Hermes Medical Imaging Suite v5.5

K142631 · Hermes Medical Solutions AB · KPS · Dec 18, 2014 · Radiology

Device Facts

• Record ID: K142631
• Device Name: Hermes Medical Imaging Suite v5.5
• Applicant: Hermes Medical Solutions AB
• Product Code: KPS · Radiology
• Decision Date: Dec 18, 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 medical imaging data transferred from other workstation or acquisition stations.

Device Story

Hermes Medical Imaging Suite v5.5 is a software-based medical imaging workstation. It receives nuclear medicine and other medical imaging data from external acquisition stations or workstations. The device provides tools to process, display, analyze, and manage these images. A key feature is the 'Hybrid Recon' reconstruction software, which enables quantitative reconstruction of imaging data. The device is intended for use by healthcare professionals in clinical settings to assist in the review and analysis of medical images. By providing quantitative reconstruction capabilities, the device aims to improve the accuracy of activity concentration measurements in reconstructed images, aiding clinicians in diagnostic decision-making.

Clinical Evidence

Bench testing only. Performance was evaluated using Jaszczak and IEC phantoms to compare true activity versus reconstructed activity in various regions of interest (ROIs). Results indicated an error rate of approximately 5% for reconstructed activity concentration in large targets (e.g., 37mm) and similar error rates for background activity. The study noted that partial volume effects reduced accuracy in smaller targets, consistent with expected performance.

Technological Characteristics

Software-based image processing system. Features 'Hybrid Recon' module for quantitative reconstruction of nuclear medicine data. Operates on standard workstation hardware. Connectivity via data transfer from external acquisition stations. Verification performed via phantom-based bench testing.

Indications for Use

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

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 v5.4 (K140269)
• Hermes Medical Imaging Suite v5.3 (K131233)
• Xeleris 3.1 processing and review workstation (K130884)

Submission Summary (Full Text)

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

December 18, 2014

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

Re: K142631

Trade/Device Name: Hermes Medical Imaging Suite v5.5 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: August 18, 2014 Received: September 22, 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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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.

Robert A Ochs

Robert A. Ochs. Ph.D. Acting 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) K142631

Device Name HERMES Medical Imaging Workstation

#### 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 acquisition stations.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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] 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:

2014-08-14

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

- Proprietary/Trade name ● Hermes Medical Imaging Suite v5.5
- . Common name Image processing systems
- . Classification name Emission Computer Tomography System, Class II, 21CFR892.1200
- . Product code KPS

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

Following legally marketed device has been used for comparison.

- . Hermes Medical Imaging Suite v5.4 (K140269)
- Hermes Medical Imaging Suite v5.3 (K131233) ●
- Xeleris 3.1 processing and review workstation (K130884) ●

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

The base product design of Hermes Medical Imaging Suite v5.5 is the same as for the Hermes Medical Imaging Suite v5.4 (K140269). A modification has been made in the reconstruction software Hybrid Recon™ where a new feature is added to enable quantitative reconstruction. The Hermes Medical Imaging Suite provides software applications used to process, display, analyze and manage nuclear medicine and other 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 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. A modification has been made in the reconstruction software Hybrid Recon™ where a new feature is added to enable quantitative reconstruction, 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.

We conducted bench testing using both Jaszczak phantom and IEC phantom, and compared the true activity and reconstructed activity in different ROIs. The results showed that the error of the reconstructed activity concentration is around 5% when the target is large enough (e.g. 37mm object). For background activity, the error of the reconstructed activity concentration is also around 5%. In small targets the partial volume effect lowers the accuracy as expected.

# l. Substantially Equivalent/Conclusions:

The proposed device Hermes Medical Imaging Suite v5.5 and the predicate devices HERMES Medical Imaging Suite v5.4 (K140269) 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 v5.5 and Hermes Medical lmaging Suite v5.4 (K140269), Hermes Medical Imaging Suite v5.3 (K131233) and Xeleris 3.1 processing and review workstation (K130884).

In summary, the Hermes Medical Imaging Suite v5.5 described in this submission is in our opinion substantially equivalent to the predicate devices.