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.

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

AI/ML Overview

The provided text describes the VERITON CT 300/400 Series Digital SPECT/CT System, a modification of previously cleared devices (VERITON CT 64 and VERITON CT 16). The submission focuses on demonstrating substantial equivalence to the predicate device VERITON CT 16 (K190457).

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that "All testing has met the acceptance criteria for the proposed device" for various performance metrics, but it does not explicitly list the specific acceptance criteria values for each test. It only states that the tests were conducted against the predicate device's performance.

Acceptance Criteria	Reported Device Performance (as stated in the document)
General Performance:	"All testing has met the acceptance criteria for the proposed device."
Energy Resolution	Met acceptance criteria (no specific value given)
Count Rate Linearity	Met acceptance criteria (no specific value given)
Uniformity	Met acceptance criteria (no specific value given)
System Resolution	Met acceptance criteria (no specific value given)
Lesion Detectability	Met acceptance criteria (no specific value given)
Software	Substantial equivalence based on "Moderate" level of concern
EMC Safety Compliance	Met acceptance criteria
Usability	Met acceptance criteria
Image Quality (Clinical Evaluation)	"images were of diagnostic quality"

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size (Clinical Evaluation): The document states "Sample clinical images." It does not specify the number of images or cases used in this clinical evaluation.
Data Provenance (Clinical Evaluation): The document does not specify the country of origin of the clinical data nor whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Number of Experts: "a board-certified radiologist" (singular).
Qualifications of Experts: "board-certified radiologist." The document does not provide information on the years of experience of this radiologist.

4. Adjudication Method:

The document describes a single board-certified radiologist evaluating "sample clinical images" to confirm diagnostic quality. This indicates no formal adjudication method (like 2+1 or 3+1) was used, as it was a single reader assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The clinical evaluation involved a single radiologist confirming diagnostic quality, not comparing human readers with and without AI assistance to measure an effect size.

6. Standalone Performance Study:

Yes, a standalone performance was done for several technical aspects. The document describes "non-clinical performance evaluations" using "a variety of test methods and phantoms" to characterize the performance of the device's functionality. This included areas like energy resolution, count rate linearity, uniformity, system resolution, and lesion detectability. These tests assess the algorithm's direct output on controlled inputs (phantoms) or simulated conditions, rather than human-in-the-loop performance.

7. Type of Ground Truth Used:

For Non-Clinical Performance Tests (Standalone): The ground truth would typically be established by the characteristics of the phantoms used and the expected physical and mathematical properties of the SPECT/CT system being tested. These are objective measures based on known inputs.
For Clinical Evaluation: The ground truth for this simple evaluation was the expert opinion/assessment of diagnostic quality by a board-certified radiologist. It doesn't mention more definitive ground truths like pathology or long-term clinical outcomes.

8. Sample Size for the Training Set:

The document does not provide any information regarding the sample size of a training set. Given that the device is presented as a modification of existing systems, and the focus is on hardware/software modifications and demonstrating equivalence, it's possible that a new, extensive training set was not required if the underlying algorithms are largely unchanged. However, the document does not clarify this.

9. How the Ground Truth for the Training Set Was Established:

Since there is no information on a training set, there is also no information on how its ground truth was established.

Summary

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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.

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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.

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

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Indications for Use

Submission Number (if known)

K230600

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)

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.

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)

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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 ParkCaesarea, Israel 3079837.
Submitter Contact:	Mr. Igor Naroditsky, VP QA/RATel: + (972) 73-737-4548Fax: + (972) 73-737-4502Email: igorn@spectrum-dynamics.com
Device Trade Name:	VERITON CT 300 Series Digital SPECT/CT System (VERITON CT316/364)VERITON CT 400 Series Digital SPECT/CT System (VERITON CT416/464)
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)

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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 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:

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.

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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)

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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

Regulation Number and Section

§ 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.