(140 days)
Not Found
No
The device description focuses on the manufacturing process of physical beam-shaping components based on designs provided by a separate treatment planning system. There is no mention of AI/ML being used in the design generation or manufacturing process itself.
Yes
The device directly modifies the proton beam for radiation therapy, which is a therapeutic intervention for cancer treatment.
No
This device, consisting of apertures and range compensators, is used to shape and control a proton beam during radiation therapy. It is part of the treatment delivery system and does not gather or interpret data about a patient's health condition to determine a diagnosis.
No
The device description clearly states that the device is a physical aperture made of brass and a range compensator made of acrylic or wax. These are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The described device (proton radiation therapy beam-shaping aperture and range compensator) is used externally to shape and control a proton beam for cancer treatment. It does not analyze or interact with specimens taken from the patient's body.
- Intended Use: The intended use is to modify the delivery of external beam proton radiation therapy, not to diagnose or monitor a condition through analysis of biological samples.
Therefore, this device falls under the category of a therapeutic device used in radiation oncology, not an IVD.
N/A
Intended Use / Indications for Use
Proton Systems' proton radiation therapy beam-shaping aperture and range compensator manufacturing service manufactures the solid apertures and range compensators for intensity modulation of external beam proton radiation therapy. The apertures and range compensators are designed by the customer's treatment planning system to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.
Product codes (comma separated list FDA assigned to the subject device)
IXI
Device Description
Proton Systems manufactures radiation therapy beam-shaping apertures and range compensators to customer patient-specific specifications.
In proton therapy for cancer, a proton beam is aimed at the cancerous tissue using a large "snout". The snout is rotated around the patient using a large, three-story gantry. While the patient lies on a treatment table, the gantry rotates around and points the snout at predetermined positions to maximize efficiency and dose delivery to the tumor volume. Each gantry angle, or port, requires two custom-made, beam-modifying patient-specific devices: an aperture and a range compensator.
The aperture is inserted into the gantry's snout to shape and focus the proton beam as it exits the gantry en route to the targeted area. The aperture is made of brass 360 with a 2D pattern / hole cut out of it, which defines the area that is to be treated with the proton beam. The range compensator is made of acrylic or wax and controls the depth at which the proton beam energy is delivered. The custom shape and design for apertures and range compensators are generated out of the hospital's treatment planning software and are unique to each patient and each gantry angle (most patients will have two to three different gantry angles).
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
Not Found
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)
Non-Clinical Testing: Testing to support this submission can be found in Appendix 5 - Performance Testing.
Clinical Testing: There was no clinical testing required to support the medical device as the indications for use are equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
OCT 23 2012
SECTION 5 - 510(k) Summary for Radiation Therapy Beam-Shaping Aperture and Range Compensator
1. Submission Sponsor
Proton Systems 2901 Danese St Jacksonville, FL 32206 Tel: (904) 633-5001 Fax: (904) 633-6060 Contact: Shawn Lednick, President www.protonsystems.com/
2. Submission Correspondent
Emergo Group 611 West 5th Street, Third Floor Austin, TX 78701 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Mike Begala, Emergo Group Senior Consultant Email: project.management@emergogroup.com
3. Date Prepared
25 May 2012
4. Device Name
Trade/Proprietary Name: Proton radiation therapy beam-shaping aperture and range compensator
Common/Usual Name: Proton radiation therapy beam-shaping aperture and range compensator
Classification Name: Radiation Therapy Beam-Shaping Block
Classification Requlation: 892.5710
Classification Panel: Radiology
Product Code: IXI Device Class: II
Page 1 of 5
1
5. Predicate Devices
6. Device Description
Proton Systems manufactures radiation therapy beam-shaping apertures and range compensators to customer patient-specific specifications.
In proton therapy for cancer, a proton beam is aimed at the cancerous tissue using a large "snout". The snout is rotated around the patient using a large, three-story gantry. While the patient lies on a treatment table, the gantry rotates around and points the snout at predetermined positions to maximize efficiency and dose delivery to the tumor volume. Each gantry angle, or port, requires two custom-made, beam-modifying patient-specific devices: an aperture and a range compensator.
The aperture is inserted into the gantry's snout to shape and focus the proton beam as it exits the qantry en route to the targeted area. The aperture is made of brass 360 with a 2D pattern / hole cut out of it, which defines the area that is to be treated with the proton beam. The range compensator is made of acrylic or wax and controls the depth at which the proton beam energy is delivered. The custom shape and design for apertures and range compensators are generated out of the hospital's treatment planning software and are unique to each patient and each gantry angle (most patients will have two to three different gantry angles).
7. Intended Use
Proton Systems' proton radiation therapy beam-shaping aperture and range compensator manufacturing service manufactures the solid apertures and range compensators for intensity modulation of external beam proton radiation therapy. The apertures and range compensators are designed by the customer's treatment planning system to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.
2
8. Technological Characteristics and Substantial Equivalence
The following Table 5.1 compares the Proton Systems proton radiation therapy beam-shaping aperture and range compensator to the Predicate Devices with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
| Table 5.1
| Substantial Equivalence Comparison | ||
|---|---|---|
| Proton Systems, Inc. | . Decimal, Inc. | |
| Trade Name | Proton radiation therapy | |
| beam-shaping aperture | ||
| and range compensator | . Decimal Aperture | |
| . Decimal Range | ||
| Compensator | ||
| Product Code | IXI | IXI |
| Regulation | ||
| Number | 892.5710 | 892.5710 |
| Regulation | ||
| Name | Radiation Therapy Beam- | |
| Shaping Block | Radiation Therapy Beam- | |
| Shaping Block | ||
| 510(k) Numbers | TBD | K071077 - Dot Decimal |
| Aperture, | ||
| K071078 - Dot Decimal | ||
| Range Compensator | ||
| Indications for | ||
| Use | Proton Systems' proton | |
| radiation therapy beam- | ||
| shaping aperture and | ||
| range compensator | ||
| manufacturing service | ||
| manufactures the solid | ||
| apertures and range | ||
| compensators for intensity | ||
| modulation of external | ||
| beam proton radiation | ||
| therapy. The apertures | ||
| and range compensators | ||
| are designed by the | ||
| customer's treatment | .decimal's Aperture | |
| manufacturing service | ||
| manufactures the solid | ||
| apertures for intensity | ||
| modulation of external | ||
| beam proton radiation | ||
| therapy. The apertures are | ||
| designed by the customer's | ||
| treatment planning system | ||
| to block radiation from | ||
| hitting critical structures and | ||
| healthy tissue while guiding | ||
| the radiation to the targeted | ||
| area | ||
| Table 5.1 | ||
| Substantial Equivalence Comparison | ||
| Proton Systems, Inc. | Decimal, Inc. | |
| planning system to block | ||
| radiation from hitting | ||
| critical structures and | ||
| healthy tissue while | ||
| guiding the radiation to the | ||
| targeted area. | decimal's Range | |
| Compensator | ||
| manufacturing service | ||
| manufactures the solid | ||
| Range | ||
| Compensators for intensity | ||
| modulation of external | ||
| beam proton radiation | ||
| therapy. The Range | ||
| Compensator are designed | ||
| by the customer's treatment | ||
| planning system to | ||
| block radiation from hitting | ||
| critical structures and | ||
| healthy tissue while guiding | ||
| the radiation to the targeted | ||
| area. | ||
| Type of | ||
| Radiation | ||
| Product is | ||
| Intended for | Proton Beam | Proton Beam |
| Device Material | Aperture - Brass 360 | Aperture - Brass 360 |
| Range Compensator - | ||
| Machinable Wax or Acrylic | Range Compensator - | |
| Machinable Wax or Acrylic | ||
| Device Sizes | 30 x 40 cm | |
| 100 cm | ||
| 180 cm | ||
| 250 cm | 30 x 40 cm | |
| 100 cm | ||
| 180 cm | ||
| 250 cm | ||
| Single Use | No | No |
| Supplied Sterile | No | No |
| Requires | ||
| Sterilization | No | No |
3
4
Proton Systems
Traditional 510(k) Premarket Submission Radiation Therapy Beam-Shaping Aperture and Range Compensator
9. Non-Clinical Testing
Testing to support this submission can be found in Appendix 5 - Performance Testing.
10. Clinical Testing
There was no clinical testing required to support the medical device as the indications for use are equivalent to the predicate device.
11. Conclusion
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics, and it can be demonstrated that the device is as safe and effective as the predicate device, and that the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device.
It has been shown in this 510(k) submission that the differences between the proton radiation therapy beam-shaping aperture and range compensator manufactured by Proton Systems and the predicate devices listed are insignificant and do not raise any questions regarding its safety and effectiveness. The subject device, as designed and manufactured, is as safe and effective as the predicate devices for their intended application; that is, as a radiation therapy beam-shaping block, and therefore is determined to be substantially equivalent to the referenced predicate devices in the context of that application.
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Image /page/5/Picture/0 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings. The emblem is positioned in the center of the circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle's perimeter.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
2 3 2012
Proton Systems % Mr. Mike Begala Senior Consultant Emego Group, Inc. 611 West 5th Street, Third Floor AUSTIN TX 78701
Re: K121657
Trade/Device Name: Radiation Therapy Aperture and Range Compensator Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 12, 2012 Received: September 12, 2012
Dear Mr. Begala:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
)
6
Page 2
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
7
INDICATIONS FOR USE
510(k) Number (if known): آڪٽ ا 2 ان کي ا 2 ا
Device Name
Radiation Therapy Aperture and Range Compensator
Indications for Use
Proton Systems' proton radiation therapy beam-shaping aperture and range compensator manufacturing service manufactures the solid apertures and range compensators for intensity modulation of external beam proton radiation therapy. The apertures and range compensators are designed by the customer's treatment planning system to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 CFR 801 Subpart C)
Page Page
of
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)_ Concurrence of CDRH, Office of Device Evaluation (ODE)
Muhammed Dóani
(Division Sign Off Division of Radiological Hea Office of In Vitro Diagnostics and Radiological Heatth
510(k K121657