(122 days)
Not Found
No
The summary describes a physical radiation measurement device and its associated software, with no mention of AI or ML capabilities for data analysis or interpretation.
No.
The device is described as a "ionizing radiation measurement device intended for radiotherapy quality assurance," not a device for delivering therapy itself.
No
The device is described as "a three-dimensional (3D) ionizing radiation measurement device intended for radiotherapy quality assurance," not for diagnosing medical conditions in patients.
No
The device description explicitly states it is a "three dimensional diode sensor used for ionizing radiation measurement" and a "cylindrical diode array embedded in a cylindrical plastic phantom," indicating it is a physical hardware device. While it includes software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "a three-dimensional (3D) ionizing radiation measurement device intended for radiotherapy quality assurance." This describes a device used to verify the accuracy of radiation delivery in cancer treatment, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a "diode sensor used for ionizing radiation measurement for radiotherapy quality assurance." This further reinforces its role in measuring radiation, not analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to handling or analyzing biological specimens (like blood, urine, tissue, etc.).
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device's purpose is to ensure the quality and accuracy of a medical treatment (radiotherapy), not to diagnose or monitor a patient's condition through the analysis of biological samples.
N/A
Intended Use / Indications for Use
Model 1220-MR ArcCHECK-MR 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
Model 1220-MR ArcCHECK-MR 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-MR ArcCHECK-MR by an 8 pin DIN cable and is unchanged from the K142617 predicate device.
This submission introduces Model 1220-MR ArcCHECK-MR. This model is equivalent in form and function to the cleared Model 1220, but has been verified as an MR-conditional product.
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)
Model 1220-MR ArcCHECK-MR has been tested using appropriate bench testing methods. Test results of the modified device have demonstrated that the device performs within its design specifications and equivalently to the predicate K142617 Model 1220 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles or faces, depicted in a dark color.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 13, 2016
Sun Nuclear Corporation % Mr. James Luker Regulatory Affairs Manager 3275 Suntree Blvd. MELBOURNE FL 32940
Re: K160057
Trade/Device Name: ArcCHECK-MR Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: April 15, 2016 Received: April 19, 2016
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
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
| Food and Drug Administration | |
|---|---|
| Indications for Use | Form Approved: OMB No. 0910-0120 |
| Expiration Date: January 31, 2017 | |
| See PRA Statement below |
| 510(k) Number (if known) | K160057 |
|---|---|
| Device Name | Model 1220-MR ArcCHECK-MR |
| Indications for Use (Describe) | Model 1220-MR ArcCHECK-MR 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
"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."
| FORM FDA 3881 (8/14) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
3
Image /page/3/Picture/0 description: The image contains the logo for Sun Nuclear Corporation. The logo consists of a blue square with rounded corners on the left side, inside of which is a yellow circle with several horizontal lines. To the right of the square is the text "SUN NUCLEAR" in blue, with the word "corporation" underneath it in a smaller font size, also in blue.
510(k) Summary
Provided in accordance with 21 CFR 807.92 (c)
1 General Provisions
Date Prepared:
March 25, 2016
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-MR ArcCHECK-MR
Establishment Registration Number:
1038814
Classification:
Requlation Number: 21 CFR 892.5050 Name: Medical charged-particle radiation therapy system Product code: IYE
Class II
Predicate Device(s):
| Model Name: | Model 1220 ArcCHECK |
|---|---|
| Common Name: | Dosimetric Quality Assurance for Patient Specific |
| Radiation Treatment | |
| 510(k) # | K142617 (primary predicate), K131466 |
| Manufacturer: | Sun Nuclear Corporation. |
| Submitted: | September 16, 2014, May 21, 2013 |
The predicate devices have not been subject to a design-related recall.
4
2 Description and Use:
Model 1220-MR ArcCHECK-MR 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-MR ArcCHECK-MR by an 8 pin DIN cable and is unchanged from the K142617 predicate device.
This submission introduces Model 1220-MR ArcCHECK-MR. This model is equivalent in form and function to the cleared Model 1220, but has been verified as an MR-conditional product.
3 Intended Use Statement:
Model 1220-MR ArcCHECK-MR is a three-dimensional (3D) ionizing radiation measurement device intended for radiotherapy quality assurance.
ব Technological Characteristics
The following table provides a comparison between Model 1220-MR ArcCHECK-MR and the predicate Model 1220 ArcCHECK device.
| 1220-MR ArcCHECK MR (subject device) | 1220 ArcCHECK (predicate device) | Comparison |
|---|---|---|
| The primary technological | ||
| characteristics of model 1220-MR | ||
| ArcCHECK-MR 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 primary technological | |
| characteristics of model 1220 | ||
| ArcCHECK 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. | Both the subject device and | |
| predicate device have the same | ||
| primary technological | ||
| characteristics. | ||
| Model 1220-MR ArcCHECK-MR is an | ||
| MR Conditional device. | Model 1220 ArcCHECK is an MR | |
| unsafe device. | The subject device has been | |
| designed and tested for conditional | ||
| use in an MR environment. Each | ||
| model will be labeled appropriately | ||
| for its use environment. | ||
| Model 1220-MR ArcCHECK-MR | ||
| serves as a 3D Phantom. | Model 1220 ArcCHECK serves as a 3D | |
| Phantom | Both the subject device and | |
| predicate device serve as 3D | ||
| Phantoms | ||
| Hardware/software platform- | Hardware/software platform- | Both the subject device and |
| Industry Standard personal computer | ||
| hardware and Windows based | ||
| software | Industry Standard personal computer | |
| hardware and Windows based software | predicate device use Industry | |
| Standard personal computer | ||
| hardware and Windows based | ||
| software | ||
| Materials | Materials | The subject device utilizes |
| PMMA cylinder with printed circuit | ||
| boards. Use of stainless steel | ||
| hardware. | PMMA cylinder with printed circuit | |
| boards. Use of some carbon steel | ||
| hardware. | Stainless steel in an attempt to | |
| minimize the potential magnetic | ||
| attraction properties |
5
5 Performance Data and Comparison with Predicate
Model 1220-MR ArcCHECK-MR has been tested using appropriate bench testing methods. Test results of the modified device have demonstrated that the device performs within its design specifications and equivalently to the predicate K142617 Model 1220 ArcCHECK device.
6 Summary
Model 1220-MR ArcCHECK-MR 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 Model 1220-MR ArcCHECK-MR is as safe, as effective, and performs as well as the K142617 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.