SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System

• K Number: K163140
• Device Name: SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System
• Manufacturer: GEMSS MEDICAL SYSTEMS CO., LTD
• Date Cleared: 2017-05-26 ( 198 days)
• Product Code: OWB JAA OXO
• Regulation Number: 892.1650

Intended Use

SPINEL 12HD Surgical Mobile Fluoroscopic X-ray System is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to digital subtraction angiography, orthopedic, neurological, abdominal, vascular, cardiac, critical care and emergency room procedures.

Device Description

The SPINEL 12HD Surgical Mobile Fluoroscopic 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 to be used for mammography applications. SPINEL 12HD 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 a flat panel detector. This system can be applied in emergency room, operation room, cast room or etc. of a hospital.

Predicate Devices

K032761

Reference Devices

K133580

AI/ML (Artificial Intelligence / Machine Learning)

No
The document mentions "Intelligent object dose control (IODC)" and "Metal Detected Control (MDC)" which are likely image processing or control algorithms, but there is no explicit mention of AI, ML, or related terms, nor is there any description of training or test data sets typically associated with AI/ML development.

Therapeutic

No
The device is used for imaging and diagnosis, not for treating diseases or conditions.

Diagnostic

Yes

The "Intended Use / Indications for Use" states that the device is "intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures." Additionally, the "Device Description" mentions it is "primarily used in a hospital for diagnosis of diseases in skeletal, respiratory and urinary systems".

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components including a high voltage (HV) inverter generator, a tube support unit, an X-ray beam limiting device, mobile cart, a detector, and a tube. While it includes operating software, it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the SPINEL 12HD Surgical Mobile Fluoroscopic X-ray System is not an IVD (In Vitro Diagnostic) device.

Here's why:

• IVD devices are used to examine specimens taken from the human body. This includes things like blood, urine, tissue, etc.
• The SPINEL 12HD is an imaging device. It uses X-rays to visualize the internal structures of the patient's body directly, without taking any samples.
• The intended use and device description clearly state its purpose is for imaging the patient during procedures and for diagnosis of diseases within the body.

Therefore, the SPINEL 12HD falls under the category of medical imaging devices, not IVD devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

SPINEL 12HD Surgical Mobile Fluoroscopic X-ray System is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to digital subtraction angiography, orthopedic, neurological, abdominal, vascular, cardiac, critical care and emergency room procedures.

Product codes (comma separated list FDA assigned to the subject device)

OWB, OXO, JAA

Device Description

The SPINEL 12HD Surgical Mobile Fluoroscopic 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 to be used for mammography applications.

SPINEL 12HD 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 a flat panel detector. This system can be applied in emergency room, operation room, cast room or etc. of a hospital.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray fluoroscopy

Anatomical Site

skeletal, respiratory and urinary systems such as the skull, spinal column, chest, abdomen, extremities, and other body parts.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

hospital, emergency room, operation room, cast room

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 studies were performed, and the results were deemed robust. The device complies with relevant FDA and international standards, including IEC60601-1:2005, IEC60601-1-2:2007, IEC60601-1-3:2008, IEC60601-2-43:2010, IEC60601-2-54:2009, NEMA PS 3.1-3.20, and ISO14971:2012. Electrical, EMC, and mechanical safety and performance testing were successfully conducted, raising no new safety questions or concerns. The V&V Report for Intelligent object dose control (IODC) and Metal Detected Control (MDC) contains software quality and performance testing activities, validating the efficacy of both functions through comparison of images before and after applying each function.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K032761

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K133580

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.

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

May 26, 2017

GEMSS MEDICAL SYSTEMS CO., LTD. % Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway Houston, Texas 77025

Re: K163140

Trade/Device Name: SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, OXO, JAA Dated: April 25, 2017 Received: April 28, 2017

Dear Dave Kim:

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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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/ResourcesforYou/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.

Robert Ochs

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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Indications for Use

510(k) Number (if known) K163140

Device Name SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System

Indications for Use (Describe)

SPINEL 12HD Surgical Mobile Fluoroscopic X-ray System is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to digital subtraction angiography, orthopedic, neurological, abdominal, vascular, cardiac, critical care and emergency room procedures.

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR Part 807.92.

Date: May 18, 2016

1. General Information:

Establishment: GEMSS MEDICAL SYSTEMS CO., LTD. 2nd Floor, 29, Dunchon-daero 541 beon-gil, Jungwon-gu, seongnam-si, KOREA, REPUBLIC OF 13216

GMESS MEDICAL SYSTEMS CO., LTD. is the holder/owner for this 510(k).

2. Official Correspondent Contact:

Dave Kim Mtech Group 8310 Buffalo Speedway Houston, TX 77025 TEL : [phone]

FAX : [phone]

E-mail : [e-mail]

3. Device name and Classification

Trade Name	: SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System
Classification Name	: Image Intensified Fluoroscopic X-ray System
Classification Panel	: Radiology
Classification Regulation	: 21 CFR 892. 1650
Device Classification	: Class II
Product Code	: OWB, OXO, JAA

4. Legally Marketed Predicated Device

Trade Name	: KMC-950
510(k) Clearance #	: K032761
Clearance date	: 05/14/2004
Classification Name	: Image Intensified Fluoroscopic X-ray System
Classification Panel	: Radiology
CFR Section	: 21CFR 892.1650
Device Class	: Class II
Product Code	: JAA, OWB, OXO

5. Reference Device

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Trade Name	: Artis one Angiographic System
510(k) Clearance #	: K133580
Clearance date	: 04/28/2014
Classification Name	: Image Intensified Fluoroscopic X-ray System
Classification Panel	: Radiology
CRF Section	: 21CFR 892.1650
Device Class	: Class II
Product Code	: OWB, JAA, IZI

6. Device Description

The SPINEL 12HD Surgical Mobile Fluoroscopic 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 to be used for mammography applications.

SPINEL 12HD 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 a flat panel detector. This system can be applied in emergency room, operation room, cast room or etc. of a hospital.

6. Indications for Use

SPINEL 12HD Surgical Mobile Fluoroscopic X-ray System is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to digital subtraction angiography, orthopedic, neurological, abdominal, vascular, cardiac, critical care and emergency room procedures.

7. Substantial Equivalence

SPINEL 12HD is substantially equivalent to the commercially available KMC-950 of GEMSS Medical System (K032761). The detailed SE discussion is provided in SECTION 12.

	Predicate device	Proposed device
Model Name	KMC-950	SPINEL 12HD
510(k) Number	K032761
Indications for Use	The KMC-950 is intended to provide
fluoroscopic and radiographic imaging of the
patient during diagnostic, surgical and
interventional procedures. Clinical
applications may include but are not limited
to digital subtraction angiography,
orthopedic, neurological, abdominal,
vascular, cardiac, critical care and
emergency room procedures.
The system may be used for other RF
imaging application at physician's discretion.	SPINEL 12HD Surgical Mobile Fluoroscopic
X-ray System is intended to provide
fluoroscopic and radiographic imaging of
the patient during diagnostic, surgical and
interventional procedures. Clinical
applications may include but are not
limited to digital subtraction angiography,
orthopedic, neurological, abdominal,
vascular, cardiac, critical care and
emergency room procedures.

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| | | Predicate device
KMC-950 (K032761) | Proposed device
SPINEL 12HD
| Justification |
|----------------------|------------------------------------------|---------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| X-ray tube | Manufacturer | Varian (RAD-99) | Toshiba (E7833X) | New X-ray tube was used for the
subject device due to the aspect
of cost and supply capacity of the
manufacturer. Both X-ray tube
have equivalent technical
specification. There is no
difference in the safety and
effectiveness for both X-ray
tubes. The following risk factors
were considered and reviewed※ |
| | Anode Type | Rotating | Rotating | |
| | Heat Capacity | 300,000 HU | 300,000 HU | |
| | Anode Heat
Cooling | 70kHU/min | 70kHU/min | have equivalent technical |
| | Cooling | | | Hazard ID : RM-12HD-01 / RM-
12HD-02 / RM-12HD-03 / RM-12HD-
09 / RM-12HD-43 / RM-12HD-44 /
RM-12HD-45 / RM-12HD-49 / RM-
12HD-50 / RM-12HD-51 / RM-12HD-
52 / RM-12HD-53 / RM-12HD-70 /
RM-12HD-72 / RM-12HD-74 / RM-
12HD-75 IEC60601-1, IEC60601-1-3 |
| | Focal size | 0.3mm / 0.6mm | 0.3mm / 0.6mm | |
| | | | | |
| X-ray
generator | Manufacturer | POSKOM | POSKOM | |
| | X-ray
Generator Type | High frequency /
inverter type | High frequency /
inverter type | |
| | Power Output | 12 kW | 12 kW | |
| | | | | |
| Fluoroscopic
Mode | kV range | 40 to 125 kV See below
discussion for
differences | 40 to 120 kV See below
discussion for
differences | Changed X-ray control range to
improve output stability and
effectiveness compared to the
predicate device. |
| | | | | kV → Adjusted the kV range to
be aligned with the X-ray
exposure setting. |
| | mA range | 0.5 to 5 mA. See below
discussion for
differences | 0.2 to 10 mA. See
below discussion for
differences | mA → Adjusted and broadened
the mA range for more stable X-
ray exams of different human
body parts. |
| | Pulse Fluoro | Yes | Yes | ※Hazard ID : RM-12HD-01 / RM-
12HD-02 / RM-12HD-03 / RM-12HD-
43 / RM-12HD-49 / RM-12HD-50 /
RM-12HD-51 / RM-12HD-52 / RM-
12HD-53 / RM-12HD-70 / RM-12HD-
74 / RM-12HD-75 |
| | ABS function | Yes | Yes | |
| | Snap Shot | 8.0 mA shot available | 6 mA shot available | |
| | Boost Shot | 20.0 mA shot available | 8mA / 20.0 mA shot
available | |
| | | | | |
| | | | | |
| Detector | Manufacturer | Thales (TH9428HP2)
Image Intensifier | Pixium 2630S Flat
Panel Detector (cleared
under K133580) | The new digital FPD of the
subject device has better
performance specification
compared to the image intensifier
of the predicate device in terms
of image quality and resolution.
The following risk factors have
been considered and reviewed. |
| | Size | 9" | 11.3 x 10.3 " | |
| | Magnification | 9" / 6" / 4.5" | 10 " / 9" / 7-7/8" / 4.5"
(square) | |
| | DQE | 65 | 70 (@ 0 lp/mm) | |
| | MTF | 92 (@ 2 lp/cm) | 59 (@ 1 lp/mm) | |
| | Central
resolution | 48 μm | 92 μm (184 μm in 2x2
binning) | ※Hazard ID : RM-12HD-04 / RM-
12HD-16 / RM-12HD-17 / RM-12HD-
18 / RM-12HD-19 / RM-12HD-20 /
RM-12HD-21 / RM-12HD-22 / RM-
12HD-23 / RM-12HD-37 / RM-12HD-
54 / RM-12HD-64 / RM-12HD-65 /
RM-12HD-71 / RM-12HD-73 |
| | Pixel size | | 1800 (h) x 1500 (v) | |
| | | | | |
| Camera | Manufacturer | | | |
| | Manufacturer | RAYSIS | N/A | N/A |
| | Type | ½" CCD | N/A | N/A |
| | Active pixels | 512 x 512 | N/A | N/A |
| C-arm | Manufacturer | | | The range of C-arm movement
has been broadened to result the
coverage of larger region of
interest during a patient exam.
The following risk factors have
been considered an reviewed.
※Hazard ID : RM-12HD-10 / RM-
12HD-25 / RM-12HD-28 / RM-12HD-
29 / RM-12HD-30 / RM-12HD-32 /
RM-12HD-33 / RM-12HD-34 / RM-
12HD-35 / RM-12HD-36 / RM-12HD-
37 / RM-12HD-38 / RM-12HD-39 /
RM-12HD-40 / RM-12HD-41 / RM-
12HD-42 / RM-12HD-56 / RM-12HD-
57 / RM-12HD-58 / RM-12HD-67 /
RM-12HD-68 / RM-12HD-69 |
| | Manufacturer | GEMSS medical
Systems Co., Ltd | GEMSS medical
Systems Co., Ltd | |
| | SID | 950mm | 1000mm | |
| | Range of C-ram
Rail Rotation | 115° (90° / 25°) | 165° (120° / 45°) | |
| | Range of the
Liner FR-arm
Movement | 200 mm | 220 mm | |
| | Range of the
Linear T-arm
Movement | 500 mm | 500 mm | |
| | Range of
Swing-arm
Rotation | ± 12.5° | ± 12.5° | |
| | Range of Stay-
arm Rotation | 360° | 225° | |
| Image
Processing | Storage
Capacity | Digital | Digital | The monitor size has increased to
provide better image viewing
experience for the user.
※Hazard ID : RM-12HD-04 / RM-
12HD-65 |
| | Image Matrix
Size | 5,000 images | 5,000 images | |
| | Monitor Size | 17" | 19" | |
| Collimator | Model Name | KMC-950CM | SPINEL 12HDCMR | |

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8. Summary of technological characteristics of the device compared to the predicate device

The indications for use, operating principle, technical specifications such as X-ray tube head and generator as well as safety characteristics of SPINEL 12HD are identical to those of the predicate device. SPINEL 12HD is designed as a set of components (X-ray tube and housing, detector, digital imaging system, collimator, qenerator etc.) similar to the predicate device KMC-950 (K032761). Based on the recognized standard conformity evidences related to electro-, mechanical-, software-, and risk management, GEMSS Medical System certifies that technological characteristics of SPINEL 12HD are substantially equivalent to KMC-950, the predicate device. SPINEL 12HD consists of many critical parts same as KMC-950, the predicate device (Collimator, X-ray imager, digital image processing and viewing program, C-arm, etc.),

Even though the hardware specification of X-ray generator is the same, the operating ranges of KV and mA setting of SPINEL 12HD are different compared to KMC-950 to improve the effectiveness of the fluoroscopic exam of different human body type.

• The X-ray Generator for the subject and predicate device have the identical specification. The dose difference is small under the same irradiation conditions.
  The SID and the location of ISO center is different for the subject device compared to the predicate
  device which results a difference in the dose measurement. The measurement was done 150mm away from the ISO center toward the tube.

→ The measurement distance from the X-ray tube for SPINEL 12HD is longer than the distance
between the measurement position of the tube of the KMC-950 resulting the dose of slightly lower overall.

The viewing software of the subject device is an updated version of CXV viewing software also used for the The subject device is equipped with a digital flat panel detector with higher DQE and predicate device. MTF performance characteristics compared to the predicate device. The pixel size (1800x1500) of the subject device is better than the active pixel (512x512) of the predicate device. The safety and effectiveness of Pixium 2630S flat panel detector equipped for SPINEL 12HD has been reviewed and cleared by FDA under 510k No: K133580.

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The V&V Report for Intelligent object dose control (IODC) and Metal Detected Control (MDC) for SPINEL 12HD contains the software quality and performance testing activities.

The Intelligent Object Dose Control (IODC) is a function to adjust the intensity of the X-ray using the detected object, and the brightness of the desired image can be obtained by optimizing the function of ABC (Auto Brightness Control) according to the distribution of the detected object.

With metal detected control, the brightness of the image is adjusted by distinquishing the attributes of the human body and the attributes of the metal, and reflecting only the attributes of the human body except for the metal part

Both IODC and MDC function are added to optimize (Check the type and position of the object and perform fast process speed and accurate processing.) the ABC function which is already included in the predicate.

The report also contains the device hazard analysis related to IODC and MDC. The images of before and after applying each function have been compared which validates the efficacy of both IODC and MC functions.

The differences between the subject and predicate device do not introduce any new safety or effectiveness concerns for SPINEL 12HD and the sponsor concludes that SPINEL 12HD is substantially equivalent with KMC-950, the predicated device.

• 9. General Safety and Effectiveness Concern
     To minimize electrical, mechanical, and radiation hazards, GEMSS MEDICAL SYSTEMS CO., LTD. adheres to established industry practice and all equipment are in compliance with the relevant FDA and international standards.

Electrical, EMC, mechanical safety and performance testing according to FDA recognized standards were performed as verification and validation activities to verify the safety and effectiveness of SPINEL 12HD. Engineering testing and standards compliance testing were successfully conducted and did not raise any new safety questions or concerns or identify new risks. The instruction for use is included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner.

. All test results were satisfactory. Applied standards are as follows:

• IEC60601-1:2005

• A IEC60601-1-2:2007
• A IEC60601-1-3:2008
• ▲ IEC60601-2-43: 2010
• IEC60601-2-54:2009 A
• A NEMA PS 3.1-3.20
• A ISO14971:2012

The subject device meets EPRC regulation requirements.

• A 21CFR1020.30
• A 21CFR1020.32

FDA quidance documents:

• FDA quidance for SSXI devices,

• A FDA guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

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Based on the robust set of results from the non-clinical studies that have been performed, SPINEL 12HD has been found to be substantially equivalent to the predicate device as well as found to be a safe and effective surgical mobile fluoroscopic X-ray imaging system.

10. Conclusion as to Substantial Equivalence

SPINEL 12HD is substantially equivalent to the predicate device KMC-950 (K032761). These two devices are same or very similar in the intended use, the design principle, the performance and the applicable standards. Some characteristics, for example, capacity of X-ray tube housing and generators, X-ray imager as well as user interfaces are different. However, the compliance reports and descriptions in this submission STED provide demonstration that these differences do not raise any new questions of safety and effectiveness. Therefore, it is the sponsor's opinion that SPINEL 12HD is substantially equivalent with the predicate device KMC-950 (K0327618).