(88 days)
No
The document describes a standard X-ray system for hand imaging and does not mention any AI or ML components, image processing capabilities beyond basic image generation, or performance metrics typically associated with AI/ML algorithms.
No
The device is an X-ray source for diagnosis, specified for generating radiographic images, which is not a therapeutic function.
Yes.
The "Intended Use / Indications for Use" section explicitly states, "The product is intended as an X-Ray source for diagnosis" and "The device is stationary digital diagnostic x-ray system that is indicated for use in generating radiographic images of hands of adults and children." These statements clearly indicate its diagnostic purpose.
No
The device description explicitly lists hardware components such as a system enclosure, X-ray module (including tube, generator, beam limiter), CCD camera, and LCD. It also mentions operating with a Flat Panel Digital X-ray Detector. This indicates it is a hardware-based medical device, not software-only.
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.
- Device Function: The Hand Diagnostic Radiography Imaging System is an X-ray system. It generates radiographic images of hands and wrists. This is an in vivo diagnostic method, meaning it involves imaging the body directly, not testing samples taken from the body.
- Intended Use: The intended use is for generating radiographic images for diagnosis, which is a form of medical imaging, not in vitro testing.
Therefore, the device described is a medical imaging device, specifically an X-ray system, and does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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.
The major functions of the Hand Diagnostic Radiography Imaging System is including:
- Hand and Wrist radiography
- Hand PA, AP, Oblique, Lateral
Product codes
KPR
Device Description
The Hand Diagnostic Radiography Imaging System is a stationary digital 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Hands, wrist
Indicated Patient Age Range
adults and children
Intended User / Care Setting
X-ray Technicians trained to operate the system
Prescription Use
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)
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:
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 Control Module
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
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
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
2
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
4
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 |
5
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.
6
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.
7
Functional Specification Comparison Table for the Hand Diagnostic Radiography Imaging System and DIAMOND-5A/6A/8A (K202156) :
| Specification | Hand Diagnostic Radiography
Imaging System (Subject) | DIAMOND-5A/6A/8A
(K202156) (Predicate) | Comparison
Result |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| 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 for
Use | The device is stationary digital
diagnostic x-ray system that is
indicated for use in generating
radiographic images of hands or
wrist. | The device is a stationary digital
diagnostic x-ray system that is
indicated for use in generating
radiographic images of human
anatomy. | Similar* |
| Intended users | X-ray Technicians trained to
operate the system | X-ray Technicians trained to
operate the system | Same |
| Physical Characteristics | | | |
| FPD Detector | The Hand Diagnostic Radiography
Imaging System is designed to operate
with a Flat Panel Digital X-ray Detector
Model Yushan 1417C, manufactured by
InnoCare Inc (K201528). | The DIAMOND-5A/6A/8A can user
three previously cleared digital flat
panel detectors are:
- Fujifilm, DR-ID 1272SE/ DR-ID
1274SE cleared under K142003 - Varex, PaxScan4343W cleared under
K161459 - i-Ray, Mano4343W cleared under
K201043 | Same |
| Active Imaging
Area 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 |
| Rotate
CW/CCW | Available | Available | Same |
| Text Annotation | Unavailable | Available | Different* |
| Ruler: Distance
tool | Unavailable | Available | Different* |
| Angle
measurement
tool | Unavailable | Available | Different* |
| Zoom | Available | Available | Same |
| Magnify | Available | Available | Same |
| Image panning | Available | Available | Same |
| Auto fitting to
window size | Available | Available | Same |
| Image crop/cut
function | Available | Available | Same |
| Image copy | Unavailable | Available | Different* |
| Recover the
original image | Unavailable | Available | Different* |
| Window level | Unavailable | Available | Different* |
| CD Burning | Unavailable | Available | Different* |
| DICOM Print | Unavailable | Available | Different* |
| Image Stitching | Unavailable | Available | Different* |
8
*: The label will be explained in the executive summary.
9
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 Control |
| Module |
| 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 |
10
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
11
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 |
12
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 Software | |
| Contained in Medical Devices | May 11, 2005 |
| Content of Premarket Submissions for Management of Cybersecurity in | |
| Medical 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 Food | |
| and Drug Administration Staff | July 11, 2016 |
| Appropriate Use of Voluntary Consensus Standards in Premarket | |
| Submissions for Medical Devices Guidance for Industry and Food and | |
| Drug Administration Staff | September 14, 2018 |
| The 510(k) Program: Evaluating Substantial Equivalence in Premarket | |
| Notifications [510(k)] Guidance for Industry and Food and Drug | |
| Administration 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 in | |
| Medicine (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.