(24 days)
The equipment is intended to be used for the fluoroscopy/radiography diagnosis in hospital. The equipment must only be operated by qualified personnel, such as radiography technicians or those with equivalent qualifications. The equipment is used for total patient population. The equipment is NOT intended to be used for Mammography screening. The equipment is NOT intended to be used for interventional procedure. The equipment is used for radiographic, fluoroscopic, angiographic and pediatric examinations. Stored images in the equipment can be used for re-monitoring, image processing, storing to optical media (CD/DVD), and sending to DICOM server. The Tomosynthesis option for the SONIALVISION G4 is intended to generate tomographic images of human anatomy including chest or extremities. Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction of tomographic acquisition. The device is not intended for mammographic applications
The Shimadzu SONIALVISION G4 is a universal X-ray RF system offering radiographic, fluoroscopic, angiographic and tomosynthesis techniques. Tomosynthesis technique is enabled by additional software option to the digital radiography system of the SONIALVISION G4. The Shimadzu SONIALVISION G4 is floor mounted table, and the system can be configured with Digital Radiography System, X-ray High Voltage Generator, Collimator and X-ray Tube. The purpose of this submission is to introduce an additional compatible digital x-ray receptor panel. This panel is manufactured by Canon. The panel was cleared by FDA for fluoroscopic use in K171194.
The provided document is a 510(k) summary for the Shimadzu SONIALVISION G4, an image-intensified fluoroscopic x-ray system. The submission is to introduce an additional compatible digital x-ray receptor panel (Canon AS-10, CXDI-401RF) to the existing SONIALVISION G4 system.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" but rather presents a comparison of the technical characteristics of the modified device with the predicate device to demonstrate substantial equivalence. The implication is that if the modified device's performance is equivalent or better than the predicate, it meets the unstated acceptance criteria for safety and effectiveness.
| Characteristic | Predicate Device (K142341, SONIALVISION G4) | Modified Device (SONIALVISION G4 with Canon panel) | Acceptance Criteria (Implied) | Reported Performance (Modified Device) |
|---|---|---|---|---|
| Indications for Use | Same as Modified Device | Same as Predicate Device | Equivalent to Predicate | Exactly the same |
| Manufacturer (Panel) | Varian Medical Systems | Varian Medical Systems OR Canon Medical Equipment Group | Equivalent performance/safety to predicate | Canon Medical Equipment Group compatible |
| Model (Panel) | PaxScan™ 4343CB, SDF-1717AF | PaxScan™ 4343CB, SDF-1717AF OR Canon AS-10, CXDI-401RF | Equivalent performance/safety to predicate | Canon AS-10, CXDI-401RF compatible |
| Size (Panel) | 43 x 43 CM | SAME | Equivalent to Predicate | Same |
| Pixel Size | 139μm | 160 μm | Equivalent clinical utility | 160 μm |
| Number of Pixels | 3072 x 3072 | 2,688 x 2,688 | Equivalent clinical utility | 2,688 x 2,688 |
| Acquisition (fps, 1x1) | Up to 3 fps (1x1) | Up to 3 fps (1x1) | Equivalent to Predicate | Up to 3 fps (1x1) |
| Acquisition (fps, 1x1 or 2x2) | Up to 15 fps (1x1 or 2x2) | Up to 15 fps (1x1) | Equivalent to Predicate | Up to 15 fps (1x1) |
| Acquisition (fps, 2x2) | Up to 30 fps (2x2) | Up to 30 fps (2x2) | Equivalent to Predicate | Up to 30 fps (2x2) |
| Spatial Resolution [MTF@2cycle/mm, RQA5] | 0.28 | 0.28 Same performance | Equivalent or better | 0.28 Same performance |
| Modes (Binning) [DQE @ 1 µGy in 0 lp/mm, RQA5] | 0.75 Slightly better | 0.70 Equivalent performance | Equivalent or better | 0.70 Equivalent performance |
| A/D Conversion | 16 Bit | 16 Bit | Equivalent to Predicate | 16 Bit |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. The submission does not describe a test set of clinical images or patient data to evaluate the device's diagnostic performance in a clinical setting.
- Data Provenance: Not applicable. The study relies on non-clinical (bench) testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. No clinical test set requiring expert ground truth was used.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. No clinical test set requiring adjudication was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an x-ray system, not an AI-powered diagnostic tool requiring human reader assistance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable in the context of an AI algorithm. The device itself is an imaging system. The comparison focuses on the technical specifications of the new X-ray detector panel to demonstrate its equivalence (or non-inferiority) to the predicate panel. The "standalone" performance here refers to the physical and imaging characteristics of the detector itself, which were evaluated by Canon (the manufacturer of the new panel) as referenced in K171194.
7. The type of ground truth used:
- Type of Ground Truth: The ground truth for this submission is based on non-clinical (bench) testing standards and technical specifications that define image quality and system performance for X-ray systems. The comparison is made against the established performance parameters of the predicate device and relevant industry standards.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This submission is for an X-ray imaging system with a new detector panel, not an AI or machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. There is no training set mentioned or implied in this submission, as it's not an AI/ML device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Shimadzu Corporation % Daniel Kamm, P.E. Principal Engineer Kamm & Associates 8870 Ravello Ct. NAPLES FL 34114
March 15, 2019
Re: K190373
Trade/Device Name: SONIALVISION G4 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: JAA Dated: January 27, 2019 Received: February 19, 2019
Dear Mr. 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); 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 (OS) 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,
Michael D. O'Hara
Thalia Mills, 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)
Device Name SONIALVISION G4
Indications for Use (Describe)
The equipment is intended to be used for the fluoroscopy/radiography diagnosis in hospital.
The equipment must only be operated by qualified personnel, such as radiography technicians or those with equivalent qualifications.
The equipment is used for total patient population.
The equipment is NOT intended to be used for Mammography screening.
The equipment is NOT intended to be used for interventional procedure.
The equipment is used for radiographic, fluoroscopic, angiographic and pediatric examinations.
Stored images in the equipment can be used for re-monitoring, image processing, storing to optical media (CD/DVD), and sending to DICOM server.
The Tomosynthesis option for the SONIAL VISION G4 is intended to generate tomographic images of human anatomy including chest or extremities. Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction of tomographic acquisition. The device is not intended for mammographic applications
| 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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510(k) Summary: 510(k) Number K190373 Shimadzu Corporation 1, Nishinokyo-Kuwabaracho, Nakagyo-ku, Kyoto, 604-8511, Japan Registration Number: 8030233 Phone : +81-75-823-1305 Fax : +81-75-823-1377 Date Prepared: March 4, 2019 Contact: Toshio Kadowaki; Phone: +81-75-823-1920 E-mail: kadowaki@shimadzu.co.jp
-
- Identification of the Device: Trade/Device Names: SONIALVISION G4 Regulation Number: 21CFR892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Common/Usual Name: fluoroscopic x-ray system
-
- Equivalent legally marketed device: K142341 Trade/Device Name: SONIALVISION G4 Manufacturer: Shimadzu. Regulation Number: 21CFR892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Common/Usual Name: fluoroscopic x-ray system
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- Reference device (new digital panel employed: K171194) Trade/Device Name: AS-10, CXDI-401RF Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA, MQB
-
- Indications for Use (intended use): The equipment is intended to be used for the fluoroscopy/radiography diagnosis in hospital. The equipment must only be operated by qualified personnel, such as radiography technicians or those with equivalent qualifications. The equipment is used for total patient population. The equipment is NOT intended to be used for Mammography screening. The equipment is NOT intended to be used for interventional procedure. The equipment is used for radiographic, fluoroscopic, angiographic and pediatric examinations. Stored images in the equipment can be used for re-monitoring, image processing, storing to optical media (CD/DVD), and sending to DICOM server. The Tomosynthesis option for the SONIALVISION G4 is intended to generate tomographic images of human anatomy including chest or extremities. Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction of tomographic acquisition. The device is not intended for mammographic applications.
-
- Description of the Device: The Shimadzu SONIALVISION G4 is a universal X-ray RF system offering radiographic, fluoroscopic, angiographic and tomosynthesis techniques. Tomosynthesis technique is enabled by additional software option to the digital radiography system of the SONIALVISION G4.
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The Shimadzu SONIALVISION G4 is floor mounted table, and the system can be configured with Digital Radiography System, X-ray High Voltage Generator, Collimator and X-ray Tube. The purpose of this submission is to introduce an additional compatible digital x-ray receptor panel. This panel is manufactured by Canon. The panel was cleared by FDA for fluoroscopic use in K171194.
-
- Safety and Effectiveness, comparison to predicate device. The results of bench testing indicates that the new device is as safe and effective as the predicate device. Proper system operation is fully verified upon installation.
| K142341, SONIALVISION G4 | MODIFIED SONIALVISION G4 | |
|---|---|---|
| Indications forUse: | The equipment is intended to be used for thefluoroscopy/radiography diagnosis in hospital. Theequipment must only be operated by qualifiedpersonnel, such as radiography technicians or thosewith equivalent qualifications. The equipment is usedfor total patient population. The equipment is NOTintended to be used for Mammography screening. Theequipment is NOT intended to be used forinterventional procedure. The equipment is used forradiographic, fluoroscopic, angiographic and pediatricexaminations. Stored images in the equipment can beused for re-monitoring, image processing, storing tooptical media (CD/DVD), and sending to DICOM server.The Tomosynthesis option for the SONIALVISION G4 isintended to generate tomographic images of humananatomy including chest or extremities. Tomosynthesistechnique is used to produce a specific cross-sectionalplane of the body by reconstruction of tomographicacquisition. The device is not intended formammographic applicationsNote: All technical characteristics for the predicate and the modified system are IDENTICAL except for the digitalreceptor panels, which are compared below. | The equipment is intended to be used for thefluoroscopy/radiography diagnosis in hospital. Theequipment must only be operated by qualifiedpersonnel, such as radiography technicians or thosewith equivalent qualifications. The equipment is usedfor total patient population. The equipment is NOTintended to be used for Mammography screening. Theequipment is NOT intended to be used forinterventional procedure. The equipment is used forradiographic, fluoroscopic, angiographic and pediatricexaminations. Stored images in the equipment can beused for re-monitoring, image processing, storing tooptical media (CD/DVD), and sending to DICOM server.The Tomosynthesis option for the SONIALVISION G4 isintended to generate tomographic images of humananatomy including chest or extremities. Tomosynthesistechnique is used to produce a specific cross-sectionalplane of the body by reconstruction of tomographicacquisition. The device is not intended formammographic applications EXACTLY THE SAME |
| Manufacturer | Varian Medical Systems | Varian Medical Systems ORCanon Medical Equipment Group |
| Model | PaxScan™ 4343CB, our model numberSDF-1717AF | PaxScan™ 4343CB, our model numberSDF-1717AFOR:Canon AS-10, CXDI-401RF (K171194)our model number SFD-1717BF |
| Size | 43 x 43 CM | SAME |
| Pixel Size | 139μm | 160 μm |
| Number of Pixels | 3072 x 3072 | 2,688 x 2,688 |
| Acquisition | Up to 3 fps (1x1)Up to 15 fps (1x1 or 2x2) | Up to 3 fps (1x1)Up to 15 fps (1x1) |
| K142341, SONIALVISION G4 | MODIFIED SONIALVISION G4 | |
| Spatial Resolution[MTF@2cycle/mm,RQA5] | 0.28 | 0.28 Same performance |
| A/D Conversion | 16 Bit | 16 Bit |
| Photo of Panel (themodified part) | Added Compatible Panel |
Up to 30 fps (2x2)
0.75 Slightly better
Equivalent performance
-
- Substantial Equivalence Chart: Below.
Up to 30 fps (2x2)
- Substantial Equivalence Chart: Below.
0.70
Modes (Binning)
DQE @ 1 µGy in 0
lp/mm, RQA5
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-
- Summary of non-clinical testing: The additional digital receptor panel was subjected to non-clinical testing by its manufacturer, Canon. See K171194 at: https://www.accessdata.fda.gov/cdrh_docs/pdf17/[K171194](https://510k.innolitics.com/search/K171194).pdf Our own testing consisted of integration testing, taking and evaluation of test images (both moving and still) and risk analysis oriented to the risks of making the panel manufacturer change. The Users Manual was updated, and supplements were added for Pediatric Imaging (FDA Guidance: Pediatric Information for X-ray Imaging Device Premarket Notifications ) and for Cybersecurity (FDA Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.)
-
- Summary of clinical testing: Not applicable. Clinical testing was not deemed to show substantial equivalence. We relied on non-clinical testing and compliance with standards.
-
- Conclusion: After analyzing bench tests, it is the conclusion of Shimadzu Corporation that the MODIFIED SONIALVISION G4 is as safe and effective as the predicate device, has few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.
§ 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.