K Number

Device Name

OARtrac System with Skin Sensors

Manufacturer

RadiaDyne, LLC

Date Cleared

2015-06-16

(89 days)

Product Code

NZT

Regulation Number

892.5050

Intended Use

The OARtrac® System pre-calibrated skin sensors are specifically indicated for use during cancer treatments to measure photon beam therapy as an adjunct to treatment planning permitting measurement of radiation dose received on the surface of the skin. OARtrac® System pre-calibrated skin sensors are indicated for use when adhered to the skin using medical grade adhesive and with a medical grade bolus buildup placed directly on top of the sensor.

Device Description

The OARtrac® System with Skin Sensors provides Radiation Oncologists with near real-time, multi-point radiation-dose information obtained from two (2) Radiatrac® Plastic Scintillating Detectors (PSD) located on the surface of the patient's skin to monitor dose photon based radiation therapy for cancer treatment. This information allows the physician to monitor the dose at the skin surface, compare the actual dose relative to the planned dose, and provides graphs and dose information for the current treatment as well as a log of the dose from five previous treatments. The actual verification of the dose radiation is accomplished by the other main components of the OARtrac® System, those being the Clinical Detector Unit (CDU) with its Charged Coupled Device (CCD) camera and the system's own proprietary dose management software.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K141154

Reference Devices

K141154

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a system for measuring radiation dose using physical detectors and proprietary software for dose management. There is no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

No.
The OARtrac® System is used to measure radiation dose received on the surface of the skin during cancer treatments and to monitor photon beam therapy. It provides information to physicians to compare actual dose relative to planned dose. It is a measurement and monitoring device, not a device that directly treats or prevents a disease.

Diagnostic

No.
The device measures radiation dose received on the surface of the skin and compares it to a planned dose, which is a monitoring and measurement function rather than diagnosing a medical condition.

SaMD (Software as a Medical Device)

The device description explicitly mentions hardware components like "pre-calibrated skin sensors," "Radiatrac® Plastic Scintillating Detectors (PSD)," and a "Clinical Detector Unit (CDU) with its Charged Coupled Device (CCD) camera." While it includes proprietary dose management software, it is not solely software.

IVD (In Vitro Diagnostic)

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.
Device Function: The OARtrac® System measures radiation dose on the surface of the skin during cancer treatment. It does not analyze biological samples taken from the body.
Intended Use: The intended use clearly states it measures radiation dose received on the surface of the skin as an adjunct to treatment planning.

Therefore, the OARtrac® System falls under the category of a medical device used for monitoring and measurement during a medical procedure, not an in vitro diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

NZT

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

surface of the skin

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Radiation Oncologists

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

Non-Clinical Performance Data: As part of demonstrating the safety and effectiveness of the OARtrac® System with Skin Sensors and in showing substantial equivalence to the predicate device that is the subject of this 510(k) submission, RadiaDyne completed a number of tests. The OARtrac® System with Skin Sensors meets all the requirements for overall design, biocompatibility, package shelf life, electrical safety and EMC, which confirms that the output meets the design inputs and specifications for the device. The OARtrac® System with Skin Sensors passed all the testing in accordance with national and international standards shown below to support substantial equivalence of the subject device to the predicate device for which substantial equivalence is being claimed.

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
Package Shelf-Life per ASTM F1980-07
Device Risk Analysis per ISO 14971
Dose Range Verification Testing
Ship Testing Calibration

Clinical Performance Data: There was no human clinical testing required to support the OARtrac® System with Skin Sensors as the original OARtrac® System was not subjected to any human clinical studies. The non-clinical testing detailed in this submission supports the substantial equivalence of the OARtrac® System with Skin Sensors to the predicate device. The purpose of this testing was to verify that the OARtrac® System skin sensors with Radiatrac® PSD detectors provide results that are acceptable to current clinical standards when simulating treatments from a standard LINAC machine and the Accuray CyberKnife system. RadiaDyne showed that using the Radiatrac® PSD to take measurements at the surface of the skin is accurate to that within the established accuracy of the original OARtrac® System cleared under K141154.

Key Metrics

Not Found

Predicate Device(s)

K141154

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three curved lines that resemble a person in profile. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern.

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

June 16, 2015

RadiaDyne, LLC % Mr. Stuart Goldman Senior Consultant Emergo Group 816 Congress Avenue, Suite 1400 AUSTIN TX 78701

Re: K150719

Trade/Device Name: OARtrac® System with Skin Sensors Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged Particle Radiation Therapy System Regulatory Class: II Product Code: NZT Dated: March 18, 2015 Received: March 19, 2015

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 (reporting of medical device-related 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.

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 (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours.

Michael O'Hara

For

Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known)

K150719

Device Name OARtrac® System with Skin Sensors

Indications for Use (Describe)

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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510(k) Summary

for

OARtrac® System with Skin Sensors

1. Submission Sponsor

RadiaDyne, LLC 2313 W. Sam Houston Pkwy N Suite 107 Houston Texas, 77043, USA Phone: 281.759.9600 Fax: 281.759.9609 Contact: John Isham, President & CEO

2. Submission Correspondent

Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701, USA Office Phone: 512.327.9997 Fax: 512.327.9998 Contact: Stuart R. Goldman, Senior Consultant, RA/QA Email: project.management@emergogroup.com

3. Date Prepared

March 18, 2015

4. Device Identification

Trade/Proprietary Name:	OARtrac® System with Skin Sensors
Common/Usual Name:	Dose radiation verification
Classification Name:	dosimeter, ionizing radiation, implanted
Classification Regulation:	892.5050
Product Code:	NZT
Device Class:	Class II
Classification Panel:	Radiology

5. Legally Marketed Predicate Device

RadiaDyne, LLC OARtrac® System (K141154)

6. Device Description

graphs and dose information for the current treatment as well as a log of the dose from five previous treatments. The actual verification of the dose radiation is accomplished by the other main components of the OARtrac® System, those being the Clinical Detector Unit (CDU) with its Charged Coupled Device (CCD) camera and the system's own proprietary dose management software.

7. Indication for Use Statement

The OARtrac® System pre-calibrated skin sensors are specifically indicated for use during cancer treatments to measure photon beam therapy as an adjunct to treatment planning permitting measurement of radiation dose received on the surface of the skin. OARtrac® System pre-calibrated skin sensors are indicated for use when adhered to the surface of the skin using medical grade adhesive and with a medical grade bolus buildup placed directly on top of the sensor.

8. Substantial Equivalence Discussion

RadiaDyne has chosen its own OARtrac® System as the predicate device which was previously cleared under K141154, and indicated for male prostate cancer treatment to measure photon beam therapy as an adjunct to treatment planning permitting measurement of in-vivo radiation dose received at the protatic rectal interface. The following table compares the OARtrac® System with Skin Sensors to the original OARtrac® System with respect to intended use, indications for use, and performance testing between the subject and predicate device, thus demonstrating the basis for determination of substantial equivalence between the two devices.

Device	RadiaDyne	Similarities/Differences
Trade Name:	OARtrac® System with Skin Sensors	OARtrac® System	-
510(k):	Pending	K141154	-
Product Code:	NZT	NZT + PCT	The OARtrac® System with Skin
Sensors is based on the same
technology of the original
OARtrac® System.
Regulation:	§892.5050	§892.5050
§892.5720	The subject and predicate
device act as a radiation dose
verification system.
Class:	II	II	Same
Intended Use:	The OARtrac® System with
Skin Sensors is intended for
use in photon beam
radiation therapy to monitor
and verify radiation
treatment dose at the	The OARtrac® System is
intended for use in photon
beam radiation therapy to
monitor and verify radiation
treatment dose to the
surrounding organs at risk,	The subject and predicate
device act as a radiation dose
verification system.
		rectal interface, during
prostate external beam
radiation treatment.
Indications for
Use:	The OARtrac® System pre-
calibrated skin sensors are
specifically indicated for use
during cancer treatments to
measure photon beam
therapy as an adjunct to
treatment planning
permitting measurement of
radiation dose received on
the surface of the skin.
OARtrac® System pre-
calibrated skin sensors are
indicated for use when
adhered to the surface of
the skin using medical grade
adhesive and with a medical
grade bolus buildup placed
directly on top of the
sensor.	The OARtrac® System is
specifically indicated for
male prostate cancer
treatment to measure
photon beam therapy as an
adjunct to treatment
planning permitting
measurement of in-vivo
radiation dose received on
the anterior surface of a
modified prostate
Endorectal Balloon (ERB)
device to monitor and verify
the surrounding organs at
risk, specifically the protatic
rectal interface.	The OARtrac® System with Skin
Sensors is indicated for
placement on the surface of the
skin, while the OARtrac® System
is specifically indicated for
placement near the prostate.
Material:	Plastic scintillation detectors
(PSD) are made from
polyurethane.	Plastic scintillation detectors
(PSD) are made from
polyurethane.	Same
Implantable:	No	No	Same
Body Location:	Skin contacting	Placed in rectum	The OARtrac® System with Skin
Sensors makes skin contact,
while the OARtrac® System
makes contact with the protatic
rectal interface.
Sterile:	No	No	Same
Single Use:	Yes	Yes	Same
Biocompatibility
Testing per ISO
10993-1	Yes	Yes	Same
Electrical Safety
Testing per IEC
60601-1	Yes	Yes	Same
EMC Testing per
IEC 60601-1-2	Yes	Yes	Same

Table 1 - OARtrac® System with Skin Sensors vs. OARtrac® System

9. Non-Clinical Performance Data

As part of demonstrating the safety and effectiveness of the OARtrac® System with Skin Sensors and in showing substantial equivalence to the predicate device that is the subject of this 510(k) submission, RadiaDyne completed a number of tests. The OARtrac® System with Skin Sensors meets all the requirements for overall design, biocompatibility, package shelf

life, electrical safety and EMC, which confirms that the output meets the design inputs and specifications for the device.

The OARtrac® System with Skin Sensors passed all the testing in accordance with national and international standards shown below to support substantial equivalence of the subject device to the predicate device for which substantial equivalence is being claimed.

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
. Package Shelf-Life per ASTM F1980-07
. Device Risk Analysis per ISO 14971
. Dose Range Verification Testing
Ship Testing Calibration

10. Clinical Performance Data

There was no human clinical testing required to support the OARtrac® System with Skin Sensors as the original OARtrac® System was not subjected to any human clinical studies. The non-clinical testing detailed in this submission supports the substantial equivalence of the OARtrac® System with Skin Sensors to the predicate device. The purpose of this testing was to verify that the OARtrac® System skin sensors with Radiatrac® PSD detectors provide results that are acceptable to current clinical standards when simulating treatments from a standard LINAC machine and the Accuray CyberKnife system. RadiaDyne showed that using the Radiatrac® PSD to take measurements at the surface of the skin is accurate to that within the established accuracy of the original OARtrac® System cleared under K141154.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared device, or has the same intended use and different technological characteristics, but it can be demonstrated that the new device is substantially equivalent to the predicate device, and that the new device does not raise any questions regarding its safety and effectiveness when compared to the predicate device.

The OARtrac® System with Skin Sensors functions as a radiation does verification system when the patient receives their radiation treatment to the targeted area of their body applied at the surface of their skin. Therefore, based on the substantial equivalence analysis described above, the OARtrac® System with Skin Sensors, as designed, developed and manufactured for RadiaDyne, is determined to be substantially equivalent to the company's original OARtrac® System (K141154).