INTDose

K213137 · Carina Medical, LLC · IYE · May 13, 2022 · Radiology

Device Facts

• Record ID: K213137
• Device Name: INTDose
• Applicant: Carina Medical, LLC
• Product Code: IYE · Radiology
• Decision Date: May 13, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

INTDose is a software-based quality assurance tool for radiation therapy clinics. It performs independent dose verification by simulating ionizing radiation transport using a Monte Carlo algorithm. The system architecture consists of one or more clients communicating calculation requests to a central dose calculation server. Trained radiation oncology personnel operate the software to verify doses generated by primary treatment planning systems. The output provides an independent dose calculation for comparison against the primary plan, assisting clinicians in quality assurance workflows. It does not control treatment delivery devices or contact patients; it serves as an analytical aid to ensure treatment plan accuracy.

Clinical Evidence

Bench testing only. Performance evaluated through software verification and validation testing, including simulation performance and usability testing. Compatibility testing performed with multiple treatment delivery machines: Accuray TomoTherapy HDA, Varian TrueBeam, Varian Clinac (21EX-Platinum, iX), and Varian Halcyon. No clinical data provided.

Technological Characteristics

Software-based secondary check dose calculation tool. Utilizes Monte Carlo simulation for radiation transport. Operates via client-server architecture. Compatible with various radiation therapy delivery systems (TomoTherapy, Varian TrueBeam/Clinac/Halcyon).

Indications for Use

Indicated for use by trained radiation oncology personnel as a quality assurance tool to support radiation therapy treatment planning via independent dose verification. No specific patient population, age, or gender restrictions stated; not for direct patient contact or treatment delivery control.

Regulatory Classification

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.

Predicate Devices

• SciMoCa (K180595)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| <span style="font-family: Arial;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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#### Summary 510(k)

K213137

#### 1. Applicant:

Carina Medical LLC 1233 Lichfield Ln Lexington, KY, 40513 USA Contact Name: Xue Feng - Chief Executive Officer Phone: [phone] Fax: [phone] E-mail: [e-mail]

#### 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

[e-mail]

[phone]

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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.