(92 days)
Not Found
No
The summary describes image processing and reconstruction software but does not mention AI, ML, or related terms. The performance studies focus on phantom testing, which is typical for image processing software validation, not necessarily AI/ML.
Yes
The device processes, displays, analyzes, and manages medical imaging data for diagnostic purposes, which is a common function of therapeutic devices.
No
Explanation: The device processes, displays, analyzes, and manages medical imaging data but does not provide a medical diagnosis on its own. It is a tool for clinicians rather than a diagnostic device itself.
Yes
The device is described as a "software suite" that processes, displays, and manages medical imaging data. While it interacts with other workstations and acquisition stations, the description focuses solely on the software's functionality and modifications, without mentioning any accompanying hardware components included in the submission. The performance studies also focus on the software's reconstruction accuracy using phantom data.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes processing, displaying, and managing medical imaging data. This is typical for medical image analysis software, not for testing samples taken from the human body (which is the core of IVD).
- Device Description: The description reinforces the focus on processing and analyzing imaging data.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.
- Input Data: The input is medical imaging data, not data from in vitro tests.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device operates on images, which are generated from the patient's body but are not biological samples themselves.
N/A
Intended Use / Indications for 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 acquisition stations.
Product codes
KPS
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
nuclear medicine and other medical imaging data
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 stylized caduceus symbol, which features a staff with a serpent entwined around it, overlaid on three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
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.
1
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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."
3
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: +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:
2014-08-14
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) ●
4
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.