(43 days)
The HP PRO Positioning Device is indicated to assist in the proper positioning of patients for radiation therapy and radiosurgery and treatment with protons.
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.
The HP PRO Positioning Device is made up of 4 components: Base Plate (PMMA and Carbon Fiber), Interface (Aluminum), Indexing Pins (POM (Polyoxymethylene)), and Sheet Screws (Stainless Steel).
The provided document describes the HP PRO Positioning Device and its substantial equivalence to a predicate device, K151207 Proton Immobilization Solution. The study focuses on demonstrating that the new device performs comparably to the predicate device across various physical and dosimetric properties.
Here's an analysis of the acceptance criteria and study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria/Requirement | Reported Device Performance (HP PRO Positioning Device) |
|---|---|---|
| Physical Properties | ||
| Length | Range 45-52" | 50.17 inches (within range) |
| Width | 21" | 21.61 inches (comparable, deemed SE) |
| Height | 1.9" | 1.62 inches (comparable, deemed SE) |
| Sag at cranial end (135kg distributed load) | 2.51 mm (from predicate) | 9.21 mm (Predicate: 2.51mm; Device: 9.21mm; Deemed SE, with a note that a 6DOF Robotic patient couch top can compensate for bending effect. Implicit acceptance: Sag + Creep < 25mm.) |
| Creep at cranial end (135kg, 60 min) | 0.0785 mm (from predicate) | 0.214 mm (Predicate: 0.0785mm; Device: 0.214mm; Deemed SE, with a note that a 6DOF Robotic patient couch top can compensate for bending effect. Implicit acceptance: Sag + Creep < 25mm.) |
| Flatness Test | Not explicitly stated for predicate but implied to be acceptable. | $\Delta$ < 1 mm deviation (meets specifications) |
| Surface Morphology | Visually inspected for polishing, milling, and absence of edge or surface damage or cavities. | Meets specifications. |
| Dimensions Tolerance | Not explicitly stated as acceptance criteria, but mentioned for performance. | All falling within specifications and tolerance of 0.1 – 0.2mm. |
| Mechanical Strength (IEC60601-1) | ||
| Patient Weight Distribution | Up to 135 kg. Patient lower parts of legs not resting/supported. | Designed for Patients of up to 135 kg. Lower legs not supported (SE to predicate). |
| Tensile Safety Factor | Safety factor of 6. Patient weight reduced by 14.8% for calculation. | Tensile Safety Factor of 6 (SE to predicate). |
| Tensile Safety Weight | Device passes total load of 933.65kg for 1 minute when calculated at 85.2% of 135kg. | Device passes total load of 933.65kg for 1 minute (SE to predicate). |
| Elongation | Elongation of break less than 5%. | Elongation of break < 5% (SE to predicate). |
| Wear | Device not impaired by wear. | Neither the predicate nor proposed system is impaired by wear (SE to predicate). |
| Mechanical Strength | Handle a 150kg load for minimum of 1 minute with no deformation or risks. | Both devices can handle a 150kg load for minimum of 1 minute with no deformation or risks (SE to predicate). |
| Mechanical Strength Sitting | Handle a load of 60% of safe working load (min 80kg) for one minute, center 60mm from outer edge. | Device was tested with 90kg for 1 minute and passed (SE to predicate). |
| Dynamic Forces | Handle loads with a total mass of 153.3 kg hanging 150mm and dropped on surface. | Both devices can handle loads with a total mass of 153.3 kg hanging a distance of 150 mm, and then dropped on the surface (SE to predicate). |
| Dosimetric Properties | ||
| Water Equialence Thickness (WET) | 5.22mm (from predicate) | 41.35mm (Predicate: 5.22mm; Device: 41.35mm; Deemed SE. WET value is compensated for in treatment planning software when considered too high. This implies the increased WET is acceptable due to software compensation.) |
| Secondary Radiation | Half-life lower than 1 hour; same half-life of 20 minutes as predicate. No long-lived radio-isotopes. | Both proposed and predicate device experience SE values of secondary radiation, half-life lower than 1 hour, same half-life of 20 minutes. No long-lived radio-isotopes are created (SE to predicate). |
| Spot Size | SE lateral growth in spot size; 1.7-2.2mm both upstream and downstream. | Both devices have SE lateral growth in spot size of a high-energy proton beam as it emerges. Spot sizes are the same 1.7-2.2mm both upstream and downstream (SE to predicate). |
| WET and Distal Dose Falloff | Perform comparably to predicate when a monoenergetic proton beam is directed into a MLIC. | Both devices perform SE when a monoenergetic proton beam of 228.8 MeV is directed into a MLIC. WET is compensated in treatment planning software (SE to predicate). |
Note on "SE" (Substantially Equivalent): The document frequently uses "SE" to indicate that the performance of the proposed device is considered substantially equivalent to the predicate device, even if the numerical values are different (e.g., sag, creep, WET). The justification for "SE" for these differences is provided in the "SE Discussion" column or within the "SE Summary Statement."
Study Information & Acceptance Criteria Details:
The study described is not a clinical effectiveness study, but rather a set of engineering and physical performance tests designed to demonstrate substantial equivalence to a predicate device for regulatory clearance (510(k)). Therefore, many of the typical clinical study parameters (like test sets, ground truth from experts, MRMC, or standalone performance for an AI algorithm) are not applicable here.
1. A table of acceptance criteria and the reported device performance:
- See the table above. The acceptance criteria for many parameters are implicitly defined by the performance of the predicate device, or by general engineering/safety standards (e.g., IEC60601-1). The document states that the HP PRO Positioning Device is "SE" based on these comparisons and justifications.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This is not a clinical study involving patient data. The "test set" consists of physical tests and measurements performed on the device itself. The document does not specify a "sample size" in the traditional sense for these engineering tests. Each test (e.g., sag, creep, mechanical strength, dosimetric properties) would have been performed on one or more units of the HP PRO Positioning Device and compared against the predicate's known performance or against established engineering limits.
- Data provenance is not explicitly stated in terms of country, but the applicant (Orfit Industries NV) is based in Belgium, implying the tests may have been conducted internally or by a contracted lab. The data is prospective in the sense that these tests were conducted on the new device for the purpose of this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable as this is not a clinical study involving expert interpretation of data or images. The "ground truth" for the physical and dosimetric properties would be established through calibrated measuring equipment and standard testing methodologies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no human adjudication process involved in these physical and dosimetric measurements. The evaluation is based on direct comparison to predicate device performance or engineering standards.
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 a patient positioning accessory, not an AI-powered diagnostic or treatment planning system that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" in this context refers to the measured physical properties and dosimetric characteristics of the device, obtained through standardized engineering and radiation physics tests. The predicate device's established performance served as a primary reference for substantial equivalence.
8. The sample size for the training set:
- Not applicable. This device does not involve a "training set" as it is not an AI or machine learning model.
9. How the ground truth for the training set was established:
- Not applicable.
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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
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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
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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)
| Prescription Use (Part 21 CER 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.
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.
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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.
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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.
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SE Table of Attributes
| Basic UnitCharacteristics | Predicate K151207 ProtonImmobilization Solution, OrfitIndustries NV | K171734 HP PRO PositioningDevice, Orfit Industries NV | Difference |
|---|---|---|---|
| Indications for Use | Indicated to assist in the properpositioning and repositioning ofpatients for radiation therapy andradiosurgery and treatment includingelectron, photon, and proton treatments. | Indicated to assist in the properpositioning and repositioning ofpatients for radiation therapy andradiosurgery and treatment withprotons. | Removed treatment with electron,photon from indications sincesubject device is not intended to beused with these therapies. |
| Intended Use | Designed to be used for the positioningand repositioning of patients forreceiving radiation therapy. | Designed to be used for thepositioning and repositioning ofpatients for receiving radiationtherapy. | None |
| Prescription | Rx | Rx | None |
| CFR | 892.5050 | 892.5050 | None |
| Materials ofConstruction | Base plate: Carbon fiberIndexing pins: Stainless steel | Base plate: PMMA and carbon fiberInterface plate: AluminumIndexing pins: POMSheet screws: Stainless steel | No new patient contactingmaterials added to subject device. |
| Fabrication | Machined and creation of sandwichstructure with carbon fiber | Machined and creation of sandwichstructure 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 equivalencethickness | 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-at 60min. | 0.0785mm (135kg distributed load) | 0.214 mm (135kg distributed load) | SE |
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SE Table of Performance
| Performance Category | SE Discussion |
|---|---|
| Patient WeightDistribution IEC60601-1 | Patient lower part of legs not resting/supported by the proposed orpredicate devices, both devices designed for Patients of up to 135kg. |
| Tensile Safety factorIEC60601-1 | Patients 135 kg. weight is to be reduced by $2 \times 7.4% = 14.8%$ sincethe patient lower parts of legs are not supported in both devices.Tensile Safety Factor of 6. |
| Tensile Safety weightIEC60601-1 | 100% - 2 x (7.4%) = 85.2% leads to a total weight of 85.2% of thePatient weight, thus we get 135kg x 0.852= 115kg for both devices,all other tests are for 135kg. Device passes total load of 933.65kg.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 StrengthIEC60601-1 | Both devices can handle a 150kg load to simulate the Patient(135kg) and the accessory (15kg). This weight was distributedaround the Top Layer and carried the weight for minimum of 1minute with no deformation or risks. |
| Mechanical StrengthSitting IEC60601-1 | Both devices can handle a load of 60 % of the safe working loadrepresenting the patient or operator or a minimum 80 kg for oneminute with the center of the load 60 mm from the outer edge ofthe support system. Device was tested with 90kg for 1 minute andpassed. |
| Dynamic ForcesIEC60601-1 | Both devices can handle loads with a total mass of 153.3 kg.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, andabsence of edge or surface damage or cavities meets specifications. |
| Sag | Sum of the sag and creep values (after 60minutes) is lower than25mm. A 6DOF Robotic patient couch top can compensate thebending effect from patient weight. |
| Dimensions | Subject device has dimensions in thickness, length, and width allfalling with specifications and tolerance of 0.1 – 0.2mm. |
| Creep | Sum of the sag and creep values (after 60minutes) is lower than25mm. A 6DOF Robotic patient couch top can compensate thebending effect from patient weight. |
| Secondary radiation | Both proposed and predicate device experience SE values ofsecondary radiation when a patient plan using a typical spotscanning proton plan intended to deliver 1.8 Gy to a target volume ofapproximately 1 liter is simulated. Both have a half-life lower than 1hour. Both have the same half-life of 20 minutes. No long- livedradio-isotopes are created by irradiating an acrylic couch top with ahigh energy proton beam. |
| Performance Category | SE Discussion |
| Spot Size | Both devices have SE lateral growth in spot size of a high-energyproton beam as it emerges. When a single spot of 228.8 MeVprotons is directed through the devices the Gaf Chromic films arescanned and a two- dimensional Gaussian is fit to the exposedbeam spots to determine the minor and major axis lengths of theelliptical beam spot and both spot sizes are the same1.7-2.2mm both upstream and downstream. |
| WET and Distal DoseFalloff | Both devices perform SE when a monoenergetic proton beam of228.8 MeV is directed into a Multi-Layer Ionization Chamber(MLIC). The charge is collected on each plane of the device andplotted against water equivalent depth to construct an integrateddepth dose curve. The distal R80 (Depth of 80% dose) is recorded,as well as the distal falloff (distance between distal 90% and 20%dose levels). WET value of product that beam passes through iscompensated for in treatment planning software, when it isconsidered too high. |
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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.
§ 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.