(232 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 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.
The provided text describes the 510(k) summary for the HERMES Medical Imaging Suite v5.2, but it does not contain the specific details required to complete all sections of your request regarding acceptance criteria and the study proving the device meets them.
The document states that "The testing results supports that all the software specifications have met the acceptance criteria," and "Comparisons were made between Hybrid Display and e.cam computer / e.soft workstation (K023190), and between Hybrid Recon™ and Xeleris 2 processing and review workstation (K051673). The results showed a good compliance." However, it does not provide the quantitative acceptance criteria, reported device performance, or detailed information about the studies.
Therefore, I will fill in the table and other sections with what can be inferred from the text, and clearly state where information is Not Provided (NP).
Description of the Acceptance Criteria and the Study
The HERMES Medical Imaging Suite v5.2 underwent verification and validation testing following Hermes Medical Solutions AB design controlled procedures. The testing aimed to demonstrate that all software specifications met the defined acceptance criteria and that the device was substantially equivalent to its predicate devices. The primary focus of the comparison appears to be on the equivalence in processing, display, analysis, and management of nuclear medicine and other medical imaging data. Specific comparisons were made for the "Hybrid Display" and "Hybrid Recon™" features against existing, legally marketed workstations to show "good compliance," implying that their performance matched or was equivalent to the predicate devices.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Quantitative if available) | Reported Device Performance |
|---|---|---|
| Overall Software Specification Compliance | All software specifications are met. | All software specifications were met. |
| Risk Mitigation | Identified hazards are mitigated through risk controls. | Risk control implemented to mitigate identified hazards. |
| Hybrid Display Feature | Performance equivalent to e.cam computer / e.soft workstation (K023190). | Showed "good compliance" with predicate device. |
| Hybrid Recon™ Feature | Performance equivalent to Xeleris 2 processing and review workstation (K051673). | Showed "good compliance" with predicate device. |
| Intended Use Compliance | Device can process, display, analyze, and manage nuclear medical imaging data. | Device fulfills intended use as described. |
| Technological Characteristics Equivalence | Same technological characteristics and indication for use as original device (K021656, K002782) with specified modifications. | Similar technology, fundamental concepts, and operation as predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not Provided (NP). The document mentions "testing" and "comparisons" but does not specify the number of cases, images, or data points used in these assessments.
- Data Provenance: Not Provided (NP). The document does not specify the country of origin of the data or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not Provided (NP).
- Qualifications of Experts: Not Provided (NP).
4. Adjudication method for the test set
- Adjudication Method: Not Provided (NP).
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
- MRMC Study Done: No. The provided text refers to comparisons between software applications, not studies involving human readers or AI assistance.
- Effect Size of Human Readers Improvement with AI: Not Applicable (NA), as no MRMC study with AI assistance for human readers was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Yes, implied. The "good compliance" results for "Hybrid Display" and "Hybrid Recon™" against predicate devices suggest an evaluation of the device's processing and display capabilities independent of human interpretation or intervention, focusing on its functional equivalence to existing validated software.
7. The type of ground truth used
- Type of Ground Truth: Implied to be comparison against the performance and output of previously cleared, legally marketed predicate devices (e.g., e.cam computer / e.soft workstation, Xeleris 2 processing and review workstation). This is a form of predicate device equivalence, where the "ground truth" is established by the accepted performance of the predicate.
8. The sample size for the training set
- Sample Size for Training Set: Not Provided (NP). The document does not mention any machine learning or AI components that would require a distinct "training set."
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not Applicable (NA), as no training set for machine learning was mentioned.
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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
- +46 8 19 03 25 Phone: +46 708 19 03 08
- Cell: +46 8 18 43 54 Fax:
- joakim.arwidson@hermesmedical.com E-mail:
Contact person
- Joakim Arwidson
- Quality Manager
- Hermes Medical Solutions AB
- Skeppsbron 44 : 111 30 Stockholm
- Sweden.
Registration number 9710645
-
B. Preparation date: 2012-04-16
- C. Proprietary/Trade name, Common name, Classification name: Proprietary/Trade name
- Hermes Medical Imaging Suite v5.2
Common name
Image processing systems
- Classification name
- Emission Computer Tomography System, Class II, 21CFR892.1200
D. Legally marketed device (predicate device):
- Following legally marketed devices has been used for comparison.
E. Description of the device that is subject of this premarket notification:
The base product design of Hermes Medical Imaging Suite is the same as for the Hermes Workstation (K021656, K002782), except that some third party applications and the acquisition
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station is removed and addition of two applications, as described in the 510(k) submission. 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, except that some third party applications and the acquisition station is removed and addition of two applications, 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.
I. Substantially Equivalent/Conclusions:
The proposed device Hermes Medical Imaging Suite and the predicate devices Nuclear Diagnostics HERMES HDAQ Acquisition Station and Hermes Workstation (K021656, K002782) have the same indication for use, except that the acquisition station is removed from the HERMES Medical Imaging Suite.
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 Hybrid Display and e.cam computer / e.soft workstation (K023190), and between Hybrid Recon™ and Xeleris 2 processing and review workstation (K051673). The results showed a good compliance.
In summary, the HERMES Medical Imaging Suite, 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 consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 18, 2012
Mr. Joakim Arwidson Quality Manager Hermes Medical Solutions AB Skeppsbron 44 Stockholm, 11130 SWEDEN
Re: K121278
Trade/Device Name: HERMES Medical Imaging Workstation. Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: November 1, 2012 Received: November 21, 2012
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
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Page 2-Mr. Arwidson
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Janine M. Morris -S
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):
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)
Janine M. Morris -S
(Division Sign Off)
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Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health
510(k) K121278
§ 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.