(59 days)
Allengers Wireless / Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR is used to acquire/ Process/ Display/ Store/ Export radiographic images of all body parts using Radiographic techniques. It is intended for use in general radiographic applications wherever a conventional film/screen or CR system is used
Allengers Wireless/ Wired X-Ray Flat Panel Detector is not intended for mammography applications.
Wireless/ Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR is substantially equivalent product of its predicate device, Yushan X-Ray Flat Panel Detector with DROC, K201528, K210988, K220510. There are 8 models in this submission G4336RWC, G4336RWG, G4343RWC, G4343RWG, T4336RWC, T4336RWG are portable (wireless) and G4336RWC, G4336RWG, G4343RWC, G4343RWG, T4336RWC, T4336RWG, G4343RG, G4343RC (wired) Digital are non-portable detectors. The Wireless/ Wired X-Ray Flat Panel Detectors is designed to be used in any environment that would typically use a radiographic cassette for examinations. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for nongrid or free cassette exams. These medical devices have memory exposure mode, and extended image readout feature. Additionally, rounded-edge design for easy handling, image compression algorithm for faster image transfer, LED design for easy detector identification, extra protection against ingress of water.
This Device is currently indicated for general projection radiographic applications and the scintillator material is using cesium iodide (Csl) or gadolinium oxy sulfide (GOS).
The Wireless/ Wired X-Ray Flat Panel Detectors sensor can automatically collect x-ray from an x-ray source. It collects the x-ray and converts it into digital image and transfers it to Desktop computer / Laptop/ Tablet for image display. The x-ray generator (an integral part of a complete x-ray system), is not part of the submission. The sensor includes a flat panel for x-ray acquisition and digitization and a computer (including proprietary processing software) for processing, annotating and storing x-ray images, the personal computer is not part of this submission.
Wireless/ Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR, runs on a Windows based Desktop computer/ Laptop/ Tablet as a user interface for radiologist to perform a general radiography exam. The function includes:
-
- User Login
-
- Display Connectivity status of hardware devices like detector
-
- Patient entry (Manual, Emergency and Worklist)
-
- Exam entry
-
- Image processing
-
- Search patient Data
-
- Print DICOM Image
-
- Exit
The provided text outlines the performance data for the "Wireless/Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR." However, it does not specifically present a table of acceptance criteria and reported device performance in a quantitative manner (e.g., sensitivity, specificity, accuracy). Instead, it primarily focuses on compliance with recognized standards and guidance documents, emphasizing non-clinical tests.
Here's an analysis of the information provided, addressing your specific points:
1. A table of acceptance criteria and the reported device performance
The document does not provide a quantitative table of acceptance criteria (e.g., specific metrics like DQE values, spatial resolution, or SNR targets) with corresponding reported device performance values. Instead, it states that the device "confirms to the voluntary standards" and that "the image quality evaluation confirmed that the image quality of the Wireless/ Wired X-Ray Flat Panel Detectors is substantially equivalent to that of the predicate device."
The acceptance criteria are implicitly tied to the successful demonstration of compliance with a long list of international and FDA-recognized consensus standards and guidance documents. The reported performance is that the device "Met all requirements" for each of these standards.
Implicit Acceptance Criteria and Reported Performance (based on document content):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with AAMI / ANSI ES60601-1 (Basic Safety & Performance) | Met all requirements |
| Compliance with IEC 60601-1-2 (Electromagnetic Compatibility) | Met all requirements; results were satisfactory |
| Compliance with IEC 62304 (Software Life Cycle Processes) | Met all requirements |
| Compliance with IEC 60601-1-6 (Usability) | Met all requirements |
| Compliance with ANSI AAMI IEC 62366-1 (Usability Engineering) | Met all requirements |
| Compliance with ISO 10993-1 (Biological Evaluation) | Met all requirements; material safe and effective |
| Compliance with ISO 10993-10 (Irritation & Skin Sensitization) | Met all requirements |
| Compliance with ISO 14971 (Risk Management) | Met all requirements |
| Compliance with ISO 15223-1 (Symbols for Information) | Met all requirements |
| Compliance with ANSI AAMI HE75 (Human Factors Engineering) | Met all requirements |
| Compliance with ISO 10993-5 (Cytotoxicity) | Met all requirements |
| Compliance with IEC 62220-1-1 (Detective Quantum Efficiency) | Met all requirements |
| Compliance with IEC 62133-2 (Safety of Lithium Systems) | Met all requirements |
| Compliance with ISO 20417 (Information by Manufacturer) | Met all requirements |
| Compliance with FDA Guidance for Solid State X-ray Imaging Devices | Met all requirements |
| Compliance with FDA Guidance for Cybersecurity in Medical Devices | Met all requirements; no new/increased cybersecurity risks |
| Compliance with FDA Guidance for Content of Premarket Submissions for Software | Met all requirements |
| Image quality comparable to predicate devices | Image quality confirmed substantially equivalent |
| Load-bearing characteristics | Tested and passed |
| Protection against ingress of water | Tested and passed |
| EMC emission testing (IEC 60601-1-2) | Demonstrated through testing; results satisfactory |
| Biocompatibility | Demonstrated through ISO 10993 series |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes non-clinical performance data (bench testing). There is no mention of a specific "test set" with a sample size of patient data. The provenance of testing (e.g., country of origin, retrospective/prospective) for these non-clinical tests is not detailed, beyond being conducted by Allengers Medical Systems Limited and likely by accredited testing labs for compliance with international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable or not provided since no clinical study with a "test set" requiring expert ground truth establishment for diagnostic performance is described. The evaluation focuses on engineering and regulatory compliance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or not provided as there was no clinical test set requiring expert adjudication.
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
No MRMC comparative effectiveness study was done or reported. The document explicitly states: "Clinical Performance Data: No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies." Furthermore, this device is an X-ray flat panel detector and associated acquisition software, not an AI-powered diagnostic algorithm designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not directly applicable in the context of an X-ray detector. The device itself is a component for acquiring images. Its "standalone performance" is assessed through engineering metrics and compliance with imaging standards (e.g., DQE, MTF, noise characteristics), which are part of the non-clinical testing. It's not an "algorithm" in the sense of a standalone diagnostic AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" is typically defined by the technical specifications of the standards and test methodologies themselves. For example:
- For IEC 62220-1-1 (DQE), the ground truth is the physical properties of the detector under specific X-ray conditions, measured according to the standard's protocol.
- For biocompatibility (ISO 10993), the ground truth is the absence of adverse biological reactions as determined by standardized in vitro and in vivo tests.
- For safety (IEC 60601-1), the ground truth is meeting the safety limits and design requirements outlined in the standard.
There is no mention of clinical ground truth (expert consensus, pathology, outcomes data) as no clinical studies were performed.
8. The sample size for the training set
Not applicable. This device is a hardware component (X-ray detector) and its associated acquisition software. It is not described as involving a machine learning algorithm that requires a "training set" of data for diagnostic purposes. The software mentioned ([AWS] Synergy DR FDX/ Synergy DR) is for image acquisition, processing, display, and storage, not for AI-driven detection or diagnosis.
9. How the ground truth for the training set was established
Not applicable for the reasons stated in point 8.
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Image /page/0/Picture/0 description: The image shows 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.
November 27, 2022
Allengers Medical Systems Limited % Sanjeev Marjara Additional Managing Director FDA Hall Unit-2, Bhankarpur, Mubarakpur Road Derabassi, Distt. Mohali, Punjab 140507 INDIA
Re: K223009
Trade/Device Name: Wireless/Wired X-Ray Flat Panel Detectors Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MQB Dated: September 29, 2022 Received: September 29, 2022
Dear Sanjeev Marjara:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
2022.11.27
20:51:59
-05'00'
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of 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) K223009
Device Name Wireless/ Wired X-Ray Flat Panel Detectors
Indications for Use (Describe)
Allengers Wireless / Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR is used to acquire/ Process/ Display/ Store/ Export radiographic images of all body parts using Radiographic techniques. It is intended for use in general radiographic applications wherever a conventional film/screen or CR system is used
Allengers Wireless/ Wired X-Ray Flat Panel Detector is not intended for mammography applications.
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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510(k) Summary
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92.
I. SUBMITTER
| Company Name: | Allengers Medical Systems Limited |
|---|---|
| Company Address: | FDA Hall, Unit-2, Bhankarpur, Mubarakpur Road, Derabassi,Distt Mohali-140507, India |
| Telephone No: | +91 1762-282600, +919872980168,ra.fdaindia@allengers.net, rnd@allengers.net |
| Contact Person: | Sanjeev K. Marjara |
| Date Prepared: | Sep 26, 2022 |
II. PROPOSED DEVICE
| Device (trade) name: | Wireless/ Wired X-Ray Flat Panel Detectors | |
|---|---|---|
| Model Name: | Wireless X-Ray Flat Panel Detectors | G4336RWC |
| G4336RWG | ||
| G4343RWC | ||
| G4343RWG | ||
| T4336RWC | ||
| T4336RWG | ||
| Wired X-Ray Flat Panel Detectors | G4336RWC | |
| G4336RWG | ||
| G4343RWC | ||
| G4343RWG | ||
| T4336RWC | ||
| T4336RWG | ||
| G4343RC | ||
| G4343RG | ||
| Regulation description: | Stationary x-ray system | |
| Review Panel: | Radiology | |
| Regulation Number : | 21 CFR 892.1680 | |
| Device Class: | Class II | |
| Product Code: | MOB |
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III. PREDICATE DEVICE
Substantial equivalence to the following predicate device is as follows:
| Device (trade) name: | Yushan X-Ray Flat Panel Detector with DROC |
|---|---|
| 510(K) Number : | K201528 |
| Manufacturer : | InnoCare Optoelectronics Corp. |
| Decision Date : | October 11, 2020 |
| Regulation description: | Stationary x-ray system. |
| Review Panel: | Radiology |
| Regulation Number : | 21 CFR 892.1680 |
| Device Class : | Class II |
| Product Code: | MQB |
| Device (trade) name: | Yushan X-Ray Flat Panel Detector with DROC |
|---|---|
| 510(K) Number: | K210988 |
| Manufacturer: | InnoCare Optoelectronics Corp. |
| Decision Date: | April 21, 2021 |
| Regulation description: | Stationary x-ray system. |
| Review Panel: | Radiology |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
| Product Code: | MQB |
| Device (trade) name: | Yushan X-Ray Flat Panel Detector with DROC |
|---|---|
| 510(K) Number : | K220510 |
| Manufacturer : | InnoCare Optoelectronics Corp. |
| Decision Date : | April 14, 2022 |
| Regulation description: | Stationary x-ray system. |
| Review Panel: | Radiology |
| Regulation Number : | 21 CFR 892.1680 |
| Device Class : | Class II |
| Product Code: | MQB |
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IV.DESCRIPTION OF THE DEVICE SUBJECT TO PREMERKET NOTIFICATION
Wireless/ Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR is substantially equivalent product of its predicate device, Yushan X-Ray Flat Panel Detector with DROC, K201528, K210988, K220510. There are 8 models in this submission G4336RWC, G4336RWG, G4343RWC, G4343RWG, T4336RWC, T4336RWG are portable (wireless) and G4336RWC, G4336RWG, G4343RWC, G4343RWG, T4336RWC, T4336RWG, G4343RG, G4343RC (wired) Digital are non-portable detectors. The Wireless/ Wired X-Ray Flat Panel Detectors is designed to be used in any environment that would typically use a radiographic cassette for examinations. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for nongrid or free cassette exams. These medical devices have memory exposure mode, and extended image readout feature. Additionally, rounded-edge design for easy handling, image compression algorithm for faster image transfer, LED design for easy detector identification, extra protection against ingress of water.
This Device is currently indicated for general projection radiographic applications and the scintillator material is using cesium iodide (Csl) or gadolinium oxy sulfide (GOS).
The Wireless/ Wired X-Ray Flat Panel Detectors sensor can automatically collect x-ray from an x-ray source. It collects the x-ray and converts it into digital image and transfers it to Desktop computer / Laptop/ Tablet for image display. The x-ray generator (an integral part of a complete x-ray system), is not part of the submission. The sensor includes a flat panel for x-ray acquisition and digitization and a computer (including proprietary processing software) for processing, annotating and storing x-ray images, the personal computer is not part of this submission.
Wireless/ Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR, runs on a Windows based Desktop computer/ Laptop/ Tablet as a user interface for radiologist to perform a general radiography exam. The function includes:
-
- User Login
-
- Display Connectivity status of hardware devices like detector
-
- Patient entry (Manual, Emergency and Worklist)
-
- Exam entry
-
- Image processing
-
- Search patient Data
-
- Print DICOM Image
-
- Exit
{6}------------------------------------------------
The software level of concern has been determined to be moderate based on the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
The cybersecurity risks have been addressed to assure that no new or increased cybersecurity risks were introduced as a part of device risk analysis. These risks are defined as sequence of events leading to a hazardous situation and the controls for these risks were treated and implemented as proposed in the risk analysis (e.g. requirements, verification). The device software is being used unchanged from the predicate system.
Software System: "AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR" is the user interface application of the Digital Radiography System. New patient register/ Work list retrieving, exposure control, image acquisition, image processing and data transmitting are all achieved at the Synergy DR FDX/ Synergy DR. The Synergy DR FDX/ Synergy DR also provide the control functions responsible for synchronizing the states of detector with the X-Ray generator. Synergy DR FDX/ Synergy DR Features:
- . Patient entry and Patient information storage
- Image Acquisition, processing and storage
- DICOM 3.0 MWL, MPPS, DICOM send, DICOM print
- . Post processing such as Zoom, PAN, Annotations etc.
- Advanced Features like automatic image stitching, Dual energy, auto positioning, dose display, automatic collimation etc.
୍ଧି Level of Concern:
According to IEC 62304:2006/Amd 1:2015 "Medical device software - Software life cycle processes", the software for this device was considered as a class B level of concern, since failures or latent flaws in the software could directly result in non-serious injury to the patient, operator, and/or bystander.
V. Indications for Use
Allengers Wireless/ Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR is used to acquire/ Process/ Display/ Store/ Export radiographic images of all body parts using Radiographic techniques. It is intended for use in general radiographic applications wherever a conventional film/screen or CR system is used.
Allengers Wireless/ Wired X-Ray Flat Panel Detector is not intended for mammography applications.
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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Wireless/ Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR have the similar Indications for Use and substantially equivalent design, functional requirements as the models in K201528,
| Feature | Subject Device | Predicate Device | ||
|---|---|---|---|---|
| 510(k) | This submission | K201528 | K210988 | K220510 |
| 2. Product Code | ||||
| ProductClassificationCode | MQB | MQB | MQB | MQB |
| 3. Product Classification | ||||
| Classification | 21 CFR 892.1680 | 21 CFR 892.1680 | 21 CFR 892.1680 | 21 CFR 892.1680 |
| 4. Product name | ||||
| Product name | Wireless/ Wired X-Ray Flat PanelDetectors used with AWS (Acquisi-tion Workstation Software) Syner-gy DR FDX/ Synergy DR | Yushan X-Ray Flat Panel Detector with DROC | ||
| 5. Model name | ||||
| Model name | G4336RWC | V14C | - | - |
| G4336RWG | V14G | - | - | |
| G4343RWC | V17C | - | - | |
| Feature | Subject Device | Predicate Device | ||
| G4343RWG | V17G | - | ||
| G4343RG | V17Ge | - | ||
| T4336RWC | - | F14C | ||
| T4336RWG | - | F14G | ||
| G4343RC | - | V17Ce | ||
| 6. Clinical | ||||
| Indications for Use | Allengers Wireless (/ Wired X-RayFlat Panel Detectors used withAWS (Acquisition WorkstationSoftware) Synergy DR FDX/ Syner-gy DR is used to acquire/ Process/Display/ Store/ Export radiograph-ic images of all body parts usingRadiographic techniques. It is in-tended for use in general radio-graphic applications wherever aconventional film/screen or CRsystem is used.Allengers Wireless/ Wired X-Ray | The Wireless(V14C, V14G,V17C, V17G)/Wired(V14C,V14G, V17C, V17G, V17Ge)Yushan X-Ray Flat Panel De-tector with DROC is intend-ed to capture for displayradiographic images of hu-man anatomy. It is intend-ed for use in general pro-jection radiographic appli-cations wherever conven-tional film/screen or CR sys-tems may be used. TheYushan X-Ray Flat Panel De- | The Wireless/WiredYushan X-Ray Flat PanelDetector is intended tocapture for display radio-graphic images of humananatomy. It is intendedfor use in general projec-tion radiographic applica-tions including pediatricand neonatal examswherever conventionalfilm/screen or CR sys-tems may be used. TheYushan X-Ray Flat Panel | The Wired Yushan X-Ray Flat Panel Detec-tor is intended to cap-ture for display radio-graphic images of hu-man anatomy. It is in-tended for use in gen-eral projection radio-graphic applicationswherever convention-al film/screen or CRsystems may be used.The Yushan X-Ray FlatPanel Detector is notintended for mam- |
| Flat Panel Detectors is not intend-ed for mammography applica- | tector with DROC is not in-tended for mammography, | Detector is not intendedfor mammography, | mography, fluorosco- |
K210988, K220510. The comparisons of technological characteristics are listed in the following table.
Allengers Medical Systems Limited - 510(K)
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Allengers Medical Systems Limited - 510(K)
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| Feature | Subject Device | Predicate Device |
|---|---|---|
| tions. | fluoroscopy, tomography, and angiography applications. Yushan series provide either raw X ray image or corrected image for system integrator to do further image process. py, tomography, and angiography applications. The use of this product is not recommended for pregnant women and the risk of radioactivity must be evaluated by a physician. | |
| Compliance standard | FDA Standards 21 CFR 892.1680 for stationary x-ray systemISO 13485ISO 14971ANSI/AAMI ES60601-1IEC 62220-1-1ISO 20417IEC 60601-1-2IEC 62304IEC 60601-1-6IEC 62366-1ISO 10993-1ISO 10993-5ISO 10993-10ISO 15223-1ANSI AAMI HE75 | FDA Standards 21 CFR 892.1680 for stationary x-ray systemEuropean Medical Devices Directive (93/42/EEC)EN ISO 13485ISO 14971ANSI/AAMI ES60601-1CAN/CSA C22.2 No. 60601-1:14IEC 60601-1-2IEC 62304IEC 60601-1-6IEC 62366-1ISO 10993-1ISO 10993-5ISO 10993-10ISO 15223-1ANSI AAMI HE75 |
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| Feature | Subject Device | Predicate Device | |||
|---|---|---|---|---|---|
| Dimensions (inch.) | G4336RWG: (W)14X(H)17G4336RWC: (W)14X(H)17G4343RWG: (W)17X(H)17G4343RWC: (W)17X(H)17G4343RG: (W)17X(H)17T4336RWG: (W)14X(H)17T4336RWC: (W)14X(H)17G4343RC: (W)17X(H)17 | V14G: (W)14X(H)17V14C: (W)14X(H)17V17G: (W)17X(H)17V17C: (W)17X(H)17V17Ge: (W)17X(H)17 | F14G: (W)14X(H)17F14C: (W)14X(H)17 | V17Ce: (W)17X(H)17 | |
| Weight (Kg) | G4336RWG: 2.7G4336RWC: 2.7G4343RWG: 3.2G4343RWC: 3.2G4343RG: 3.5T4336RWG: 2.3T4336RWC: 2.5G4343RC: 3.6 | V14G: @3V14C: @3V17G: @3V17C: @3V17Ge: @3 | F14G: @2F14C: @2 | V17Ce: @3.5 | |
| Feature | Subject Device | Predicate Device | |||
| Substrate | G4336RWGG4336RWCG4343RWGG4343RWCG4343RGG4343RC | GlassNon-Glass | Glass | Non-Glass(polyethylene tereph-thalate laminate) | Glass |
| T4336RWGT4336RWC | |||||
| Scintillator | G4336RWGG4343RWGG4343RGT4336RWGG4336RWC | ૯૦૮ | V14G: GOSV14C: CslV17G: GOSV17C: CslV17Ge: GOS | F14G: GOSF14C: Csl | V17Ce: Csl |
| G4343RWCT4336RWCG4343RC | Cal | ||||
| A/D Conversion | 16 bit | 16 bit | 16 bit | 16 bit | |
| Feature | Subject Device | Predicate Device | |||
| Pixels | G4336RWG: 2500 x 3052G4336RWC: 2500 x 3052G4343RWG: 3072 x 3072G4343RWC: 3072 x 3072G4343RG: 3072 x 3072T4336RWG: 2500 x 3052T4336RWC: 2500 x 3052G4343RC: 3072 x 3072 | V14G: 2500 x 3052V14C: 2500 x 3052V17G: 3072 x 3072V17C: 3072 x 3072V17Ge: 3072 x 3072 | F14G: 2500 x 3052F14C: 2500 x 3052 | V17Ce: 3072 x 3072 | |
| Interface | Wired: Gigabit EthernetWireless: IEEE802.11 ac /a/g/n | Wired: Gigabit EthernetWireless: IEEE802.11 ac/a/g/n | Wired: Gigabit EthernetWireless: IEEE802.11 ac/a/g/n | Wired: Gigabit Ether-net | |
| Power | Rechargeable Lithium Battery*G4343RG, G4343RC Have noBattery | Rechargeable Lithium Bat-tery* V17Ge has no Battery | Rechargeable LithiumBattery | No Battery | |
| 8. Biological | |||||
| Biological safety | All material contact with patientsis in accordance with ISO 10993. | All material contact withpatients is in accordancewith ISO 10993. | All material contact withpatients is in accordancewith ISO 10993. | All material contactwith patients is in ac-cordance with ISO10993. | |
| 9. Others | |||||
| Allengers Medical Systems Limited - 510(K)5-0-10Section 5-0 | |||||
| Feature | Subject Device | Predicate Device | |||
| Accessories | - Battery (Optional)*- * G4343RG, G4343RC are not applicable- Power supply (Adapter)- SE cable (Back-up cable)- Power Cord (Optional)- Charger (Optional)- Charger Adapter (Optional)- AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR | - Battery (Optional)*- * V17Ge is not applicable- Power supply (Adapter)- SE cable (Back-up cable)- Power Cord | - Battery (Optional)- Power supply (Adapter)- SE cable (Back-up cable)- Power Cord (Optional)- Charger (Optional)- Charger Adapter (Optional)- DROC Dongle (Optional) | - Power supply (Adapter)- SE cable (Back-up cable)- Power Cord |
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Allengers Medical Systems Limited - 510(K)
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VII. PERFORMANCE DATA
Non-clinical Performance Data: Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR confirms to the voluntary standards such as AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 60601-1-6, ANSI AAMI IEC 62366-1 and ANSI/AAMI HE75. In addition, the FDA's Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices (issued on September 1, 2016) was followed to describe the detector characteristics; Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued on May 11, 2005) was followed to evaluate the level of concern as moderate; Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (issued on October 02, 2014) was also followed to consider issues related to cybersecurity in the design and development process of this device. Additionally, the risk analysis, necessary verification and validation activities were performed. Load-bearing characteristics and protection against ingress of water were tested and passed. The internal circuit design was demonstrated through EMC emission testing: IEC 60601-1-2 and the results were satisfactory. Biocompatibilities were demonstrated through ISO 10993 series to prove the using material safe and effective. Furthermore, the image quality evaluation confirmed that the image quality of the Wireless/ Wired X-Ray Flat Panel Detectors is substantially equivalent to that of the predicate device. Clinical Performance Data: No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies.
For 8 models in this submission, G4336RWC, G4336RWG, G4343RWC, G4343RWG, T4336RWC, T4336RWG, G4343RG, G4343RC, which are the subsequently equivalent model in K201528, K210988, K220510, only with slight change of product name, appearance and the labeling, therefore the performance data is the same and need no extra validation. Please refer to the following comparison table for models difference
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Table 1
| Manufacturer | InnoCare Optoelectronics Corp. | Allengers Medical Systems Limited |
|---|---|---|
| Product Name | Yushan X-Ray Flat Panel Detectorwith DROC | Wireless/ Wired X-Ray Flat Panel Detectors |
| Model Name | FDA Cleared Device: K201528 | |
| V14C | G4336RWC | |
| V14G | G4336RWG | |
| V17C | G4343RWC | |
| V17G | G4343RWG | |
| V17Ge | G4343RG | |
| FDA Cleared Device: K210988 | ||
| F14C | T4336RWC | |
| F14G | T4336RWG | |
| FDA Cleared Device: K220510 | ||
| V17Ce | G4343RC |
VIII. Description of Non Clinical & Clinical testing
Non Clinical performance testing has been performed on the Wireless/ Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR system and it demonstrates compliance with the following relevant voluntary FDA Recognized Consensus Standards as listed in the table below:
| Standard/Guidance | Standard Title | Status | FDA Con-sensusNumber | Self- De-clared | Comments/Deviations |
|---|---|---|---|---|---|
| Standard | AAMI / ANSI ES60601-1:2005/(R) 2012 And A1:2012, C1:2009/(R) 2012 AndA2:2010/ (R) 2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, | Met allrequirements | 19-4 | Yes | No deviationsfrom standard |
| Mod). (General II (ES/EMC)) | |||||
| Standard | IEC 60601-1-2: 2014_Medi-cal Electrical Equipment -Part 1-2: General Require-ments For Basic Safety AndEssential Performance - Col-lateral Standard: Electro-magnetic Compatibility - Re-quirements And Tests | Met allrequire-ments | 19-8 | Yes | No deviationsfrom standard |
| Standard | IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSIONMedical device software -Software life cycle processes | Met allrequire-ments | 13-79 | Yes | No deviationsfrom standard |
| Standard | IEC 60601-1-6 Edition 3.12013-10, Medical ElectricalEquipment - Part 1-6: Gen-eral Requirements For BasicSafety And Essential Perfor-mance - Collateral Standard:Usability. (General I(QS/RM)) | Met allrequire-ments | 5-89 | Yes | No deviationsfrom standard |
| Standard | ANSI AAMI IEC 62366-1 Edi-tion 1.0 2015-02 Medical de-vices - Part 1: Application ofusability engineering to med-ical devices [Including COR-RIGENDUM 1 (2016)] | Met allrequire-ments | 5-114 | Yes | No deviationsfrom standard |
| Standard | ISO 10993-1 Fifth edition2018-08 Biological evalua- | Met allrequire-ments | 2-258 | Yes | No deviationsfrom standard |
| tion of medical devices - Part1: Evaluation and testingwithin a risk managementprocess | ments | ||||
| Standard | ISO 10993-10: Fourth edition2021-11 Biological evalua-tion of medical devices --Part 10: Tests for irritationand skin sensitization | Met allrequire-ments | 2-174 | Yes | No deviationsfrom standard |
| Standard | ISO 14971 Third Edition2019-12 Medical devices -Application of risk manage-ment to medical devices | Met allrequire-ments | 5-125 | Yes | No deviationsfrom standard |
| Standard | ISO 15223-1 Third edition2016-11-01 Medical de-vices - Symbols to be usedwith information to be sup-plied by the manufacturer -Part 1: General requirements | Met allrequire-ments | 5-117 | Yes | No deviationsfrom standard |
| Standard | ANSI AAMI HE75:2009/(R)2013 Human factors engi-neering - Design of medicaldevices | Met allrequire-ments | 5-57 | Yes | No deviationsfrom standard |
| Standard | ISO 10993-5 Third edition2009-06-01Biological evalua-tion of medical devices - Part5: Tests for in vitro cytotoxi-city | Met allrequire-ments | 2-245 | Yes | No deviationsfrom standard |
| Standard | IEC 62220-1-1 Edition 1.02015-03 Medical electricalequipment-Characteristics ofdigital X-ray imaging devicesPart 1-1: Determination ofthe detective quantum effi-ciency Detectors used in ra-diographic imaging | Met allrequire-ments | 12-289 | Yes | No deviationsfrom standard |
| Standard | IEC 62133-2 Edition1.0 2017-02 Secondary cells and bat-teries containing alkaline orother non-acid electrolytes -Safety requirements forportable sealed secondarycells, and for batteries madefrom them, for use in porta-ble applications - Part 2: Lith-ium systems | Met allrequire-ments | 19-33 | Yes | No deviationsfrom standard |
| Standard | ISO 20417 First edition 2021-04 Corrected version 2021-12 Medical devices -Information to be suppliedby the manufacturer | Met allrequire-ments | 15-135 | Yes | No deviationsfrom standard |
| Guidance | Submission of 510(k)s forSolid State X-ray Imaging De-vices (issued on September1, 2016) | Met allrequire-ments | N/A | Yes | No deviationsfrom guidance |
| Guidance | Content of Premarket Sub-missions for Management ofCybersecurity in Medical De- | Met allrequire-ments | N/A | Yes | No deviationsfrom guidance |
| vices (issued on October 2,2014) | ments | ||||
| Guidance | eCopy Program for MedicalDevice Submissions (issuedon April 27, 2020) | Met allrequire-ments | N/A | Yes | No deviationsfrom guidance |
| Guidance | Guidance for the Content ofPremarket Submissions forSoftware Contained in Medi-cal Devices (issued on May11, 2005) | Met allrequire-ments | N/A | Yes | No deviationsfrom guidance |
| Guidance | Appropriate Use of Volun-tary Consensus Standards inPremarket Submissions forMedical Devices (issued onSeptember 14,2018) | Met allrequire-ments | N/A | Yes | No deviationsfrom guidance |
| Guidance | Use of International Stand-ard ISO 10993-1, "Biologicalevaluation of medical devic-es - Part 1: Evaluation andtesting within a risk man-agement process (issued onSeptember 4, 2020) | Met allrequire-ments | N/A | Yes | No deviationsfrom guidance |
| Guidance | Information to Support aClaim of ElectromagneticCompatibility (EMC) of Elec-trically-Powered MedicalDevices (issued on July 11,2016) | Met allrequire-ments | N/A | Yes | No deviationsfrom guidance |
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Non-clinical verification test results demonstrate that the Wireless/ Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR system complies with the aforementioned international and FDA recognized consensus standards and FDA guidance documents. Also Non clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed device. Bench testing was performed to assess the device safety and effectiveness.
IX. CONCLUSIONS
Wireless/ Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR is substantially equivalent to the predicate device in technical characteristics, design features, operating principles, functional and performance characteristics, and for the intended uses in the stated medical specialties.
Wireless/ Wired X-Ray Flat Panel Detectors are designed to comply with applicable federal and international safety and performance standards.
Based upon the supporting data summarized above, only changing on the product name, product appearance and labeling will not raise extra concerns on safety and effectiveness perspective.
§ 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.