(228 days)
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No
The description focuses on Monte Carlo simulation for dose verification and does not mention AI or ML.
No
The device is a software product for quality assurance and dose verification in radiation therapy; it does not directly treat patients.
No
INTDose is described as a "quality assurance tool" and an "analysis tool" for "independent dose verification" in radiation therapy treatment planning. It performs a "second check of a radiotherapy dose" and is used for "treatment plan verification." It does not diagnose any medical condition or disease in a patient.
Yes
The device is explicitly described as a "software product" and its function is solely computational (Monte Carlo simulation for dose verification). It does not include or control any hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- INTDose Function: INTDose is a software product used for radiation therapy treatment planning verification. It simulates the transport of radiation within a patient's body based on data from a treatment planning system.
- No Patient Samples: The description explicitly states that INTDose "never comes into contact with patients" and operates on data, not biological samples.
Therefore, INTDose does not fit the definition of an in vitro diagnostic device. It is a software tool used in the field of radiation oncology for quality assurance purposes.
N/A
Intended Use / Indications for Use
INTDose is a software product intended to support the radiation therapy treatment planning process by providing independent dose verification through Monte Carlo simulation. INTDose is not a treatment planning system or a radiation delivery device and should only be used by trained radiation oncology personnel as a quality assurance tool.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
INTDose is a software product used within a radiation therapy clinic for quality assurance and treatment plan verification. It allows clinicians to perform a second check of a radiotherapy dose generated by a treatment planning system by simulating the transport of ionizing radiation in patients using an independent Monte Carlo algorithm. INTDose is implemented such that one or more clients may communicate calculation requests to a central dose calculation server.
While INTDose operates in the field of radiation therapy, it is neither a treatment planning system nor radiation delivery device. INTDose never comes into contact with patients and cannot control treatment delivery devices or any other medical devices. It is an analysis tool to be used only by trained radiation oncology personnel for quality assurance purposes.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
trained radiation oncology personnel
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The safety and performance of INTDose has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing. Non-clinical verification and validation test results, including simulation performance and software usability, established that the device meets its design requirements and intended use, that it is as safe and as effective as the predicate device, and that no new issues of safety and effectiveness were raised.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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.
Carina Medical LLC % Dr. Xue Feng Chief Executive Officer 1233 Litchfield Lane LEXINGTON KY 40513
Re: K213137
Trade/Device Name: INTDose Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: April 11, 2022 Received: April 11, 2022
Dear Dr. Xue Feng:
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
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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,
Julie Sullivan, Ph.D. Assistant Director DHT 8C: 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
510(k) Number (if known) K213137
Device Name INTDose
Indications for Use (Describe)
INTDose is a software product intended to support the radiation therapy treatment planning process by providing independent dose verification through Monte Carlo simulation. INTDose is not a treatment planning system or a radiation delivery device and should only be used by trained radiation oncology personnel as a quality assurance tool.
| 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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Summary 510(k)
1. Applicant:
Carina Medical LLC 1233 Lichfield Ln Lexington, KY, 40513 USA Contact Name: Xue Feng - Chief Executive Officer Phone: 434-284-1073 Fax: 855-615-2856 E-mail: xfeng@carinaai.com
2. Device:
Trade Name: INTDose Common Name: Secondary Check QA Software Model Number: 1.0 Product Code: IYE Regulation Description: Medical charged-particle radiation therapy system Regulation Number: 21 CFR 892.5050 Device Class: II
3. Predicate Device:
Trade Name: SciMoCa Manufacturer: Radialogica, LLC Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Device Class: II Product Code: IYE 510(k) Number: K180595 510(k) Clearance Date: 04/04/2018
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CARINA
4. Preparation Date
September 16, 2021
5. Device Description
INTDose is a software product used within a radiation therapy clinic for quality assurance and treatment plan verification. It allows clinicians to perform a second check of a radiotherapy dose generated by a treatment planning system by simulating the transport of ionizing radiation in patients using an independent Monte Carlo algorithm. INTDose is implemented such that one or more clients may communicate calculation requests to a central dose calculation server.
While INTDose operates in the field of radiation therapy, it is neither a treatment planning system nor radiation delivery device. INTDose never comes into contact with patients and cannot control treatment delivery devices or any other medical devices. It is an analysis tool to be used only by trained radiation oncology personnel for quality assurance purposes.
6. Intended Use
INTDose is a software product intended to support the radiation therapy treatment planning process by providing independent dose verification through Monte Carlo simulation. INTDose is not a treatment planning system or a radiation delivery device and should only be used by trained radiation oncology personnel as a quality assurance tool.
7. Indications for Use Statement
INTDose is a software product intended to support the radiation therapy treatment planning process by providing independent dose verification through Monte Carlo simulation. INTDose is not a treatment planning system or a radiation delivery device and should only be used by trained radiation oncology personnel as a quality assurance tool.
8. Technological Characteristics
The principal technological characteristic of INTDose and its predicate device is a second check dose calculation algorithm that allows clinicians to compare the dose calculated by a treatment planning system to an independently-calculated second check dose for the purpose of quality
+1 434-284-1073
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CARINA
assurance in a radiation medicine clinic. Detailed technological characteristics and indications for use presented in the full set of submitted documentation for this 510(k) application support the claim that INTDose is substantially equivalent to the predicate devices.
9. Performance Data
The safety and performance of INTDose has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing. Non-clinical verification and validation test results, including simulation performance and software usability, established that the device meets its design requirements and intended use, that it is as safe and as effective as the predicate device, and that no new issues of safety and effectiveness were raised.
The following treatment delivery machines have successfully completed compatibility testing with INTDose
- Accuray TomoTherapy HDA (v2.1.4)
- Varian TrueBeam (v2.0)
- Varian Clinac (21EX-Platinum)
- Varian Clinac (iX)
- Varian Halcyon (v2.0)
Further, during the development, potential hazards were controlled by a risk management plan including risk analysis, risk mitigation, verification and validation.
10. Substantial Equivalence Conclusion
INTDose is believed to be substantially equivalent to the predicate device in terms of its indications for use, technical characteristics, and overall performance. The information provided in this submission indicates substantial equivalence to the predicate device. It is in the opinion of Carina Medical, LLC that the medical device, INTDose, is as safe and effective as the predicate, and does not raise different questions of safety and effectiveness.