CDR Systems Precision Patient Positioning System is indicated to assist in the proper positioning of patients for radiation therapy and radiosurgery simulation and treatment including electron, photon and proton treatments. Place a clean sheet over the device to ensure a clean device from patient to patient.

Device Description

The CDR Systems Precision Patient Positioning System consists of several options that may be purchased individually or as a complete system.

The CDR Systems Freedom SBRT Immobilization System is designed to provide an easy to use means to immobilize, position and reposition patients undergoing stereotactic radiation therapy. The SBRT Immobilization System is manufactured from Vinvl skinned flexible polyurethane foam and carbon fiber/epoxy components.
The CDR Systems Couch Overlay and Couch Extension are manufactured from carbon fiber/epoxy over a foam core providing a rigid radio-translucent platform to immobilize and position the Head, Neck and Shoulders of a patient.
The CDR Systems Belly Board System has a generally rectangular contour with a firm base that provides patient support and locations for softer modules that provide additional support for a patient's pelvis and head. The indexing bars ensure secure fixation of the Belly Board to the treatment couch.
The CDR Systems Prone Breast Patient Positioning System is generally rectangular in shape with firm base and soft cushions with a specific location for, pelvis, head and breasts. An interchangeable left or right contra-lateral breast support provides support for the breast not requiring radiation treatment. The breast opposite to the contralateral breast is intentionally unsupported and is allowed to hang providing unobstructed treatment access.
The CDR Systems Prone Head and Neck Immobilization System is a headboard that attaches to a base plate that locates onto a couch tabletop, onto a Couch Overlay or Couch Extension and provides adjustable positive and negative tilt for patient's head. The Prone Head and Neck Immobilization System can be used for support of a patient's head in supine or prone position.
The CDR Systems InstaForm Foam is designed to provide an easy to use means to stabilize, position and reposition patients undergoing radiation therapy on a treatment couch. Shortly after the foam has completed expanding inside a plastic bag it becomes rigid, resulting in a customized mold of the patient's anatomy for accurate positioning and stabilization for subsequent patient setups requiring the same initial position.
The CDR Systems Vacuum Cushion is constructed from vinyl coated nylon material that is filled with small polystyrene beads to immobilize the patient. Once evacuated, the Vacuum Cushion holds a rigid shape over the course of a specific patients radiation therapy treatment.
The CDR Systems Indexing Bar is designed for the indexing of patient immobilization devices onto a treatment couchtop.

AI/ML Overview

The provided text is a 510(k) summary for the CDR Systems Precision Patient Positioning System, a medical device used to position patients for radiation therapy. This document primarily focuses on establishing "substantial equivalence" to predicate devices based on intended use and technological characteristics, particularly beam attenuation.

Crucially, this document does NOT contain information about a study proving the device meets acceptance criteria related to AI or a "human-in-the-loop" performance study. The device described is a physical patient positioning system, not an AI software or a device that would require such studies for its performance. The "performance testing" mentioned is "Bench (Tab 12) indicates that CDR devices attenuate a 6 MeV radiation beam by less than 3%." This is the only direct performance metric stated.

Therefore, I cannot provide details on the following as they are not present in the provided text:

A table of acceptance criteria for AI performance and reported device performance.
Sample size used for an AI test set or data provenance.
Number of experts used to establish ground truth for an AI test set or their qualifications.
Adjudication method for an AI test set.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
Standalone (algorithm only) performance study.
Type of ground truth used for AI (expert consensus, pathology, outcomes data, etc.).
Sample size for an AI training set.
How ground truth for an AI training set was established.

**Based on the provided text, the only "acceptance criteria" discussed are related to the device's physical properties and its substantial equivalence to predicate devices, specifically:

1. Acceptance Criteria and Reported Device Performance (as stated for this physical device):

Acceptance Criteria (Implied from Predicate Comparison)	Reported Device Performance (where stated)
Intended Use: For positioning and repositioning patients undergoing radiation therapy.	Device Performance: Meets this intended use.
Classification: Class II device.	Device Performance: Classified as Class II.
Material Properties (Radiolucency): Minimal beam attenuation.	Device Performance: Attenuates a 6 MeV radiation beam by less than 3%. (This is the specific numerical acceptance criteria mentioned). Also stated as "Minimal beam attenuation" or "Air-equivalent radiolucency" for various components.
Compatibility: Locates onto treatment couch/interfaces with other components.	Device Performance: Designed to locate onto treatment couches and interface with various components.
Safety Characteristics: Same as comparable predicate devices.	Device Performance: Stated to have the "same safety characteristics as the comparable predicate devices."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not applicable in the context of AI or clinical performance for this physical device as described. The "performance testing" cited refers to bench testing (attenuation of a radiation beam), not a study with a "test set" of patient data.
Data Provenance: Not applicable. The performance data is from laboratory/bench testing of materials, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth for an AI model is not relevant here as this is a physical medical device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is not an AI system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is not an AI system or an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Not applicable. The performance evaluation here is based on physical properties (beam attenuation) measured through bench testing against a specified threshold.

8. The sample size for the training set:

Not applicable. There is no training set for a physical patient positioning device.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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K122888
Page 1 of 9

Attachment 3

APR 3 0 2
ems

Viou AR Canada T1 21 950-7025 Ev. 14021

September 11. 2012

Tab 5 Revised 01/10/13

510{k} Summary

Manufacturer's Name: Address:

CDR Systems, Inc. #33, 235105 Wrangler Drive S.W. Calgary, Alberta, Canada T1X OK3

Corresponding Official: Title: Telephone: Fax:

Carl Denis CEO 403-850-7035 403-271-0201

Trade Name:

Common Name:

Classification Name:

Accessory to Medical Linear Accelerator, 90IYE, and Accessory to Medical Charded Particle Radiation Therapy System, 90LHN, (per 21 CFR section 892,5050)

CDR Systems Precision Patient Positioning System

Radiation therapy patient positioning devices

Predicates:

Bionix Development Corporation K100691: Omni V SBRT Positioning System K050701: Thigh and Foot Positioner. SuProne Plus K040773: Pelvis BellyBoard Plus Patient Positioning System, SecureFoam System, SecureFit Bar K030051: Versaboard Patient Positioning System

Civco Medical Solutions K111340: MR Patient Positioning Devices

Device Description: The CDR Systems Precision Patient Positioning System consists_ of several options that may be purchased individually or as a complete system.

The CDR Systems Freedom SBRT Immobilization System is designed to provide an easy to use means to immobilize, position and reposition patients undergoing stereotactic radiation therapy. The SBRT Immobilization System is

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manufactured from Vinvl skinned flexible polyurethane foam and carbon fiber/epoxy components.

The CDR Systems Couch Overlay and Couch Extension are manufactured from carbon fiber/epoxy over a foam core providing a rigid radio-translucent platform to immobilize and position the Head, Neck and Shoulders of a patient.
The CDR Systems Belly Board System has a generally rectangular contour with a firm base that provides patient support and locations for softer modules that provide additional support for a patient's pelvis and head. The indexing bars ensure secure fixation of the Belly Board to the treatment couch.
The CDR Systems Prone Breast Patient Positioning System is generally rectangular in shape with firm base and soft cushions with a specific location for, pelvis, head and breasts. An interchangeable left or right contra-lateral breast support provides support for the breast not requiring radiation treatment. The breast opposite to the contralateral breast is intentionally unsupported and is allowed to hang providing unobstructed treatment access.
The CDR Systems Prone Head and Neck Immobilization System is a headboard that attaches to a base plate that locates onto a couch tabletop, onto a Couch Overlay or Couch Extension and provides adjustable positive and negative tilt for patient's head. The Prone Head and Neck Immobilization System can be used for support of a patient's head in supine or prone position.
The CDR Systems InstaForm Foam is designed to provide an easy to use means to stabilize, position and reposition patients undergoing radiation therapy on a treatment couch. Shortly after the foam has completed expanding inside a plastic bag it becomes rigid, resulting in a customized mold of the patient's anatomy for accurate positioning and stabilization for subsequent patient setups requiring the same initial position.
The CDR Systems Vacuum Cushion is constructed from vinyl coated nylon material that is filled with small polystyrene beads to immobilize the patient. Once evacuated, the Vacuum Cushion holds a rigid shape over the course of a specific patients radiation therapy treatment.
The CDR Systems Indexing Bar is designed for the indexing of patient immobilization devices onto a treatment couchtop.

Intended Use: CDR Systems Precision Patient Positioning System is indicated to assist in the proper positioning of patients for radiation therapy and radiosurgery simulation and treatment including electron, photon and proton treatments.

Performance Testing - Bench (Tab 12) indicates that CDR devices attenuate a 6 MeV radiation beam by less than 3%.

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Technological Characteristics: See the attached Predicate Comparison Table

#	Feature	Predicate Device(s):BionixOmni V SBRT PositioningSystem - Whole BodyStereotactic Immobilizer	Device(s):CDR Systems Freedom SBRTImmobilization Systemwith Compression Bridge,Arms Down Module andArms Up Module
1	Intended Use	For positioning andrepositioning patientsundergoing radiation therapy	For positioning andrepositioning patientsundergoing radiation therapy
2	Classification	Class II (K100691 - Bionix)	Class II
3	Features	Has several componentsdesigned to work together toprovide an easy to use means ofreproducing the position of apatient undergoing externalbeam Stereotactic radiationtherapy. Locates onto anattachment bar for location ontreatment couch. Integrated railsfor attaching other componentsof the system including breath-suppression and fiducial arches.	Designed to be used to positionand immobilize the patient'shead, neck and shoulders. Theimmobilization system locatesonto treatment couch using anindexing bar. The SBRT systemhas same head and neck featuresas the Overlay and Extensionwith the addition of molded-inattachment points to locate othercomponents of the system,including a compression bridge.The system has various modulesthat are combined to easilysetup patients for specifictechniques of treatmentincluding an arms up position,an arms down position using theArms Up module or ArmsDown Hand PositioningModule, and a contoured shapelocation of a vacuum cushion-type body immobilizing support.The SBRT system is designed tofunction with both the Knee/LegModule and Foot positioningModule.
4	Material 1	Acrylic/PVC Carbonfiber/epoxy laminate material	Carbon fiber/epoxy laminatematerial with foam core
5	Material 2	Civco K111340MR Kevlar	MR Safe - Kevlar/epoxylaminate material with foamcore
#	Feature	Predicate Device(s):BionixThigh Bolster andFoot Positioner(Comfort Hold™)	CDR Device(s):CDR Systems Leg/Kneepositioning module,Indexable foot positioningmodule, wedges supportsand positioning aids
1	Intended Use	For positioning andrepositioning patientsundergoing radiation therapy insupine or prone position	For positioning andrepositioning patientsundergoing radiation therapy, insupine or prone position
2	Classification	Class II (K050701 - Bionix)	Class II
3	Features	Designed to be used together asa combined thigh and footsupport or alone as a foot orthigh and calve support. Alsowill interface with Bionixsecure bar allowing it to besecured to the treatment couch.	Designed to provide support andpositioning of a patient's thigh,calves, knees and feet. Each canbe used alone or in combinationwith each other (knee and footpositioner). A variety of shapesare offered to optimize patientsetup and comfort. Regardlessof shape used, the purpose foruse identical. Can be used freeon couchtop surface or indexedusing indexing bar allowing it tobe indexed on treatment couch.
4	Material	ABS Plastic	MR Safe - ABS plastic, foamwith vinyl cover.
5	Beam Attenuation	Minimal beam attenuation	Minimal beam attenuation
#	Feature	Predicate Device(s):	CDR Device(s):
1	Intended Use	For positioning andrepositioning patientsundergoing radiation therapy insupine and prone position	For positioning andrepositioning patientsundergoing radiation therapy, insupine and prone position
2	Classification	Class II (K030051 - Bionix)	Class II
3	Features	Generally torso shaped incontour with an areaspecifically designed for head,shoulders and back. Allows forprone as well as supinepositioning of patient. Simpleinterlock device to locate tocouch tabletop and others tolocate low-melt thermoplastic tobe formed into a mask thatcontours the patient.	Generally torso shaped incontour and designed to positionpatient's head, neck andshoulders and a simple fixationdevice for patient specific lowtemperature thermoplastic maskthat contours the patient andsimple fixation device forShoulder Depression. Positionsonto treatment couch with theextension interface at end oftreatment couch provides anintegrated pitch adjustmentknob allowing for correction forcouch sag. Provides a platformfor both prone and supinepatient position. Roll adaptermodule provides Roll axis ofadjustment.
5	Material 1	Carbon fiber/epoxy laminatematerial with foam core	Carbon fiber laminate materialwith foam core and aluminumbase
6	Material 2	Civco K111340MR Kevlar	Kevlar/epoxy laminate materialwith foam core and aluminumbase
7	Beam Attenuation	Minimal beam attenuation	Minimal beam attenuation
		BionixVersaBoard Patient PositioningSystem	CDR Systems Couch Overlay,Couch Extension withShoulder Depression andRoll adjustment couchextension adapter
#	Feature	Predicate Device(s):BionixPelvis BellyBoard Plus PatientPositioning System	CDR Device:CDR Systems Koilia-MikrosBelly Board and ProneBreast Patient PositioningSystem
1	Intended Use	For positioning andrepositioning of patientsreceiving radiation therapy.	For positioning andrepositioning of patientsreceiving radiation therapy.
2	Classification	Class II (K040773 - Bionix)	Class II
3	Features	A generally rectangular contourwith rigid base and specificlocation for head abdominal andleg cushions	A generally rectangular contourwith firm base and soft cushionswith specific location for, pelvis,head and breast, a contra-lateralbreast support with throughopening to allow treatment sidebreast to hang unobstructed.
4	Material	Thermoplastic shell with foamcore base with Velcro attachablecushions for head abdomen andlegs	Thermoplastic shell with foamcore base / Firm cushion basewith Velcro attachable cushionsfor head abdomen and hips andlegs.
5	Beam Attenuation	Minimal beam attenuation	Minimal beam attenuation

Predicate Device Comparison Table

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: :

1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -

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100 - 100 -

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and the control control control control control of the control of the controlled

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#	Feature	Predicate Device(s):BionixSuProne Plus	CDR Device:CDR Systems Prone Head andNeck ImmobilizationSystem
1	Intended Use	For positioning andrepositioning of patientsreceiving radiation therapy.	For positioning andrepositioning of patientsreceiving radiation therapy.
2	Classification	Class II (K050701 - Bionix)	Class II
3	Features	A headboard that affixes to abase plate that can be secured toa couch tabletop or VersaBoard(as shown in Bionix catalog)and provides an adjustable tiltfor patient's head. Can be usedfor support of a patient's headin supine or prone position.	A headboard that attaches to abase plate that locates onto acouch tabletop, onto a CDRCouch Overlay or CouchExtension and providesadjustable positive and negativetilt for patient's head. Can beused for support of a patient'shead in supine or prone position.A low temperaturethermoplastic mask can be usedfor additional immobilization.
4	Material 1	Optional acrylic base, Carbonfiber/epoxy laminate materialwith foam core	Carbon fiber/epoxy laminatematerial with foam core
5	Material 2	Civco K111340MR Kevlar	MR Safe - Kevlar/epoxylaminate material with foamcore
6	Beam Attenuation	Minimal beam attenuation	Minimal beam attenuation

#	Feature	Predicate Device(s):BionixSecureFoam	CDR Device:CDR Systems InstaForm Foam
1	Intended Use	For positioning and re-positioning of patients receivingradiation therapy.	For positioning and re-positioning of patients receivingradiation therapy.
2	Classification	Class II (K040773 -Bionix)	Class II
3	Method	Mix A part (diisocyanate) withB (polyol) to form water blownfoam	Mix A part (diisocyanate) withB (polyol) to form water blownfoam
4	Barrier	Plastic bag	Plastic bag or plastic Sheet
5	Common Name	2 part foaming agent	2 part foaming agent
6	Beam Attenuation	Air-equivalent radiolucency,minimal beam attenuation	Air-equivalent radiolucency,minimal beam attenuation

and the comments of the country

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#	Feature	Predicate Device(s):Bionix SecureVacImmobilization System	CDR Device:CDR Systems VacuumCushion
1	Intended Use	Designed to be used for thepositioning and repositioningof patients for receivingradiation therapy	Designed to be used for thepositioning and repositioningof patients for receivingradiation therapy
2	Classification	Class II (K040773 - Bionix)	Class II
3	Method	SecureVac bags areconstructed from strong, vinylcoated nylon material that isfilled with small polystyrenespheres to immobilize thepatient. Each bag is doublesealed airtight and fitted witha self-closing valve for easeof use. It also features a pinchclamp system for moresecurity. Once evacuated,the SecureVac cushion holdsa rigid shape over thecourse of the radiationtherapy treatmentregimen	The CDR Systems VacuumCushion is constructed fromvinyl coated nylon materialthat is filled with smallpolystyrene beads toimmobilize the patient.Each bag is sealed airtightand fitted with a self-closingvalve. Once evacuated, theVacuum Cushion holds arigid shape over the courseof a specific patientsradiation therapy treatment.
4	Material	Vinyl-coated nylon materialthat is filled with smallpolystyrene spheres	MR Safe - Vinyl-coatednylon material that is filledwith small polystyrenespheres
5	Beam Attenuation	Air-equivalent radiolucency	Air-equivalent radiolucency

The state of the state

and the control control control control controllers and

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K122888
Page 9 of 9

#	Feature	Predicate Device(s):	CDR Device:
1	Intended Use	Bionix SecureFit BarFor the indexing of patientimmobilization devices totreatment couchtop	CDR Systems Indexing BarFor the indexing of patientimmobilization devices totreatment couchtop
2	Classification	Class II (K040773 - Bionix)	Class II
3	Method	Located onto treatmentcouch using location pins onbottom of bar that interfacewith a treatment couchesfeatures designed to acceptand with pins on thesurface that interface withpatient immobilization devicesuch as a Belly Board	Located onto a treatmentcouch using location pins onthe bottom of the IndexingBar that interface with atreatment couch and also withpins on the surface thatinterface with patientimmobilization device such asa Belly Board
4	Material 1	Aluminum or carbonfiber/epoxy laminatematerial	Aluminum or carbonfiber/epoxy laminatematerial
5	Material 2	Civco K111340MR Kevlar	MR Safe - Kevlar/epoxylaminate material
6	Beam Attenuation		Aluminum is not intended tobe in the beam while carbonfiber or Kevlar /epoxylaminate material isacceptable if required to be inthe path of the beam.

The CDR Systems Precision Patient Positioning System has the same intended use and safety characteristics as the comparable predicate devices.

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Image /page/9/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 30. 2013

CDR Systems, Inc. % Mr. Carl Denis CEO #33, 235105 Wrangler Drive S.W. Calgary, Alberta, CANADA TIX OK3

Re: K122888 .

Trade/Device Name: CDR Systems Precision Patient Positioning System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: March 25, 2013 Received: April 2, 2013

Dear Mr. Denis:

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

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Page 2 - Mr. Carl Denis

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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 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" (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 Small Manufacturers, International and Consumer Assistance 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 D. O'Hara

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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Indications for Use

510(k) Number (if known): K122888

Device Name:

CDR Systems Precision Patient Positioning System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michael D. O'Hara

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) K122888

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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.