(430 days)
Not Found
No
The description focuses on radiation measurement, dose comparison using standard metrics (gamma, DTA), and MLC pattern analysis based on a fixed threshold (5mm). There is no mention of learning, adaptation, or complex pattern recognition beyond predefined rules.
No.
The device is described as a "three-dimensional (3D) ionizing radiation measurement device intended for radiotherapy quality assurance," not for administering therapy itself.
No
This device is described as a "three-dimensional (3D) ionizing radiation measurement device intended for radiotherapy quality assurance." Its purpose is to measure and compare radiation doses and MLC patterns for QA, not to diagnose a medical condition in a patient.
No
The device description clearly states that the ArcCHECK, Model 1220 is a "three dimensional diode sensor used for ionizing radiation measurement" and is "embedded in a cylindrical plastic phantom." This indicates the device includes significant hardware components beyond just software. While the submission focuses on a software modification, the device itself is not software-only.
Based on the provided text, the ArcCHECK, Model 1220 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "for radiotherapy quality assurance." This involves measuring ionizing radiation delivered to a phantom, not analyzing biological samples (like blood, urine, or tissue) to diagnose or monitor a disease or condition.
- Device Description: The device measures radiation dose using diodes embedded in a phantom. It compares planned radiation doses with measured doses. This is a physical measurement process related to the delivery of radiation therapy, not a diagnostic test performed on a patient's biological sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological specimens, detecting biomarkers, or providing information for diagnosis, monitoring, or prognosis of a disease.
Therefore, the ArcCHECK, Model 1220 is a device used for quality assurance in radiotherapy, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
ArcCHECK, Model 1220 is a three-dimensional (3D) ionizing radiation measurement device intended for radiotherapy quality assurance.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
ArcCHECK, Model 1220 is a three dimensional diode sensor used for ionizing radiation measurement for radiotherapy quality assurance. The cylindrical diode array is embedded in a cylindrical plastic phantom that allows for dosimetry measurements to be made from all gantry angles as the therapy beam rotates about the diode array.
The provided GUI 'SNC Patient' software application installed on the user's computer and connected to the Model 1220 ArcCHECK by an 8 pin DIN cable, includes the following functions:
- . Array and dose calibration.
- Measurement and display of the spatial distribution of the dose resulting from delivery of a radiation treatment plan.
- . Save measurements.
- Import treatment plan dose map in the phantom and compares with the measurement dose points.
- . Compare the measured and planned dose distribution using the analysis methods of gamma or dose difference and distance to agreement (DTA) with user specified analysis criteria.
- Report of the analysis including a percent pass rate. ●
- Perform quality assurance (QA) on the planned versus delivered multi leaf ● collimator (MLC) pattern as a function of time. The MLC QA is capable of detecting an error of 5mm or greater in the planned position of an MLC leaf.
This submission introduces a 'primary' software modification to the cleared Model 1220 ArcCHECK device (K131466). Sun Nuclear intends to introduce a software feature which allows for the user to perform quality assurance (QA) on the planned versus delivered Multi Leaf Collimator (MLC) pattern. The MLC QA is capable of detecting an error of 5mm or greater in the planned position of an MLC leaf. This 'primary' modification which is believed to affect the indications for use, but not the intended use, is the subject of this premarket notification.
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)
ArcCHECK. Model 1220 has been tested using appropriate bench testing methods. We have determined the software to be of 'Major Level of Concern' and have performed appropriate verification and validation testing.
Test results of the modified device have demonstrated that the device performs within its design specifications and equivalently to the predicate K131466 ArcCHECK 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected by a flowing line that resembles a ribbon or wave.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 20, 2015
Sun Nuclear Corporation % Mr. James Luker Regulatory Affairs Consultant 2640 Nobility Avenue MELBOURNE FL 32934
Re: K142617
Trade/Device Name: ArcCHECK. Model 1220 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: November 15, 2015 Received: November 17, 2015
Dear Mr. Luker:
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.
1
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'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
2
Indications for Use
510(k) Number (if known) K142617
Device Name ArcCHECK, Model 1220
Indications for Use (Describe)
ArcCHECK, Model 1220 is a three-dimensional (3D) ionizing radiation measurement device intended for radiotherapy quality assurance.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Sun Nuclear Corporation. The logo consists of a blue square with rounded corners on the left side, containing a yellow sun-like design with horizontal lines. To the right of the square, the words "SUN NUCLEAR" are written in blue, with the word "corporation" written in a smaller font size below it.
510(k) Summary
Provided in accordance with 21 CFR 807.92 (c)
1 General Provisions
Date Prepared:
November 17, 2015
Submitted by:
Sun Nuclear Corporation 3275 Suntree Blvd. Melbourne, FL 32940 Ph: 321-259-6862 Fax: 321-259-7979 Web: www.sunnuclear.com
Contact Person:
James Luker JamesLuker@sunnuclear.com
Ph: 321-259-6862 extension 2428
Common Name:
Dosimetric Quality Assurance for Patient Specific Radiation Treatment
Proprietary Names:
Model 1220 ArcCHECK
Establishment Registration Number:
1038814
Classification:
Regulation Number: 21 CFR 892.5050 Name: Medical charged-particle radiation therapy system Product code: IYE
Class II
4
Predicate Device(s):
| Model Name: | Model 1220 ArcCHECK |
|---|---|
| Common Name: | Dosimetric Quality Assurance for Patient Specific |
| Radiation Treatment | |
| 510(k) # | K131466 |
| Manufacturer: | Sun Nuclear Corporation. |
| Submitted: | May 21, 2013 |
2 Description and Use:
ArcCHECK, Model 1220 is a three dimensional diode sensor used for ionizing radiation measurement for radiotherapy quality assurance. The cylindrical diode array is embedded in a cylindrical plastic phantom that allows for dosimetry measurements to be made from all gantry angles as the therapy beam rotates about the diode array.
The provided GUI 'SNC Patient' software application installed on the user's computer and connected to the Model 1220 ArcCHECK by an 8 pin DIN cable, includes the following functions:
- . Array and dose calibration.
- Measurement and display of the spatial distribution of the dose resulting from delivery of a radiation treatment plan.
- . Save measurements.
- Import treatment plan dose map in the phantom and compares with the measurement dose points.
- . Compare the measured and planned dose distribution using the analysis methods of gamma or dose difference and distance to agreement (DTA) with user specified analysis criteria.
- Report of the analysis including a percent pass rate. ●
- Perform quality assurance (QA) on the planned versus delivered multi leaf ● collimator (MLC) pattern as a function of time. The MLC QA is capable of detecting an error of 5mm or greater in the planned position of an MLC leaf.
This submission introduces a 'primary' software modification to the cleared Model 1220 ArcCHECK device (K131466). Sun Nuclear intends to introduce a software feature which allows for the user to perform quality assurance (QA) on the planned versus delivered Multi Leaf Collimator (MLC) pattern. The MLC QA is capable of detecting an error of 5mm or greater in the planned position of an MLC leaf. This 'primary' modification which is believed to affect the indications for use, but not the intended use, is the subject of this premarket notification.
5
3 Intended Use Statement:
ArcCHECK. Model 1220 is a three-dimensional (3D) ionizing radiation measurement device intended for radiotherapy quality assurance.
ব Technological Characteristics
The primary technological characteristics of ArcCHECK, Model 1220 is the high spatial resolution of the diode detector with an array size and a detector density that enables measurement of dose distributions that have high dose gradients found in radiotherapy deliveries. The spatial resolution of the diode detector results in very little dose volume averaging over the high dose gradient regions in the plan.
The ArcCHECK serves as a 3D Phantom with the detectors located on a 3D cylindrical surface embedded at a radiological depth of 3.3g/cm².
5 Performance Data and Comparison with Predicate
ArcCHECK. Model 1220 has been tested using appropriate bench testing methods. We have determined the software to be of 'Major Level of Concern' and have performed appropriate verification and validation testing.
Test results of the modified device have demonstrated that the device performs within its design specifications and equivalently to the predicate K131466 ArcCHECK device.
6 Summary
ArcCHECK. Model 1220 is believed to be substantially equivalent to the predicate ArcCHECK device due to the similarities in function, technology, and performance. The intended use, performance testing, safety and effectiveness reviews demonstrate that ArcCHECK, Model 1220 is as safe, as effective, and performs as well as the predicate device. The changes to the predicate device described within this submission are not thought to not raise new types of safety or effectiveness questions.