(39 days)
No
The document does not mention AI, ML, or related terms, nor does it describe any features or processes that typically involve these technologies, such as image processing algorithms trained on data. The performance studies focus on standard imaging metrics and functional testing.
No
The device is described as an imaging camera for diagnostic purposes, specifically to image and measure the distribution of radiopharmaceuticals in the body to determine metabolic and physiologic functions. It does not provide any treatment or therapy.
Yes
Explanation: The device is intended 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," which is a diagnostic purpose.
No
The device description explicitly states it is a "PET imaging camera" equipped with "gamma-ray detectors," which are hardware components.
Based on the provided information, the Radialis PET Camera 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.
- Radialis PET Camera Function: The description clearly states that the Radialis PET Camera images and measures the distribution of injected radiopharmaceuticals within the human body. It collects gamma rays emitted by the radiopharmaceutical in a patient's body part.
This device operates in vivo (within the living body), not in vitro (in glass or outside the body). Therefore, it falls under the category of medical imaging devices, not IVD devices.
N/A
Intended Use / Indications for Use
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.
Product codes
KPS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET
Anatomical Site
Not Found
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
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. Test results show that the Radialis PET Camera complies with its predetermined specifications and with applicable standards.
Key Metrics
Not Found
Predicate Device(s)
Naviscan PEMFlex Solo II High Resolution PET Scanner (K090553)
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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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
1
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)
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.
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
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
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.
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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 for
biocompatibility in accordance with applicable standards. |
|--------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical Safety /
Electromagnetic
Compatibility
Testing | The Radialis PET Camera has undergone electrical safety testing per AAMI /
ANSI ES60601-1:2005/(R)2012 and A1:2012, and electromagnetic
compatibility (EMC) testing per IEC 60601-1-2:2014. |
| Performance
Testing | Functional testing and software validation to design input requirements was
completed, 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 developed
according to a robust software development process, and was rigorously
verified and validated, in accordance with IEC 62304 Medical Device
Software - Software Life Cycle Processes and the Guidance For The
Content Of Premarket Submissions For Software Contained In Medical
Devices - 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. |
|---|---|
| ----------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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.