HERMES MEDICAL IMAGING SUITE V5.4

K140269 · Hermes Medical Solutions AB · KPS · May 8, 2014 · Radiology

Device Facts

• Record ID: K140269
• Device Name: HERMES MEDICAL IMAGING SUITE V5.4
• Applicant: Hermes Medical Solutions AB
• Product Code: KPS · Radiology
• Decision Date: May 8, 2014
• 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, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.

Device Story

Hermes Medical Imaging Suite v5.4 is a software-based medical imaging workstation; processes, displays, analyzes, and manages nuclear medicine and other medical imaging data; inputs data transferred from external workstations or acquisition stations; features BRASS™ application for amyloid PET imaging management and analysis; operates on Microsoft® Windows environment; used by clinicians to review imaging data; supports clinical decision-making through image processing and analysis tools; benefits patients by facilitating accurate interpretation of nuclear medicine studies.

Clinical Evidence

Bench testing only. Verification and validation testing performed according to design control procedures. Risk analysis conducted and risk controls implemented. Results confirmed software specifications met all acceptance criteria.

Technological Characteristics

Software-based medical imaging suite; operates on Microsoft® Windows environment; provides tools for processing, display, analysis, and management of nuclear medicine imaging data; includes BRASS™ application for amyloid PET imaging; standalone software application.

Indications for Use

Indicated for processing, displaying, analyzing, and managing nuclear medicine and other medical imaging data transferred from other workstations or acquisition stations. No specific patient population, age, or gender restrictions are defined.

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 Workstation (K131233)
• HERMES HDAQ Acquisition Station and Hermes Workstation (K021656)
• Xeleris 3.1 processing and review workstation (K130884)
• Scenium 3.0 (K123528)

Submission Summary (Full Text)

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K140269
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MAY 0 8 2014

# 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] |
|---------|-----------------------------------|
| Cell: | [phone] |
| Fax: | [phone] |
| 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:

2014-01-14

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

Hermes Medical Imaging Suite v5.4

#### Common name

Image processing systems

#### Classification name

Emission Computer Tomography System, Class II, 21CFR892.1200

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

Following legally marketed device has been used for comparison.

HERMES Medical Imaging Workstation (K131233) HERMES HDAQ Acquisition Station and Hermes Workstation (K021656) Xeleris 3.1 processing and review workstation (K130884) Scenium 3.0 (K123528)

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

The base product design of Hermes Medical Imaging Suite v5.4 is the same as for the Hermes Medical Imaging Suite v5.3 (K131233). A modification has been made of the product where the imaging processing application BRASS™ has been transferred from the Oracle® Solaris

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K140269
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environment to the Microsoft® Windows environment. BRASS™ has also been updated with improved support for management and analysis of amyloid PET imaging as described in the 510(k) submission. The Hermes Medical Imaging Suite provides software applications used to process, display, analyze and manage nuclear 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, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.

#### G. Technological characteristics:

The proposed device Hermes Medical Imaging Suite has the same technological characteristics as the original device and the same indication for use; except that the imaging processing application BRASS™ has improved support for management and analysis of amyloid PET imaging and is now available in the Microsoft® Windows environment as described in the 510(k) submission.

#### H. Testing:

The tests for verification and validation followed Hermes Medical Solutions AB design controlled procedures. The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria.

## l. Substantially Equivalent/Conclusions:

The proposed device HERMES Medical Imaging Suite v5.4 and the predicate devices HERMES Medical Imaging Suite v5.3 (K131233) 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 v5.4 and HERMES Medical lmaging Workstation (K131233), HERMES HDAQ Acquisition Station and Hermes Workstation (K021656), Xeleris 3.1 processing and review workstation (K130884) and Scenium v3.0 (K123528). The results showed a good compliance.

In summary, the HERMES Medical Imaging Suite v5.4 described in this submission is in our opinion substantially equivalent to the predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing another person, or a symbol representing care and support.

Public Health Service

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

May 8, 2014

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

Re: K140269

Trade/Device Name: HERMES Medical Imaging Suite v5.4 Regulation Number: 21CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: March 31, 2014 Received: April 21, 2014

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.

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Page 2 - Mr. Joakim Arwidson

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/dcfault.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,

Michael D. O'Hara

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): K140269

Device Name: HERMES Medical Imaging Workstation

Indications for Use:

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

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

Michael D. O'Hara

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) _140269_

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