Hermes Medical Imaging Suite v5.6

K153056 · Hermes Medical Solutions AB · KPS · Jun 1, 2016 · Radiology

Device Facts

• Record ID: K153056
• Device Name: Hermes Medical Imaging Suite v5.6
• Applicant: Hermes Medical Solutions AB
• Product Code: KPS · Radiology
• Decision Date: Jun 1, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

HERMES Medical Imaging Suite that provides software applications used to process, display, and manage nuclear medicine and other medical imaging data transferred from other workstation or acquistion stations.

Device Story

Hermes Medical Imaging Suite v5.6 is a software-based medical imaging workstation application. It receives medical imaging data (specifically nuclear medicine data) transferred from external acquisition stations or workstations. The software processes, displays, and manages this data to assist clinicians in reviewing medical images. The device is used in clinical environments by healthcare professionals. It functions as a platform for various analysis applications, including BRASS, DaTscan, and Thyroid Analysis. The primary modification in this version is the migration of these applications from the legacy Oracle/SUN Solaris environment to the Microsoft Windows operating system. The device does not acquire images directly but serves as a post-processing and review tool for diagnostic imaging data.

Clinical Evidence

Bench testing only. Verification and validation were performed according to design control procedures and risk analysis to ensure software specifications met acceptance criteria. No clinical data was required or provided.

Technological Characteristics

Software-only medical imaging suite. Operates on Microsoft Windows platform (migrated from legacy Oracle/SUN Solaris). Provides processing, display, and management of nuclear medicine imaging data. Connectivity via data transfer from external acquisition stations/workstations. No hardware components.

Indications for Use

Indicated for processing, displaying, and managing nuclear medicine and other medical imaging data transferred from other workstations or acquisition stations.

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

• Hermes Medical Imaging Suite v5.5 (K142631)
• Hermes Medical Imaging Suite v5.3 (K131233)
• Xeleris 3.1 processing and review workstation (K130884)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles stacked on top of each other, with flowing lines extending from the bottom profile.

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

Hermes Medical Solutions, AB % Mr. Joakim Arwidson Quality Manager Skeppsbron 44 Stockholm, 111 30 SWEDEN

Re: K153056

Trade/Device Name: Hermes Medical Imaging Suite v5.6 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: April 26, 2016 Received: May 2, 2016

Dear Mr. Arwidson:

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.

June 1, 2016

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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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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K153056

#### Device Name

HERMES Medical Imaging Suite v5.6

#### Indications for Use (Describe)

HERMES Medical Imaging Suite that provides software applications used to process, display, and manage nuclear medicine and other medical imaging data transferred from other workstation or acquistion stations.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

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# 5.0 510 (k) SUMMARY

### A. Submitted by:

- Submitters name and address: . Hermes Medical Solutions AB Skeppsbron 44 111 30 Stockholm Sweden
#### Submitters telephone number .

[phone] Phone: [phone] Cell: [phone] Fax: [e-mail] E-mail:

#### Contact person .

Joakim Arwidson Quality Manager Hermes Medical Solutions AB Skeppsbron 44 111 30 Stockholm Sweden

Registration number . 9710645

#### B. Preparation date:

2015-10-05

# C. Proprietary/Trade name, Common name, Classification name:

#### Proprietary/Trade name . Hermes Medical Imaging Suite v5.6

- . Common name Image processing systems
- Classification name . Classinoation ham Tomography System, Class II, 21CFR892.1200

## D. Legally marketed device (predicate device):

Following legally marketed device has been used for comparison.

- Hermes Medical Imaging Suite v5.5 (K142631) .
- Hermes Medical Imaging Suite v5.3 (K131233) .
- Xeleris 3.1 processing and review workstation (K130884) .

# E. Description of the device that is subject of this premarket is the same of

E. Description of the device that 18 odical Imaging Suite v5.6 is the same as for the Hermes The base product design of Hemies Medical includes transfer of the BRASS DatScan
Medical Imaging Suite v5.5 (K142631). The modification includes transfer of SUN Soloris, See Medical Imaging Sulte V3.5 (K14203). The mountained (Oracle ® SUN Solaris, see support and Thyrold Analysis from the Old Hemrol Strillor Striller of Microsoft ® Windows.

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The Hermes Medical Imaging Suite provides software applications used to process, display, The Hermes Medical Infaging Outle province of the medical imaging data transferred from other workstation or acquisition stations.

#### F. Intended use:

Hermes Medical Imaging suite that provides software applications used to process, display, Herhies Medical maging Suite and other medical imaging data transferred from other workstation or acquisition stations.

### G. Technological characteristics:

G. Technological characteriorious Suite has the same technological characteristics as the original device and the same indication for use.

#### H. Testing:

ri. Testing.
The tests for verification and validation followed Hermes Medical Solutions AB design controlled rire tests for vermution and risk control implemented to mitigate identified procedures. The hisk andrylis that all the software specifications have met the acceptance criteria.

## I. Substantially Equivalent/Conclusions:

The proposed device Hermes Medical Imaging Suite v5.6 and the predicate devices HERMES Medical Imaging Suite v5.5 (K142631) have the same indication for use.

The proposed device will use similar technology and fundamental concepts and operation are also the same, as described in the 510(k) submission.

Comparisons were made between Hermes Medical Imaging Suite v5.6 and Hermes Medical Compansons were made betweermes Medical Imaging Suite v5.3 (K131233) and Xeleris 3.1 maging Suite V5.3 (R142031), Termett (K130884). The results showed a good compliance.

In summary, the Hermes Medical Imaging Suite v5.6 described in this submission is in our opinion substantially equivalent to the predicate devices.