(70 days)
No
The device description and performance studies focus on hardware specifications, mechanical function, and safety interlocks. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML applications in medical devices.
Yes.
The device is used to create small circular fields for external beam radiation therapy or stereotactic radiosurgery for the treatment of tumors or lesions, which are therapeutic applications.
No
The device is described as a "tertiary collimation system used in conjunction with digital medical linear accelerators (LINAC) for external beam radiation therapy" to create "small circular fields" for the "treatment of tumors or lesions." This indicates a therapeutic function, not a diagnostic one.
No
The device description explicitly states it consists of "collimator cone inserts and a cone insert mounting adapter," which are physical hardware components. The performance studies also focus on hardware specification testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "external beam radiation therapy or stereotactic radiosurgery of the cranial or extra cranial regions for the treatment of tumors or lesions." This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a physical component (collimators and adapter) used to shape radiation beams. It does not involve the examination of specimens derived from the human body for diagnostic purposes, which is the core definition of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the Circular Small Field Collimators, Elekta Integrated, are a therapeutic device used in radiation oncology, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
IYE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial regions or extra cranial regions
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
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.
The testing has demonstrated substantial equivalence or better when compared to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing right, stacked on top of each other. The profiles are stylized and appear to be connected, forming a single, flowing shape.
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 Name | |
| and Address: | Aktina Medical Corporation |
| 360 North Route 9 W | |
| Congers, New York, 10920 | |
| Phone: 845-268-0101 | |
| Fax: 845-268-1700 | |
| Registration 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
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
Integrated Conical Collimator
Verification and Interlock system (ICVI)
Varian Medical Systems | This 510(k) Submission
Aktina Circular Small Field Collimators,
Elekta Integrated, 50-370
Aktina Medical Corp. | Equivalent
or Better
for
Intended
Use? |
|------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| 1. | Design: For compatible Linear Accelerators
(LINAC) for attenuation of the beam to
create small circular fields. | Design: For compatible Linear Accelerators
(LINAC) for attenuation of the beam to
create small circular fields. | Equivalent |
| 2. | Components: Mounting Adapter and
Conical Collimators (7 sizes, 2.5 mm
increments) | Components: Mounting Adapter and
Conical Collimators (37 sizes, 1 mm
increments) | Better |
| 3. | Technology:
a. Tertiary small field circular collimation
b. Mechanical mounting interface at LINAC
c. Automated, electronic collimator cone size
detection and interlock control.
d. LINAC jaws are electronically verified. | Technology:
a. Tertiary small field circular collimation
b. Mechanical mounting interface at LINAC
c. Automated, electronic collimator cone size
detection and interlock control.
d. LINAC jaws are electronically verified. | a. Equivalent
b. Equivalent
c. Equivalent
d. 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. | Not
applicable |
| 6. | Sterility: Non-sterile. | Sterility: Non-sterile. | Not
applicable |
| 7. | Compatibility with Environment
Environment during use is a linear
accelerator suite in the radiation therapy | Compatibility with Environment
Environment during use is a linear
accelerator suite in the radiation therapy | Equivalent |
| | department of a hospital or similar
environment. | department of a hospital or similar
environment. | |
| 8. | Compatibility with Other Devices
Does not attach or electrically connect to any
other devices except the linear accelerators
described in the manufacturer's labeling. | Compatibility with Other Devices
Does not attach or electrically connect to any
other devices except the linear accelerators
described in the manufacturer's labeling. | Equivalent |
| 9. | Electrical / Mechanical / Radiation Safety
Compliant with applicable IEC safety,
usability and performance standards and ISO
14971 Risk management Standard. | Electrical / Mechanical / Radiation Safety
Compliant with applicable IEC safety,
usability and performance standards and ISO
14971 Risk management Standard. | Equivalent |
| 10. | Chemical / Thermal Safety
Not applicable. The device does not generate
or contain hazardous chemicals or thermal
energy. | Chemical / Thermal Safety
Not applicable. The device does not generate
or contain hazardous chemicals or thermal
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.