(59 days)
No
The document describes standard SPECT/CT imaging technology and image processing techniques like registration, but does not mention AI, ML, or related concepts.
No
The device is described as aiding in detecting, localizing, diagnosing, and staging of lesions and diseases, and for evaluating organ function, which are diagnostic functions, not therapeutic ones. While it mentions "planning, guiding, and monitoring therapy," this refers to using the diagnostic output for these purposes, not the device itself delivering therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging of lesions, disease and organ function for the evaluation of diseases and disorders". Additionally, the "Device Description" mentions that the system enables "independent functionality of SPECT and CT as stand-alone diagnostic imaging devices."
No
The device description explicitly states that the VERITON™ CT consists of SPECT scanners and integrated X-Ray Computed Tomography (CT), which are hardware components.
Based on the provided information, the Spectrum Dynamics Medical's VERITON™ CT is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The VERITON™ CT is an imaging device that directly examines the human body using SPECT and CT technologies. It detects and images the distribution of radionuclides and produces cross-sectional images of the body.
- The intended use and device description clearly indicate it's an in vivo imaging system. It's used to aid in detecting, localizing, diagnosing, staging of lesions, disease and organ function within the body.
- The input is imaging data from the patient's body, not a biological specimen.
Therefore, the VERITON™ CT falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Spectrum Dynamics Medical's VERITON™ CT is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging of lesions, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and trauma. The system output can be used for planning, guiding, and monitoring 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. The CT part is indicated for pediatric and adult patients.
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.
Product codes
KPS, JAK
Device Description
VERITON™ CT consists of Single Photon Emission Computed Tomography (SPECT) scanners and integrated X-Ray Computed Tomography (CT). 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 the CT's anatomical details for precise reference of the location of the metabolic activity. The CT component 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 stand- alone diagnostic imaging devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Single Photon Emission Computed Tomography (SPECT), X-Ray Computed Tomography (CT)
Anatomical Site
Body or organ
Indicated Patient Age Range
pediatric and adult patients
Intended User / Care Setting
appropriately trained health care 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 Biocompatibility, Software, Electrical Safety / 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 system was designed and will be manufactured under the Quality System Requlations of 21CFR 820 and 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)
Reference Device(s)
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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November 9, 2018
Spectrum Dynamics Medical Ltd % Igor Naroditsky Director QA/RA 22 Bareket St. North Industrial Park CAESAREA 3088900 ISRAEL
Re: K182484
Trade/Device Name: VERITON CT whole body SPECT/CT system Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: Class II Product Code: KPS, JAK Dated: August 15, 2018 Received: September 11, 2018
Dear Mr. 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Hol 2. Nils
for Robert A. 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
VERITON™ CT whole body SPECT/CT system
Indications for Use (Describe)
The Spectrum Dynamics Medical's VERITON™ CT is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging of lesions, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and trauma. The system output can be used for planning, guiding, and monitoring 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. The CT part is indicated for pediatric and adult patients.
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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☒ For use in connection with a PPE-related Settlement Program |
|---|
| ☐ For use in connection with a PPE-related Settlement Claim |
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)
3
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Image /page/4/Picture/0 description: The image shows the logo for Spectrum Dynamics Medical. The logo consists of a blue triangular prism 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". The logo is set against a white background with a curved blue line at the bottom.
PREMARKET NOTIFICATION 510(K) SUMMARY 7.
The Company's 510(k) summary as required by 21 CFR Part 807.87(h) and 21 CFR Part 807.92(c) is provided on the following pages.
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510(k) SUMMARY OF SAFETY AND EFFECTIVNESS
510(k) Number K182484
| Date of submission: | July 31, 2018 |
|---|---|
| Submitter: | Spectrum Dynamics Medical Ltd. |
| 22 Bareket St. North Industrial Park | |
| Caesarea, Israel 3088900. | |
| Submitter Contact: | Mr. Igor Naroditsky |
| Director QA/RA | |
| Tel: + (972) 73-737-4548 | |
| Fax: + (972) 73-737-4502 | |
| Email: igorn@spectrum-dynamics.com | |
| Device Trade Name: | VERITON™ CT |
| Common | |
| Name/Classification: | Single Photon Emission Computed Tomography |
| (SPECT)/Computed Tomography (CT) system | |
| Class: | II |
| Product Code: | KPS and JAK |
| Classification Panel: | Radiology |
| Regulation No: | Emission Computed Tomography per 21 CFR |
| 892.1200 and Computed Tomography X-Ray | |
| System per 21 CFR 892.1750 |
Marketed Devices:
The Spectrum Dynamics VERITON™ CT system is a modification to the VERITON™ NM system (K180514) with the addition of the CT component to extend system's intended use. All system parts which are not related to the CT component remain the same as in the VERITON™ NM system (K180514) and have the same functionality and performance.
Predicate device:
Spectrum Dynamics Medical's VERITON™ NM (K180514)
GE Healthcare Discovery NM_CT 670 CZT (K153402)
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Referenced device:
Analogic Corporation CT6485 (K172058) Computed Tomography (CT) Scanner to support CT part used.
Siemens Symbia 6.5 system (K162337) to support SPECT/CT combination and intended use.
Device Description:
VERITON™ CT consists of Single Photon Emission Computed Tomography (SPECT) scanners and integrated X-Ray Computed Tomography (CT). 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 the CT's anatomical details for precise reference of the location of the metabolic activity. The CT component 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 stand- alone diagnostic imaging devices.
Intended Use:
The Spectrum Dynamics Medical's VERITON™ CT is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and trauma. The system output can be used for planning, guiding, and monitoring 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 imaqing.
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. The CT part is indicated for pediatric and adult patients.
7
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) imaqes.
Technological characteristic:
Spectrum Dynamics' VERITON™ CT employs the same fundamental scientific technology as it's predicate device VERITON™ NM (K180514). The CZT detectors, system architecture and SPECT performance specifications have not changed between the commercially available VERITON™ NM (K180514) and proposed VERITON™ CT system.
The CT part is similar to the Analogic Corporation CT6485 (K172058) Computed Tomography (CT) Scanner.
Determination of substantial equivalence:
Performance testing
Verification & Validation includes testing for Biocompatibility, Software, Electrical Safety / 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 system was designed and will be manufactured under the Quality System Requlations of 21CFR 820 and ISO 13485. The following quality assurance measures were applied to the development of the system:
- . Risk Analysis
8
- Design Reviews ●
- . Software Development Lifecycle
- Testing on unit level (Module verification) ●
- . Integration testing (System verification)
- . Performance testing (Verification)
- . Safety testing (Verification)
Spectrum Dynamics believes that the VERITON™ CT system is substantially equivalent to the VERITON™ NM system (K180514). 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 is substantially equivalent to the predicate device, VERITON™ NM (K180514) and hence is safe and effective for its intended use.