HP PRO Positioning Device

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 25, 2017 Orfit Industries NV % Mr. Dave Yungvirt CEO Third Party Review Group, LLC The Old Station House 24 Lackawanna Place MILLBURN NJ 07041 Re: K171734 Trade/Device Name: HP PRO Positioning Device Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 5, 2017 Received: July 7, 2017 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 {1}------------------------------------------------ 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 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. 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. Michael D. 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) K171734 Device Name HP PRO Positioning Device #### Indications for Use (Describe) The HP PRO Positioning Device is indicated to assist in the proper positioning of patients for radiation therapy and radiosurgery and treatment with protons. Type of Use (Select one or both, as applicable) | <span style="font-size: 10pt;"> <svg height="10" width="10"> <rect height="10" style="fill:lightgrey;stroke-width:1;stroke:black" width="10"></rect> <line style="stroke:black;stroke-width:1" x1="0" x2="10" y1="0" y2="10"></line> <line style="stroke:black;stroke-width:1" x1="0" x2="10" y1="10" y2="0"></line> </svg> </span> Prescription Use (Part 21 CER 801 Subpart D) | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span> <svg height="10" width="10"> <rect height="10" style="fill:white;stroke-width:1;stroke:black" width="10"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > 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. June 27, 2017 Date Prepared: Applicant Orfit Industries NV 9A Vosveld 2110 Wijnegem Belgium Contact Person c/o Raymond Kelly 68 Southwoods Terrace Southbury, CT 06488 Phone: (203) 400-7566 Alternate Contact Eddy Marivoet OA/RA Manager Orfit Industries NV 9A Vosveld 2110 Wijnegem Belgium Phone: +32 (0)3 326 20 26 | Device Information | | |----------------------|------------------------------| | Trade Name: | HP PRO Positioning Device | | Model Number: | 25000/19 | | Classification Name: | accelerator, linear, medical | | Review Panel: | Radiology | | Product Code: | IYE | | Device Class: | Class II | | Regulation: | 892.5050 | Predicate Device Information K151207 Proton Immobilization Solution. Orfit Industries NV Intended Use/Indications for Use The HP PRO Positioning Device is indicated to assist in the proper positioning and repositioning of patients for radiation therapy and radiosurgery and treatment with protons. {4}------------------------------------------------ ### Principle of Operation: The HP PRO Positioning Device is used by first attaching it to the couch top utilizing the appropriate indexing. Then the health care provider positions the immobilization devices on to the HP PRO Positioning Device. Next the patient is helped onto the couch and positioned onto HP PRO Positioning Device in the appropriate immobilization device. ### Conditions of Use: The HP PRO Positioning Device 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. The HP PRO Positioning Device is intended to be used by or under the direction of a licensed physician. The HP PRO Positioning Device can be cleaned and disinfected by means of soapy water or an isopropanol based disinfectant, applied with a soft cloth. Periodic checks of the HP PRO Positioning Device should be done to insure the parts are not worn and require repair or replacement ### Models: | Model Name | Model Number | |---------------------------|--------------| | HP PRO Positioning Device | 25000/19 | ### Accessories: There are no accessories marketed with the HP PRO Positioning Device. The HP PRO Positioning Device is made up of 4 components: | Quantity | Component Name | Component Material | |----------|----------------|------------------------| | 1 | Base Plate | PMMA and Carbon Fiber | | 1 | Interface | Aluminum | | 4 | Indexing Pins | POM (Polyoxymethylene) | | 8 | Sheet Screws | Stainless Steel | ### Description: The HP PRO Positioning Device is used by first attaching the base plate to the couch top utilizing the appropriate indexing. Then the health care provider positions the immobilization devices on to the HP PRO Positioning Device. Next the patient is helped onto the couch and positioned onto HP PRO Positioning Device in the appropriate immobilization device. An example of an immobilization device is the overlay base plate of the Proton Immobilization Solution. The HP PRO Positioning Device is a device that assists in the proper positioning and repositioning of patients for radiation therapy and radiosurgery with protons. It is an accessory to the Proton Immobilization Solution. The HP PRO Positioning Device is typically attached to the treatment table and supports the patient during treatment. The proposed HP PRO Positioning Device is essentially an extension of the treatment table. {5}------------------------------------------------ The Proton Immobilization Solution is a device which consists of a base plate which is attached to the treatment table. The patient lies on the base plate and a mask may be attached to the base plate so the patient is immobilized. The beam can pass through the mask and the base plate. Proposed HP PRO Positioning Device is a device which is a rectangular piece of material onto which an immobilization device can be attached. This immobilization device can be a base plate for a mask. The patient lies on the base plate and a mask may be attached to the base plate so the patient is immobilized. The beam can pass through the mask and the base plate and through the HP PRO Positioning Device. Dimensions - Length 50.17 inches . - . Width - 21.61 inches - . Height - 1.62 inches Weight - 68.3 lbs. . Performance Sag at cranial end - distributed weight 135kg: | Distributed weight | 135 kg | |--------------------|---------| | Sag | 9.21 mm | Creep at cranial end - distributed weight 135 kg: | Time | 60 min. | |-------|----------| | Creep | 0.214 mm | Dosimetric Properties: The HP PRO Positioning Device has a uniform water equivalence thickness of 41.35mm. This means that the displacement of the maximum doses in the tissue towards the skin surface is 41.35mm. Compatible devices and Thermoplastic Material: The HP PRO Positioning Device is made from equivalent materials as the Proton Immobilization Solution. {6}------------------------------------------------ ## SE Table of Attributes | Basic Unit<br>Characteristics | Predicate K151207 Proton<br>Immobilization Solution, Orfit<br>Industries NV | K171734 HP PRO Positioning<br>Device, Orfit Industries NV | Difference | |------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | Indicated to assist in the proper<br>positioning and repositioning of<br>patients for radiation therapy and<br>radiosurgery and treatment including<br>electron, photon, and proton treatments. | Indicated to assist in the proper<br>positioning and repositioning of<br>patients for radiation therapy and<br>radiosurgery and treatment with<br>protons. | Removed treatment with electron,<br>photon from indications since<br>subject device is not intended to be<br>used with these therapies. | | Intended Use | Designed to be used for the positioning<br>and repositioning of patients for<br>receiving radiation 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 | | Materials of<br>Construction | Base plate: Carbon fiber<br>Indexing pins: Stainless steel | Base plate: PMMA and carbon fiber<br>Interface plate: Aluminum<br>Indexing pins: POM<br>Sheet screws: Stainless steel | No new patient contacting<br>materials added to subject device. | | Fabrication | Machined and creation of sandwich<br>structure with carbon fiber | Machined and creation of sandwich<br>structure with carbon fiber | None | | L x W x H | 45-52" x 21" x 1.9" | 50.17" x 21.61" x 1.62" | SE | | water equivalence<br>thickness | 5.22mm | 41.35mm | SE | | Sag at cranial end | 2.51mm (135kg distributed load) | 9.21 mm (135kg distributed load) | SE | | Creep at cranial end<br>-at 60min. | 0.0785mm (135kg distributed load) | 0.214 mm (135kg distributed load) | SE | {7}------------------------------------------------ ## SE Table of Performance | Performance Category | SE Discussion | |-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Patient Weight<br>Distribution IEC60601-1 | Patient lower part of legs not resting/supported by the proposed or<br>predicate devices, both devices designed for Patients of up to 135<br>kg. | | Tensile Safety factor<br>IEC60601-1 | Patients 135 kg. weight is to be reduced by $2 \times 7.4\% = 14.8\%$ since<br>the patient lower parts of legs are not supported in both devices.<br>Tensile Safety Factor of 6. | | Tensile Safety weight<br>IEC60601-1 | 100% - 2 x (7.4%) = 85.2% leads to a total weight of 85.2% of the<br>Patient weight, thus we get 135kg x 0.852= 115kg for both devices,<br>all other tests are for 135kg. Device passes total load of 933.65kg.<br>for 1 minute. | | Elongation IEC60601-1 | Elongation of break for both devices is less than 5% | | Wear IEC60601-1 | Neither the predicate or proposed system is impaired by wear | | Mechanical Strength<br>IEC60601-1 | Both devices can handle a 150kg load to simulate the Patient<br>(135kg) and the accessory (15kg). This weight was distributed<br>around the Top Layer and carried the weight for minimum of 1<br>minute with no deformation or risks. | | Mechanical Strength<br>Sitting IEC60601-1 | Both devices can handle a load of 60 % of the safe working load<br>representing the patient or operator or a minimum 80 kg for one<br>minute with the center of the load 60 mm from the outer edge of<br>the support system. Device was tested with 90kg for 1 minute and<br>passed. | | Dynamic Forces<br>IEC60601-1 | Both devices can handle loads with a total mass of 153.3 kg.<br>hanging a distance of 150 mm, and then dropped on the surface. | | Flatness Test | Subject device has Flatness $\Delta$ < 1 mm deviation | | Surface Morphology | Subject device when visually inspected for polishing, milling, and<br>absence of edge or surface damage or cavities meets specifications. | | Sag | Sum of the sag and creep values (after 60minutes) is lower than<br>25mm. A 6DOF Robotic patient couch top can compensate the<br>bending effect from patient weight. | | Dimensions | Subject device has dimensions in thickness, length, and width all<br>falling with specifications and tolerance of 0.1 – 0.2mm. | | Creep | Sum of the sag and creep values (after 60minutes) is lower than<br>25mm. A 6DOF Robotic patient couch top can compensate the<br>bending effect from patient weight. | | Secondary radiation | Both proposed and predicate device experience SE values of<br>secondary radiation when a patient plan using a typical spot<br>scanning proton plan intended to deliver 1.8 Gy to a target volume of<br>approximately 1 liter is simulated. Both have a half-life lower than 1<br>hour. Both have the same half-life of 20 minutes. No long- lived<br>radio-isotopes are created by irradiating an acrylic couch top with a<br>high energy proton beam. | | Performance Category | SE Discussion | | Spot Size | Both devices have SE lateral growth in spot size of a high-energy<br>proton beam as it emerges. When a single spot of 228.8 MeV<br>protons is directed through the devices the Gaf Chromic films are<br>scanned and a two- dimensional Gaussian is fit to the exposed<br>beam spots to determine the minor and major axis lengths of the<br>elliptical beam spot and both spot sizes are the same<br>1.7-2.2mm both upstream and downstream. | | WET and Distal Dose<br>Falloff | Both devices perform SE when a monoenergetic proton beam of<br>228.8 MeV is directed into a Multi-Layer Ionization Chamber<br>(MLIC). The charge is collected on each plane of the device and<br>plotted against water equivalent depth to construct an integrated<br>depth dose curve. The distal R80 (Depth of 80% dose) is recorded,<br>as well as the distal falloff (distance between distal 90% and 20%<br>dose levels). WET value of product that beam passes through is<br>compensated for in treatment planning software, when it is<br>considered too high. | {8}------------------------------------------------ ## SE Summary Statement Difference in Indications for Use: Although we have removed treatment with electron or photon radiation therapies from the indications for use, no different questions of safety or effectiveness are raised when the subject device is used for its intended use (Proton Therapy). The subject device is substantially equivalent to the predicate device when used for its intended use (Proton Therapy). Difference in Materials of Construction: Although we have added some materials to the subject device (PMMA, aluminum, and POM), no different questions of safety or effectiveness are raised when the subject device is used for its intended use because none of these materials have direct or indirect patient contact. The subject device is substantially equivalent to the predicate device when used for its intended use and according to its instructions for use. ### SE Conclusion: The HP PRO Positioning Device is substantially equivalent to K151207 Proton Immobilization Solution. Orfit is seeking FDA clearance for the HP PRO Positioning Device to market the subject device. There are no differences between the proposed and predicate devices other than minor differences explained in the SE Summary Statement. The proposed device is found to be SE to the predicate device.