ArcCHECK-MR

K160057 · Sun Nuclear Corporation · IYE · May 13, 2016 · Radiology

Device Facts

• Record ID: K160057
• Device Name: ArcCHECK-MR
• Applicant: Sun Nuclear Corporation
• Product Code: IYE · Radiology
• Decision Date: May 13, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

Model 1220-MR ArcCHECK-MR is a three-dimensional (3D) ionizing radiation measurement device intended for radiotherapy quality assurance.

Device Story

Device is a 3D ionizing radiation measurement tool for radiotherapy quality assurance; consists of a cylindrical diode array embedded in a plastic phantom. Captures radiation dose distributions from all gantry angles during beam rotation. Connects to a PC via 8-pin DIN cable; uses 'SNC Patient' software for data processing and visualization. Operated by medical physicists or technicians in a clinical environment. Primary benefit is enabling measurement of high dose gradients in radiotherapy deliveries. Subject device is an MR-conditional version of the predicate, utilizing stainless steel hardware to minimize magnetic attraction.

Clinical Evidence

Bench testing only. Testing demonstrated that the modified device performs within design specifications and is equivalent to the predicate Model 1220 ArcCHECK.

Technological Characteristics

3D diode sensor array in a PMMA cylinder phantom. Materials include PMMA, printed circuit boards, and stainless steel hardware. Connectivity via 8-pin DIN cable to an industry-standard PC. MR-conditional design. Software platform is Windows-based.

Indications for Use

Indicated for radiotherapy quality assurance using 3D ionizing radiation measurement.

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

• Model 1220 ArcCHECK (K142617)
• Model 1220 ArcCHECK (K131466)

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

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.

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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.'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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | |
|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Indications for Use | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>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) | |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <div> <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </div> <div> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </div> |

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| FORM FDA 3881 (8/14) | Page 1 of 1 |
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# 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: [phone] Web: www.sunnuclear.com

Contact Person:

James Luker [e-mail]

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<br>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.

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#### 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<br>characteristics of model 1220-MR<br>ArcCHECK-MR is the high spatial<br>resolution of the diode detector with<br>an array size and a detector density<br>that enables measurement of dose<br>distributions that have high dose<br>gradients found in radiotherapy<br>deliveries. | The primary technological<br>characteristics of model 1220<br>ArcCHECK is the high spatial resolution<br>of the diode detector with an array size<br>and a detector density that enables<br>measurement of dose distributions that<br>have high dose gradients found in<br>radiotherapy deliveries. | Both the subject device and<br>predicate device have the same<br>primary technological<br>characteristics. |
| Model 1220-MR ArcCHECK-MR is an<br>MR Conditional device. | Model 1220 ArcCHECK is an MR<br>unsafe device. | The subject device has been<br>designed and tested for conditional<br>use in an MR environment. Each<br>model will be labeled appropriately<br>for its use environment. |
| Model 1220-MR ArcCHECK-MR<br>serves as a 3D Phantom. | Model 1220 ArcCHECK serves as a 3D<br>Phantom | Both the subject device and<br>predicate device serve as 3D<br>Phantoms |
| Hardware/software platform- | Hardware/software platform- | Both the subject device and |
| Industry Standard personal computer<br>hardware and Windows based<br>software | Industry Standard personal computer<br>hardware and Windows based software | predicate device use Industry<br>Standard personal computer<br>hardware and Windows based<br>software |
| Materials | Materials | The subject device utilizes |
| PMMA cylinder with printed circuit<br>boards. Use of stainless steel<br>hardware. | PMMA cylinder with printed circuit<br>boards. Use of some carbon steel<br>hardware. | Stainless steel in an attempt to<br>minimize the potential magnetic<br>attraction properties |

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#### 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.