CSMC Cardiac Suite

K172609 · Cedars-Sinai Medical Center · KPS · Nov 3, 2017 · Radiology

Device Facts

• Record ID: K172609
• Device Name: CSMC Cardiac Suite
• Applicant: Cedars-Sinai Medical Center
• Product Code: KPS · Radiology
• Decision Date: Nov 3, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Cedars-Sinai Cardiac Suite of applications is intended to enable an automated display, review, and quantification of Nuclear Medicine Cardiology medical images and datasets. Cedars-Sinai Cardiac Suite may be used in multiple settings including the hospital, clinic, doctors office, or remotely. The results provided should be reviewed by qualified healthcare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians) trained in the use of medical imaging devices.

Device Story

Standalone software suite for processing/reviewing cardiac SPECT and PET images; inputs camera-independent reconstructed image files; performs automated quantification and display of perfusion and gated data; includes modules for QPS/QGS, QBS, QPET, motion correction (MOCO), and image fusion (SPECT/PET/CT/CTA); operates on standard PC hardware or iPad; used by cardiologists/radiologists to assist in clinical assessment of cardiac function; output facilitates diagnostic decision-making by providing quantitative metrics and visual representations of cardiac perfusion and motion; benefits include standardized, automated analysis of nuclear cardiology datasets.

Clinical Evidence

Bench testing only. Software validation was performed to confirm all device features were compliant with software requirements. No clinical data provided.

Technological Characteristics

Standalone software for cardiac image processing. Compatible with Windows, Mac OS X, and Linux; iPad viewer component available. Features include QPS, QGS, QBS, QPET, motion correction, and fusion. Connectivity via network adapter. Software-based analysis.

Indications for Use

Indicated for patients undergoing Nuclear Medicine Cardiology SPECT or PET procedures. Intended for use by radiologists, cardiologists, or general nuclear medicine physicians in hospitals, clinics, or remote settings.

Regulatory Classification

Identification

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Predicate Devices

• CSMC Cardiac Suite- Nuclear Medicine Software (K141652)

Submission Summary (Full Text)

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November 3, 2017

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Cedars-Sinai Medical Center % Geoff Pollard Sr. Project Manager 8700 Beverly Blvd LOS ANGELES CA 90048

Re: K172609

Trade/Device Name: CSMC Cardiac Suite 2017 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: Class II Product Code: KPS Dated: August 8, 2017 Received: August 31, 2017

Dear Geoff Pollard:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael D. O'Hara For

Robert A. 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) K172609

Device Name CSMC Cardiac Suite 2017

#### Indications for Use (Describe)

The Cedars-Sinai Cardiac Suite of applications is intended to enable an automated display, review, and quantification of Nuclear Medicine Cardiology medical images and datasets. Cedars-Sinai Cardiac Suite may be used in multiple settings including the hospital, clinic, doctors office, or remotely. The results provided should be reviewed by qualified healthcare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians) trained in the use of medical imaging devices.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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#### 6. 510(k) Summary

This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| APPLICANT: | Cedars-Sinai Medical Center, Department of Medicine,<br>Artificial Intelligence in Medicine Program |
|---------------------------|-----------------------------------------------------------------------------------------------------|
| DATE PREPARED: | 27 October 2016 |
| CONTACT PERSON: | Geoff Pollard, Program Manager<br>8700 Beverly Blvd<br>Los Angeles, CA 90048<br>Phone: [phone] |
| TRADE NAME: | Cedars-Sinai Cardiac Suite Nuclear Medicine Software |
| CLASSIFICATION<br>NAME: | Emission Computed Tomography System |
| DEVICE<br>CLASSIFICATION: | Class II |
| REGULATION<br>NUMBER | 892.1200 |
| PRODUCT CODE | KPS |
| PREDICATE DEVICES: | CSMC Cardiac Suite- Nuclear Medicine Software (K141652) |

## Substantially Equivalent To:

The CSMC Cardiac Suite v2017- Nuclear Medicine Software is substantially equivalent in intended use, principal of operation and technological characteristics to the previously cleared CSMC Cardiac Suite v2015- Nuclear Medicine Software (K141652).

## Description of the Device Subject to Premarket Notification:

The Cedars-Sinai Cardiac Suite is a stand-alone software solution for Cardiac SPECT and PET imaging processing and review. The Indication/Intended Use and the fundamental scientific technology of the modified device has not been changed and the same as those described in the unmodified predicate device

As with the original (K141652) Cedars-Sinai Cardiac Suite, the modified Cedars-Sinai Cardiac Suite (non-viewer) minimum system requirements include a computer with at least 2GB RAM, 200MB hard disk space for software installation, a display resolution of at least 1024x768 with 16-bit color, a network adapter, a mouse (or other pointer device; trackpad, trackball, etc ... ) and one of the following operating systems: Windows (10, Vista, 7, 8 & 8,1), Windows Server (2008, 2012 & 2016) Mac OS X, Linux (SUSE 11) The viewer component of the Cedars-Sinai Cardiac Suite minimum system requirements is iPad (4th generation & air) and iPad Mini. The Cedars-Sinai Cardiac Suite operates on

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camera independent reconstructed SPECT and/or PET image files. CSMC Cardiac Suite will be marketed as a comprehensive application suite that includes QPS+QGS (Quantitative Perfusion SPECT + Ouantitative Gated SPECT) and CSImport applications. This allows automatic processing and review of quantitative and qualitative information generated by nuclear medicine studies. Purchasable Options consist of Quantitative Blood Pool SPECT (QBS), ARG/QARG (for reporting purposes), Fusion (SPECT/CT/CTA and/or PET/CT/CTA), Motion Correction (MOCO), Automated Reconstruction (AutoRECON), CSView (Cedars-Sinai Viewer) and QPET. QPET also includes viability quantification and two additional databases (rubidium and ammonia) for processing PET studies.

#### Indication for Use:

The Cedars-Sinai Cardiac Suite of applications is intended to enable an automated display, review, and quantification of Nuclear Medicine Cardiology medical images and datasets. Cedars-Sinai Cardiac Suite may be used in multiple settings including the hospital, clinic, doctors office, or remotely. The results provided should be reviewed by qualified healthcare professionals (e.g., radiologists, or general nuclear medicine physicians) trained in the use of medical imaging devices.

## Technological Characteristics:

The modified CSMC Cardiac Suite- Nuclear Medicine Software has the same technological characteristics and is similar in data display and analysis compared to the predicates. The table below illustrates the similarities and differences in Technological Characteristics between the devices.

| | Modified CSMC Cardiac Suite | CSMC Cardiac Suite (K141652) |
|-------------------------------|--------------------------------------------------------------------------------------|------------------------------|
| Use | | |
| Patient population | Patients who are undergoing<br>Nuclear Medicine Cardiology<br>SPECT or PET procedure | SAME |
| User | Radiologists, cardiologists, or<br>general nuclear medicine<br>physicians | SAME |
| Use environment | Multiple settings including the<br>hospital, clinic, doctors office, or<br>remotely | SAME |
| Features | | |
| Quantitative Gated SPECT | Yes | SAME |
| Quantitative Perfusion SPECT | Yes | SAME |
| Quantitative Blood Pool SPECT | Yes | SAME |
| Quantitative PET | Yes | SAME |
| Correction of motion artifact | Yes | SAME |
| Reconstruction Package | Yes | SAME |
| iPad Viewer | Yes | SAME |
| Cedars-Sinai Viewer | Yes | N/A |

Page 12 of 38 Premarket Notification

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## Performance Data

Support of the substantial equivalence of the CSMC Cardiac Suite was provided as a result of software validation, which confirms all features of the device were compliant with the software requirements.

## Basis for Determination of Substantial Equivalence:

Upon reviewing and comparing intended use, design, principle of operation and overall technological characteristics, the CSMC Cardiac Suite is determined by Cedars-Sinai Medical Center to be substantially equivalent to existing legally marketed device.