(168 days)
No
The summary describes automated image processing and quantification but does not mention AI, ML, or any related terms. The performance studies compare the device to existing software, not against a ground truth derived from AI/ML training.
No.
The device is described as software for processing and managing medical imaging data, specifically for quantifying lung lobe anatomy and relating it to function. It does not directly provide therapy or therapeutic intervention, but rather aids in diagnosis and assessment.
Yes
Explanation: The device processes medical imaging data to quantify 3D lobar anatomy and relate it to functional images, which is used to derive information for the purpose of diagnosis.
Yes
The device description explicitly states it is a "software application" and its function is to "process, display, and manage" imaging data. While it interacts with other hardware (workstations, acquisition stations), the device itself, as described, is the software module.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device processes, displays, and manages medical imaging data. It works with images from modalities like CT, SPECT, and MRI.
- No Sample Analysis: There is no mention of analyzing biological samples or performing tests on bodily fluids or tissues.
The device is a medical imaging software application used for processing and analyzing images, which falls under the category of medical devices, but not specifically in vitro diagnostics.
N/A
Intended Use / Indications for Use
Hybrid3D 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 Lung Lobe Quantification module in Hybrid 3D, introduces an efficient and automated workflow solution to accurately compute 3D lobar anatomy from CT (with or without contrast). The workflow supports the addition of functional images (SPECT V/Q, SUV SPECT, CT iodine maps, hyperpolarized xenon MRI, etc.) to accurately relate lobar anatomy to function.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
nuclear medicine and other medical imaging data, CT, SPECT V/Q, SUV SPECT, CT iodine maps, hyperpolarized xenon MRI
Anatomical Site
Lung
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
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. Comparisons were made between the module Lung Lobe Quantification in Hybrid3D v1.0 and Hermes Medical Imaging Suite v5.6 (K153056), Hybrid3D v1.0 and PMOD. The results showed a good compliance.
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.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines above them that resemble a wing or a stylized representation of human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 22, 2017
Hermes Medical Solutions AB % Joakim Arwidson Quality Manager Skeppsbron 44 Stockholm, 11130 SWEDEN
Re: K163394 Trade/Device Name: Hybrid3D Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: March 27, 2017 Received: March 30, 2017
Dear Joakim 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 (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,
Michael D. O'Hara
For
Robert Ochs, Ph.D. 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 Hybrid3D
Indications for Use (Describe)
Hybrid3D 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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: +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 § 111 30 Stockholm Sweden
- Registration number 9710645
B. Preparation date:
2016-11-22
C. Proprietary/Trade name, Common name, Classification name:
- Proprietary/Trade name ● Hybrid3D v1.0
- . 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 Suite v5.6 (K153056) .
E. Description of the device that is subject of this premarket notification:
The Lung Lobe Quantification module in Hybrid 3D, introduces an efficient and automated workflow solution to accurately compute 3D lobar anatomy from CT (with or without contrast). The workflow supports the addition of functional images (SPECT V/Q, SUV SPECT, CT iodine maps, hyperpolarized xenon MRI, etc.) to accurately relate lobar anatomy to function.
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F. Intended use:
Hybrid3D 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 Hybrid3D has the same technological characteristics as the predicate device and the same indication for use.
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 Hybrid3D and the predicate devices HERMES Medical Imaging Suite v5.6 (K153056) 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 the module Lung Lobe Quantification in Hybrid3D v1.0 and Hermes Medical Imaging Suite v5.6 (K153056), Hybrid3D v1.0 and PMOD. The results showed a good compliance.
In summary, the Hybrid3D v1.0 described in this submission is in our opinion substantially equivalent to the predicate devices.