(28 days)
No
The summary does not mention AI, ML, or any related terms, and the description focuses on standard fluoroscopy technology and image processing functions like calibration.
No.
The device is described as a mobile fluoroscopy system designed to provide images for diagnostic and interventional procedures, visualizing anatomical structures. It does not perform a therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that OSCAR is a "mobile fluoroscopy system designed to provide fluoroscopic and spot film images of the patient during diagnostic, surgical and interventional procedures." The term "diagnostic" directly indicates its use for diagnosis.
No
The device description explicitly states it is composed of hardware components like an X-ray Tube, X-ray tube assembly, x-ray controller, and image receptor. It is a mobile fluoroscopy system, which is a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- Device Function: The description clearly states that OSCAR is a mobile fluoroscopy system that provides fluoroscopic and spot film images of the patient during diagnostic, surgical, and interventional procedures. It visualizes anatomical structures by converting x-radiation into a visible image. This is an in vivo (within the living body) imaging technique.
- Intended Use: The intended use describes visualizing patient anatomy and providing real-time images during procedures, not analyzing samples taken from the patient.
Therefore, the function and intended use of the OSCAR device fall under the category of medical imaging equipment, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
OSCAR is a mobile fluoroscopy system designed to provide fluoroscopic and spot film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, and stone localization.
Product codes
OWB, JAA
Device Description
OSCAR Prime and OSCAR Classic are classified according to the option of image acquisition parts. Flat panel detector is OSCAR Prime, and Image intensifier is OSCAR Classic. And they are called OSCAR as the brand name.
OSCAR is consist of X-ray Tube, X-ray tube assembly, x-ray controller, image receptor and some accessories. There is no wireless function in this device.
The OSCAR, C-Arm Mobile is the device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This device is used for providing fluoroscopic and radiographic images of patient anatomy, especially during the special procedures in a hospital clinics. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
all except children.
Intended User / Care Setting
Not Found
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)
Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-28, IEC 60601-2-43, IEC 60601-2-54 and IEC 62366 were performed.
EMC testing was conducted in accordance with standard IEC 60601-1-2.
OSCAR meets the EPRC standards (21 CFR 1020.30, 31, 32).
FDA guidance "guidance for SSXI devices", and "guidance for the Content of Premarket Submissions for Software Contained in Medical devices", was performed for OSCAR.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
August 17, 2018
GENORAY Co., Ltd. % Ms. Kaitlynn Min Business Development GENORAY America Inc. 147 E. Bristol Lane ORANGE CA 92780
Re: K181943
Trade/Device Name: OSCAR (OSCAR Prime, OSCAR Classic) Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA Dated: July 5, 2018 Received: July 20, 2018
Dear Ms. 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/cfpmp/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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Hole 2. Nils
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K181943
Device Name OSCAR (OSCAR Prime, OSCAR Classic)
Indications for Use (Describe)
OSCAR is a mobile fluoroscopy system designed to provide fluoroscopic and spot film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, and stone localization.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Poblishing Services (301) 443-6740 El
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Exhibit 5 510(k) Summary
Date of Summary Preparation: July. 05, 2018
-
- Submitter and US Official Correspondent
| Submitter : | GENORAY Co., Ltd. |
|---|---|
| Address: | 512, 560, Dunchon-daero, Jungwon-gu, |
| Seongnam-si, Gyeonggi-Do, Korea | |
| Telephone No.: | +82-31-740-4100 |
| Fax: | +82-31-737-8018 |
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: | OSCAR |
|---|---|
| OSCAR Prime, OSCAR Classic | |
| Regulation Name: | Image-Intensified 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 | |
| Device Class: | Class II per regulation 21 CFR 892.1650 |
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- 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: | Image -Intensified 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.
OSCAR Prime and OSCAR Classic are classified according to the option of image acquisition parts. Flat panel detector is OSCAR Prime, and Image intensifier is OSCAR Classic. And they are called OSCAR as the brand name.
OSCAR is consist of X-ray Tube, X-ray tube assembly, x-ray controller, image receptor and some accessories. There is no wireless function in this device.
The OSCAR, C-Arm Mobile is the device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This device is used for providing fluoroscopic and radiographic images of patient anatomy, especially during the special procedures in a hospital clinics. The fluoroscopic mode of operation is very useful to the attending physician to see the images on real time
Indications for use 6.
without the need to develop individual films.
OSCAR is a mobile fluoroscopy system designed to provide fluoroscopic and spot film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, and stone localization. The patient group using OSCAR is all except children.
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7. Substantial equivalence chart
| Name | Proposed device | Predicate device |
|---|---|---|
| OSCAR | ZEN-2090 Pro | |
| Manufacturer | GENORAY Co., Ltd. | GENORAY Co., Ltd. |
| 510(k) No. | - | K091918 |
| Indications | ||
| for use | OSCAR is a mobile fluoroscopy system designed to provide fluoroscopic and | |
| spot film images of the patient during diagnostic, surgical and interventional | ||
| procedures. Examples of clinical application may include cholangiography, | ||
| endoscopy, urologic, orthopedic, neurologic, vascular, cardiac and critical care. | ||
| The patient group using OSCAR is all except children. | 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 | 4.5kW | 2.2kW |
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| Stationary tube | Stationary tube | ||
|---|---|---|---|
| X-ray tube | Large: 1.4 / Small: 0.5 | Large : 1.5 mm / Small : 0.5 mm | |
| Detector | OSCAR Prime (Flat panel) | OSCAR Classic (Image intensifier) | ZEN-2090 Pro (Image Intensifier) |
| Option A: GFD-200 (DualRay-Q) | |||
| (Cleared under K172180) | Option A: E5830SD-P4A | ||
| (Cleared under K140041) | E5830SD-P4A | ||
| Active image area : 260 x 256 mm Central Resolution : 4.6 lp/mm Type : CMOS Resolution : 2600 x 2560 Pixel sampling resolution : 14 bits Pixel pitch : 100 μm MTF: 56% DQE: 59% Scintillator : CsI | Active image area : 9" (9"/6"/4.5") Min. Central Resolution at the monitor: |
- 9" (23cm): 2.2 lp/mm
- 6" (15cm): 2.8 lp/mm
- 6" (15cm): 3.0 lp/mm DQE: 65% (typically) | Active image area : 9" (9"/6"/4.5") Min. Central Resolution at the monitor:
- 9" (23cm): 2.2 lp/mm
- 6" (15cm): 2.8 lp/mm
- 6" (15cm): 3.0 lp/mm DQE: 65% (typically) | |
| Option B: VIVIX-D 0909G | Option B: TH 9438 QX
(Cleared under K140041). | | |
| Active image area : 229.12 x 229.12mm Central Resolution : 2.7 lp/mm Type : a-Si TFT Resolution : 2600 x 2560 Pixel sampling resolution : 16 bit Pixel pitch : 179 μm MTF: 45% DQE: 45% Scintillator : CsI | Active image area : 9" (9"/6"/4.5") Min. Central Resolution at the monitor: - 9" (23cm): 2.2 lp/mm
- 6" (15cm): 2.8 lp/mm
- 6" (15cm): 3.0 lp/mm DQE: 65% (typically) | | |
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| Fluoroscopy | 40-120 kV / 0.2-6.0 mA | 40-110 kV/ 0.2-6.0 mA |
|---|---|---|
| Pulsed | ||
| Fluoroscopy | 0.2 - 10.0 mA | 0.2-6.0 mA |
| Radiography | 40-120 kV / 0.6-200 mAs | 40-110 kV / 0.4-100 mAs |
| Dimensions | SID : 1000 mm | SID : 960 mm |
| Panning Rotation: ±12.5° | Panning Rotation: ±12.5° | |
| Orbital Rotation: 155° | Orbital Rotation: 120° | |
| Vert. Travel: 500 mm | Vert. Travel: 400 mm | |
| Horiz. Travel: 200 mm | Horiz. Travel: 200 mm |
The proposed OSCAR is based on the predicate device, ZEN-2090 Pro (K091918). There are several difference between OSCAR (Prime, Classic) and predicate device (ZEN-2090 Pro) is the options of Image acquisition parts. OSCAR Prime is the flat panel detector and predicate device is Image Intensifier. As mentioned in the comparison table, predicate device DQE is higher than OSCAR Prime. However, predicate device DQE is the DQE of the image intensifier is combined with CCD camera the DQE camera the DQE decreases. In conclusion, the DQE of the complete predicate device is 51%. So the OQE of the OSCAR Prime is more effective and safety than predicate device. Also flat panel detector type has excellent image uniformity, no veiling glare or vignetting, small and thin physical size as compared to the Image Intensifier type.
The OSCAR is substantially equivalent to the predicate device, ZEN-2090 Pro (K091918).
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8. Safety, EMC and Performance data comparison to Predicate
OSCAR complies with industry standards such as IEC 60601-1 Series and 21 CFR 1020.30, 21 CFR 1020.31 and 21 CFR 1020.32 to minimize electrical, mechanical and radiation hazards.
-
Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-28, IEC 60601-2-43, IEC 60601-2-54 and IEC 62366 were performed.
-
EMC testing was conducted in accordance with standard IEC 60601-1-2.
-
OSCAR meets the EPRC standards (21 CFR 1020.30, 31, 32).
-
FDA guidance "guidance for SSXI devices", and "guidance for the Content of Premarket Submissions for Software Contained in Medical devices", was performed for OSCAR.
The software features has been changed compare to predicate device as below:
- Enhance Image Calibration function.
- Display exposure modes shows on the LCD touch panel.
- Add Angiography functions.
Changes to the predicate device software were tested and they do not affect the device safety and effectiveness. Also, the device software is moderate level of concern.
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 OSCAR is safe and effective as predicate device, and has no new indication for use. Therefore, OSCAR is substantially equivalent to predicate device.