(78 days)
No
The summary describes a system for measuring radiation dose using physical sensors and proprietary software for dose management and display. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on direct measurement and data logging.
No.
The device measures in-vivo radiation dose during cancer treatment, but it does not directly treat or prevent a disease or condition. Its purpose is to monitor and verify dose, not to provide therapy itself.
No
Explanation: The device measures in-vivo radiation dose to "monitor and verify" surrounding organs at risk during prostate cancer treatment. This is a monitoring and verification function during treatment, not a diagnostic one. It assesses the received dose, not a disease or condition.
No
The device description explicitly mentions hardware components like "Radiatrac® Plastic Scintillating Detectors (PSD) sensors," a "Clinical Detector Unit (CDU) with its Charged Coupled Device (CCD) camera," and a "modified clinically accepted OARtrac® prostate Endorectal Balloon (ERB)." While it includes proprietary dose management software, it is not solely software.
Based on the provided information, the OARtrac® System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- OARtrac® System Function: The OARtrac® System measures radiation dose in vivo (within the living body) during prostate cancer treatment. It does not analyze specimens taken from the body. Its purpose is to monitor and verify the radiation dose delivered to the patient's organs at risk during therapy.
Therefore, the OARtrac® System falls under the category of a therapeutic or monitoring device used during a medical procedure, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
NZT, PCT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate, rectal prostatic interface
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 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
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.
Key Metrics
Dose Accuracy: +- 6% at 95% confidence interval
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
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
1
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.
7. Indication for Use Statement
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.
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 Verification | |||
| System | Prostate Immobilizer Rectal | |||
| Balloon (PIRB) | OARtrac® System | - | ||
| 510(k): | K083035 | K132194 | Pending | |
| Product Code: | NZT | PCT | NZT + | |
| PCT | The OARtrac® | |||
| System's technology | ||||
| is based on | ||||
| elements of both | ||||
| predicate device |
| Table 5-1 |
|---|
| OARtrac® System vs. Predicate Devices - Similarities and Differences |
2
| Regulation: | §892.5050 | §892.5720 | §892.5050 +
§892.5720 | product codes in
that it acts as a
radiation dose
verification system
and as a prostate
immobilization
device.
The OARtrac®
System's technology
is based on
elements of both
predicate device
regulation numbers
in that it acts as a
radiation dose
verification system
and as a prostate
immobilization
device. | | | | | |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Class: | II | II | II | II | Mode of
Operation: | Metal oxide
semiconductor field-
effect transistor
(MOSFET) is implanted
in patient to allow for
dose verification of
their radiation
treatment procedure.
The dosimeter is
powered
telemetrically and
measures radiation
using two MOSFETs.
The MOSFETs are
hermetically sealed in
a biocompatible glass
capsule. | Polyurethane balloon is
designed as an immobilizer
to assist in positioning the
prostate during CT exams,
and during radiation
treatment therapy
procedures. | Plastic
scintillation
detectors (PSD)
have been
imbedded in the
center of the
previously
cleared
RadiaDyne PIRB
device to allow
for dose
verification of the
patient's
radiation
treatment
procedures. | The OARtrac®
System's dose
verification
technology is based
on fiber optics and
PSD sensor
technology, while
the DVS device uses
MOSFET technology
to achieve its dose
verification
function. |
| Intended Use: | The Dose Verification
System (DVS) is
intended for use in
radiation therapy to
verify treatment
planning and radiation
dose to tissue and
organs in or near the
irradiated areas of a
patient. | The RadiaDyne Prostate
Immobilizer Rectal Balloon
(PIRB) is intended to be
used for the temporary
positioning of the rectal
wall and adjacent structure
in the male human
anatomies. | 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
tissue during
prostate external
beam radiation
treatment. | The OARtrac®
System shares
technical elements
of the DVS and PIRB
in that it functions
as both a radiation
does verification
system and a
prostate
immobilizer and
positioning device. | Material: | Glass capsule | Polyurethane | Polyurethane | Same as above. |
| Indications for
Use: | The DVS system is
specifically indicated
for breast and
prostate cancer to
measure photon beam
therapy and as an
adjunct to treatment
planning to permit
measurement of
the in vivo radiation
dose received at the
tumor periphery,
tumor bed and/or
surrounding normal
tissues for validation
of the prescribed
dose. | The RadiaDyne Prostate
Immobilizer Rectal Balloon
is a single-use disposable,
inflatable, non-powered
positioning device intended
to be used for the
temporary positioning of
the rectal wall and adjacent
structure in the male
human anatomies. The
purpose of the device is to
stabilize the prostate
during Computed
Tomography (CT) exam, X-
ray, or Radiation Therapy
(RT) treatments. The
placement of the balloon
requires a Physician or a
Physician directed
healthcare professional,
and is performed as a
separate procedure outside
of the standard CT exam
and RT treatment. | 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 | The OARtrac®
System and PIRB are
indicated for the
treatment of the
prostate only, while
the Sicel DVS is
indicated for use on
the breast and
prostate. | Implantable: | Yes, 3-12 cm
maximum depth from
any skin surface. | No | No | The OARtrac®
System's ERB
component is not
implanted in the
body while the
DVS's MOSFET
dosimeter is. |
| Body Location: | Implanted under skin
in the target area. | Placed in rectum | Placed in rectum | The OARtrac®
System's ERB and
PIRB are indicated
for placement in the
rectum while the
DVS's MOSFET
dosimeter is
indicate for
placement under
the skin. | | | | | |
| Target Area: | Breast and Prostate | Prostate | Prostate | The OARtrac®
System and PIRB are
indicated for
treatment of the
prostate while the
DVS is indicated for
treatment of the
prostate and breast. | | | | | |
| Fiducial Marker: | Yes | Yes | Yes | All three devices
have a fiducial
marker that is used
as an aid for device
position and
location in the
patient. | | | | | |
| Sterile: | EtO | No | No | The OARtrac®
System's ERB
component and
PIRB are provided
non-sterile and not | | | | | |
:
:
:
.
・
:
3
. . . .
:
.
4
| | | | | intended to be
sterilized, while the
DVS's implantable
MOSFET dosimeter
is provided EtO
sterilized. |
|---------------------|--------------------------------|-----|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Single Use: | Yes | Yes | Yes | All three devices are
for single use. |
| Hard Wired: | No, powered
telemetrically. | NA | Yes, fiber optic
cable. | The OARtrac®
System's ERB
component is hard
wired to the robust
cable that is wired
to the clinical
detector unit, while
the DVS employs no
hard wiring and
operates
telemetrically. |
| Pre-Calibrated: | Yes (Cobalt-60) | NA | Yes (Cobalt-60) | Both the OARtrac®
System and DVS are
pre-calibrated using
Cobalt-60. |
| System
Software: | Yes | NA | Yes | Both the OARtrac®
System and DVS run
on their own
custom software
platforms. |
| Energy Range: | 6-18
MV Photon Dose | NA | 1-20
MV Photon Dose | Both the OARtrac®
System and DVS
have the ability to
measure the energy
range of the
radiation photon
dose administered
to the patient, but
use different
technologies to
accomplish this. PSD
fibers measure light
output in the
OARtrac® System,
while the DVS uses
MOSFET technology. |
| Dose Range: | 80 Gy maximum | NA | 90 Gy maximum | The capability of the
OARtrac® System to
measure a dose
range to the patient
10 Gy higher than
the DVS is purely a
function of the
higher cumulative
dose regimes used
in current prostate
radiation treatment
plans compared to
when the predicate
device was cleared
in 2008, and was
specified by |
.
:
5
| Dose Per
Fraction: | 150-250 cGY | NA | 1-2000 cGy
At dose rates of 1
cGy/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 Read
Dosimeter: | Up to 10 minutes
following radiation
therapy. Optimal
read time is 2 to 3
minutes following
irradiation. | 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 |
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:
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| wand. | ||||
|---|---|---|---|---|
| Dose | ||||
| Accuracy: | Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov |
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."