The Garion is intended to be used and operated by: adequately trained, qualified and authorized health care professionals who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.

Device Description

GARION is mobile fluoroscopy system is designed to provdie fluoroscopic and spot-film images of thepatient during diagnostic, surgical procedures. This device is a digital X-ray radiographic equipment that consists of high voltage generator, X-ray control unit, X-ray tube unit, Collimator, image processing unit. The image processing unit consists of medical image detector, power supply, medical image collecting unit and relevant software.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Garion", an image-intensified fluoroscopic x-ray system. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device, "Zenition 70".

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on demonstrating substantial equivalence to a predicate device rather than defining specific performance acceptance criteria for the Garion device against a set of quantitative metrics. The "performance" is implicitly assessed through a comparison of technical characteristics to the predicate.

Acceptance Criteria (Implicit from Substantial Equivalence Claim)	Reported Device Performance (Comparison to Predicate: Zenition 70 K183040)
Indications for Use	Same as predicate
X-ray Tube Anode Type	Rotating Anode (Same as predicate)
X-ray Tube Anode Target Angle	10° (Same as predicate)
X-ray Tube Focal Size	0.3/0.6 (Same as predicate)
Fluoroscopic Mode kV range	40-125 kV (Similar, slightly higher peak kVp than predicate's 40-120 kV)
Fluoroscopic Mode mA range	0.1-100 mA (Similar, slightly higher mA than predicate's 0.5-60 mA)
Pulse Fluoro	YES (Same as predicate)
ABS function	YES (Same as predicate)
FPD Scintillator	Cesium Iodide (Same as predicate)
FPD Detector type	Amorphous silicon detector (Same as predicate)
FPD Active detector size	228.6 mm x 228.6 mm (Similar, slightly larger image than predicate's 207x207 mm)
FPD Total pixel matrix	1024x1024 (Similar to predicate's 1344x1344)
FPD Pixel pitch	205 μm (Similar to predicate's 154 μm)
FPD A/D Conversion	16 bit (Same as predicate)
FPD MTF (1.0 lp/mm)	0.64 (Similar, slightly better than predicate's 0.59)
FPD DQE (0 lp/mm)	0.77 (Same as predicate)
SID	980mm (Similar to predicate's 993mm)
C-arm Rail Rotation Range	±180° (Similar to predicate's ±200°)
Linear FR-arm Movement Range	200mm (Same as predicate)
Linear T-arm Movement Range	400mm (Similar to predicate's 490 mm)
Swing-arm Rotation Range	±15° (Similar, slightly better than predicate's ±10°)
Collimator Control	Motor control / rotation (Same as predicate)

The acceptance criterion, in this context, is that the Garion device's technological characteristics are substantially equivalent to the predicate device, implying similar safety and effectiveness. The reported performance is the direct comparison of these characteristics.

2. Sample Size Used for the Test Set and Data Provenance:

The document explicitly states: "9. Summary of clinical testing: Not required for a finding of substantial equivalene." This indicates that no clinical test set was used to evaluate the device's performance against specific acceptance criteria. The evaluation relies on comparing the technical specifications of the new device to the predicate device and adherence to relevant IEC standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Since no clinical test set was used, there were no experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document states that clinical testing was not required for substantial equivalence.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The "Garion" is an X-ray system, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in the same way as it would be for a pure software device. The evaluation is of the hardware and integrated software for image acquisition and display.

7. The Type of Ground Truth Used:

The "ground truth" for the substantial equivalence claim is effectively the established safety and effectiveness of the legally marketed predicate device (Zenition 70), supported by the device's compliance with applicable performance standards (IEC and FDA Radiation Safety Performance Standard). The comparison of technical specifications aims to show that the Garion device is sufficiently similar to the predicate to assume similar safety and effectiveness.

8. The Sample Size for the Training Set:

The concept of a "training set" is typically associated with machine learning or AI algorithms. Since this submission is for an X-ray system and does not mention any AI components requiring supervised learning, there is no training set in the conventional sense.

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

Not applicable, as there is no mention of a training set or AI algorithms requiring ground truth establishment.

Summary

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October 6, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of a human figure, while the right side features the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

SG Healthcare CO. LTD. % Daniel Kamm Principal Engineer Kamm & Assosciates 8870 Ravello Ct NAPLES FL 34114

Re: K222080

Trade/Device Name: Garion Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB Dated: July 8, 2022 Received: July 15, 2022

Dear Daniel Kamm:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222080

Device Name Garion

Indications for Use (Describe)

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, 510(k) K222080

Submitter: SG Healthcare Co., Ltd. 10 Yangnyeong-ro, Moga-myeon, Icheon-si, Gyeonggi-do, 17408 Seoul, Republic of Korea Tel: +82 2 449 6908 Fax: +82 2 449 6909 www.sghealthcare.com Contact: Byungju Kang, bjkang@sghealthcare.com Date Prepared: September 14, 2022

1. Identification of the Device:

Trade/Device Name: Garion Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: II Product Code: OWB

2. Equivalent legally marketed device: K183040, Philips Medical Systems International B.V.

Trade/Device Name: Zenition 70 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB

3. Reference Device:

The digital x-ray image acquisition panel employed has been cleared for the same intended use within: K200218 Trade/Device Name: Digiscan FDX Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA, OXO

4. Indications for Use

The Garion is intended to be used and operated by: adequately trained, qualified and authorized health care professionals who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.

5. Description of the Device:

GARION is mobile fluoroscopy system is designed to provdie fluoroscopic and spot-film images of thepatient during diagnostic, surgical procedures.

This device is a digital X-ray radiographic equipment that consists of high voltage generator, X-ray control unit, X-ray tube unit, Collimator, image processing unit. The image processing unit consists of medical image detector, power supply, medical image collecting unit and relevant software.

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Fine-Tuned Movement
5kW FPD Surgical C-arm

• Garion is equipped with a high resolution FPD. Its composition, along with othe components such as positive/negative inversion, realtime zoom & rotation,as well as advanced noise reduction and optimized contrast/brightness, providing clear and enhanced image quality.

Attachable Grid
The Grid can be attached and detached, allowing low-dose examination for each part.
Dual Laser Pointer
Using the dual laser pointer, it is possible to set the patient's position without unnecessary exposure.

Comparison Table with the Predicate Device for technological characteristics:

· Powerful Digital Image, Processing and Display

The combination of Dynamic FPD means that Garion provides a excellent quality on screen image. Our advanced image-processing technology enables you to utilize various functions such as image flip (horizontal & vertical), image rotation (360°), realtime zoom, noise reduction, and realtime edge enhancement, etc.

Safety and Effectiveness, comparison to predicate device. This device has the same indications for use and very similar technological characteristics as the predicate device. This can be readily seen in the comparison table presented below. Many of the characteristics compared are the same, while other differences are insignificant in nature. The digital receptor panel chosen has already been cleared (reference device) for the same intended use.

Detailed comparison chart
	Predicate device Zenition 70 K183040	Proposed device Garion	SE
Indications for Use	The Zenition 70 device is intended to be used and operated by: adequately trained, qualified and authorized health care professionals who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.	The Garion is intended to be used and operated by: adequately trained, qualified and authorized health care professionals who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.	SAME
X-ray Tube	Anode TypeRotating Anode	Rotating Anode	SAME
	Anode target angle10°	10°	SAME
	Focal size0.3/0.6	0.3/0.6	SAME
Fluoroscopic Mode	kV range40-120 kV	40-125 kV	Similar.Slightlyhigher
		Predicate device Zenition 70 K183040	Proposed device Garion	SE
				peakkVp
	mA range	0.5-60 mA	0.1-100 mA	Similar,slightlyhighermA
	PulseFluoro	YES	YES	SAME
	ABSfunction	YES	YES	SAME
FPDImageDetect-or	Make	Trixell's PX2121S	IRAY 's, Mercu 0909F	--
	Model	8.15" x 8.15"	9" x 9"	Similar,slightlylargerimage.
	Scintilla-tor	Cesium lodide	Cesium lodide	SAME
	Detectortype	amorphous silicon detector	amorphous silicon detector	SAME
	Activedetectorsize	207×207 mm	228.6 mm x228.6 mm	Similar,slightlylargerimage
	Total pixelmatrix	1344 x 1344	1024×1024	Similar
	Pixel pitch	154 μm	205 μm	Similar
	A/DConvers-ion	16 bit	16 bit	SAME
	MTF (1.0lp/mm)	0.59	0.64	Similar,slightlybetter.
	DQE (0lp/mm)	0.77	0.77	SAME
	Manu-facturer	Philips	SG HealthCare Co. Ltd.	--
	SID	993mm	980mm	Similar
C-arm	Range ofC-arm RailRotation	±200°	±180°	Similar
	Range ofthe LinearFR-armMove-ment	200 mm	200mm	SAME
	Range ofthe LinerT-armMove-ment	490 mm	400 mm	Similar
		Predicate device Zenition 70 K183040	Proposed device Garion	SE
	Range ofswing-armRotation	$\pm 10°$	$\pm 15$	Similar,slightlybetter.
Collimator		Motor control / rotation	Motor control / rotation	SAME
Photo		Image: Predicate device Zenition 70 K183040	Image: Proposed device Garion	Similar

Detailed comparison chart

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8. Summary of non-clinical testing: We employed applicable IEC standards:

IEC60601-1, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

IEC60601-1-2, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests

IEC60601-1-3, Medical electrical equipment – Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

IEC60601-1-6, Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance -Collateral Standard: Usability

IEC60601-2-28 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis

IEC60601-2-54 Medical electrical equipment Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

IEC62366 Medical device – Application of usability engineering to medical devices

In addition, the device complies with the FDA Radiation Safety Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 1020.32, 1020.32, 1020.33); Small Entity Compliance Guide. In addition, labeling was developed and information provided in accordance with this FDA Guidance Document: Pediatric Information for X-ray Imaging Device Premarket Notifications, Guidance for Industry and Food and Drug Administration Staff. Labeling also includes reference to the Image Gently website (http://www.imagegently.org/). Also we observed the recommendations contained in the FDA Guidance Document: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff

Summary of clinical testing: Not required for a finding of substantial equivalene..
Conclusion: After analyzing bench tests, and safety testing data, SG Healthcare concludes that the "Garion" is as safe and effective as the predicate device "Zenition 70" has few technological differences and has identical indications for use, thus rendering it substantially equivalent to the predicate device.

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.