The SPINEL 3G, Surgical Mobile Fluoroscopic X-ray system, is indicated for use in generating fluoroscopic / radioscopic images of human anatomy. This device is not intended for interventional quided procedure & mammographic applications.

Device Description

The Image Intensified Fluroscopic X-ray System consists of a high voltage (HV) inverter generator, a tube support unit, an X-ray beam limiting device, mobile cart, a detector, operating software, and a tube, and is primarily used in a hospital for diagnosis of diseases in skeletal, respiratory and urinary systems such as the skull, spinal column, chest, abdomen, extremities, and other body parts. This device is not intended for interventional quided procedure & mammographic applications.

AI/ML Overview

This document is a 510(k) Summary for the Spinel 3G, a Surgical Mobile Fluoroscopic X-ray system. The purpose of this document is to demonstrate that the Spinel 3G is substantially equivalent to a legally marketed predicate device (KMC-950).

Here's an analysis of the acceptance criteria and supporting study information, based on your request:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the traditional sense of quantified performance metrics like sensitivity, specificity, or accuracy for a diagnostic task. Instead, the "acceptance criteria" or rather, the basis for substantial equivalence, is rooted in demonstrating that the Spinel 3G has similar technological characteristics and intended use as the predicate device, and that it meets recognized safety and performance standards.

The reported "device performance" is primarily presented as meeting these safety and performance standards and having similar technical specifications.

Acceptance Criteria (Implied)	Reported Device Performance
Intended Use Equivalence: Device has the same intended use.	The Spinel 3G is indicated for use in generating fluoroscopic / radioscopic images of human anatomy. This is consistent with what is typically expected of a Surgical Mobile Fluoroscopic X-ray System, which the predicate also is. Both devices are explicitly not for interventional guided procedures & mammographic applications.
Technological Characteristics Equivalence: Device has similar technological characteristics to the predicate.	The comparison table (page 5) details many similar technical specifications: - X-ray Tube: Rotating anode, 300,000 HU heat capacity, 15kHU/min anode heat cooling, 0.3mm/0.6mm focal size (choice of Varian or Toshiba for proposed, Varian for predicate). - X-ray Generator: High frequency/inverter type, 12.0 kVA power output (same for both). - Fluoroscopic Mode: kV range (40-120 kV for proposed vs 40-125 kV for predicate - a slight difference but considered acceptable), mA range (0.2-10 mA for proposed vs 0.5-5 mA for predicate - proposed has a wider range), Pulse Fluoro (Yes for both), ABS function (Yes for both), Snap Shot (8.0 mA for both), Boost Shot (20.0 mA for both). - Image Intensifier: 9" size, 9"/6"/4.5" magnification (same for both, but different manufacturers for the image intensifier). - Camera: 1/2" CCD type (same), but proposed has higher active pixels (1024x1024) compared to predicate (512x512). This is a technical improvement but not deemed to alter fundamental safety or effectiveness. - C-arm: Similar mechanical movements and dimensions (e.g., SID, Linear FR-arm movement, Linear T-arm movement, Swing-arm rotation – though the C-arm rail rotation range is wider for the proposed device: 135° vs 115°). - Image Processing: Both digital storage, but proposed has significantly larger storage capacity (HDD 500G, >35,000 pictures) and a larger monitor (19" vs 17"). - Collimator: Motor control/rotation, DC 24V power requirements (same).
Safety and Performance Standards Compliance: Device meets recognized safety, EMC, and performance standards.	Electrical, mechanical, environmental safety and performance testing according to FDA recognized standards were performed, and all test results were satisfactory. Applied standards include: - IEC60601-1:2005 (Medical electrical equipment - General requirements for basic safety and essential performance) - IEC60601-1-2:2007 (Electromagnetic compatibility - Requirements and tests) - IEC60601-1-3:2008 (General requirements for protection against undesirable radiation in diagnostic X-ray equipment) - IEC60601-2-28:2010 (Requirements for the safety of X-ray source assemblies and X-ray generators for medical diagnosis) - IEC60601-2-54:2009 (Requirements for the safety of X-ray equipment for radiography and radioscopy) - NEMA PS 3.1-3.20 (DICOM standards for image communication) - ISO14971:2012 (Medical devices - Application of risk management to medical devices) - EPRC regulation (21CFR1020.32) was satisfactory. - FDA guidance for Solid State X-ray Imaging Devices was satisfactorily considered.

2. Sample size used for the test set and the data provenance

The document does not describe a "test set" in terms of patient data or images used to evaluate diagnostic performance (e.g., how accurate it is at detecting specific conditions). The "testing" mentioned is focused on engineering and regulatory compliance (safety, EMC, performance standards).

Therefore, there is no information on:

Sample size for a clinical test set.
Data provenance (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Since there was no "clinical test set" described for diagnostic performance evaluation, there is no information provided regarding experts or ground truth establishment in that context. The "acceptance criteria" here are engineering and regulatory compliance, not diagnostic accuracy.

4. Adjudication method for the test set

Similarly, because there was no clinical test set for diagnostic performance, there is no adjudication method described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was mentioned or conducted. This device is a standard X-ray imaging system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a hardware imaging device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

As noted, for the "substantial equivalence" determination, the "ground truth" refers to compliance with established engineering standards and regulations, and the technical specifications of a legally marketed predicate device.

8. The sample size for the training set

Not applicable. This device is an X-ray system, not a machine learning model that requires a training set of data.

9. How the ground truth for the training set was established

Not applicable. No training set was used.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing movement or connection.

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

October 10, 2014

GEMSS Medical Systems Co., Ltd. % Mr. Harvey Knauss Delphi Consulting Group 11874 South Evelyn Circle HOUSTON TX 77071

Re: K132289 Trade/Device Name: Spinel 3G Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA, OXO Dated: May 22, 2014 Received: May 23, 2014

Dear Mr. Knauss:

This letter corrects our substantially equivalent letter of June 16, 2014.

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 (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.

Sm. 7)

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K132289

Device Name

Spinel 3G

Indications for Use (Describe)

The SPINEL 3G, Surgical Mobile Fluoroscopic X-ray system, is indicated for use in generating fluoroscopic / radioscopic images of human anatomy. This device is not interventional guided procedure & mammographic applications.

Type of Use (Select one or both, as applicable)

X 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 A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Robert A. Ochs

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510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: May 22, 2014

1. Company and correspondent making the submission:

Company Name: GEMSS MEDICAL SYSTEMS Co., LTD.
Address : 61,Dunchon-daero 541(obaeksasibil), Jungwon-gu, Seongnam-si, yeonggi-do, Korea
Telephone : +82-31-764-7321~3
► Fax: +82-31-764-7324
Contact: Mr. Sangwoo Lee
Internet: http://www.gemss-medical.com

2. General information for predicate & proposed device

	Predicate device	Proposed device
Manufacturer	United Radiology Systems, Inc.	GEMSS MEDICAL SYSTEMS Co., LTD.
510(k) number	K032761(Decision Date - May. 14. 2004)	K132289
Common Name	Surgical Mobile Fluoroscopic X-raySystem	Surgical Mobile Fluoroscopic X-raySystem
Trade/proprietaryname	KMC-950	SPINEL 3G
Classification rule	21CFR 892.1650	21CFR 892.1650
Classification Name	Image Intensified Fluroscopic X-raySystem	Image Intensified Fluroscopic X-raySystem
Product code	JAA & OXO & OWB	JAA & OXO

3. Description:

3.1 General:

3.2 Product features:

The SPINEL 3G is a solution to produce radiological images of patient during medical operations. This inverter control X-ray unit visualizes the anatomical structure on screen, which is obtained by X-ray fluoroscopy and the image intensifier. This system can be applied in emergency room, operation room, cast room or etc. of hospital.

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The SPINEL 3G has following features.

The high voltage generation circuit uses the method of inverter with a high power of 12kVA, to ensure that stable X-Ray with small amount of ripples are obtained.

The X-Ray tube system uses the X-Ray tube with rotating anode, thus enabling to obtain high-quality images necessary for the longtime operation or diagnosis.

Control panel adopting TACT key, B/W LCD and touch screen for excellent controllability,

Soft but solid motions of the large size C-Arm, which has a 768mm radius, gives facility to perform an operation.(Depth:692mm)

For fluoroscopy, the collimator is used to reduce an unnecessary irradiation of X-Ray.

Using the built-in SNAP SHOT mode, the image quality is improved further, and it has built-in DIS (Digital Interface System).

The SPINEL 3G has PACS connectivity with DICOM 3.0.

Thermal sensor prevents the tube from overheating. If the tube is overheated, thermal sensor attached to the exterior of it warns the system and 'Tube Limit' sign will be displayed on the touch screen. Then the machine can work again by the time the tube gets cooled.

4. Intended use

SPINEL 3G is intended to be used as a universal diagnostic imaging system and fluoroscopic studies. Using an Image intensifier and CCD camera, it can perform a range of applications including general fluoroscopy, diagnostic fluoroscopy. SPINEL 3G, Mobile Fluoroscopy System is designed to provide fluoroscopic of the patient during diagnostic, surqical procedures. Examples of clinical application may include horologic, orthopedic, neurologic, critical care and emergency room procedures.

5. Indications for use

6. Comparison with predicate device:

		Predicate device	Proposed device
Model name		KMC-950	SPINEL 3G
510(k) number		K032761	K132289
510(k) owner		United RadiologySystems, Inc.	GEMSS Medical SystemsCo., Ltd.
X-ray Tube	Model name	Varian:RAD-99	Toshiba:E7833X,Varian:RAD-99
	Manufacturer	Varian	Toshiba/Varian
	Anode Type	Rotating	Rotating
	Heat Capacity	300,000 HU	300,000HU
		Predicate device	Proposed device
	Anode heat cooling	15kHU/min	15kHU/min
	Focal Size	0.3 mm / 0.6 mm	0.3 mm / 0.6 mm
	Model name	HTC-120	HTC-120
	Manufacturer	POSKOM	POSKOM
X-ray Generator	X-ray Generator Type	High frequency / invertertype	High frequency / invertertype
	Power Output	12.0 kVA	12.0 kVA
Fluoroscopic	kV range	40 to 125 kV	40 to 120 kV
Mode		See below differentdiscussion	See below differentdiscussion
	mA range	0.5 to 5 mA	0.2 to 10 mA
		See below differentdiscussion	See below differentdiscussion
	Pulse Fluoro	Yes	Yes
	ABS function	Yes	Yes
	Snap Shot	8.0 mA shot available	8.0 mA shot available
	Boost Shot	20.0 mA sot available	20.0 mA shot available
ImageIntensifier	Model name	Thales:TH9428HP2	Toshiba:E5830SD-P4A,Thales:TH9438QX
	Manufacturer	Thales	Toshiba/Thales
	Size	9"	9"
	Magnification	9" / 6" / 4.5"	9" / 6" / 4.5"
	Model name	RS-138EDR	LUNA-1K
Camera	Manufacturer	RAYSIS	GEMSS Medical SystemsCo., Ltd.
	Type	1/2" CCD	1/2" CCD
	active pixel	512X512	1024X1024
C-arm	Manufacturer	COMED Medical SystemsCo., Ltd.	GEMSS Medical SystemsCo., Ltd.
	SID	950 mm	1000 mm
	Range of C-arm RailRotation	115° (90° / 25°)	135° (90° / 45°)
	Range of the Liner FR-arm Movement	200 mm	200 mm
	Range of the Linear T-arm Movement	500 mm	500 mm
	Range of Swing-armRotation	± 12.5°	± 12.5°
	Range of Stay-armRotation	360°	± 225°
Image	Storage Capacity	Digital	HDD 500G
Processing	Image Matrix size	5,000 Images	store more than 35,000pictures(1 image is approximately2MB)
	Monitor Size	17"	19"
		Predicate device	Proposed device
Collimator	Model name	KMC-950CM	KMC-950CMR1
	Manufacturer	COMED Medical SystemsCo., Ltd.	GEMSS Medical SystemsCo., Ltd.
	Collimator	Motor control / rotation	Motor control / rotation
	Power Requirements	DC 24V	DC 24V

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GEMSS MEDICAL SYSTEMS CO., LTD., believes that the SPINEL 3G is substantially equivalent to the KMC-950 of United Radiology Systems, Inc. The SPINEL 3Gdescribed in this 510(k) has the similar intended use and similar technical and construction characteristics as the KMC-950 of United Radiology Systems, Inc.

7. Safety, EMC and Performance Data:

Electrical, mechanical, environmental safety and performance testing according to FDA recognized standards were performed. All test results were satisfactory. Applied standards are as follows:

IEC60601-1:2005
IEC60601-1-2:2007
IEC60601-1-3:2008
IEC60601-2-28:2010
IEC60601-2-54:2009
NEMA PS 3.1-3.20
ISO14971:2012

And, EPRC requlation was satisfactory.

▷ 21CFR1020.32
In addition, FDA guidance was satisfactorily considered.
Guidance for the Submissions of 510(k)s for Solid State X-ray Imaging Devices

8. Conclusions:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification GEMSS MEDICAL SYSTEMS CO., LTD. concludes that the SPINEL 3G is safe and effective and substantially equivalent to predicate devices as described herein.

Regulation Number and Section

N/A