The Raycast High Precision Lung Board Solution is a patient positioning device intended to be used for the positioning and re-positioning of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases. It is intended to be used by or under the direction of a licensed physician.

Device Description

The Raycast High Precision Lung Board is used to position the patient supine on the treatment couch with the arms lifted above the head. This will keep the arms outside of the treatment field, which is the thorax in this case. The Raycast High Precision Lung Board is attached to the treatment couch with a 2-vin indexing bar in order to reproduce the same position each day. The Raycast High Precision Lung Board should be fully supported by the treatment couch. Then the patient is asked to lie down on the couch with his head in a head support that is attached to the Raycast High Precision Lung Board. Once the patient is lying down, he can lift up his arms until the elbows rest against the 'wings' of the board and the hands can reach the T-shaped handgrip.

The position of the T-shaped handgrip can be adjusted both in height and length according to the patient's anatomy. To adjust the height of the handgrip, pull the white knob on the side and move the grip pole up or down. To adjust the length of the handgrip, pull the white knob at the cranial side and slide the handgrip more caudally or cranially. Various head supports can be placed on the Raycast High Precision Lung Board depending on the physician's preference. The standard set-up will be with an Orfit Head Support, but it is also possible to use a Silverman or Timo Head Support which they might already have available in their department.

Once the patient is set-up correctly, the arms should not be treatment field anymore, which is the thorax area in this case. This allows the physician to irradiate the thorax from various angles, including laterally without passing through the arms of the patient. The Raycast High Precision Lung Board itself will not be in the treatment field and as such will not be irradiated through.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "Raycast High Precision Lung Board Solution". This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment cannot be directly extracted from this document.

The document primarily relies on a comparative analysis with a previously cleared predicate device (K040773 Extended Butterfly Board, Bionix Development Corp.) to establish substantial equivalence.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't define explicit acceptance criteria in the typical sense of a clinical study (e.g., target sensitivity/specificity). Instead, it demonstrates equivalence to a predicate device across various attributes. The "acceptance criteria" are implied by the features and performance of the predicate device.

Acceptance Criteria (Implied by Predicate Device)	Reported Device Performance (Raycast High Precision Lung Board Solution)
Indications for Use: Patient positioning/re-positioning for external beam radiation therapy for cancer and other diseases, by/under direction of a licensed physician.	Identical.
Intended Use: Patient positioning/re-positioning for radiation therapy.	Identical.
Prescription Status: Prescription Use (Rx).	Identical (Rx).
CFR Regulation: 892.5050.	Identical (892.5050).
Material Board Assembly: Acrylic.	Identical (Acrylic).
Material T Handle Base and Posts: POM + Nylon.	Identical (POM + Nylon).
Material Flat Screws: Nylon.	Identical (Nylon).
Material Socket Head Cap Screws and Knurled Thumbscrews: Nylon.	Not applicable (proposed device does not have these screws). This difference is deemed not to raise new questions of safety or effectiveness.
Material Hand Grip Assembly: Vinyl.	POM + Nylon. Difference noted, but deemed similar in grip characteristics and resistance to extreme temperatures not applicable. No new questions of safety or effectiveness raised.
Material Attachment Pins: POM.	Identical (POM).
Hand Grip Spring: None.	Polyamide. Predicate device does not have this spring; this difference is deemed not to raise new questions of safety or effectiveness.
Fabrication: Machined and Thermoformed.	Identical (Machined and Thermoformed).
Design: Elevated thermoformed "wings" for upper arm support and patient positioning.	Identical.
Positioning: Handgrip for patient positioning and re-positioning.	Identical.
Mounting Holes: Yes.	Identical (Yes).
Thickness: 0.31".	Identical (0.31").
LxWxH: 22.4" x 21.3" x 6.7".	Identical (22.4" x 21.3" x 6.7").
Cleaning/Disinfection in Labeling: Water-based antiseptic cleaner/foam, no alcohol.	Soapy water or isopropanol-based disinfectant with soft cloth. Minor difference in description, scope is the same, no difference in SE.
Weight: 6.24 lbs.	Identical (6.24 lbs).
MR Safety: (Implied to be acceptable for predicate).	MR Safe.
Attenuation/SBU: (Implied to be acceptable for predicate).	~6MV (4.15%) attenuation, ~mmH2O/11mm Skin Build Up. Extrapolated based on performance testing and SE comparison of materials, fabrication, thickness, and density to predicate.

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

Sample Size: Not applicable. This is not a clinical study involving a "test set" of patients or data in the typical sense. The primary "test" is a comparative analysis of the device's characteristics against a predicate device.
Data Provenance: Not applicable. The data is primarily derived from the technical specifications and performance testing of the proposed device and comparison to the predicate device's known characteristics. No mention of country of origin or retrospective/prospective data collection in a clinical context.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. There is no "ground truth" establishment in a clinical setting as this is a device comparison for substantial equivalence. The "truth" is established by the specifications and performance of the proposed device and the predicate.

4. Adjudication Method for the Test Set:

Not applicable. No clinical test set requiring adjudication in this context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. This type of study is not mentioned or implied because the device is a patient positioning board, not an imaging or diagnostic AI device that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is not an algorithm or AI. It's a physical medical device. Performance testing for a physical device typically involves bench testing, which was done for dosimetry (attenuation, water thickness) and MR safety.

7. The Type of Ground Truth Used:

The "ground truth" in this context is the technical specifications, material properties, and physical performance data of both the proposed device and the predicate device. For example, material composition (Acrylic, POM, Nylon), dimensions, weight, and results of physical bench tests such as dosimetry and MR safety. The "truth" is effectively the established characteristics of the predicate device against which the new device is compared.

8. The Sample Size for the Training Set:

Not applicable. This is a physical device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. No training set for this type of device.

Additional Study Information from the Text:

Bench Testing: "Bench testing was performed and includes a dosimetry test report for the device including device attenuation and water thickness, which have been validated to demonstrate SE to the predicate in safety and effectiveness."
MR Safety Studies: "Additional studies performed are the MR safety studies performed in order to demonstrate that the device tested as MR safe."

In summary, the provided document is a 510(k) submission focused on demonstrating substantial equivalence for a physical patient positioning device. It directly compares the proposed device to a legally marketed predicate based on technical specifications and bench testing, rather than reporting on a clinical study with acceptance criteria and a test set against a clinical ground truth.

Summary

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

November 9, 2016

Orfit Industries NV % Mr. Dave Yungvirt CEO Third Party Review Group, LLC The Old Station House 24 Lackawanna Place MILLBURN NJ 07041

Re: K162862

Trade/Device Name: Raycast High Precision Lung Board Solution Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: October 13, 2016 Received: October 14, 2016

Dear Mr. Yungvirt:

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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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. 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)

K162862

Device Name

Raycast High Precision Lung Board Solution

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

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510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Date Prepared: October 10, 2016

Applicant Orfit Industries NV 9A Vosveld 2110 Wijnegem Belgium

Contact Person c/o Raymond Kelly 68 Southwoods Terrace Southbury, CT 06488 Phone: (203) 4007566

Alternate Contact Eddy Marivoet QA/RA Manager Orfit Industries NV 9A Vosveld 2110 Wijnegem Belgium Phone: +32 (0)3 326 20 26

Device Information
Trade Name:	Raycast High Precision Lung Board Solution
Model Number:	29115
Classification Name:	accelerator, linear, medical
Review Panel:	Radiology
Product Code:	IYE
Device Class:	Class II
Regulation:	892.5050

Predicate Device Information K040773 Extended Butterfly Board, Bionix Development Corp.,

Intended Use/Indications for Use

The Raycast High Precision Lung Board is a patient positioning device intended to be used for the positioning and re-positioning of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases. It is intended to be used by or under the direction of a licensed physician.

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Principle of Operation

This product is a medical device used for positioning patients in radiation therapy. This system is used to position the arms over the head, for treating the thorax area.

Device Description

Accessories Description

There are no accessories marketed with the Raycast High Precision Lung Board.

Performance

No performance standards or special controls have been developed under Section 514 of the Federal Food, Drug, and Cosmetic Act ("FD&C Act") for the Raycast High Precision Lung Board. Bench testing was performed and includes a dosimetry test report for the device including device attenuation and water thickness, which have been validated to demonstrate SE to the predicate in safety and effectiveness.

Additional studies performed are the MR safety studies performed in order to demonstrate that the device tested as MR safe.

Substantial Equivalence

Equivalence was determined using a side by side tabular comparison between the predicate and proposed devices which included: Features. Intended Use. Labeling, Materials, Specifications, Performance Data, and Technological Aspects. The proposed device is substantially equivalent to the K040773 Bionix Extended Butterfly Board.

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SE Table of Attributes
Basic UnitCharacteristics	Predicate K040773Bionix Development Corp.,Extended Butterfly Board	Proposed RaycastHigh Precision Lung Board	Difference
Indications for Use	To be used for the positioning andrepositioning of patients undergoingor receiving a course of externalbeam radiation therapy for thetreatment of cancer and otherdiseases. It is intended to be used byor under the direction of a licensedphysician.	To be used for the positioning andrepositioning of patientsundergoing or receiving a courseof external beam radiation therapyfor the treatment of cancer andother diseases. It is intended to beused by or under the direction of alicensed physician.	None
Intended Use	Designed to be used for thepositioning and repositioning ofpatients for receiving radiationtherapy.	Designed to be used for thepositioning and repositioning ofpatients for receiving radiationtherapy.	None
Prescription	Rx	Rx	None
CFR	892.5050	892.5050	None
Material BoardAssembly	Acrylic	Acrylic	None
Material T HandleBase and Posts	POM + Nylon	POM + Nylon	None, to the best of our knowledge the predicate deviceaccessories are made from the same POM and Nylonmaterials as the subject device. No different questions ofsafety or effectiveness are raised.
Material FlatScrews	Nylon	Nylon	None, to the best of our knowledge the predicate deviceaccessories are made from the same POM and Nylonmaterials as the subject device. No different questions ofsafety or effectiveness are raised.
Material SocketHead Cap Screwsand KnurledThumbscrews	Nylon	None	Proposed device does not have these screws; SE is notaffected since the proposed design does not require thesescrews to be SE. No different questions of safety oreffectiveness are raised.
Basic UnitCharacteristics	Predicate K040773Bionix Development Corp.,Extended Butterfly Board	Proposed RaycastHigh Precision Lung Board	Difference
Material Hand GripAssembly	Vinyl	POM + Nylon	Both polymers are similar in grip characteristics. Both vinyland nylon are SE materials for the hand grip, the primarydifference between the materials is resistance to extremetemperatures, not applicable to this device. No differentquestions of safety or effectiveness are raised.
MaterialAttachment Pins	POM	POM	None, to the best of our knowledge the predicate deviceaccessories are made from the same POM and Nylonmaterials as the subject device. No different questions ofsafety or effectiveness are raised.
Hand Grip Spring	None	Polyamide	Predicate device does not have this spring; SE is notaffected since the predicate design does not require thisspring to be SE. No different questions of safety oreffectiveness are raised.
Fabrication	Machined and Thermoformed	Machined and Thermoformed	None
Design	Has elevated thermoformed "wings"on either side to support the patient'supper arms and facilitate patientpositioning	Has elevated thermoformed"wings" on either side to supportthe patient's upper arms andfacilitate patient positioning	None
Positioning	Handgrip included to help facilitatepatient positioning and repositioning.	Handgrip included to helpfacilitate patient positioning andrepositioning.	None
Mounting Holes	Yes	Yes	None
Thickness	0.31"	0.31"	None
LxWxH	22.4" x 21.3" x 6.7"	22.4" x 21.3" x 6.7"	None
Cleaning/Disinfection inLabeling	To clean, wipe thoroughly withwater based antiseptic cleaner orfoam. Allow to dry before nextpatient use. Notice: Do not usealcohol based cleaners on thisproduct	this product can be cleaned anddisinfected by means of soapywater or an isopropanol baseddisinfectant, applied with a softcloth	Minor difference in way of describing thecleaning/disinfection method, but the scope is the same, nodifference in SE.
Basic UnitCharacteristics	Predicate K040773Bionix Development Corp.,Extended Butterfly Board	Proposed RaycastHigh Precision Lung Board	Difference
Weight	6.24 lbs	6.24 lbs	None
MR Safety		MR Safe	SE for attenuation, MR Safety, and skin build up was
Attenuation/SBU		~6MV (4.15%)	extrapolated based on the performance testing on the
Skin Build Up	Unknown	~mmH2O/11mm	proposed device, and the SE comparison of material,fabrication method, thickness, and materialdensity/thickness between the proposed and predicatedevice. The predicate device is made from similar non-magnetic material which contains a similar attenuationcoefficient. It is fabricated using similar manufacturingmethods to a similar thickness. The dimensions and weightare similar and the materials have similar density. Theamount of attenuation and skin build up is directly related tothe material properties, fabrication method, density, andthickness. Therefore, the predicate device contains similarinherent properties as the proposed device includingattenuation and skin build up and MR safety.
Differences/Conclusion: There are no significant differences between the proposed and predicate devices, no new patient contacting materials are being
introduced. Minor differences in the way labeling sections are described, some differences in the number of components included in the submission. The
proposed device labeling is written to be more descriptive than the predicate labeling which does not introduce different questions of safety or effectiveness
because the labeling is more clear. The proposed device contains less components compared to the predicate device, this does not introduce different questions
of safety or effectiveness because the device functions equivalently to the predicate and introduces less materials and components to the patient. The proposed
device is found to be SE to the predicate device.

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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.