HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM

• K Number: K131777
• Device Name: HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM
• Manufacturer: HYPER TECHNOLOGY INC
• Date Cleared: 2014-02-28 ( 256 days)
• Product Code: IWB
• Regulation Number: 892.5750

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 Description

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

Predicate Devices

K102533

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or related terms, and the description focuses on mechanical and control systems typical of traditional teletherapy devices.

Therapeutic

Yes
The device is described as a "teletherapy device" indicated for "stereotactic irradiation," which are therapeutic applications.

Diagnostic

No
Explanation: The device is described as a "teletherapy device indicated for use in stereotactic irradiation," which means it is used for treatment (therapy), not for diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components like "Main Mechanical System" and "Localization Device," indicating it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is "stereotactic irradiation of intracranial structures." This describes a therapeutic procedure performed on a patient's body, not a test performed on a sample taken from the body.
• Device Description: The description mentions components like a "Main Mechanical System," "Localization Device," "Control System," and "Therapy Planning System." These are typical components of a radiation therapy device, not an IVD.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements associated with in vitro diagnostics.

In summary, the Hyper Source-unit Rotating Gamma System (SGS-1+) is a therapeutic device used for radiation treatment, not a diagnostic device used for testing samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

IWB

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Intracranial structures

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)

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 requirements for the safety of gamma beam therapy equipment.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K102533

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.5750 Radionuclide radiation therapy system.

(a)
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.(b)
Classification. Class II.

Summary

0

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

2

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
Gamma System (SGS-I+)	Rotating Gamma System
Infini™
Product Code	IWB	SAME
Regulation No.	21 CFR 892.5750	SAME
Class	Class II	SAME
Intended Use	The Hyper Source-unit
Rotating Gamma System
(SGS-I+) is a teletherapy
device indicated for use in
stereotactic irradiation of
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
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
mm	SIMILAR
Treatment Bed Maximum Loading
Capacity	135 kg	SIMILAR
Treatment Bed Linear Travel Error
(X,Y and Z)	0.1mm	SIMILAR
Treatment Bed Traveling speed	X, Z: 600mm/min
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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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

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

5

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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