(56 days)
No
The summary describes a standard SPECT/CT imaging system and its components. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The focus is on the hardware capabilities and image reconstruction techniques.
No
Explanation: The device is described as an imaging system intended for detection, localization, diagnosis, staging, and restaging of conditions, as well as for planning, guiding, and monitoring therapy, but not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "to aid in the detection, localization, diagnosis, staging and restaging of lesions, diseases, and organ function." The "Device Description" also mentions independent functionality of SPECT and CT as "stand-alone diagnostic imaging devices."
No
The device description explicitly states that the VERITONCT 300/400 Series consists of "back - to - back Single Photon Emission Computed Tomography (SPECT) and X-Ray Computed Tomography (CT) scanners," which are hardware components. While it uses software, it is not a software-only device.
Based on the provided information, the Spectrum Dynamics Medical VERITON system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- VERITON's Function: The VERITON system is an imaging device that uses SPECT and CT technologies to image the distribution of radionuclides and produce cross-sectional images within the human body. It directly interacts with the patient to acquire images, rather than analyzing samples taken from the patient.
The intended use and device description clearly indicate that the VERITON system is an in vivo imaging device used for diagnostic purposes, but not an IVD.
N/A
Intended Use / Indications for Use
Spectrum Dynamics Medical's VERITON system is intended for use by trained healthcare professionals to aid in the detection, localization, diagnosis, staging and restaging of lesions, diseases, and organ function. For evaluating diseases and disorders such as cardiovascular disease, neurological disorders, and trauma. System outcomes can be used to plan, guide, and monitor therapy.
SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), using the following techniques: whole body and tomographic imaging.
CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data (anatomy) from either the same axial plane taken at different angles or spiral planes take at different angles.
SPECT+CT: The SPECT and CT components used together acquire SPECT/CT images. The SPECT images can be corrected for attenuation with the CT images, and can be combined (image registration) to merge the patient's physiological (SPECT) and anatomical (CT) images.
Product codes (comma separated list FDA assigned to the subject device)
KPS, JAK
Device Description
The VERITONCT 300/400 Series consist of back - to - back Single Photon Emission Computed Tomography (SPECT) and X-Ray Computed Tomography (CT) scanners. The SPECT subsystem images and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and integrates CT's anatomical detail for precise reference of the location of the metabolic activity. CT subsystem produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The system can be used as an integrated SPECT and CT modality while also enabling independent functionality of SPECT and CT as standalone diagnostic imaging devices.
All models employ a same software version 2.3.0
The proposed series consists of four variations:
VERITON CT 316, Energy range: 40-300 keV, Integrated CT: 16 Slices
VERITON CT 364, Energy range: 40-300 keV, Integrated CT: 64 Slices
VERITON CT 416, Energy range: 40-400 keV, Integrated CT: 16 Slices
VERITON CT 464, Energy range: 40-400 keV, Integrated CT: 64 Slices
Modifications in VERITON Family include:
Enhanced CZT module's introduction to support an extended energy range
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
SPECT, CT
Anatomical Site
Body or organ
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained healthcare professionals
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing: Verification & Validation includes testing for Software, EMC, Consensus Standard testing applicable for SPECT/CT scanners, mitigation measures set forth in device specific regulations (21CFR §1020.30, §1020.33), and usability. These tests were conducted to characterize the performance of the proposed device functionality against that of the predicate device. The supplementary non-clinical performance evaluations used a variety of test methods and phantoms appropriate for the performance metric/claim that was to be tested and evaluated. Mathematical and physics analysis were performed to demonstrate that each performance metric/claim was successfully verified and substantiated. The areas additionally evaluated included energy resolution, count rate linearity, uniformity, system resolution and lesion detectability. All testing has met the acceptance criteria for the proposed device.
Summary of Non-Clinical Testing: The device has successfully completed all design control testing as per our quality system. No new hazards were identified, and no unexpected test results were obtained. The VERITON CT 300/400 Series were designed and will be manufactured under the Quality System Regulations of 21CFR 820 and MDSAP/ISO 13485.
Summary of Clinical Testing: Sample clinical images of the SPECT, CT and SPECT/CT modalities were evaluated by a board-certified radiologist to confirm that the images were of diagnostic quality.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 28, 2023
Spectrum Dynamics Medical Ltd % Igor Naroditsky Vice President, Quality and Regulatory Affairs 22 Bareket St. North Industrial Park Caesarea. 3079837 ISRAEL
Re: K230600
Trade/Device Name: VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS, JAK Dated: February 28, 2023 Received: March 3, 2023
Dear Igor Naroditsky:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
D
Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)
VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364)
Indications for Use (Describe)
Spectrum Dynamics Medical's VERITON system is intended for use by trained healthcare professionals to aid in the detection, localization, diagnosis, staging and restaging of lesions, diseases, and organ function. For evaluating diseases and disorders such as cardiovascular disease, neurological disorders, and trauma. System outcomes can be used to plan, guide, and monitor therapy.
SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), using the following techniques: whole body and tomographic imaging.
CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data (anatomy) from either the same axial plane taken at different angles or spiral planes take at different angles.
SPECT+CT: The SPECT and CT components used together acquire SPECT/CT images. The SPECT images can be corrected for attenuation with the CT images, and can be combined (image registration) to merge the patient's physiological (SPECT) and anatomical (CT) images.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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 reqarding 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
Image /page/3/Picture/0 description: The image shows the logo for Spectrum Dynamics Medical. The logo consists of a blue triangular shape on the left and the text "SPECTRUM" and "Dynamics Medical" on the right. The text is also in blue, with "SPECTRUM" being in a larger font size than "Dynamics Medical".
510(k) SUMMARY OF SAFETY AND EFFECTIVNESS
K230600 510(k) Number: __
| Date of submission: | March 06, 2023 |
|---|---|
| Submitter: | Spectrum Dynamics Medical Ltd. |
| 22 Bareket St. North Industrial Park | |
| Caesarea, Israel 3079837. | |
| Submitter Contact: | Mr. Igor Naroditsky, VP QA/RA |
| Tel: + (972) 73-737-4548 | |
| Fax: + (972) 73-737-4502 | |
| Email: igorn@spectrum-dynamics.com | |
| Device Trade Name: | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT |
| 316/364) | |
| VERITON CT 400 Series Digital SPECT/CT System (VERITON CT | |
| 416/464) | |
| Medical Specialty: | Radiology |
| Regulation: | 21 CFR 892.1200 - Emission Computed Tomography |
| Product Codes: | KPS and JAK (Class 2) |
| Common Name/Classification: | Single Photon Emission Computed Tomography |
| (SPECT)/Computed Tomography (CT) system |
Marketed Devices:
The Spectrum Dynamics VERITON CT 300/400 Series are a modification of VERITON CT 64 system (K182484) and VERITON CT 16 System (K190457).
Predicate device:
Spectrum Dynamics Medical's VERITON® CT 16 (K190457)
Referenced device:
Spectrum Dynamics Medical's VERITON® CT 64 (K182484)
4
Image /page/4/Picture/0 description: The image shows the logo for Spectrum Dynamics Medical. The logo consists of a blue geometric shape on the left, resembling a three-dimensional triangle or pyramid. To the right of the shape, the word "SPECTRUM" is written in a bold, blue sans-serif font. Below "SPECTRUM", the words "DYNAMICS MEDICAL" are written in a smaller, blue sans-serif font.
Device Description:
The VERITONCT 300/400 Series consist of back - to - back Single Photon Emission Computed Tomography (SPECT) and X-Ray Computed Tomography (CT) scanners. The SPECT subsystem images and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and integrates CT's anatomical detail for precise reference of the location of the metabolic activity. CT subsystem produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The system can be used as an integrated SPECT and CT modality while also enabling independent functionality of SPECT and CT as standalone diagnostic imaging devices.
All models employ a same software version 2.3.0
The proposed series consists of four variations:
| Energy range | Integrated CT | |
|---|---|---|
| VERITON CT 316 | 40-300 keV | 16 Slices |
| VERITON CT 364 | 40-300 keV | 64 Slices |
| VERITON CT 416 | 40-400 keV | 16 Slices |
| VERITON CT 464 | 40-400 keV | 64 Slices |
Modifications in VERITON Family include:
Enhanced CZT module's introduction to support an extended energy range
Intended Use:
Spectrum Dynamics Medical's VERITON system is intended for use by trained healthcare professionals to aid in the detection, localization, diagnosis, staging of lesions, diseases, and organ function. For evaluating diseases and disorders such as cardiovascular disease, neurological disorders, and trauma. System outcomes can be used to plan, guide, and monitor therapy.
SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), using the following techniques: whole body and tomographic imaging.
CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data (anatomy) from either the same axial plane taken at different angles or spiral planes take at different angles.
5
Image /page/5/Picture/0 description: The image contains the logo for Spectrum Dynamics Medical. The logo consists of a blue geometric shape resembling a stylized pyramid or three-dimensional triangle on the left. To the right of the shape is the company name, "SPECTRUM" in a larger, bolder blue font, with "DYNAMICS MEDICAL" in a smaller blue font underneath it.
SPECT+CT: The SPECT and CT components used together acquire SPECT/CT images can be corrected for attenuation with the CT images and can be combined (image registration) to merge the patient's physiological (SPECT) and anatomical (CT) images.
Technological characteristic:
Spectrum Dynamics' VERITON CT 300/400 Series employ the same fundamental scientific technology as it's predicate device VERITON® CT 16 (K190457) and referenced VERITON® CT 64 (K182484). The system architecture has not been changed between the commercially available VERITON CT 16 (K190457)/ VERITON CT 64 (K182484) and proposed VERITON 300/400 Series.
Determination of substantial equivalence:
Performance testing
Verification & Validation includes testing for Software, EMC, Consensus Standard testing applicable for SPECT/CT scanners, mitigation measures set forth in device specific regulations (21CFR §1020.30, §1020.33), and usability. These tests were conducted to characterize the performance of the proposed device functionality against that of the predicate device. The supplementary non-clinical performance evaluations used a variety of test methods and phantoms appropriate for the performance metric/claim that was to be tested and evaluated. Mathematical and physics analysis were performed to demonstrate that each performance metric/claim was successfully verified and substantiated. The areas additionally evaluated included energy resolution, count rate linearity, uniformity, system resolution and lesion detectability. All testing has met the acceptance criteria for the proposed device.
Summary of Non-Clinical Testing:
The device has successfully completed all design control testing as per our quality system. No new hazards were identified, and no unexpected test results were obtained. The VERITON CT 300/400 Series were designed and will be manufactured under the Quality System Regulations of 21CFR 820 and MDSAP/ISO 13485. The following quality assurance measures were applied to the development of the system:
- l Risk Analysis
- -Design Reviews
- -Software Development Lifecycle
- -Testing on unit level (Module verification)
- -Integration testing (System verification)
- | Performance testing (Verification)
- l EMC Safety testing (Verification)
6
Image /page/6/Picture/0 description: The image shows the logo for Spectrum Dynamics Medical. The logo consists of a blue triangular shape on the left and the words "SPECTRUM" and "DYNAMICS MEDICAL" in blue on the right. The word "SPECTRUM" is in a larger font than "DYNAMICS MEDICAL."
Spectrum Dynamics believes that the VERITON CT 300/400 Series are substantially equivalent to the VERITON" CT 16 system (K190457). The substantial equivalence was also based on software documentation for a "Moderate" level of concern device.
Summary of Clinical Testing:
Sample clinical images of the SPECT, CT and SPECT/CT modalities were evaluated by a board-certified radiologist to confirm that the images were of diagnostic quality.
Conclusion:
Based on the conformance to standards, development under Spectrum Dynamics quality system, the successful verification testing, additional engineering testing, and the clinical evaluation, Spectrum Dynamics Medical believes that the VERITON CT 300/400 Series are substantially equivalent to the predicate device, VERITON® CT 16 system (K190457) and hence is safe and effective for its intended use