The Radialis PET Camera is intended for medical purposes to image and measure the distribution of injected positron emitting radiopharmaceuticals in human beings for the purpose of determining various metabolic and physiologic functions within the human body.

Device Description

The Radialis PET Camera is a high spatial resolution, small field-of-view PET imaging camera specifically developed for close-range, organ-targeted (i.e., limited field) imaging. The Radialis PET Camera is a partial-ring planar PET camera, equipped with lutetium-containing gamma-ray detectors, which collect gamma rays emitted by injected positron-emitting radiopharmaceuticals, and generates images corresponding to the relative concentrations of these radiopharmaceuticals in the body. The Radialis PET Camera is designed to collect gamma rays emitted by the injected radiopharmaceutical in a patient's body part with high efficiency.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria in a table format for performance metrics. Instead, it lists various performance aspects that were tested and states that the device "complies with its predetermined specifications and with applicable standards." The "Reported Device Performance" is generally descriptive rather than numerical.

Performance Aspect	Acceptance Criteria (Implicit/General)	Reported Device Performance
Radiation	Compliance with applicable standards	Tested and found compliant
Resolution	Meets predetermined specifications	Tested and found compliant; images demonstrate high-resolution
Spatial Linearity	Meets predetermined specifications	Tested and found compliant
System Sensitivity	Meets predetermined specifications	Tested and found compliant
Flood Field Uniformity	Meets predetermined specifications	Tested and found compliant
Coincidence	Meets predetermined specifications	Tested and found compliant
Scatter	Meets predetermined specifications	Tested and found compliant
Imaging Workflow	Meets predetermined specifications	Tested and found compliant
Notifications	Meets predetermined specifications	Tested and found compliant
Cleaning	Meets predetermined specifications	Tested and found compliant
Lifecycle	Meets predetermined specifications	Tested and found compliant
Biocompatibility	Compliance with applicable standards	Patient contact material tested and found compliant
Electrical Safety / Electromagnetic Compatibility	Compliance with AAMI / ANSI ES60601-1:2005/(R)2012 and IEC 60601-1-2:2014	Undergone testing and found compliant
Software Testing	Compliance with IEC 62304 and FDA Guidance	Designed and developed according to robust SDLC, rigorously verified and validated

2. Sample Size for the Test Set and Data Provenance

The non-clinical testing included an imaging study with:

Sample Size for Test Set: Three (3) patients.
Data Provenance: Not specified, but the submission is from a Canadian company (Radialis Inc. Suite 2300B, 290 Munro Street Thunder Bay, Ontario P7A 7T1 Canada), so the data could be from Canada. The study type is presumably prospective in nature for these three patients to acquire images for demonstration.

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

This information is not provided in the document. The text states "Three (3) patients were imaged with the Radialis PET Camera and the images were provided. The images demonstrate the high-resolution image capability of the Radialis PET Camera." There is no mention of experts reviewing these images to establish a ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the limited description of clinical imaging (only 3 patients for demonstration), it's unlikely a formal adjudication process was described for these images.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The submission focuses on the technical performance and substantial equivalence of the device itself, not on human reader performance with or without AI assistance. The device in question is a PET Camera, not an AI diagnostic tool that assists human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

The Radialis PET Camera is a hardware device (an Emission Computed Tomography System), not an algorithm that performs standalone analysis. Therefore, a standalone algorithm performance study as typically defined for AI/ML devices was not done. The "performance testing" described refers to the functional performance of the hardware and its associated software for image acquisition and processing.

7. The Type of Ground Truth Used

For the very limited "clinical images" set (3 patients), the type of ground truth used is not explicitly stated. However, the purpose was to "demonstrate the high-resolution image capability." This suggests the images were likely reviewed based on visual assessment of image quality, potentially against expected physiological distribution of radiopharmaceuticals, rather than a definitive "ground truth" for a diagnostic task (e.g., pathology, outcomes).

For the broader performance testing (Resolution, Sensitivity, etc.), the "ground truth" would be established by physical phantom measurements and documented engineering specifications conforming to NEMA NU 4:2008 and other relevant standards.

8. The Sample Size for the Training Set

This device appears to be a traditional medical imaging device (PET Camera) and not an AI/ML device that requires a "training set" in the context of machine learning. The section on "Software Testing" refers to robust software development processes, verification, and validation, but this pertains to the software functionality of the imaging system, not an AI model trained on a dataset. Therefore, there is no mention of a training set sample size.

9. How the Ground Truth for the Training Set was Established

As there is no mention of a training set, this question is not applicable.

Summary

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February 4, 2022

Image /page/0/Picture/1 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Radialis Inc. % Eileen Heller Final Reviewer BeanStock Ventures 8885 Rio San Diego Dr. #237 SAN DIEGO CA 92108

Re: K214062

Trade/Device Name: Radialis PET Camera Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS Dated: December 23, 2021 Received: December 27, 2021

Dear Eileen Heller:

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.

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) for devices

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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 mediation-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.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K214062

Device Name Radialis PET Camera

Indications for Use (Describe)

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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510(k) SUMMARY

Radialis PET Camera

K214062

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Radialis Inc. Suite 2300B, 290 Munro Street Thunder Bav. Ontario P7A 7T1 Canada

Phone: 1-800-601-3177 Contact Person: Michael Waterston

Date Prepared:2021-07-25

Name of Device

Radialis PET Camera

Device Classification and Product Code

Emission computed tomography system, 21 CFR 892.1200, Class II, KPS

Predicate Devices

Naviscan PEMFlex Solo II High Resolution PET Scanner (K090553, Predicate Device)

Indications for Use

Device Description

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Standards Compliance

The Radialis PET Camera has been tested and found to be in compliance with the following standards:

ANSI AAMI ES60601-1:2005(R)2012 and A1:2012, Medical Electrical Equipment Part 1: ● General Requirements for Basic Safety And Essential Performance
. ANSI AAMI IEC 60601-1-2:2014 Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety And Essential Performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
o NEMA NU 4:2008 Performance Measurements of Small Animal Positron Emission Tomographs

Summary of Non-Clinical Testing

Biocompatibility	The patient contact material in the Radialis PET Camera was tested forbiocompatibility in accordance with applicable standards.
Electrical Safety /ElectromagneticCompatibilityTesting	The Radialis PET Camera has undergone electrical safety testing per AAMI /ANSI ES60601-1:2005/(R)2012 and A1:2012, and electromagneticcompatibility (EMC) testing per IEC 60601-1-2:2014.
PerformanceTesting	Functional testing and software validation to design input requirements wascompleted, including testing for:- Radiation- Resolution- Spatial Linearity- System Sensitivity- Flood Field Uniformity- Coincidence- Scatter- Imaging Workflow- Notifications- Cleaning- Lifecycle
Software Testing	Software for the Radialis PET Camera was designed and developedaccording to a robust software development process, and was rigorouslyverified and validated, in accordance with IEC 62304 Medical DeviceSoftware - Software Life Cycle Processes and the Guidance For TheContent Of Premarket Submissions For Software Contained In MedicalDevices - Guidance For Industry And FDA Staff.

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Clinical Images	Three (3) patients were imaged with the Radialis PET Camera and the images were provided. The images demonstrate the high-resolution image capability of the Radialis PET Camera.
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Test results show that the Radialis PET Camera complies with its predetermined specifications and with applicable standards.

Substantial Equivalence

The subject device, Radialis PET Camera, is substantially equivalent to the legally marketed predicate device, Naviscan PEMFlex Solo II (K090553). The Radialis PET Camera has the same intended use and indications for use as its predicate device, as well as similar technological characteristics and principles of operation to its predicate device.

Bench testing results also demonstrate that the Radialis PET Camera is substantially equivalent to the predicate device.

Conclusions

The Radialis PET Camera has the same intended use as its predicate device. Any minor differences in the technological characteristics do not raise any new or different questions of safety or effectiveness. Bench testing to FDA-recognized standards has demonstrated the safety and effectiveness of the Radialis PET Camera with regards to differences in technological characteristics. Therefore, the Radialis PET Camera is substantially equivalent to the Naviscan PEMFlex Solo II.

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.