(43 days)
No
The device description and performance studies focus on mechanical properties and patient positioning, with no mention of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is described as assisting in the proper positioning of patients for radiation therapy, radiosurgery, and treatment with protons. It is an accessory to an immobilization solution and functions as an extension of the treatment table, supporting the patient during treatment. It does not directly provide therapy or affect the patient's body in a therapeutic manner.
No
The device is a positioning device used to assist in the proper positioning and repositioning of patients for radiation therapy and radiosurgery. It is an accessory to an immobilization solution and acts as an extension of the treatment table. Its function is to support patients and ensure correct positioning for therapeutic procedures, not to diagnose a condition.
No
The device description explicitly lists physical components (Base Plate, Interface, Indexing Pins, Sheet Screws) made of materials like PMMA, Carbon Fiber, Aluminum, POM, and Stainless Steel. It also describes the physical process of attaching the device to a couch and positioning patients on it. Performance studies focus on mechanical properties and physical interactions, not software performance.
Based on the provided information, the HP PRO Positioning Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "assist in the proper positioning of patients for radiation therapy and radiosurgery and treatment with protons." This is a physical positioning aid for a medical treatment, not a diagnostic test performed on biological samples.
- Device Description: The description details a physical device made of materials like PMMA, Carbon Fiber, Aluminum, POM, and Stainless Steel, used to support and position a patient on a treatment table. It does not involve the analysis of biological specimens.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The HP PRO Positioning Device is clearly described as an accessory for patient positioning during radiation therapy, which is a therapeutic procedure, not a diagnostic one.
N/A
Intended Use / Indications for Use
The HP PRO Positioning Device is indicated to assist in the proper positioning of patients for radiation therapy and radiosurgery and treatment with protons.
Product codes
IYE
Device 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.
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. .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The HP PRO Positioning Device is intended to be used by or under the direction of a licensed physician.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
The device passed tests for Patient Weight Distribution (up to 135kg), Tensile Safety factor (6), Tensile Safety weight (933.65kg for 1 minute), Elongation (less than 5%), Mechanical Strength (handle 150kg load for 1 minute), Mechanical Strength Sitting (handle 90kg for 1 minute), Dynamic Forces (handle 153.3 kg loads), Flatness Test (Delta
§ 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.
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)
| 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.
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.
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SE Table of Attributes
| Basic Unit
Characteristics | Predicate K151207 Proton
Immobilization Solution, Orfit
Industries NV | K171734 HP PRO Positioning
Device, Orfit Industries NV | Difference |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Indicated to assist in the proper
positioning and repositioning of
patients for radiation therapy and
radiosurgery and treatment including
electron, photon, and proton treatments. | Indicated to assist in the proper
positioning and repositioning of
patients for radiation therapy and
radiosurgery and treatment with
protons. | Removed treatment with electron,
photon from indications since
subject device is not intended to be
used with these therapies. |
| Intended Use | Designed to be used for the positioning
and repositioning of patients for
receiving radiation therapy. | Designed to be used for the
positioning and repositioning of
patients for receiving radiation
therapy. | None |
| Prescription | Rx | Rx | None |
| CFR | 892.5050 | 892.5050 | None |
| Materials of
Construction | Base plate: Carbon fiber
Indexing pins: Stainless steel | Base plate: PMMA and carbon fiber
Interface plate: Aluminum
Indexing pins: POM
Sheet screws: Stainless steel | No new patient contacting
materials added to subject device. |
| Fabrication | Machined and creation of sandwich
structure with carbon fiber | Machined and creation of sandwich
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
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
-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 Weight | |
| Distribution IEC60601-1 | Patient lower part of legs not resting/supported by the proposed or |
| predicate devices, both devices designed for Patients of up to 135 | |
| kg. | |
| Tensile Safety factor | |
| IEC60601-1 | Patients 135 kg. weight is to be reduced by $2 \times 7.4% = 14.8%$ since |
| the patient lower parts of legs are not supported in both devices. | |
| Tensile Safety Factor of 6. | |
| Tensile Safety weight | |
| IEC60601-1 | 100% - 2 x (7.4%) = 85.2% leads to a total weight of 85.2% of the |
| Patient 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 Strength | |
| IEC60601-1 | Both devices can handle a 150kg load to simulate the Patient |
| (135kg) and the accessory (15kg). This weight was distributed | |
| around the Top Layer and carried the weight for minimum of 1 | |
| minute with no deformation or risks. | |
| Mechanical Strength | |
| Sitting IEC60601-1 | Both devices can handle a load of 60 % of the safe working load |
| representing the patient or operator or a minimum 80 kg for one | |
| minute with the center of the load 60 mm from the outer edge of | |
| the support system. Device was tested with 90kg for 1 minute and | |
| passed. | |
| Dynamic Forces | |
| IEC60601-1 | 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 $\Delta$ |