(273 days)
Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms, and the device description focuses on standard X-ray components and real-time fluoroscopy.
No
Explanation: This device is used for providing fluoroscopic images for diagnostic purposes, not for treating conditions.
Yes
The device provides fluoroscopic images during diagnostic, surgical, and interventional procedures, allowing the physician to "see the images on real-time," which is a form of real-time diagnostic imaging.
No
The device description explicitly states that the device consists of hardware components such as an X-ray tube, X-ray tube assembly, X-ray controller, XTV Camera, and accessories.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The ZEN-2090 Turbo, C-Arm mobile is an imaging device that uses X-rays to provide real-time images of the patient's internal anatomy. It does not analyze biological specimens.
- Intended Use: The intended use is to provide fluoroscopic images of patient anatomy, especially during diagnostic, surgical and interventional procedures. This is a direct imaging function, not an in vitro analysis.
The device is clearly an in vivo imaging device, meaning it is used to examine the body directly, rather than analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
ZEN-2090 Turbo, C-Arm mobile is used for providing fluoroscopic images of patient anatomy in a hospital or medical clinics.
Product codes (comma separated list FDA assigned to the subject device)
OWB. JAA. OXO
Device Description
ZEN-2090 Turbo, C-arm mobile is used for providing fluoroscopic image of patient anatomy, especially during diagnostic, surgical and interventional procedures. The fluoroscopic mode of operation is very useful to the attending physician to see the images on real time without the need to develop individual films.
ZEN-2090 Turbo is consisting of the X-ray tube, X-ray tube assembly, X-ray controller, XTV Camera and some accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic X-Ray
Anatomical Site
patient anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
attending physician / hospital or medical clinics
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)
ZEN-2090 Turbo has successfully completed verification and validation testing per GENORAY quality system as well engineering bench testing in support of this submission. The system has been tested and is compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-28, IEC 60601-2-43, IEC 60601-2-54 and IEC 62366. Also all applicable 21 CFR performance standards (21 CFR 1020.30, 1020.31, 1020.32) are met.
And Software verification testing of the functional requirements as well as performance and safety has been performed to verify that all the requirements of System Requirements Specification as well as the safety risk control measures from the Detailed Risk Management Matrix and the Privacy and Security requirements and mitigations have been implemented. FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical devices", FDA Guidance "Guidance for the content of premarket submissions for management of cyber security" to ensure substantial equivalence. Results demonstrated that all executed verification tests were passed.
Non-clinical validation testing has been performed to validate that ZEN-2090 Turbo conforms to the intended use, claims, user needs, effectiveness of safety measures and instructions for use.
As a results, all test results were satisfactory and the result of bench and clinical evaluation indicates that the new device is as safe and effective as 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.
Not Found
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
March 9, 2022
GENORA Y Co., Ltd. % Kaitlynn Min Business Development Manager GENORAY America Inc. 147 E. Bristol Lane ORANGE CA 92780
Re: K211780
Trade/Device Name: ZEN-2090 Turbo Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB. JAA. OXO Dated: February 17, 2022 Received: February 18, 2022
Dear Ms. Kaitlynn Min:
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
1
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 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 medical devices and radiation-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 Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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)
Device Name ZEN-2090 Turbo
Indications for Use (Describe)
ZEN-2090 Turbo, C-Arm mobile is used for providing fluoroscopic images of patient anatomy in a hospital or medical clinics.
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)
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Exhibit 5 510(k) Summary
Date of Summary Preparation: June. 04, 2021
-
- Submitter and US Official Correspondent
| Submitter: | GENORAY Co., Ltd. |
|---|---|
| Address: | 512, 560, Dunchon-daero, Jungwon-gu, |
| Seongnam-si, Gyeonggi-Do, Korea | |
| Telephone No.: | +82-31-5178-5500 |
| Fax: | +82-31-5178-5599 |
Official Correspondent (U.S): Kaitlynn Min - Business Manager
| Correspondent: | GENORAY America Inc. |
|---|---|
| Address: | 147 E. Bristol Lane, Orange, CA 92865 USA |
| Telephone No.: | +1-855-436-6729 |
| Fax: | +1-714-786-8919 |
| Email: | kaitlynn@genorayamerica.com |
2. Establishment Registration Number 3005843418
Device Information 3.
| Trade/Device Name: | ZEN-2090 Turbo |
|---|---|
| Regulation Name: | Fluoroscopic X-ray System |
| Classification Name: | Interventional Fluoroscopic X-Ray System |
| Product Code: | OWB / Interventional Fluoroscopic X-Ray System |
| Subsequence product code: | JAA / System, X-Ray, Fluoroscopic, Image-Intensified |
| OXO / Image-intensified fluoroscopic x-ray system, mobile | |
| Device Class: | Class II per regulation 21 CFR 892.1650 |
4
- Predicate Device (Equivalent Legally Marketed Device) 4.
| Manufacturer: | GENORAY Co., Ltd |
|---|---|
| Device Name: | ZEN-2090 Pro |
| 510(k) Number: | K091918 (Decision Date - October 07, 2009) |
| Classification Name: | Interventional Fluoroscopic X-Ray System |
| Primary Product Code: | OWB / Interventional Fluoroscopic X-ray System |
| Secondary product code: | JAA / system, x-ray, fluoroscopic, image-intensified |
| OXO / image-intensified fluoroscopic x-ray system, mobile | |
| Device Class: | Class II per regulation 21 CFR 892.1650 |
Description of the Device 5.
ZEN-2090 Turbo, C-arm mobile is used for providing fluoroscopic image of patient anatomy, especially during diagnostic, surgical and interventional procedures. The fluoroscopic mode of operation is very useful to the attending physician to see the images on real time without the need to develop individual films.
ZEN-2090 Turbo is consisting of the X-ray tube, X-ray tube assembly, X-ray controller, XTV Camera and some accessories.
6. Indications for use
ZEN-2090 Turbo, C-Arm mobile is used for providing fluoroscopic and radiographic images of patient anatomy in a hospital or medical clinics.
5
7. Substantial equivalence chart
| Proposed device | Predicate device | |
|---|---|---|
| Name | ZEN-2090 Turbo | ZEN-2090 Pro |
| Manufacturer | GENORAY Co., Ltd. | GENORAY Co., Ltd. |
| 510(k) No. | - | K091918 |
| Indications | ||
| for use | ZEN-2090 Turbo, C-Arm mobile is used for providing | |
| fluoroscopic and radiographic images of patient anatomy | ||
| in a hospital or medical clinics. | ZEN-2090 Pro is a mobile digital C-arm designed to provide | |
| fluoroscopic and radiographic images of the patient during | ||
| diagnostic, surgical and interventional procedures. Examples of | ||
| clinical application may include cholangiography, endoscopy, | ||
| orthopedic, neurologic, stone localization, critical care and | ||
| emergency room procedures i.e. surgical interventions needing | ||
| X-ray imaging and/or guidance and interventions inside and | ||
| outside the operating room. | ||
| Generator | High Frequency Inverter | High Frequency Inverter |
| Max. output | ||
| power | 2.0kW | 2.2kW |
| X-ray tube | Stationary tube | Stationary tube |
| 0.6 mm | Large : 1.5 mm / Small : 0.5 mm |
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| Name | Proposed device | Predicate device |
|---|---|---|
| ZEN-2090 Turbo | ZEN-2090 Pro | |
| Detector | ||
| (Image | ||
| Intensifier) | E5830SD-P4A | E5830SD-P4A |
| • Active image area : 9" (9"/6"/4.5") | • Active image area : 9" (9"/6"/4.5") | |
| • Min. Central Resolution at the monitor: |
- 9" (23cm): 2.2 lp/mm
- 6" (16cm): 2.8 lp/mm
- 4.5" (12cm): 3.0 lp/mm | • Min. Central Resolution at the monitor:
- 9" (23cm): 2.2 lp/mm
- 6" (16cm): 2.8 lp/mm
- 4.5" (12cm): 3.0 lp/mm |
| | • DQE: 65% | • DQE: 65% |
| | | |
| Fluoroscopy | 40-110 kV / 0.2-12.0 mA | 40-110 kV/ 0.2-6.0 mA |
| Pulsed
Fluoroscopy | 1.0 - 24.0 mA | 0.2-6.0 mA |
| Dimensions | SID : 960 mm | SID : 960 mm |
| | Panning Rotation: ±12.5° | Panning Rotation: ±12.5° |
| | Orbital Rotation: 135° | Orbital Rotation: 120° |
| | Vert. Travel: 500 mm | Vert. Travel: 400mm |
| | Horiz. Travel: 200 mm | Horiz. Travel: 200mm |
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K211780
The proposed ZEN-2090 Turbo is based on the predicate device, ZEN-2090 Pro (K091918).
ZEN-2090 Pro supports both Radiography mode and Fluoroscopy mode, while ZEN-2090 Turbo supports only Fluoroscopy mode.
For Fluoroscopy mode, ZEN-2090 Pro consists of single dose mode, and the maximum X-ray output power is 440W at 110xV, 4mA and the focal size is 0.5 mm with small focus. This is the same for both Continuous Fluoroscopy mode.
ZEN-2090 Turbo can select 3 dose modes (low, normal, high mode), and the focal size is 0.6 mm with single focus. Normal mode of ZEN-2090 Turbo in Continuous Fluoroscopy mode is the same as ZEN-2090 Pro, and high mode is limited to 880W at 110kV, 8mA, it is the twice than normal mode. ZEN-2090 Turbo in Pulsed Fluoroscopy mode is set higher than ZEN-2090 Pro in both normal and high mode.
Among them, high mode is limited to 2000W at 110kV, 18.1mA.
According to the above, ZEN-2090 Turbo is 2 times more than ZEN-2090 Pro in Continuous Fluoroscopy mode, and about 5 times difference in Pulsed Fluoroscopy mode.
Therefore, we have justified that ZEN-2090 Turbo has better image quality than predicate device, ZEN-2090 Pro (K091918).
8
Safety, EMC and Performance data comparison to Predicate 8.
ZEN-2090 Turbo has successfully completed verification and validation testing per GENORAY quality system as well engineering bench testing in support of this submission. The system has been tested and is compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-28, IEC 60601-2-43, IEC 60601-2-54 and IEC 62366. Also all applicable 21 CFR performance standards (21 CFR 1020.30, 1020.31, 1020.32) are met.
And Software verification testing of the functional requirements as well as performance and safety has been performed to verify that all the requirements of System Requirements Specification as well as the safety risk control measures from the Detailed Risk Management Matrix and the Privacy and Security requirements and mitigations have been implemented. FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical devices", FDA Guidance "Guidance for the content of premarket submissions for management of cyber security" to ensure substantial equivalence. Results demonstrated that all executed verification tests were passed.
Non-clinical validation testing has been performed to validate that ZEN-2090 Turbo conforms to the intended use, claims, user needs, effectiveness of safety measures and instructions for use.
As a results, all test results were satisfactory and the result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate device.
9. Conclusion
In reference to the comparison information provided in substantial equivalence chart, and the most of functions and electronic features are similar with predicate device. We believe that the ZEN-2090 Turbo is safe and effective as predicate device, and has no new indication for use. Therefore, ZEN-2090 Turbo is substantially equivalent to predicate device.