of the Perfusion Index and TPR Maps. Pl is the ratio of the Mean Myocardial CT value to the LV blood pool CT value. TPR is provided as a ratio per sector of the Endocardial CT value to the mean Epicardial CT value.

### 14. INDICATIONS FOR USE:

This software is intended to be used for the visualization of non-reversible perfusion defects (hypo/hyper dense areas) in patients with angina or with a previous myocardial infarct. Included software tools may aid a trained user in monitoring the disease state and treatment over time. This software provides maps and the values used to generate the maps. The information provided is intended to be qualitative in nature and when used by a qualified physician may aid in the identification of myocardial enhancement defects and the follow up of such findings.

### 15. SUBSTANTIAL EQUIVALENCE:

MyoPerfusion, CSMP-001A, performs in a manner similar to and is intended for the same use as the predicate devices in that all are post processing software used to visualize cardiovascular anatomy and pathology. All of these devices utilize CT angiography images/data in order to display various diagnostically useful functions such as the display of polar maps based upon the CT values of the myocardium. In addition, MyoPerfusion provides numerical values used to calculate comparison ratios including Perfusion Index and Transmural Perfusion Ratio. The implementation of these additional features does not result in additional indications of use but rather a variation in the method of displaying the polar maps.

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#### 16. SAFETY:

This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. 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

Hazard analysis, verification/validation and performance testing conducted through bench testing are included in this submission which demonstrates that the design specifications established for the device have been met and that the perfusion map calculation and auto segmentation used by the software will appropriately display visualization tools used by physicians to analyze myocardial perfusion.

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

#### 18. CONCLUSION

MyoPerfusion, CSMP-001A, performs in a manner similar to and is intended for the same use as the predicate devices. Based upon the data presented in this submission including application of design controls and performance data, Toshiba America Medical Systems, believes that MyoPerfusion, CSMP-001A, is substantially equivalent in safety and effectiveness to the predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

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

December 12, 2013

Toshiba Medical Systems Corporation % Mr. Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. 244 I Michelle Drive TUSTIN CA 92780

Re: K132523

· Trade/Device Name: MyoPerfusion, CSMP-001A Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 12, 2013 Received: September 13, 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 10 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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Page 2-Mr. Biggins

1f 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/Resources/orYou/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.fdagov/McdicalDevices/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.hum.

Sincerely yours,


for

Janine M. Могтіs 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):

K132523

Device Name:

MyoPerfusion, CSMP-001A

Indications for Use:

This software is intended to be used for the visualization of non-reversible perfusion defects (hypo/hyper dense areas) in patients with angina or with a previous myocardial infarct. Included software tools may aid a trained user in monitoring the disease state and treatment over time. This software provides maps and the values used to generate the maps. The information provided is intended to be qualitative in nature and when used by a qualified physician may aid in the identification of myocardial enhancement defects and the follow up of such findings.

Prescription Use_ x (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 CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k)________________________________________________________________________________________________________________________________________________________________________ K132523

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