(88 days)
The product is intended as an X-Ray source for diagnosis. Operators of the Hand Diagnostic Radiography Imaging System are healthcare professionals familiar with and responsible for the X-Ray examinations being performed.
Indication for use – The device is stationary digital diagnostic x-ray system that is indicated for use in generating radiographic images of hands of adults and children.
Limitations for use – This device is not intended for general radiographic X-Ray examinations other than the indicated use, or for mammographic, bone density, fluoroscopy and angiography applications.
The major functions of the Hand Diagnostic Radiography Imaging System is including:
- Hand and Wrist radiography
- · Hand PA, AP, Oblique, Lateral
The Hand Diagnostic Radiography Imaging System is a stationary digital diagnostic X-ray system designed to use in generating radiographic images of hands or wrist.
The Hand Diagnostic Radiography Imaging System consists of a system enclosure (with shielding to protect users from exposure to radiation); an X-ray module consists of the X-ray tube (consists of the X-ray tube, cooling fluid, electronics, and casing), generator, and beam limiter; a CCD camera assists the hand position; and the LCD which provides a imagine to make sure the hand on the right position.
The Hand Diagnostic Radiography Imaging System is designed to operate with a Flat Panel Digital X-ray Detector Model Yushan 1417C (K201528), manufactured by InnoCare Inc.
The intended operators of the Hand Diagnostic Radiography Imaging System are healthcare professionals familiar with and responsible for the X-ray examinations being performed.
To minimize electrical, mechanical, and radiation hazards, the Hand Diagnostic Radiography Imaging System adheres to recognized and established industry practices and standards.
The provided text describes the Hand Diagnostic Radiography Imaging System (K220271) and its comparison to a predicate device (DIAMOND-5A/6A/8A, K202156) for 510(k) clearance. However, it does not contain specific acceptance criteria, reported device performance data, details of a clinical study, or information related to AI/algorithm performance (standalone or human-in-the-loop). It focuses on non-clinical testing, standards compliance, and a comparison of technical specifications to a predicate device.
Therefore, I cannot fully answer your request based only on the provided text. The document primarily addresses the substantial equivalence determination for a stationary X-ray system, which typically involves demonstrating that the new device is as safe and as effective as a legally marketed predicate device. This often relies on engineering and performance specifications, and compliance with recognized standards, rather than full-scale clinical trials with acceptance criteria for diagnostic accuracy metrics.
Here's what can be inferred or stated based on the provided text, and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions "predetermined acceptance criteria were met" for non-clinical testing, but it does not provide a specific table of acceptance criteria or corresponding reported device performance metrics in terms of diagnostic accuracy (e.g., sensitivity, specificity, AUC) that would typically be associated with AI/algorithm performance.
The "Performance Data" section primarily lists internal validation and verification (V&V) test plans and reports, which relate to:
- Hardware Architecture Development
- Software Development
- Production Process Development
- Validation of I/O Back Board Assembly
- Validation of Distribution Board Assembly
- Validation of Mini Console Assembly
- Validation of the Assembly of the Light Strip Control Module
- Communication Test Validation of the Final Product
- Validation of the Functionality of the Final Product
These are engineering and system validation tests, not clinical performance studies measuring diagnostic accuracy against a ground truth.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable/Not mentioned. The document focuses on non-clinical testing (V&V) rather than a clinical "test set" in the context of diagnostic accuracy. There's no mention of patient data, images, or a test set used for performance evaluation against acceptance criteria related to diagnostic performance.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable/Not mentioned. Since no clinical test set for diagnostic performance is described, there's no mention of experts or ground truth establishment in that context.
4. Adjudication Method for the Test Set:
Not applicable/Not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. The document does not describe an MRMC study. The device is an X-ray imaging system, not an AI or CAD (Computer-Aided Detection/Diagnosis) algorithm designed to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to the described device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No. The device is an X-ray system, not a standalone algorithm. Its performance is related to image generation and system functionality, not algorithmic interpretation of images.
7. The Type of Ground Truth Used:
Not applicable/Not mentioned for diagnostic accuracy. The "ground truth" implied for this device would be its adherence to engineering specifications and safety standards during the non-clinical V&V testing. For example, "Validation of the Functionality of the Final Product" would imply testing whether the system performs its intended functions correctly, with internal benchmarks serving as the "ground truth." This is different from ground truth for clinical diagnostic accuracy (e.g., pathology, expert consensus).
8. The Sample Size for the Training Set:
Not applicable/Not mentioned. The device is an X-ray system, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable/Not mentioned.
Summary of what the document does provide:
- Device Type: Stationary Digital Diagnostic X-ray System for hands or wrists.
- Purpose of Study/Testing: To demonstrate substantial equivalence to a predicate device (DIAMOND-5A/6A/8A, K202156) through non-clinical testing and comparison of specifications.
- Non-Clinical Testing: A list of internal Validation and Verification (V&V) test plans and reports related to hardware, software, production, and functional validation of the system components.
- Standards Compliance: The device has met requirements of various IEC and ISO standards related to medical electrical equipment, radiation protection, software lifecycle, usability, and risk management (e.g., IEC 60601 series, IEC 62304, ISO 14971).
- Safety and Effectiveness Conclusion: Based on V&V testing, the device was found to have a safe and effective profile similar to the predicate device and is substantially equivalent.
In conclusion, the provided text describes the regulatory clearance process for an X-ray imaging system, focusing on engineering validation and adherence to recognized standards for safety and performance, rather than a clinical study evaluating the diagnostic accuracy of a software algorithm against specific acceptance criteria.
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 29, 2022
NanoRay Biotech Co., Ltd % Alice Chen Regulatory Affair 7F., No.91, Xinhu 1st Rd., Neihu Dist. Taipei City, 114 TAIWAN
Re: K220271
Trade/Device Name: Hand Diagnostic Radiography Imaging System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: KPR Dated: January 31, 2022 Received: January 31, 2022
Dear Alice Chen:
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
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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 (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 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 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) K220271
Device Name
Hand Diagnostic Radiography Imaging System
Indications for Use (Describe)
The product is intended as an X-Ray source for diagnosis. Operators of the Hand Diagnostic Radiography Imaging System are healthcare professionals familiar with and responsible for the X-Ray examinations being performed.
Indication for use - The device is stationary digital diagnostic x-ray system that is indicated for use in generating radiographic images of hands of adults and children.
Limitations for use – This device is not intended for general radiographic X-Ray examinations other than the indicated use, or for mammographic, bone density, fluoroscopy and angiography applications.
The major functions of the Hand Diagnostic Radiography Imaging System is including:
- Hand and Wrist radiography
- · Hand PA, AP, Oblique, Lateral
| 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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Image /page/3/Picture/0 description: The image shows the logo for NanoRay. The word "Nano" is in red, and the word "Ray" is in dark gray. The font is sans-serif and modern.
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act (SMDA) of 1990. The assigned 510(k) number is K220271 .
| Submitter: | NanoRay Biotech Co., Ltd. |
|---|---|
| 7F., No.91, Xinhu 1st Rd., Neihu Dist. | |
| Taipei City 114, Taiwan | |
| Phone: +886-2-2796-8909 | |
| Fax: +886-2-2796-8910 | |
| Contact Person: | ALICE CHEN/ RA |
Email: alice@nanoray.com Phone: +886-2-2796-8909
- Date Prepared: October 1, 2021
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Subjective Device Name and Classification
| Product Name: | Hand Diagnostic Radiography Imaging System |
|---|---|
| Common Name: | Digital Diagnostic X-Ray System |
| Regulation Name: | Stationary X-Ray System |
| CFR Classification: | 21 CFR 892.1680 |
| Device Class: | II |
| Product Code: | KPR |
| Panel: | Radiology |
Legally Marketed Predicate Device
| Product Name: | DIAMOND-5A/6A/8A |
|---|---|
| 510(k) #: | K202156 |
| Clearance Date: | September 10, 2020 |
| Common Name: | Digital Diagnostic X-Ray System |
| Regulation Name: | Stationary X-Ray System |
| Device Class: | II |
| Product Code: | KPR |
| Panel: | Radiology |
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Device Description:
The Hand Diagnostic Radiography Imaging System is a stationary digital diagnostic X-ray system designed to use in generating radiographic images of hands or wrist.
The Hand Diagnostic Radiography Imaging System consists of a system enclosure (with shielding to protect users from exposure to radiation); an X-ray module consists of the X-ray tube (consists of the X-ray tube, cooling fluid, electronics, and casing), generator, and beam limiter; a CCD camera assists the hand position; and the LCD which provides a imagine to make sure the hand on the right position.
The Hand Diagnostic Radiography Imaging System is designed to operate with a Flat Panel Digital X-ray Detector Model Yushan 1417C (K201528), manufactured by InnoCare Inc.
The intended operators of the Hand Diagnostic Radiography Imaging System are healthcare professionals familiar with and responsible for the X-ray examinations being performed.
To minimize electrical, mechanical, and radiation hazards, the Hand Diagnostic Radiography Imaging System adheres to recognized and established industry practices and standards.
Indications for Use:
The product is intended as an X-Ray source for diagnosis. Operators of the Hand Diagnostic Radiography Imaging System are healthcare professionals familiar with and responsible for the X-Ray examinations being performed.
Indication for use – The device is stationary digital diagnostic x-ray system that is indicated for use in generating radiographic images of hands of adults and children.
Limitations for use - This device is not intended for general radiographic X-Ray examinations other than the indicated use, or for mammographic, bone density, fluoroscopy and angiography applications.
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inanoRay
Summary of the technological characteristics:
Hand Diagnostic Radiography Imaging System is functionally equivalent to the following predicate device: DIAMOND-5A/6A/8A (K202156) cleared September 10, 2020.
The following tables demonstrates the intended uses and technical characteristics of Hand Diagnostic Radiography Imaging System are substantially equivalent to the predicate devices.
Any differences between the subject device and the predicated device has no negative impact on safety or efficacy of the subject device and does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices.
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Functional Specification Comparison Table for the Hand Diagnostic Radiography Imaging System and DIAMOND-5A/6A/8A (K202156) :
| Specification | Hand Diagnostic RadiographyImaging System (Subject) | DIAMOND-5A/6A/8A(K202156) (Predicate) | ComparisonResult |
|---|---|---|---|
| Device class | II | II | Same |
| Classification | Mobile x-ray system, Class II;21 CFR 892.1680 | Mobile x-ray system, Class II;21 CFR 892.1680 | Same |
| Product code | KPR | KPR | Same |
| Indications forUse | The device is stationary digitaldiagnostic x-ray system that isindicated for use in generatingradiographic images of hands orwrist. | The device is a stationary digitaldiagnostic x-ray system that isindicated for use in generatingradiographic images of humananatomy. | Similar* |
| Intended users | X-ray Technicians trained tooperate the system | X-ray Technicians trained tooperate the system | Same |
| Physical Characteristics | |||
| FPD Detector | The Hand Diagnostic RadiographyImaging System is designed to operatewith a Flat Panel Digital X-ray DetectorModel Yushan 1417C, manufactured byInnoCare Inc (K201528). | The DIAMOND-5A/6A/8A can userthree previously cleared digital flatpanel detectors are:1. Fujifilm, DR-ID 1272SE/ DR-ID1274SE cleared under K1420032. Varex, PaxScan4343W cleared underK1614593. i-Ray, Mano4343W cleared underK201043 | Same |
| Active ImagingArea Size | 27 cm X 32 cm | 43 cm X 43 cm | Similar* |
| Image Transfer | Gb Ethernet or 802.11 WiFi | Gb Ethernet or 802.11 WiFi | Same |
| Data Standard | DICOM | DICOM | Same |
| X-Ray Source | |||
| Energy Range | 40 to 80 kV | 40 to 150 kV | Same |
| Anode | Fixed anode | Rotating anode | Same |
| Tube Current | 0.01 to 0.50 mA | 10 to 640 mA | Different* |
| Exposure | 0.005 to 0.250 mAs | 0.1 to 500 mAs | Different* |
| Focal Spot Size | 0.2 mm | 0.6/1.2 mm | Similar* |
| Image Management Software | |||
| Horizontal Flip | Available | Available | Same |
| Vertical Flip | Available | Available | Same |
| RotateCW/CCW | Available | Available | Same |
| Text Annotation | Unavailable | Available | Different* |
| Ruler: Distancetool | Unavailable | Available | Different* |
| Anglemeasurementtool | Unavailable | Available | Different* |
| Zoom | Available | Available | Same |
| Magnify | Available | Available | Same |
| Image panning | Available | Available | Same |
| Auto fitting towindow size | Available | Available | Same |
| Image crop/cutfunction | Available | Available | Same |
| Image copy | Unavailable | Available | Different* |
| Recover theoriginal image | Unavailable | Available | Different* |
| Window level | Unavailable | Available | Different* |
| CD Burning | Unavailable | Available | Different* |
| DICOM Print | Unavailable | Available | Different* |
| Image Stitching | Unavailable | Available | Different* |
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*: The label will be explained in the executive summary.
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NanoRay
Performance Data
Nonclinical Testing:
The Hand Diagnostic Radiography Imaging System, has been assessed and has passed predetermined testing criteria. The Validation Test Plan was designed to evaluate input functions, output functions, and actions performed by the subject device and followed the process documented in the System Validation Test Plan.
Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met.
Summary:
Based on the performance as documented in the V&V Testing, the subject device was found to have a safe and effectiveness profile that is similar to the predicate device.
V&V Testing Plan and Reports: The list is as follows
| Test Plan and Reports |
|---|
| A15_Design Verification Proposal_Complete System Development |
| A16_Design Verification Proposal_Hardware Architecture Development |
| A17_Design Verification Proposal_Software development |
| A18_Design Verification Proposal_Production process development |
| A19_Design Verification Report_Hardware Architecture Development |
| A20_Design Verification Report_Software development |
| A21_Design Verification Proposal_Validation of I/O Back Board Assembly |
| A22_Design Verification Proposal_Validation of Distribution Board Assembly |
| A23_Design Verification Proposal_Validation of Mini Console Assembly |
| A24_Design Verification Proposal_Validation of the Assembly of the Light Strip ControlModule |
| A25_Design Verification Proposal_Communication Test Validation of the Final Product |
| A26_Design Verification Proposal_Validation of the Functionality of the Final Product |
| A27_Product Engineering Test Report_Validation of I/O Back Board Assembly |
| A28_Product Engineering Test Report_Validation of Distribution Board Assembly |
| A29_Product Engineering Test Report_Validation of Mini Console Assembly |
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A30_Product Engineering Test Report_Validation of the Assembly of the Light Strip Control Module
A31_Product Engineering Test Report_Communication Test Validation of theFinal Product
A32_Product Engineering Test Report_Validation of the Functionality of the Final Product
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NanoRay
The following International Standards were used to develop and verify the system. The Hand Diagnostic Radiography Imaging System, device has met all the requirements listed in the Standards except for inapplicable requirements (which are listed in the various test reports):
| Std# | Safety/EMC Standards Description | FDA Rec. Standard# | Ann# |
|---|---|---|---|
| IEC 60601-1:2005/ A1:2012 | Medical electrical equipment, Part 1: General requirements for basic safety and essential performance | 19-4 | A56 |
| IEC 60601-1-2:2014 (Fourth Editiion) | Medical electrical equipment, Part 1-2: General requirements for basic safety and essential performance collateral standard: Electromagnetic compatibility | 19-8 | A55 |
| IEC 60601-1-3:2008 (second edition) + A1 2013 | Medical electrical equipment Part 1-3: General Requirements for Radiation Protection in Diagnostic X-Ray Equipment | 12-269 | A57 |
| IEC 60601-2-28:2017 | IEC 60601-2-28 Medical electrical equipment Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis | 12-309 | A52 |
| IEC 60601-2-54:2009 / A1:2015, A2:2018 | IEC 60601-2-54 Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy | 12-317 | A58 |
| IEC 62304: Edition 1.1 2015-06 CONSOLIDATED VERSION | Medical device software - Software life cycle processes | 13-79 | A36-A48 |
| IEC 62366-1 Edition 1.0 2015-02 | Medical devices - Part 1: Application of usability engineering to medical devices | 5-114 | A62 |
| ISO 14971 Third Edition 2019-12 | Medical devices - Application of risk management to medical devices | 5-125 | A3,A59-A61 |
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ma
The Hand Diagnostic Radiography Imaging System, device has followed all the guidance listed in the table:
| Guidance | Document issued on |
|---|---|
| Pediatric Information for X-ray Imaging Device Premarket Notifications | November 28, 2017 |
| Guidance for the Content of Premarket Submissions for SoftwareContained in Medical Devices | May 11, 2005 |
| Content of Premarket Submissions for Management of Cybersecurity inMedical Devices Guidance for Industry and Food and Drug Administration Staff | October 2, 2014 |
| Information to Support a Claim of Electromagnetic Compatibility (EMC)of Electrically-Powered Medical Devices Guidance for Industry and Foodand Drug Administration Staff | July 11, 2016 |
| Appropriate Use of Voluntary Consensus Standards in PremarketSubmissions for Medical Devices Guidance for Industry and Food andDrug Administration Staff | September 14, 2018 |
| The 510(k) Program: Evaluating Substantial Equivalence in PremarketNotifications [510(k)] Guidance for Industry and Food and DrugAdministration Staff | July 28, 2014 |
| Applying Human Factors and Usability Engineering to Medical Devices | February 3, 2016 |
| NEMA PS 3.1 - 3.20 (2016). Digital Imaging and Communications inMedicine (DICOM) Set DICOM Standard. | June 27, 2016 |
| Medical devices - Symbols to be used with medical device labels, labelling,and information to be supplied - Part 1: General requirements | November 01, 2016 |
(http://www.imagegently.org/).
Conclusion:
Based on comparison of indications for use, technological features, and performance testing result, the Hand Diagnostic Radiography Imaging System is found to be as safe and effective as the predicate device. It has been shown to be substantially equivalent to the predicate device.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.