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 Immobilization Endorectal Balloon (ERB) device to monitor and verify the surrounding organs at risk, specifically the protatic rectal interface.

Device Description

The OARtrac® System provides radiation oncologists with near real- time, in-vivo, multipoint radiation-dose information obtained from two (2) Radiatrac® Plastic Scintillating Detectors (PSD) sensors located on the anterior surface of a modified clinically accepted OARtrac® prostate Endorectal Balloon (ERB) to monitor dose photon based radiation therapy for prostate cancer treatment. This information allows the physician to monitor the dose at the rectal prostatic interface, compare the actual dose relative to the planned dose, and provides graphs and dose information for both the current treatment as well as a log of dose from five previous treatments. The OARtrac® System also provides dose rate during actual treatment.

The function of the OARtrac® prostate ERB is to immobilize the prostate while at the same time positioning the Radiatrac® PSD sensors so that measurement of in-vivo radiation received on the anterior surface of the balloon can be monitored to verify the radiation dose to surrounding organs at risk, specifically the protatic rectal interface. 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 that are further addressed in the remainder of this section.

AI/ML Overview

The OARtrac® System is designed to provide near real-time, in-vivo, multipoint radiation-dose information during prostate cancer treatment. It measures photon-based radiation therapy using two Plastic Scintillating Detector (PSD) sensors located on the anterior surface of a modified Endorectal Balloon (ERB). The system monitors the dose at the rectal prostatic interface, compares it to the planned dose, and provides graphs and dose information for current and past treatments. The ERB also immobilizes the prostate and positions the sensors.

Here's a breakdown of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Dose Accuracy	+/- 6% at 95% confidence interval
Dose Range	90 Gy maximum
Dose Per Fraction	1-2000 cGy at dose rates of 1 cGy/s and above
Time to Read Dosimeter	20 seconds
Energy Range	1-20 MV Photon Dose

Study Information

Sample Size and Data Provenance:
- The document indicates that no human clinical testing was required. The "Non-Clinical Performance Data" section mentions "controlled phantom data" was used to obtain the radiation dose accuracy for the OARtrac® System.
- No specific sample sizes for test sets (e.g., number of phantom measurements) or the data provenance (e.g., country of origin, retrospective/prospective) are explicitly provided in the provided text.
Number of Experts and Qualifications for Ground Truth (Test Set):
- Not applicable, as no human clinical testing was performed for the test set. Ground truth for the non-clinical tests would be established through a controlled phantom setup and precise dose delivery.
Adjudication Method (Test Set):
- Not applicable, as no human clinical testing requiring expert adjudication was performed.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was mentioned. The device is a dosimeter aimed at objectively measuring radiation dose, not interpreting images or aiding human readers in decision-making in a way that an MRMC study would typically evaluate.
Standalone Performance Study:
- Yes, a standalone performance study was done. The "Non-Clinical Performance Data" section details a series of tests, including "Dose Range Verification Testing," "Calibration Testing," and "Dose Accuracy" measurements using controlled phantom data. This implicitly demonstrates the algorithm's (or system's) standalone performance in measuring radiation dose.
Type of Ground Truth Used:
- For the non-clinical testing, the ground truth was established through controlled phantom data and presumably the known, precisely delivered radiation doses from a calibrated source.
Sample Size for Training Set:
- The document does not explicitly mention a separate "training set" or its sample size. For device calibration and verification, data would typically be collected from controlled experiments, but the text doesn't differentiate between training and testing data in a machine learning context.
How Ground Truth for Training Set was Established:
- Ground truth for calibration and verification would be established using calibrated radiation sources and dosimetric standards applied to phantoms. The document mentions the device is "Pre-Calibrated (Cobalt-60)," indicating that Cobalt-60 sources were used in establishing foundational calibration.

Summary

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K141154
Page 1 of 8

JUL 2 2 2014

510(k) Summary

for

OARtrac® System

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

May 2, 2014

4. Device Identification

Trade/Proprietary Name: OARtrac® System Common/Usual Name: Dose radiation verification and prostate immobilizer system Classification Name: Dosimeter, ionizing radiation, implanted

Classification Regulation: 892.5050 NZT and PCT Product Code: Device Class: Class II Classification Panel: Radiology

5. Legally Marketed Predicate Device(s)

Sicel Technologies, Inc., Dose Verification System (DVS) (K083055) RadiaDyne, LLC, Prostate Immobilizer Rectal Balloon (PIRB) (K132194)

6. Device Description

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therapy for prostate cancer treatment. This information allows the physician to monitor the dose at the rectal prostatic interface, compare the actual dose relative to the planned dose, and provides graphs and dose information for both the current treatment as well as a log of dose from five previous treatments. The OARtrac® System also provides dose rate during actual treatment.

7. Indication for Use Statement

8. Substantial Equivalence Discussion

RadiaDyne has chosen two predicate devices in the 510(k) submission for its OARtrac® System, the Sicel Dose Verification System (K083035) manufactured by Sicel Technologies and cleared under Product Code NZT and §892.5050, and its own Prostate Immobilizer Rectal Balloon (PIRB) approved by the FDA through a de novo application (K132194) under Product Code PCT and §892.5720.

The following table compares the OARtrac® System to the predicate devices with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

Device	Sicel Technologies	RadiaDyne	RadiaDyne	Differences
Trade Name:	Dose VerificationSystem	Prostate Immobilizer RectalBalloon (PIRB)	OARtrac® System	-
510(k):	K083035	K132194	Pending
Product Code:	NZT	PCT	NZT +PCT	The OARtrac®System's technologyis based onelements of bothpredicate device

Table 5-1
OARtrac® System vs. Predicate Devices - Similarities and Differences

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Regulation:	§892.5050	§892.5720	§892.5050 +§892.5720	product codes inthat it acts as aradiation doseverification systemand as a prostateimmobilizationdevice.The OARtrac®System's technologyis based onelements of bothpredicate deviceregulation numbersin that it acts as aradiation doseverification systemand as a prostateimmobilizationdevice.
Class:	II	II	II	II	Mode ofOperation:	Metal oxidesemiconductor field-effect transistor(MOSFET) is implantedin patient to allow fordose verification oftheir radiationtreatment procedure.The dosimeter ispoweredtelemetrically andmeasures radiationusing two MOSFETs.The MOSFETs arehermetically sealed ina biocompatible glasscapsule.	Polyurethane balloon isdesigned as an immobilizerto assist in positioning theprostate during CT exams,and during radiationtreatment therapyprocedures.	Plasticscintillationdetectors (PSD)have beenimbedded in thecenter of thepreviouslyclearedRadiaDyne PIRBdevice to allowfor doseverification of thepatient'sradiationtreatmentprocedures.	The OARtrac®System's doseverificationtechnology is basedon fiber optics andPSD sensortechnology, whilethe DVS device usesMOSFET technologyto achieve its doseverificationfunction.
Intended Use:	The Dose VerificationSystem (DVS) isintended for use inradiation therapy toverify treatmentplanning and radiationdose to tissue andorgans in or near theirradiated areas of apatient.	The RadiaDyne ProstateImmobilizer Rectal Balloon(PIRB) is intended to beused for the temporarypositioning of the rectalwall and adjacent structurein the male humananatomies.	The OARtrac®System isintended for usein photon beamradiation therapyto monitor andverify radiationtreatment doseto thesurroundingorgans at risktissue duringprostate externalbeam radiationtreatment.	The OARtrac®System sharestechnical elementsof the DVS and PIRBin that it functionsas both a radiationdoes verificationsystem and aprostateimmobilizer andpositioning device.	Material:	Glass capsule	Polyurethane	Polyurethane	Same as above.
Indications forUse:	The DVS system isspecifically indicatedfor breast andprostate cancer tomeasure photon beamtherapy and as anadjunct to treatmentplanning to permitmeasurement ofthe in vivo radiationdose received at thetumor periphery,tumor bed and/orsurrounding normaltissues for validationof the prescribeddose.	The RadiaDyne ProstateImmobilizer Rectal Balloonis a single-use disposable,inflatable, non-poweredpositioning device intendedto be used for thetemporary positioning ofthe rectal wall and adjacentstructure in the malehuman anatomies. Thepurpose of the device is tostabilize the prostateduring ComputedTomography (CT) exam, X-ray, or Radiation Therapy(RT) treatments. Theplacement of the balloonrequires a Physician or aPhysician directedhealthcare professional,and is performed as aseparate procedure outsideof the standard CT examand RT treatment.	The OARtrac®System isspecificallyindicated formale prostatecancer treatmentto measurephoton beamtherapy as anadjunct totreatmentplanningpermittingmeasurement ofin-vivo radiationdose received onthe anteriorsurface of amodifiedProstateImmobilizationEndorectalBalloon (ERB)device to monitorand verify the	The OARtrac®System and PIRB areindicated for thetreatment of theprostate only, whilethe Sicel DVS isindicated for use onthe breast andprostate.	Implantable:	Yes, 3-12 cmmaximum depth fromany skin surface.	No	No	The OARtrac®System's ERBcomponent is notimplanted in thebody while theDVS's MOSFETdosimeter is.
Body Location:	Implanted under skinin the target area.	Placed in rectum	Placed in rectum	The OARtrac®System's ERB andPIRB are indicatedfor placement in therectum while theDVS's MOSFETdosimeter isindicate forplacement underthe skin.
Target Area:	Breast and Prostate	Prostate	Prostate	The OARtrac®System and PIRB areindicated fortreatment of theprostate while theDVS is indicated fortreatment of theprostate and breast.
Fiducial Marker:	Yes	Yes	Yes	All three deviceshave a fiducialmarker that is usedas an aid for deviceposition andlocation in thepatient.
Sterile:	EtO	No	No	The OARtrac®System's ERBcomponent andPIRB are providednon-sterile and not

・

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. . . .

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				intended to besterilized, while theDVS's implantableMOSFET dosimeteris provided EtOsterilized.
Single Use:	Yes	Yes	Yes	All three devices arefor single use.
Hard Wired:	No, poweredtelemetrically.	NA	Yes, fiber opticcable.	The OARtrac®System's ERBcomponent is hardwired to the robustcable that is wiredto the clinicaldetector unit, whilethe DVS employs nohard wiring andoperatestelemetrically.
Pre-Calibrated:	Yes (Cobalt-60)	NA	Yes (Cobalt-60)	Both the OARtrac®System and DVS arepre-calibrated usingCobalt-60.
SystemSoftware:	Yes	NA	Yes	Both the OARtrac®System and DVS runon their owncustom softwareplatforms.
Energy Range:	6-18MV Photon Dose	NA	1-20MV Photon Dose	Both the OARtrac®System and DVShave the ability tomeasure the energyrange of theradiation photondose administeredto the patient, butuse differenttechnologies toaccomplish this. PSDfibers measure lightoutput in theOARtrac® System,while the DVS usesMOSFET technology.
Dose Range:	80 Gy maximum	NA	90 Gy maximum	The capability of theOARtrac® System tomeasure a doserange to the patient10 Gy higher thanthe DVS is purely afunction of thehigher cumulativedose regimes usedin current prostateradiation treatmentplans compared towhen the predicatedevice was clearedin 2008, and wasspecified by

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Dose PerFraction:	150-250 cGY	NA	1-2000 cGyAt dose rates of 1cGy/s and above	RadiaDyne in the design and development of their device.Both the OARtrac® System and DVS have the ability to measure the radiation dose per fraction administered to the patient, but use different technologies (PSD fibers vs. MOSFET technology) to accomplish this, which accounts for the differences in the range of the values shown.
Time to ReadDosimeter:	Up to 10 minutesfollowing radiationtherapy. Optimalread time is 2 to 3minutes followingirradiation.	NA	20 seconds	Both the OARtrac® System and DVS have the ability to read and store the radiation dose administered to the patient, but use different technologies (PSD fibers vs. MOSFET technology) to accomplish this which accounts for the differences in the range of the values shown. Since the OARtrac® System uses PSD fibers that are hardwired to the CDU and its camera, readings are updating every 20 seconds during the treatment. This compares to the DVS where the radiation exposure time values are first stored in the implanted dosimeter. Once the radiation is delivered to the patient, the dose information can then be retrieved with the aid of the hand hold reader

ーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー

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				wand.
DoseAccuracy:	<5.5% (2σ) up to 20 Gy<6.5% (2σ) up to 74 GyDosimeter axis isplaced roughly parallelto the body axis.Actual lot accuracy isspecified in the LotCalibration Certificate.Accuracy decreasesslightly above 74 Gy.	NA	+- 6% at 95%confidenceinterval	The radiation doseaccuracy for theOARtrac® Systemwas obtained usingcontrolled phantomdata, and is similarto accuracyreported for theDVS.

9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of the OARtrac® System and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, RadiaDyne completed a number of tests. The OARtrac® System meets all the requirements for overall design, sterilization, 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 passed all the testing in accordance with national and international standards shown below to support substantial equivalence of the subject device to the predicates 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 .
. Bioburden per ISO 11137-1
Package Shelf-Life per ASTM F1090-07
Device Risk Analysis per ISO 14971
Dose Range Verification Testing
Ship Testing Calibration Testing �
. Balloon Leak Test
. Balloon Tensile Strength Test '
. Balloon Burst Strength Test
. Balloon Stopper Resistance Test

10. Clinical Performance Data

There was no human clinical testing required to support the OARtrac® System as the indications for use is equivalent to the predicate devices. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the OARtrac® System.

11. Statement of Substantial Equivalence

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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 functions as both a radiation does verification system and as a prostate immobilizer and positioning device in one complete system, whereas the predicate devices would have to be used in combination to have the same intended use on a male subject. In addition, the OARtrac® System's ERB component is not implanted, thus reducing the risk of complications such as infection, implant migration, implant placement, and adverse reactions to implants by the patient, etc.

Therefore, based on the substantial equivalence analysis described above, the OARtrac® System, as designed, developed and manufactured for RadiaDyne, is determined to be substantially equivalent to the Dose Verification System (K083035) manufactured by Sicel Technologies, and to the Prostate Immobilizer Rectal Balloon (K132194) designed, developed and manufactured for RadiaDyne.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol featuring three abstract shapes resembling human figures or flowing lines, arranged in a stacked formation.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66.GoG9 Silver Spring, MD 20993-0002

July 22, 2014

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

K141154 Re: Trade/Device Name: OARtrac® System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: NZT and PCT Dated: May 2, 2014 Received: May 5, 2014

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.

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Page 2 - Mr. Stuart Goldman

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" (21CFR 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,

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510{k) Number (if known) Not Assigned K141154

Device Name OARtrac® System

Indications for Use (Describe)

The OARtrace System is specifically indicated for male prostate cancer treatment to measure photon beam therapy as an adjunct to treatment planning measurement of in-vivo radiation dose received on the anterior surface of a modified Prostate Immobilization Endorectal Balloon (ERB) device to monitor and verify the surrounding organs at risk, specifically the protatic rectal interface.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Smh.7)

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The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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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.