(83 days)
No
The summary mentions image processing but does not explicitly mention AI, ML, or related terms like deep learning or neural networks. The description of the device components and testing focuses on standard X-ray system elements and compliance with relevant IEC and FDA standards, without indicating any AI/ML-specific development or validation.
No
Explanation: The device is described as a mobile fluoroscopy system used for "radiological guidance and visualization during diagnostic, interventional and surgical procedures" and to "provide fluoroscopic and spot-film images." This indicates its primary function is diagnostic imaging and guidance, not direct therapeutic action.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is used for "radiological guidance and visualization during diagnostic, interventional and surgical procedures". The 'Device Description' also mentions it's for "diagnostic, surgical procedures".
No
The device description explicitly states that GARION is a mobile fluoroscopy system consisting of multiple hardware components including a high voltage generator, X-ray control unit, X-ray tube unit, Collimator, and image processing unit (which itself includes hardware like a medical image detector and power supply), in addition to relevant software. This clearly indicates it is not a software-only medical device.
Based on the provided information, the Garion device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates". This describes a device used on the patient's body for imaging purposes, not a device used to examine specimens from the body (which is the definition of an in vitro diagnostic).
- Device Description: The description details a "mobile fluoroscopy system" that provides "fluoroscopic and spot-film images of the patient". This is consistent with an imaging device used on a living patient.
- Input Imaging Modality: The input modality is X-ray, which is used for imaging the inside of the body.
- No mention of analyzing biological samples: There is no indication that the device interacts with or analyzes any biological samples (blood, urine, tissue, etc.) taken from the patient.
In vitro diagnostics are devices used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. The Garion device does not fit this description. It is an in vivo imaging device.
N/A
Intended Use / 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. 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.
Product codes (comma separated list FDA assigned to the subject device)
OWB
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.
- 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic X-Ray
Anatomical Site
Not Found
Indicated Patient Age Range
all patients, except neonates (birth to one month)
Intended User / Care Setting
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 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.
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)
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.
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.
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.
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
§ 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.
0
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
1
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
2
Indications for Use
510(k) Number (if known) K222080
Device Name Garion
Indications for Use (Describe)
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.
| 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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3
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.
4
- 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 Type | |||
| Rotating Anode | Rotating Anode | SAME | ||
| Anode target angle | ||||
| 10° | 10° | SAME | ||
| Focal size | ||||
| 0.3/0.6 | 0.3/0.6 | SAME | ||
| Fluoroscopic Mode | kV range | |||
| 40-120 kV | 40-125 kV | Similar. | ||
| Slightly | ||||
| higher | ||||
| Predicate device Zenition 70 K183040 | Proposed device Garion | SE | ||
| peak | ||||
| kVp | ||||
| mA range | 0.5-60 mA | 0.1-100 mA | Similar, | |
| slightly | ||||
| higher | ||||
| mA | ||||
| Pulse | ||||
| Fluoro | YES | YES | SAME | |
| ABS | ||||
| function | YES | YES | SAME | |
| FPD | ||||
| Image | ||||
| Detect- | ||||
| or | Make | Trixell's PX2121S | IRAY 's, Mercu 0909F | -- |
| Model | 8.15" x 8.15" | 9" x 9" | Similar, | |
| slightly | ||||
| larger | ||||
| image. | ||||
| Scintilla- | ||||
| tor | Cesium lodide | Cesium lodide | SAME | |
| Detector | ||||
| type | amorphous silicon detector | amorphous silicon detector | SAME | |
| Active | ||||
| detector | ||||
| size | 207×207 mm | 228.6 mm x228.6 mm | Similar, | |
| slightly | ||||
| larger | ||||
| image | ||||
| Total pixel | ||||
| matrix | 1344 x 1344 | 1024×1024 | Similar | |
| Pixel pitch | 154 μm | 205 μm | Similar | |
| A/D | ||||
| Convers- | ||||
| ion | 16 bit | 16 bit | SAME | |
| MTF (1.0 | ||||
| lp/mm) | 0.59 | 0.64 | Similar, | |
| slightly | ||||
| better. | ||||
| DQE (0 | ||||
| lp/mm) | 0.77 | 0.77 | SAME | |
| Manu- | ||||
| facturer | Philips | SG HealthCare Co. Ltd. | -- | |
| SID | 993mm | 980mm | Similar | |
| C-arm | Range of | |||
| C-arm Rail | ||||
| Rotation | ±200° | ±180° | Similar | |
| Range of | ||||
| the Linear | ||||
| FR-arm | ||||
| Move- | ||||
| ment | 200 mm | 200mm | SAME | |
| Range of | ||||
| the Liner | ||||
| T-arm | ||||
| Move- | ||||
| ment | 490 mm | 400 mm | Similar | |
| Predicate device Zenition 70 K183040 | Proposed device Garion | SE | ||
| Range of | ||||
| swing-arm | ||||
| Rotation | $\pm 10°$ | $\pm 15$ | Similar, | |
| slightly | ||||
| better. | ||||
| Collimator | Motor control / rotation | Motor control / rotation | SAME | |
| Photo | Image: Predicate device Zenition 70 K183040 | Image: Proposed device Garion | Similar |
Detailed comparison chart
5
6
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.