Raycast High Precision Lung Board Solution

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) ## K162862 Device Name Raycast High Precision Lung Board Solution #### Indications for Use (Describe) 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. | Type of Use (Select one or both, as applicable) | | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------| | <table><tr><td><div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div></td></tr><tr><td><div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </div></td></tr></table> | <div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | <div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> | | | | <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > 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." {3}------------------------------------------------ ### 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. {4}------------------------------------------------ ### 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 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. ### 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. {5}------------------------------------------------ | SE Table of Attributes | | | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Basic Unit<br>Characteristics | Predicate K040773<br>Bionix Development Corp.,<br>Extended Butterfly Board | Proposed Raycast<br>High Precision Lung Board | Difference | | Indications for Use | To be used for the positioning and<br>repositioning of patients undergoing<br>or receiving a course of external<br>beam radiation therapy for the<br>treatment of cancer and other<br>diseases. It is intended to be used by<br>or under the direction of a licensed<br>physician. | To be used for the positioning and<br>repositioning of patients<br>undergoing or receiving a course<br>of external beam radiation therapy<br>for the treatment of cancer and<br>other diseases. It is intended to be<br>used by or under the direction of a<br>licensed physician. | None | | Intended Use | Designed to be used for the<br>positioning and repositioning of<br>patients for receiving radiation<br>therapy. | Designed to be used for the<br>positioning and repositioning of<br>patients for receiving radiation<br>therapy. | None | | Prescription | Rx | Rx | None | | CFR | 892.5050 | 892.5050 | None | | Material Board<br>Assembly | Acrylic | Acrylic | None | | Material T Handle<br>Base and Posts | POM + Nylon | POM + Nylon | None, to the best of our knowledge the predicate device<br>accessories are made from the same POM and Nylon<br>materials as the subject device. No different questions of<br>safety or effectiveness are raised. | | Material Flat<br>Screws | Nylon | Nylon | None, to the best of our knowledge the predicate device<br>accessories are made from the same POM and Nylon<br>materials as the subject device. No different questions of<br>safety or effectiveness are raised. | | Material Socket<br>Head Cap Screws<br>and Knurled<br>Thumbscrews | Nylon | None | Proposed device does not have these screws; SE is not<br>affected since the proposed design does not require these<br>screws to be SE. No different questions of safety or<br>effectiveness are raised. | | Basic Unit<br>Characteristics | Predicate K040773<br>Bionix Development Corp.,<br>Extended Butterfly Board | Proposed Raycast<br>High Precision Lung Board | Difference | | Material Hand Grip<br>Assembly | Vinyl | POM + Nylon | Both polymers are similar in grip characteristics. Both vinyl<br>and nylon are SE materials for the hand grip, the primary<br>difference between the materials is resistance to extreme<br>temperatures, not applicable to this device. No different<br>questions of safety or effectiveness are raised. | | Material<br>Attachment Pins | POM | POM | None, to the best of our knowledge the predicate device<br>accessories are made from the same POM and Nylon<br>materials as the subject device. No different questions of<br>safety or effectiveness are raised. | | Hand Grip Spring | None | Polyamide | Predicate device does not have this spring; SE is not<br>affected since the predicate design does not require this<br>spring to be SE. No different questions of safety or<br>effectiveness are raised. | | Fabrication | Machined and Thermoformed | Machined and Thermoformed | None | | Design | Has elevated thermoformed "wings"<br>on either side to support the patient's<br>upper arms and facilitate patient<br>positioning | Has elevated thermoformed<br>"wings" on either side to support<br>the patient's upper arms and<br>facilitate patient positioning | None | | Positioning | Handgrip included to help facilitate<br>patient positioning and repositioning. | Handgrip included to help<br>facilitate patient positioning and<br>repositioning. | 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/<br>Disinfection in<br>Labeling | To clean, wipe thoroughly with<br>water based antiseptic cleaner or<br>foam. Allow to dry before next<br>patient use. Notice: Do not use<br>alcohol based cleaners on this<br>product | this product can be cleaned and<br>disinfected by means of soapy<br>water or an isopropanol based<br>disinfectant, applied with a soft<br>cloth | Minor difference in way of describing the<br>cleaning/disinfection method, but the scope is the same, no<br>difference in SE. | | Basic Unit<br>Characteristics | Predicate K040773<br>Bionix Development Corp.,<br>Extended Butterfly Board | Proposed Raycast<br>High 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,<br>fabrication method, thickness, and material<br>density/thickness between the proposed and predicate<br>device. The predicate device is made from similar non-<br>magnetic material which contains a similar attenuation<br>coefficient. It is fabricated using similar manufacturing<br>methods to a similar thickness. The dimensions and weight<br>are similar and the materials have similar density. The<br>amount of attenuation and skin build up is directly related to<br>the material properties, fabrication method, density, and<br>thickness. Therefore, the predicate device contains similar<br>inherent properties as the proposed device including<br>attenuation 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. | | | | {6}------------------------------------------------ {7}------------------------------------------------