The Circular Small Field Collimators, Elekta Integrated, are intended for use with the Elekta line of digital medical linear accelerators (LINAC) for the creation of small circular fields. These fields are used for patients who require external beam radiation therapy or stereotactic radiosurgery of the cranial or extra cranial regions for the treatment of tumors or lesions.

Device Description

This is a Traditional 510(k) that describes the Circular Small Field Collimators, Elekta Integrated, 50-370, a tertiary collimation system used in conjunction with digital medical linear accelerators (LINAC) for external beam radiation therapy. It consists of collimator cone inserts and a cone insert mounting adapter. The collimator cone inserts create small circular fields of various sizes. Each cone insert is uniquely identified with the diameter in millimeters on the top and bottom covers. The cone mounting adapter is inserted directly into the beam block tray slot of the LINAC head without any need for modification to the LINAC. The collimator cones are easily inserted into and removed from the mounting adapter without removing the adapter from the LINAC. The collimator cone inserts are also uniquely identified electronically, and use the LINAC beam block tray electronic interlock to prevent irradiation, if the cone insert size does not conform to the treatment plan.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "Circular Small Field Collimators, Elekta Integrated." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance of an AI/algorithm. Therefore, much of the requested information regarding AI study specifics cannot be extracted.

However, I can extract information related to the device's performance validation as described in this regulatory submission.

Summary of Device Performance and Validation:

The document describes the device as tertiary collimation system used with linear accelerators for creating small circular radiation fields for radiation therapy. The validation focused on demonstrating that the device meets functional, performance, safety, and labeling requirements, and performs comparably to or better than the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a medical hardware device (collimators) and not an AI/software algorithm, the "acceptance criteria" are not reported as statistical performance metrics (like sensitivity, specificity, or AUC) against a ground truth dataset in the way an AI study would. Instead, the acceptance criteria are met through compliance with established standards and successful functional and safety testing.

Acceptance Criterion (Category)	Specific Requirement / Standard Met	Reported Device Performance
Functional & Performance	All specified functional and performance requirements	The device performs its intended function of creating small circular fields for radiation therapy. The device offers 37 sizes (1 mm increments) compared to the predicate's 7 sizes (2.5 mm increments), indicating better performance in terms of flexibility and precision.
Safety	All specified safety requirements, ISO 14971 Risk Management, IEC 60601-1, IEC 60601-2-1, IEC 62366-1	Compliant with applicable IEC safety, usability, and performance standards and ISO 14971 Risk Management Standard. No new issues of safety or effectiveness introduced. Electrical/Mechanical/Radiation Safety confirmed.
Labeling	All specified labeling requirements	Met
Compatibility	Use and performance with specified linear accelerators (LINACs) and accessories	Compatible with Elekta linear accelerators and performs as specified with them. Does not attach or electrically connect to any other devices except the linear accelerators described in the manufacturer's labeling.
Biocompatibility	No patient contact; not applicable	Not applicable. No patient contact.
Sterility	Non-sterile	Non-sterile. Not applicable.
Environment	Suitable for LINAC suite in radiation therapy department	Compatible with environment of a linear accelerator suite in a hospital radiation therapy department.
Substantial Equivalence	Comparable to or better than predicate device (K123788) in design, intended use, technological, physical, safety, compatibility, and performance characteristics.	The testing has demonstrated substantial equivalence or better. The device's technological characteristics are largely equivalent, with an improvement in the number of available collimator sizes.

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

This information is not applicable as the document describes the validation of a hardware medical device (collimators) and not a data-driven AI/software device. The "test set" would refer to specific physical device units and their components being tested, rather than a dataset. The document does not specify the number of collimator units tested or the specific provenance of any data beyond compliance with standards and physical testing.

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

This information is not applicable. For this hardware device, "ground truth" is established by engineering specifications, physical measurements, and adherence to established medical device standards, rather than expert consensus on diagnostic interpretations. The document refers to "hardware specification testing" and assessment against ISO and IEC standards.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for resolving discrepancies in expert interpretations during the establishment of ground truth for image-based diagnostic AI studies. The validation of this hardware device does not involve such a process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

This information is not applicable. An MRMC study is used to evaluate the impact of an AI system on human reader performance. This document concerns a hardware device, not an AI system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

This information is not applicable. This device is a hardware component, not an algorithm. Therefore, a standalone algorithm performance study was not conducted.

7. The Type of Ground Truth Used

For this device, the "ground truth" is based on:

Engineering Specifications: The design and manufacturing specifications for the collimators (e.g., precise diameter sizes, material composition).
Physical Measurements: Verification of the actual performance (e.g., field size accuracy, beam attenuation) against these specifications.
Compliance with Standards: Adherence to recognized national and international medical device safety and performance standards (e.g., ISO 14971, IEC 60601-1, IEC 60601-2-1, IEC 62366-1).
Comparative Performance to Predicate: Demonstrating that the device performs "as well as or better than" the predicate device based on its design, intended use, and functional characteristics.

8. The Sample Size for the Training Set

This information is not applicable. This hardware device does not involve machine learning or AI, and therefore does not have a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for this hardware device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 27, 2016

Aktina Medical Corporation % Mr. Tony Spaccarotella Director, Quality Assurance/Regulatory Affairs 360 North Route 9W CONGERS NY 10920

Re: K161984

Trade/Device Name: Circular Small Field Collimators, Elekta Integrated Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 18, 2016 Received: July 19, 2016

Dear Mr. Spaccarotella:

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 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.

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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/Resourcesfor You/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 yours.

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) K161984

Device Name

Circular Small Field Collimators, Elekta Integrated

Indications for Use (Describe)

The Circular Small Field Collimators, Elekta Integrated, are intended for use with the Elektal Iinear accelerators (LINAC) for the creation of small circular fields. These fields are used for patients who require external beam radiation therapy or stereotactic radiosurgery of the cranial regions for the treatment of tumors or lesions.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

In Compliance with 21 CFR Section 807.92(c)

1. General Provisions

Device Trade Name:	Circular Small Field Collimators, Elekta Integrated
Common Name:	Circular Small Field Collimators
Owner Nameand Address:	Aktina Medical Corporation360 North Route 9 WCongers, New York, 10920Phone: 845-268-0101Fax: 845-268-1700Registration Number: 2436865
Contact Person:	Tony Spaccarotella, Director, QA/RA
Date Prepared:	July 18, 2016

4. Classification

This device is classified as a class II device according to 21 CFR 892.5050, "Medical chargedparticle radiation therapy system." The product code is IYE.

5. Predicate Device

Integrated Conical Collimator Verification and Interlock system (ICVI), 510(k) No. K123788, Varian Medical Systems, 3100 Hansen Way, Palo Alto, CA 94304 USA

6. Description

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7. Intended Use

Technological Characteristics 8.

The Table below compares the technological characteristics of the Aktina Circular Small Field Collimators to the Predicate Device:

Item	Predicate Device, K123788Integrated Conical CollimatorVerification and Interlock system (ICVI)Varian Medical Systems	This 510(k) SubmissionAktina Circular Small Field Collimators,Elekta Integrated, 50-370Aktina Medical Corp.	Equivalentor BetterforIntendedUse?
1.	Design: For compatible Linear Accelerators(LINAC) for attenuation of the beam tocreate small circular fields.	Design: For compatible Linear Accelerators(LINAC) for attenuation of the beam tocreate small circular fields.	Equivalent
2.	Components: Mounting Adapter andConical Collimators (7 sizes, 2.5 mmincrements)	Components: Mounting Adapter andConical Collimators (37 sizes, 1 mmincrements)	Better
3.	Technology:a. Tertiary small field circular collimationb. Mechanical mounting interface at LINACc. Automated, electronic collimator cone sizedetection and interlock control.d. LINAC jaws are electronically verified.	Technology:a. Tertiary small field circular collimationb. Mechanical mounting interface at LINACc. Automated, electronic collimator cone sizedetection and interlock control.d. LINAC jaws are electronically verified.	a. Equivalentb. Equivalentc. Equivalentd. Equivalent
4.	Materials:a. Mounting Adapter Materials:Aluminum, Stainless Steel, Brass,Copper, PCB, Cabling	Materials:a. Mounting Adapter Materials:Aluminum, Stainless Steel, Brass,Copper, PCB, Cabling	a. Equivalent
	b. Collimator Cone Insert Materials:Tungsten and Aluminum	b. Conical Collimator Materials:Lead and Stainless Steel	b.Equivalent
5.	Biocompatibility:Not applicable. No patient contact.	Biocompatibility:Not applicable. No patient contact.	Notapplicable
6.	Sterility: Non-sterile.	Sterility: Non-sterile.	Notapplicable
7.	Compatibility with EnvironmentEnvironment during use is a linearaccelerator suite in the radiation therapy	Compatibility with EnvironmentEnvironment during use is a linearaccelerator suite in the radiation therapy	Equivalent
	department of a hospital or similarenvironment.	department of a hospital or similarenvironment.
8.	Compatibility with Other DevicesDoes not attach or electrically connect to anyother devices except the linear acceleratorsdescribed in the manufacturer's labeling.	Compatibility with Other DevicesDoes not attach or electrically connect to anyother devices except the linear acceleratorsdescribed in the manufacturer's labeling.	Equivalent
9.	Electrical / Mechanical / Radiation SafetyCompliant with applicable IEC safety,usability and performance standards and ISO14971 Risk management Standard.	Electrical / Mechanical / Radiation SafetyCompliant with applicable IEC safety,usability and performance standards and ISO14971 Risk management Standard.	Equivalent
10.	Chemical / Thermal SafetyNot applicable. The device does not generateor contain hazardous chemicals or thermalenergy.	Chemical / Thermal SafetyNot applicable. The device does not generateor contain hazardous chemicals or thermalenergy.	Equivalent

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9. Performance Standards and Data

The FDA under Section 514 of the Food, Drug and Cosmetic Act has not established performance standards for this product

Hardware specification testing has been performed for this device to show that the verification, validation and safety requirements have been met regarding:

All specified functional, performance, safety and labeling requirements, ●
Use and performance with the linear accelerators and accessories specified, ●
Assessment against ISO 14971 Risk Management requirements, ●
. Assessment against applicable sections of these IEC Standards: 60601-1, Medical Electrical Equipment. General requirements for basic safety and essential performance; 60601-2-1, Basic safety and essential performance of electron accelerators in the range 1 Mev to 50 Mev; 62366-1, Application of usability engineering to medical devices.

This device does not contain software.

The testing has demonstrated substantial equivalence or better when compared to the predicate device.

10. Biocompatibility

Not applicable. There are no patient contact components.

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11. Summary of Substantial Equivalence

The Circular Small Field Collimators, Elekta Integrated, 50-370, is at least substantially equivalent to the predicate device in design, intended use, and all other technological, physical, safety, compatibility, and performance characteristics. The testing results have demonstrated that the device performs as well as or better than the predicate device. No new issues of safety or effectiveness are introduced by using this device. Therefore, Aktina Medical Corp. believes that the Circular Small Field Collimators, Elekta Integrated, 50-370, is substantially equivalent to the predicate device.

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.