OARtrac System with Patient Specific Reusable Universal PSD Sensors

K162954 · Radiadyne, LLC · NZT · Jun 1, 2017 · Radiology

Device Facts

• Record ID: K162954
• Device Name: OARtrac System with Patient Specific Reusable Universal PSD Sensors
• Applicant: Radiadyne, LLC
• Product Code: NZT · Radiology
• Decision Date: Jun 1, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The OARtrac® System with patient specific, reusable, pre-calibrated PSD sensors is intended for use in photon radiation therapy to monitor and validate radiation dose during External Beam Therapy and HDR Brachytherapy to the surface of the skin or the rectal prostatic interface.

Device Story

OARtrac System uses plastic scintillation detectors (PSD) to monitor/validate radiation dose during external beam therapy and HDR brachytherapy. Sensors placed on skin (with bolus) or in rectum (via endorectal balloon) measure photon radiation; data transmitted to system for comparison against planned dose. Operated by radiation oncologists/technicians in clinical settings. Output provides dose verification data; allows clinicians to assess treatment delivery and adjust plans if necessary. Benefits include improved accuracy of radiation dose delivery to targeted areas, potentially sparing surrounding organs at risk. Subject device introduces reusability (up to five times) for PSD sensors, requiring validated cleaning/disinfection protocols.

Clinical Evidence

No clinical data. Bench testing only. Validation included biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1), EMC (IEC 60601-12), software V&V (IEC 62304), shelf-life (ASTM F1980-07), risk analysis (ISO 14971), dose range verification, and cleaning/disinfection validation for reusability.

Technological Characteristics

Materials: Polyurethane plastic scintillation detectors (PSD). Energy: Photon energy range 0.37-18 MeV. Dose rate range 1.3-17.3 cGy/s. Dose range 27-1200 cGy. Accuracy: +/-6%, 2 sigma. Connectivity: Not specified. Sterilization: Not applicable (reusable via cleaning/disinfection). Software: IEC 62304 compliant.

Indications for Use

Indicated for cancer patients undergoing photon radiation therapy. Used as an adjunct to treatment planning to measure and validate radiation dose to targeted body areas. Indicated for use when adhered to skin with a bolus or inserted into the rectum via a specifically designed endorectal balloon device.

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 Skin Sensors (K150719)
• OARtrac® System (K141154)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 1, 2017

RadiaDyne, LLC % Mr. Stuart Goldman Senior Consultant Emergo Group 2500 Bee Cave Road, Bldg. 1, Suite 300 AUSTIN TX 78746

Re: K162954

Trade/Device Name: OARtrac® System with Patient Specific Reusable PSD Sensors Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: NZT Dated: May 3, 2017 Received: May 8, 2017

Dear Mr. Goldman:

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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Michael D. O'Hara
For

Robert Ochs. 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) K162954

Device Name

OARtrac® System with Patient Specific Reusable PSD Sensors

Indications for Use (Describe)

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 measurement and validation of radiation dose received by the patient to the targeted area of their body, and indicated to the skin with a bolus, or inserted into the rectum to measure the rectal prostatic interface via a specifically designed endorectal balloon device.

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

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# Section 5 – 510(k) Summary

## OARtrac® System with Patient Specific Reusable PSD Sensors

# K162954

#### 1. Submission Sponsor

RadiaDyne, LLC

10801 Hammerly Blvd.

Suite 220

Houston, TX 77043

USA

Phone number: [phone]

Contact: John Isham

Title: President & CEO

#### 2. Submission Correspondent

Emergo Global Consulting, LLC

2500 Bee Cave Road, Bldg. 1, Suite 300

Austin, TX 78746

Office Phone: [phone]

Contact: Stuart R. Goldman, Senior Consultant, RA

Email: [e-mail]

#### 3. Date Prepared

May 29, 2017

#### 4. Device Identification

| Trade/Proprietary Name: | OARtrac® System with Patient Specific Reusable PSD Sensors |
|-------------------------|------------------------------------------------------------|
| Common/Usual Name: | Radiation Dose Verification System |
| Classification Name: | Medical charged-particle radiation therapy system |

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| Regulation Number: | 892.5050 |
|-----------------------|------------------------------------------------|
| Product Code: | NZT (dosimeter, ionizing radiation, implanted) |
| Device Class: | Class II |
| Classification Panel: | Radiology |

### 5. Legally Marketed Predicate Devices

OARtrac® System with Skin Sensors (K150719)

OARtrac® System (K141154)

#### 6. Device Description

The OARtrac® System with patient specific, reusable, pre-calibrated PSD sensors is intended for use in photon radiation therapy to monitor and validate radiation dose during External Beam Therapy and HDR Brachytherapy to the surface of the skin or the rectal prostatic interface. 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 their patient. The OARtrac® System itself does not stop the radiation treatment to the patient, or change the radiation delivery, 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, 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 prostatic interface via a specifically designed endorectal balloon device.

#### 8. Substantial Equivalence Discussion

RadiaDyne has chosen its OARtrac® System (K141154) that was cleared for use at the prostatic rectal interface, and their OARtrac® System with Skin Sensors (K150719) that was cleared for use on the surface of the patient's skin as the predicate devices for its OARtrac® System with Patient Specific Reusable PSD Sensors that is the subject of this 510(k) submission. The following table compares the subject device against the two referenced predicate devices with respect to intended use, indications for use, technology and performance testing between them, thus demonstrating the basis for determination of substantial equivalence between these three devices.

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| Device | RadiaDyne | | Similarities/Differences | | |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Trade Name: | OARtrac® System<br>with Patient Specific Reusable PSD Sensors | OARtrac® System<br>with Skin<br>Sensors | OARtrac® System | - | |
| 510(k): | Pending | K150719 | K141154 | - | |
| Product Code: | NZT | NZT | NZT<br>PCT | Same | |
| Regulation: | §892.5050 | §892.5050 | §892.5050<br>§892.5720 | Same | |
| Class: | II | II | II | Same | |
| Intended Use: | The OARtrac® System with patient<br>specific, reusable, pre-calibrated PSD<br>sensors is intended for use in photon<br>radiation therapy to monitor and validate<br>radiation dose during External Beam<br>Therapy and HDR Brachytherapy to the<br>surface of the skin or the rectal prostatic<br>interface. | The OARtrac®<br>System with<br>Skin Sensors is<br>intended for<br>use in photon<br>beam<br>radiation<br>therapy to<br>monitor and<br>verify<br>radiation<br>treatment<br>dose at the<br>entrance to<br>the skin. | The<br>OARtrac®<br>System is<br>intended<br>for use in<br>photon<br>beam<br>radiation<br>therapy to<br>monitor<br>and verify<br>radiation<br>treatment<br>dose to the<br>surrounding organs at<br>risk,<br>specifically<br>the<br>prostatic<br>rectal<br>interface,<br>during<br>prostate<br>external<br>beam<br>radiation<br>treatment. | The subject and<br>predicate devices act as<br>a radiation dose<br>verification system, to<br>the prostatic rectal<br>interface, and the skin<br>of the patient, that<br>have been exposed to<br>radiation treatment. | |
| Indications for<br>Use: | The OARtrac® System with patient<br>specific, reusable, pre-calibrated PSD<br>sensors are intended for use during cancer<br>treatments to measure photon radiation<br>therapy as an adjunct to treatment<br>planning permitting measurement and<br>validation of radiation dose received by<br>the patient to the targeted area of their<br>body, and indicated for use when adhered | The OARtrac®<br>System pre-<br>calibrated skin<br>sensors are<br>specifically<br>indicated for<br>use during<br>cancer<br>treatments to | The<br>OARtrac®<br>System is<br>specifically<br>indicated<br>for male<br>prostate<br>cancer<br>treatment | The subject device has<br>expanded indications<br>where the OARtrac®<br>System PSD sensors are<br>now reusable up to five<br>times in total on the<br>same patient. | |
| | the rectum to measure the rectal prostatic | photon beam | photon | | |
| | interface via a specifically designed | therapy as an | beam | | |
| endorectal balloon device. | | adjunct to | therapy as | | |
| | | treatment | an adjunct | | |
| | | planning | to | | |
| | | permitting | treatment | | |
| | | measurement | planning | | |
| | | of radiation | permitting | | |
| | | dose received | measurem | | |
| | | on the surface | ent of in- | | |
| | | of the skin. | vivo | | |
| | | OARtrac® | radiation | | |
| | | System pre- | dose | | |
| | | calibrated skin | received on | | |
| | | sensors are | the | | |
| | | indicated for | anterior | | |
| | | use when | surface of a | | |
| | | adhered to the | | | |
| | | surface of the | modified | | |
| | | | prostate | | |
| | | skin using | Endorectal | | |
| | | medical grade | Balloon | | |
| | | adhesive and | (ERB) | | |
| | | with a medical | device to | | |
| | | grade bolus | monitor | | |
| | | buildup placed | and verify | | |
| | | directly on top | the | | |
| | | of the sensor. | surroundin | | |
| | | | g organs at | | |
| | | | risk, | | |
| | | | specifically | | |
| | | | the | | |
| | | | prostatic | | |
| | | | rectal | | |
| | | | interface. | | |
| Material: | Plastic scintillation detectors (PSD) are<br>made from polyurethane. | Plastic<br>scintillation | Plastic<br>scintillation | Same | |
| | | detectors | detectors | | |
| | | (PSD) are | (PSD) are | | |
| | | made from | made from | | |
| | | polyurethane. | polyuretha | | |
| | | | ne. | | |
| Implantable: | | No | No | Same | |
| Body Location: | No<br>Prostatic rectal interface and the skin of | Skin | Placed in | Same | |
| | the patient. | contacting. | rectum; | | |
| | | | | | |
| | | | inserted | | |
| | | | inside<br>prostate | | |
| | | | | | |
| | | | Endorectal<br>balloon. | | |
| Sterile: | No | No | No | Same | |
| Single Use: | No | Yes | Yes | The PSD sensors used | |
| |…