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.

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).

AI/ML Overview

The provided text describes a 510(k) submission for a Radiation Therapy Beam-Shaping Aperture and Range Compensator (K121657). This submission is centered on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through novel studies.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics from a formal device performance study in the way one might expect for a new, unproven technology. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to an existing legally marketed device.

Acceptance Criteria (Implicit)	Reported Device Performance
Same Intended Use as Predicate Device	Met: "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... and range compensator manufacturing service manufactures the solid Range Compensators for intensity modulation of external beam proton radiation therapy." (Matches predicate device indications for use.)
Same Technological Characteristics as Predicate Device	Met: Device material (Brass 360 for aperture, Machinable Wax or Acrylic for range compensator), device sizes (30 x 40 cm, 100 cm, 180 cm, 250 cm), type of radiation (Proton Beam), single use (No), supplied sterile (No), requires sterilization (No) are all identical to the predicate devices.
As Safe and Effective as Predicate Device	Claimed: "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..."
Does Not Raise Different Questions Regarding Safety and Effectiveness as Compared to Predicate Device	Claimed: "...and do not raise any questions regarding its safety and effectiveness."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not applicable in the context of an equivalence claim based on comparison of specifications.
Data Provenance: The submission relies on a comparison table of technological characteristics to already cleared devices (K071077 and K071078). It does not involve a "test set" of patient data in the sense of a clinical or performance study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. There was no "test set" requiring expert ground truth establishment for this type of submission.

4. Adjudication Method for the Test Set:

Not applicable. There was no "test set" requiring adjudication.

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 physical beam-shaping aperture and range compensator used in proton radiation therapy, not an AI-assisted diagnostic or treatment planning software requiring human reader evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical component, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. The ground truth for this submission is the established safety and effectiveness of the predicate devices, which have already gone through their own clearance processes. The current submission demonstrates that the new device is fundamentally the same.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. As above, no training set was used.

Summary of the Study (Non-Clinical Testing):

The "study" described in the document is a non-clinical comparison to predicate devices (K071077 and K071078).

Section 9. Non-Clinical Testing: States "Testing to support this submission can be found in Appendix 5 - Performance Testing." However, Appendix 5 is not provided in the excerpt. Based on the overall context of a 510(k) for a substantially equivalent device, this "Performance Testing" would likely involve engineering verification (e.g., dimensional accuracy, material properties, mechanical integrity) to ensure the manufactured devices meet the specifications required for their intended function, and that these specifications are equivalent to or better than the predicate devices. It would not involve clinical outcomes or expert reader studies.
Section 10. Clinical Testing: Explicitly states, "There was no clinical testing required to support the medical device as the indications for use are equivalent to the predicate device." This reinforces that the submission hinges on substantial equivalence based on technological characteristics and intended use.

In essence, this submission is a declaration that the new device is functionally identical to existing, cleared devices, and therefore, all existing safety and effectiveness data for those predicate devices apply to the new device.

Summary

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K121657

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

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5. Predicate Devices

1. . Decimal Aperture K071077
1. . Decimal Range Compensator K071078

6. Device Description

Proton Systems manufactures radiation therapy beam-shaping apertures and range compensators to customer patient-specific specifications.

7. Intended Use

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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 5.1Substantial Equivalence Comparison
	Proton Systems, Inc.	. Decimal, Inc.
Trade Name	Proton radiation therapybeam-shaping apertureand range compensator	. Decimal Aperture. Decimal RangeCompensator
Product Code	IXI	IXI
RegulationNumber	892.5710	892.5710
RegulationName	Radiation Therapy Beam-Shaping Block	Radiation Therapy Beam-Shaping Block
510(k) Numbers	TBD	K071077 - Dot DecimalAperture,K071078 - Dot DecimalRange Compensator
Indications forUse	Proton Systems' protonradiation therapy beam-shaping aperture andrange compensatormanufacturing servicemanufactures the solidapertures and rangecompensators for intensitymodulation of externalbeam proton radiationtherapy. The aperturesand range compensatorsare designed by thecustomer's treatment	.decimal's Aperturemanufacturing servicemanufactures the solidapertures for intensitymodulation of externalbeam proton radiationtherapy. The apertures aredesigned by the customer'streatment planning systemto block radiation fromhitting critical structures andhealthy tissue while guidingthe radiation to the targetedarea
Table 5.1Substantial Equivalence Comparison
	Proton Systems, Inc.	Decimal, Inc.
	planning system to blockradiation from hittingcritical structures andhealthy tissue whileguiding the radiation to thetargeted area.	decimal's RangeCompensatormanufacturing servicemanufactures the solidRangeCompensators for intensitymodulation of externalbeam proton radiationtherapy. The RangeCompensator are designedby the customer's treatmentplanning system toblock radiation from hittingcritical structures andhealthy tissue while guidingthe radiation to the targetedarea.
Type ofRadiationProduct isIntended 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 cm100 cm180 cm250 cm	30 x 40 cm100 cm180 cm250 cm
Single Use	No	No
Supplied Sterile	No	No
RequiresSterilization	No	No

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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

)

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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

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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

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 CFR 801 Subpart C)

Page Page

(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

Regulation Number and Section

§ 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.