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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence to a predicate device and safety standards, rather than defining specific acceptance criteria for a novel performance claim. The key "acceptance criteria" here is that the proposed device must be Substantially Equivalent (SE) to the predicate device, the "Rotating Gamma System Infini™", in terms of safety and effectiveness.

The table in the original document (Table 3-1) serves as a comparison of technological characteristics to support this substantial equivalence. The "Acceptance Criteria" for each item can be inferred as "SAME" or "SIMILAR" to the predicate device, as explicitly stated in the table.

Characteristic	Acceptance Criteria (compared to Predicate Device)	Reported Device Performance (Hyper Source-unit Rotating Gamma System (SGS-I+))
Product Code	SAME	IWB
Regulation No.	SAME	21 CFR 892.5750
Class	SAME	Class II
Intended Use	SAME	Stereotactic irradiation of intracranial structures.
Category	SAME	Rotational
Treatment Bed Movement	SAME	3-D movement
Collimator Diameter Sizes	SIMILAR	Φ 4mm, Φ8 mm, Φ12 mm, Φ 16mm
Number of Collimator Channels	SIMILAR	152
Target Positioning	SAME	Automated
Dose Distribution	SAME	Dose sculpturing through programmable arcs
Number of 60Co Sources	SIMILAR	38
Initial Overall Loading Activity	SIMILAR	10600 Ci/3.922x10¹⁴Bq
Focus Dose-rate at Initial Loading	SAME	≥ 3 Gy/min
Penumbra on Focal Plane	SIMILAR	≤ 12 mm
Independent Dual Timer Accuracy	SIMILAR	± 1s
Source Body Zero Position	SIMILAR	0.01°
Collimator Selection Time	SIMILAR	1s
Treatment Bed Travel	SIMILAR	X =400 mm; Y= 1057 mm; Z=300 mm
Treatment Bed Maximum Loading Capacity	SIMILAR	135 kg
Treatment Bed Linear Travel Error (X,Y and Z)	SIMILAR	0.1mm
Treatment Bed Traveling speed	SIMILAR	X, Z: 600mm/min; Y: 1000mm/min
Radiological Accuracy	SIMILAR	≤1.0 mm
Overall Length	SIMILAR	5656 mm
Overall Width	SIMILAR	4171 mm
Overall Height	SIMILAR	2943 mm
Overall Weight	SIMILAR	30 T
Power Supply	SIMILAR	AC 480V±10% / 60Hz
Backup Power Supply	SAME	≥ 30 min

Beyond this, the response to the FDA's query (K 37) indicates that specific Precision/Reproducibility and Accuracy data was provided in a "Total positional precision and dose error test report." While the report itself is not included, the acceptance criteria for this would likely be specific numerical tolerances as verified by a clinical medical physicist.

2. Sample Size and Data Provenance (for test set)

The provided text does not contain information regarding a "test set" in the context of clinical or image-based studies. The study mentioned is a "Total positional precision and dose error test," which is an analytical non-clinical test, likely conducted on the device itself or test phantoms. Therefore, concepts like "sample size used for the test set" and "data provenance" (country, retrospective/prospective) are not applicable in this context.

3. Number of Experts and Qualifications (for establishing ground truth for test set)

Similar to point 2, the document does not describe a test set that would require expert-established ground truth. The "Total positional precision and dose error test report" was reviewed by a "registered Clinical Medical Physicist, JB Yu Zhang, PhD, DABR." This expert's role seems to be validation of the test report itself, not establishing ground truth for a clinical dataset.

4. Adjudication Method (for test set)

As there is no described test set requiring expert interpretation, there is no adjudication method mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done or mentioned in the provided text. The submission focuses on demonstrating substantial equivalence through technical characteristics and non-clinical testing.

6. Standalone (Algorithm Only) Performance Study

Not applicable and not mentioned. The device described is a physical teletherapy system, not an AI algorithm.

7. Type of Ground Truth Used

For the "Total positional precision and dose error test report," the "ground truth" would be metrological standards or established physical parameters against which the device's precision and dose error are measured. This is an analytical (non-clinical) study.

8. Sample Size for the Training Set

Not applicable and not mentioned. This device is a physical medical device, not a machine learning or AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable and not mentioned. As there is no training set, there's no ground truth to establish for one.

Summary

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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.
1. 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: 225 753 3219 Fax: 225 753 3219 Email: grpstars@ yahoo.com

1. Submission Correspondent
  Ms. Diana Hong & Mr. Tarzan Wang Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

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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.

1. 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.

1. 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 RotatingGamma System (SGS-I+)	Rotating Gamma SystemInfini™
Product Code	IWB	SAME
Regulation No.	21 CFR 892.5750	SAME
Class	Class II	SAME
Intended Use	The Hyper Source-unitRotating Gamma System(SGS-I+) is a teletherapydevice indicated for use instereotactic irradiation ofintracranial 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 throughprogrammable 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=300mm	SIMILAR
Treatment Bed Maximum LoadingCapacity	135 kg	SIMILAR
Treatment Bed Linear Travel Error(X,Y and Z)	0.1mm	SIMILAR
Treatment Bed Traveling speed	X, Z: 600mm/minY: 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
Page 5 of 5

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 info@mid-link.net or via fax at (240) 238-7587.

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,
email-lee.fu@mid-link.net, c=CN
日期: 2013.11.29 15:14:10 +08'00'

Diana Hong General Manager Mid-Link Consulting Co., Ltd Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

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 (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" (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 (800) 638-2041 or (301) 796-7100 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)

[ ] 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

Page I of 1

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.