(94 days)
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.
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 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.
The provided text is a 510(k) summary for the HERMES Medical Imaging Suite v5.4. It describes the device, its intended use, and substantial equivalence to predicate devices. However, it does not contain specific details about acceptance criteria, device performance metrics, or a study design with sample sizes, ground truth establishment, or expert involvement as requested.
The summary states: "The testing results supports that all the software specifications have met the acceptance criteria." but does not elaborate on what those criteria were or how performance was measured against them. It focuses on the substantial equivalence based on technological characteristics and indication for use with predicate devices.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information for most of the numbered points, as that information is not present in the provided document.
Here's a breakdown of what can and cannot be extracted from the provided text based on your request:
Acceptance Criteria and Device Performance Study (Information Not Provided in Document)
The document states that "The testing results supports that all the software specifications have met the acceptance criteria." However, it does not provide:
- A table of acceptance criteria.
- Reported device performance metrics.
- Details of the study that proves the device meets the acceptance criteria.
Therefore, the following points cannot be addressed from the given text:
1. A table of acceptance criteria and the reported device performance
* Not provided in the document. The document only states that acceptance criteria were met.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
* Not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
* Not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
* Not provided in the document. The document describes a comparison to predicate devices, focusing on technological equivalence, not a comparative effectiveness study with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* Not provided in the document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* Not provided in the document.
8. The sample size for the training set
* Not provided in the document. This document focuses on a 510(k) submission for a software update and comparison to predicate devices, not on the deep learning aspects of an AI model's training.
9. How the ground truth for the training set was established
* Not provided in the document.
What the document does state:
- Device Description: The HERMES Medical Imaging Suite v5.4 is an update to v5.3 (K131233). The primary change is the transfer of the BRASS™ imaging processing application from Oracle® Solaris to Microsoft® Windows environment, with improved support for management and analysis of amyloid PET imaging.
- Intended Use: To process, display, analyze, and manage nuclear medicine and other medical imaging data transferred from other workstations or acquisition stations.
- 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."
- Substantial Equivalence: The device is deemed substantially equivalent to predicate devices (HERMES Medical Imaging Suite v5.3 (K131233), HERMES HDAQ Acquisition Station and Hermes Workstation (K021656), Xeleris 3.1 processing and review workstation (K130884), and Scenium 3.0 (K123528)) based on similar technology, fundamental concepts, and operation, with the specific modification for BRASS™ noted. The "results showed a good compliance."
In summary, this 510(k) primarily focuses on demonstrating that a software update to an existing device, which includes transferring a feature to a new operating system and enhancing support for amyloid PET imaging, maintains substantial equivalence without introducing new safety or effectiveness concerns requiring detailed clinical performance studies to the extent of proving specific acceptance criteria with quantifiable metrics.
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K140269
Page 1 of 2
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: | +46 8 19 03 25 |
|---|---|
| Cell: | +46 708 19 03 08 |
| Fax: | +46 8 18 43 54 |
| E-mail: | joakim.arwidson@hermesmedical.com |
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
Page 2 of 2
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 (800) 638-2041 or (301) 796-7100 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 (800) 638 2041 or (301) 796-7100 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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§ 892.1200 Emission computed tomography system.
(a)
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.(b)
Classification. Class II.