OARtrac System

K182395 · Radialdyne, LLC · NZT · Mar 22, 2019 · Radiology

Device Facts

• Record ID: K182395
• Device Name: OARtrac System
• Applicant: Radialdyne, LLC
• Product Code: NZT · Radiology
• Decision Date: Mar 22, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The OARtrac® System with patient specific, reusable up to five times, pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body. The system is indicated for use with electron energy when adhered to the skin with or without a bolus, and for photon energy when adhered to the skin with a minimum 3mm bolus or inserted into the rectum for measurements at the rectal wall during cancer treatment via a specifically designed OARtrac® endorectal balloon device.

Device Story

OARtrac System uses plastic scintillation detectors (PSD) to monitor radiation dose during external beam therapy and HDR brachytherapy. Sensors, made of polystyrene, are placed on skin or in rectum via endorectal balloon. System captures radiation signals via fiber optic cables; processes data to provide real-time dose verification. Radiation oncologists review output to compare delivered dose against treatment plan; system does not control or stop radiation delivery. Used in clinical settings by trained professionals. Benefits include improved accuracy of dose delivery to targeted areas, allowing for potential treatment plan adjustments.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), software V&V (IEC 62304), and performance testing (dose range, electron-based radiation, endorectal balloon verification).

Technological Characteristics

Polystyrene PSD sensors; fiber optic connectivity; hard-wired. Energy range: 6-18 MV (photon), 12 MeV (electron). Dose range: 2 cGy to 1 kGy. Reusable up to 5 times. Standards: ISO 10993, IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 11137-1, ISO 14971, ASTM F1090-07.

Indications for Use

Indicated for cancer patients undergoing photon or electron radiation therapy. Used for dose measurement and validation at the skin surface (with or without bolus) or rectal wall (via endorectal balloon).

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

• OARtrac® System with Patient Specific Reusable PSD Sensors (K162954)

Submission Summary (Full Text)

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RadiaDyne, LLC % Ms. Carmelina Allis Attorney The Allis Law Firm, PLLC 2437 Bay Area Blvd.. #30 HOUSTON TX 77058

March 22, 2019

Re: K182395

Trade/Device Name: OARtrac® System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: NZT Dated: February 21, 2019 Received: February 25, 2019

Dear Ms. Allis:

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara

For

Thalia Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K182395

Device Name OARtrac® System

#### Indications for Use (Describe)

The OARtrac® System with patient specific, reusable up to five times, pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body. The system is indicated for use with electron energy when adhered to the skin with or without a bolus, and for photon energy when adhered to the skin with a minimum 3mm bolus or inserted into the rectum for measurements at the rectal wall during cancer treatment via a specifically designed OARtrac® endorectal balloon device.

| Type of Use (Select one or both, as applicable) | | | |
|-------------------------------------------------------------------------------------|------------------------------------------------|----------------------------------------------------------------------------------|---------------------------------------------|
| <table><tr><td> 区 Prescription Use (Part 21 CFR 801 Subpart D) </td></tr></table> | 区 Prescription Use (Part 21 CFR 801 Subpart D) | <table><tr><td> Over-The-Counter Use (21 CFR 801 Subpart C) </td></tr></table> | Over-The-Counter Use (21 CFR 801 Subpart C) |
| 区 Prescription Use (Part 21 CFR 801 Subpart D) | | | |
| Over-The-Counter Use (21 CFR 801 Subpart C) | | | |

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### 510(k) Summary of Safety and Effectiveness

#### OARtrac® System

1. Submission Sponsor

RadiaDyne, LLC 10801 Hammerly Blvd Suite 220 Houston, Texas 77043 Phone: [phone] Fax: [phone] Contact: John Isham, Founder & CEO

### 2. Submission Correspondent

Carmelina G. Allis The Allis Law Firm, PLLC 2437 Bay Area Blvd., #30 Houston, TX 77058 Phone: [phone] Email: [e-mail]

### 3. Date Prepared

August 22, 2018

### 4. Device Identification

| Trade/Proprietary Name: | OARtrac® System |
|-------------------------|---------------------------------------------------|
| Common/Usual Name: | Radiation dose verification system |
| Regulation Name: | Medical charged-particle radiation therapy system |
| Regulation Number: | 21 C.F.R. § 892.5050 |
| Product Code: | NZT |
| Regulatory Class: | II |
| Classification Panel: | Radiology |

## 5. Legally Marketed Predicate Device(s)

Radiadyne OARtrac® System with Patient Specific Reusable PSD Sensors, K162954

### 6. Device Description

The OARtrac® System with patient specific, reusable up to five times, pre-calibrated PSD sensors is intended for use in photon and electron radiation therapy to monitor and validate radiation dose during External Beam Therapy and HDR Brachytherapy to the surface of the skin or the rectal wall. This dose verification information obtained during the treatment is then used to compare with the planned dose that the Radiation Oncologists expect to provide to the patient. The OARtrac® System itself does not stop the radiation treatment to the patient, or change the radiation delivery,

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but only provides dose data which a trained Radiation Oncologist can decipher and use to adjust a patient's treatment plan accordingly.

# 7. Indication for Use Statement

The OARtrac® System with patient specific, reusable up to five times, pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body. The system is indicated for use with electron energy when adhered to the skin with or without a bolus, and for photon energy when adhered to the skin with a minimum 3mm bolus or inserted into the rectum for measurements at the rectal wall during cancer treatment via a specifically designed OARtrac® endorectal balloon device.

# 8. Substantial Equivalence Discussion

RadiaDyne has chosen its own OARtrac® System with Patient Specific Reusable PSD Sensors (K162954), cleared under Product Code NZT and 21 C.F.R. § 892.5050 as the predicate device for its OARtrac® System.

The following table compares the OARtrac® System to the predicate device. As shown below, the subject device is substantially equivalent to the predicate device with respect to intended use, technological characteristics and principles of operation.

| Device Trade Names: | OARtrac® System | OARtrac® System with Patient Specific Reusable PSD Sensors |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k): | Pending | K162954 |
| Product Code: | NZT | NZT |
| Regulation: | §892.5050 | §892.5050 |
| Class: | II | II |
| Indications for Use: | The OARtrac® System with patient specific, reusable up to five times, pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body. The system is indicated for use with electron energy when adhered to the skin with or without a bolus, and for photon energy when | The OARtrac® System with patient specific, reusable, pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body, and indicated for use when adhered to the skin with a bolus, or inserted into the rectum to measure the rectal |
| | | |
| | adhered to the skin with a minimum | prostatic interface via a specifically |
| | 3mm bolus or inserted into the | designed endorectal |
| | rectum for measurements at the | balloon device. |
| | rectal wall during cancer treatment | |
| | via a specifically designed | |
| | OARtrac® endorectal balloon | |
| | device. | |
| Mode of Operation: | Plastic scintillation detectors (PSD) | Plastic scintillation detectors (PSD) |
| | allow for dose verification of the | allow for dose verification of the |
| | patient's radiation treatment | patient's radiation treatment |
| | procedures at the point of location. | procedures at the point of location. |
| PSD Sensors: | Simplex 0.5mm PSD | Simplex Sensor Cable |
| | Simplex 1mm PSD | Duplex Unbundled Sensors |
| | | Duplex Bundled Sensors |
| Material: | PSD sensors are made from | PSD sensors are made from |
| | polystyrene | polystyrene |
| Scintillating | 1, 1 | 1, 2, 2 |
| Fiber: | | |
| Fiducial Marker: | 1, 1 | 1, 2, 1 |
| Implantable: | No | No |
| Body Location: | The surface of the skin or inside of a | The surface of the skin or inside of a |
| | Radiadyne OARtrac rectal balloon. | Radiadyne OARtrac rectal balloon. |
| Sterile: | No | No |
| Single Use: | No, reusable up to five times | No, reusable up to five times |
| Hard Wired: | Yes, fiber optic cable | Yes, fiber optic cable |
| Pre-Calibrated: | Yes (Linac) | Yes (Cobalt-60) |
| System Software: | Yes | Yes |
| Energy Range: | 6-18 MV Photon Dose | 1-20 MV Photon Dose |
| | 12 MeV Electron Dose | |
| Dose Range: | 2 cGy – 1 kGy | 90 Gy maximum |
| | (Assumes minimum dose rate of 2 | |
| | cGy/s) | |
| Dose Per Fraction: | 200 Gy/use (up to 5 uses) | 1-2000 cGy @ dose rates of 1 cGy/s |
| | 1 kGy (single use) | and above |
| | (Assumes minimum dose rate of 2<br>cGy/s) | |
| Time to Read | 1 millisecond | 20 seconds |
| Dosimeter: | | |
| Dose | Photon and Electron based therapies: | ±6% @95% confidence interval. |
| Accuracy: | ±5% (2 sigma) | |
| | HDR based therapies: ±6 (2 sigma) | |
| | | |

Table 1

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# 9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of the OARtrac® System and in showing substantial equivalence to the predicate device, RadiaDyne completed several tests. Like the predicate device, the OARtrac® System meets all the

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requirements for overall design, sterilization, biocompatibility, packaging, shelf-life, electrical safety and EMC, which confirms that the output meets the design inputs and specifications for the device. The proposed device was subjected to the same test protocols and standard validation studies as the predicate device, which were previously accepted by FDA under K162954.

The OARtrac® System meets criteria under the same national and international test standards as the predicate device. Performance data submitted in support of the OARtrac® System demonstrate that the device is substantially equivalent to the predicate device in performance and fundamental technology and is as safe and effective as the predicate device.

- Biocompatibility Testing per ISO 10993-1 (Parts 5, 10 and 11) ●
- Electrical Safety per IEC 60601-1 ●
- EMC per IEC 60601-1-2 ●
- Software Verifications and Validation per IEC 62304
- Bioburden per ISO 11137-1
- Cleaning and disinfection per AAMI TIR 12 and AAMI TIR 30
- Package Shelf-Life per ASTM F1090-07
- . Device Risk Analysis per ISO 14971
- Dose Range Verification Testing
- Electron-based Radiation Testing
- Endorectal Balloon Verification Testing

## 10. Clinical and Animal Performance Data - Not Conducted

The OARtrac System does not introduce new intended uses, modes, features, or technologies relative to the predicate device that would require evaluation through clinical or animal testing. These types of devices, including the predicate device, have been on the market for many years with proven safety and effectiveness for their intended use. The non-clinical testing detailed in this submission is sufficient to demonstrate that the OARtrac® System is as safe and effective as the predicate device in support of a substantial equivalence determination.

## 11. Statement of Substantial Equivalence

In conclusion, the tests conducted, as well as all verification and validation activities, demonstrate that the design specifications and technological characteristics of the OARtrac® System meet applicable requirements and standards for the safety and effectiveness of the device for its intended use. The intended use and fundamental technology are the same between the subject and predicate devices. There are some differences in the indications for use and technological characteristics between the predicate and subject devices, but those differences allow for the subject device to have additional use capabilities during electron-based radiation treatments. The testing and validation activities conducted demonstrate that any differences between the devices do not raise new or different questions of safety or effectiveness as compared to the predicate device. Therefore, the OARtrac® System is substantially equivalent to the predicate device.