HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM

K131777 · Hyper Technology, Inc. · IWB · Feb 28, 2014 · Radiology

Device Facts

• Record ID: K131777
• Device Name: HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM
• Applicant: Hyper Technology, Inc.
• Product Code: IWB · Radiology
• Decision Date: Feb 28, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hyper Source-unit Rotating Gamma System (SGS-1+) is a teletherapy device indicated for use in stereotactic irradiation of intracranial structures.

Device Story

The Hyper Source-unit Rotating Gamma System (SGS-I+) is a teletherapy device for stereotactic irradiation of intracranial structures. It comprises a main mechanical system, localization device, control system, and therapy planning system (TPS). The device utilizes 38 60Co sources to deliver radiation; dose distribution is achieved through programmable arcs. Target positioning is automated. The system features a treatment bed with 3-D movement and 135 kg capacity. It is operated by clinical staff in a controlled environment. The TPS assists in planning, while the control system manages delivery. The device provides precise radiation to intracranial targets, benefiting patients by enabling non-invasive stereotactic treatment. Performance is verified through positional precision and dose error testing.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included verification of design specifications, total positional precision, and dose error, reviewed by a clinical medical physicist.

Technological Characteristics

Radionuclide radiation therapy system using 38 60Co sources. Features automated target positioning, 152 collimator channels, and programmable arc dose sculpturing. Treatment bed supports 3-D movement. Power supply: AC 480V/60Hz with ≥30 min backup. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-11. System includes mechanical, localization, control, and therapy planning components.

Indications for Use

Indicated for stereotactic irradiation of intracranial structures.

Regulatory Classification

Identification

A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.

Predicate Devices

• Rotating Gamma System Infini™ (K102533)

Submission Summary (Full Text)

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# Section 3 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: _

- Date of Submission: Jun. 8, 2013 l.
- 2. Sponsor Identification

Hyper Technology Incorporation 3404 jones creek road Baton rouge, Louisiana 70816

Establishment Registration Number: Not yet registered

Contact Person: Eugene Ji Position: General Manager Tel: [phone] Fax: [phone] Email: grpstars@ yahoo.com

- 3. Submission Correspondent
Ms. Diana Hong & Mr. Tarzan Wang Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: [phone] Fax: [phone] Email: [e-mail]

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#### 4. Proposed Device Identification

Proposed Device Name: Hyper Source-unit Rotating Gamma System (SGS-I+) Proposed Device Common Name: Gamma System

Regulatory Information Classification Name: System, Radiation Therapy, Radionuclide; Classification: II; Product Code: IWB: Regulation Number: 892.5750; Review Panel: Radiology:

#### Intended Use Statement:

The Hyper Source-unit Rotating Gamma System (SGS-1+) is a teletherapy device indicated for use in stereotactic irradiation of intracranial structures.

#### Predicate Device Identification ર .

510(k) Number: K102533 Predicate Device Name:Rotating Gamma System Infini™ Manufacturer:Measep Infini Medical Science Technology Development Co., Ltd.

#### Device Description 6.

The Hyper Source-unit Rotating Gamma System (SGS-1+) consist of Main Mechanical System, Localization Device, Control System, Therapy Planning System (TPS) etc.

- 7. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.

IEC 60601-1-2:2007, Medical Electrical Equipment - Part 1-2. General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.

IEC60601-2-11 (1997)(2004), Amendment 1 - Medical electrical equipment - Part 2-11: Particular 3-2

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requirements for the safety of gamma beam therapy equipment.

- 8. Substantially Equivalent (SE) Conclusion
The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.

| ITEM | Proposed Device | Predicate Device |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| | Hyper Source-unit Rotating<br>Gamma System (SGS-I+) | Rotating Gamma System<br>Infini™ |
| Product Code | IWB | SAME |
| Regulation No. | 21 CFR 892.5750 | SAME |
| Class | Class II | SAME |
| Intended Use | The Hyper Source-unit<br>Rotating Gamma System<br>(SGS-I+) is a teletherapy<br>device indicated for use in<br>stereotactic irradiation of<br>intracranial structures. | SAME |
| Category | Rotational | SAME |
| Treatment Bed Movement | 3-D movement | SAME |
| Collimator Diameter Sizes | Φ 4mm,Φ8 mm,Φ12 mm,Φ 16mm | SIMILAR |
| Number of Collimator Channels | 152 | SIMILAR |
| Target Positioning | Automated | SAME |
| Dose Distribution | Dose sculpturing through<br>programmable arcs | SAME |
| Number of 60Co Sources | 38 | SIMILAR |
| Initial Overall Loading Activity | 10600 Ci/3.922x1014Bq | SIMILAR |
| Focus Dose-rate at Initial Loading | ≥ 3 Gy/min | SAME |
| Penumbra on Focal Plane | ≤ 12 mm | SIMILAR |
| Independent Dual Timer Accuracy | ± 1s | SIMILAR |
| Source Body Zero Position | 0.01° | SIMILAR |

Table 3-1 Comparison of Technology Characteristics

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| Collimator Selection Time | 1s | SIMILAR |
|--------------------------------------------------|------------------------------------|---------|
| Treatment Bed Travel | X =400 mm; Y= 1057 mm; Z=300<br>mm | SIMILAR |
| Treatment Bed Maximum Loading<br>Capacity | 135 kg | SIMILAR |
| Treatment Bed Linear Travel Error<br>(X,Y and Z) | 0.1mm | SIMILAR |
| Treatment Bed Traveling speed | X, Z: 600mm/min<br>Y: 1000mm/min | SIMILAR |
| Radiological Accuracy | ≤1.0 mm | SIMILAR |
| Overall Length | 5656 mm | SIMILAR |
| Overall Width | 4171 mm | SIMILAR |
| Overall Height | 2943 mm | SIMILAR |
| Overall Weight | 30 T | SIMILAR |
| Power Supply | AC 480V±10% / 60Hz | SIMILAR |
| Backup Power Supply | ≥ 30 min | SAME |

The proposed device, Hyper Source-unit Rotating Gamma System (SGS-J+), is determined to be Substantially Equivalent (SE) to the predicate device, Rotating Gamma System Infini™, in respect of safety and effectiveness.

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K13/777
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### K131777 RTA Response

### ltem K 37)

Submission includes the following analytical studies, including associated protocols and line data.

### Comments:

Need to provide the data for the Precision/Reproducibility and Accuracy.

### Response

We have supplemented the "Total positional precision and dose error test report" of proposed device, and which has been reviewed by the registered Clinical Medical Physicist, JB Yu Zhang, PhD, DABR.

Please refer to: Exhibit #17 Total positional precision and dose error test

I wish the response could address all of your concerns. Please feel free to contact me if you have any further questions via email at [e-mail] or via fax at [phone].

Best Regards,

.

さっている。、「…

Fu, Lee
数字签名者: Fu, Lee
DN: cn=Fu, Lee, D=Mid-Link
Consulting Co., Ltd. ou=Premarket,
[e-mail], c=CN
日期: 2013.11.29 15:14:10 +08'00'

Diana Hong General Manager Mid-Link Consulting Co., Ltd Tel: [phone] Fax: [phone] Email: [e-mail]

Enclosures

3 / 3

no and discussion in the second as sider is and in the former

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/12 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle with its wings spread, surrounded by a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 28, 2014

Hyper Technology, Inc. % Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 SHANGHAI 200120 CHINA

Re: K131777

Trade/Device Name: Hyper Source-unit Rotating Gamma System (SGS-1+) Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: IWB Dated: November 27, 2013 Received: December 2, 2013

Dear Ms. Hong:

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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Page 2-Ms. Hong

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/dcfault.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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.lda.gov/MedicalDevices/ResourcesforYou/Industry/default.hum.

Sincerely yours,

Michael O. O'Hara

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Section 2 Indications for Use

K131777 510(k) Number: Device Name: Hyper Source-unit Rotating Gamma System (SGS-1+)

Indications for Use:

The Hyper Source-unit Rotating Gamma System (SCS-I+) is a teletherapy device indicated for use in stereotactic irradiation of intracranial structures,

& PRESCRIPTION USE (Part 21 CFR 801 Subpart D)

OR

[ ] OVER-THE-COUNTER USE (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Michael D. O'Hara

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)_ K131777

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