Interlocked Circular Small Field Collimators, Elekta Integrated

K161984 · Aktina Medical Corporation · IYE · Sep 27, 2016 · Radiology

Device Facts

• Record ID: K161984
• Device Name: Interlocked Circular Small Field Collimators, Elekta Integrated
• Applicant: Aktina Medical Corporation
• Product Code: IYE · Radiology
• Decision Date: Sep 27, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Tertiary collimation system for digital medical linear accelerators (LINAC); consists of cone inserts and mounting adapter. Inserts create small circular fields for radiation therapy/stereotactic radiosurgery. Adapter mounts into LINAC beam block tray; cones inserted/removed without adapter removal. Each cone uniquely identified electronically; system interfaces with LINAC beam block tray electronic interlock to prevent irradiation if cone size mismatches treatment plan. Used in hospital radiation therapy suites; operated by radiation therapy staff. Ensures precise beam shaping for tumor/lesion treatment; interlock prevents delivery of incorrect dose/field size, enhancing patient safety.

Clinical Evidence

Bench testing only. No clinical data. Testing verified functional, performance, and safety requirements, including compatibility with specified LINACs, risk management per ISO 14971, and adherence to IEC 60601-1, 60601-2-1, and 62366-1 standards.

Technological Characteristics

Tertiary collimation system; mounting adapter (aluminum, stainless steel, brass, copper, PCB, cabling) and conical collimator inserts (lead, stainless steel). Mechanical interface to LINAC; electronic cone size detection and interlock control. Non-sterile; no patient contact. Compliant with IEC 60601-1, 60601-2-1, 62366-1, and ISO 14971.

Indications for Use

Indicated for patients requiring external beam radiation therapy or stereotactic radiosurgery of cranial or extra-cranial regions for treatment of tumors or lesions.

Regulatory Classification

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.

Predicate Devices

• Integrated Conical Collimator Verification and Interlock system (ICVI) (K123788)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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) | <div> </div> |
|----------------------------------------------|--------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> </div> |

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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 Name<br>and Address: | Aktina Medical Corporation<br>360 North Route 9 W<br>Congers, New York, 10920<br>Phone: [phone]<br>Fax: [phone]<br>Registration Number: 2436865 |
| Contact Person: | Tony Spaccarotella, Director, QA/RA |
| Date Prepared: | July 18, 2016 |

#### 4. Classification

2.

3.

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

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.

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#### 7. Intended Use

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.

#### Technological Characteristics 8.

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

| Item | Predicate Device, K123788<br>Integrated Conical Collimator<br>Verification and Interlock system (ICVI)<br>Varian Medical Systems | This 510(k) Submission<br>Aktina Circular Small Field Collimators,<br>Elekta Integrated, 50-370<br>Aktina Medical Corp. | Equivalent<br>or Better<br>for<br>Intended<br>Use? |
|------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| 1. | Design: For compatible Linear Accelerators<br>(LINAC) for attenuation of the beam to<br>create small circular fields. | Design: For compatible Linear Accelerators<br>(LINAC) for attenuation of the beam to<br>create small circular fields. | Equivalent |
| 2. | Components: Mounting Adapter and<br>Conical Collimators (7 sizes, 2.5 mm<br>increments) | Components: Mounting Adapter and<br>Conical Collimators (37 sizes, 1 mm<br>increments) | Better |
| 3. | Technology:<br>a. Tertiary small field circular collimation<br>b. Mechanical mounting interface at LINAC<br>c. Automated, electronic collimator cone size<br>detection and interlock control.<br>d. LINAC jaws are electronically verified. | Technology:<br>a. Tertiary small field circular collimation<br>b. Mechanical mounting interface at LINAC<br>c. Automated, electronic collimator cone size<br>detection and interlock control.<br>d. LINAC jaws are electronically verified. | a. Equivalent<br>b. Equivalent<br>c. Equivalent<br>d. Equivalent |
| 4. | Materials:<br>a. Mounting Adapter Materials:<br>Aluminum, Stainless Steel, Brass,<br>Copper, PCB, Cabling | Materials:<br>a. Mounting Adapter Materials:<br>Aluminum, Stainless Steel, Brass,<br>Copper, PCB, Cabling | a. Equivalent |
| | b. Collimator Cone Insert Materials:<br>Tungsten and Aluminum | b. Conical Collimator Materials:<br>Lead and Stainless Steel | b.Equivalent |
| 5. | Biocompatibility:<br>Not applicable. No patient contact. | Biocompatibility:<br>Not applicable. No patient contact. | Not<br>applicable |
| 6. | Sterility: Non-sterile. | Sterility: Non-sterile. | Not<br>applicable |
| 7. | Compatibility with Environment<br>Environment during use is a linear<br>accelerator suite in the radiation therapy | Compatibility with Environment<br>Environment during use is a linear<br>accelerator suite in the radiation therapy | Equivalent |
| | department of a hospital or similar<br>environment. | department of a hospital or similar<br>environment. | |
| 8. | Compatibility with Other Devices<br>Does not attach or electrically connect to any<br>other devices except the linear accelerators<br>described in the manufacturer's labeling. | Compatibility with Other Devices<br>Does not attach or electrically connect to any<br>other devices except the linear accelerators<br>described in the manufacturer's labeling. | Equivalent |
| 9. | Electrical / Mechanical / Radiation Safety<br>Compliant with applicable IEC safety,<br>usability and performance standards and ISO<br>14971 Risk management Standard. | Electrical / Mechanical / Radiation Safety<br>Compliant with applicable IEC safety,<br>usability and performance standards and ISO<br>14971 Risk management Standard. | Equivalent |
| 10. | Chemical / Thermal Safety<br>Not applicable. The device does not generate<br>or contain hazardous chemicals or thermal<br>energy. | Chemical / Thermal Safety<br>Not applicable. The device does not generate<br>or contain hazardous chemicals or thermal<br>energy. | 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.