(59 days)
Not Found
No
The summary describes standard digital radiography technology and image processing, but there is no mention of AI or ML algorithms being used for image analysis, interpretation, or any other function.
No
This device is an X-ray flat panel detector, used for acquiring, processing, and displaying diagnostic radiographic images, not for providing therapy.
Yes
The device is described as being used to "acquire/ Process/ Display/ Store/ Export radiographic images of all body parts" and is "intended for use in general radiographic applications wherever a conventional film/screen or CR system is used." While it generates images, the subsequent processing, display, and storage of these images, which are then used by a radiologist to "perform a general radiography exam," indicates its role in aiding diagnosis. The output is an image used for interpretation, which is a key part of diagnostics.
No
The device description explicitly states that the submission includes "Wireless/ Wired X-Ray Flat Panel Detectors," which are hardware components that acquire and digitize X-rays. While it also includes software (AWS), the device as a whole is not software-only.
Based on the provided text, 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 description clearly states that this device is an X-Ray Flat Panel Detector used to acquire, process, display, store, and export radiographic images of all body parts. It works by collecting X-rays from an X-ray source and converting them into digital images.
- Lack of Biological Sample Testing: There is no mention of the device being used to test biological samples. Its function is solely related to capturing and processing medical images generated by X-rays.
Therefore, based on the intended use and device description, this product falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
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
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
all body parts/human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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
1
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
2
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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3
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 |
4
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 |
5
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.
7
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 | ||||
| Product | ||||
| Classification | ||||
| Code | 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 Panel | |||
| Detectors 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-Ray | |||
| Flat Panel Detectors used with | ||||
| AWS (Acquisition Workstation | ||||
| Software) Synergy DR FDX/ Syner- | ||||
| gy DR is used to acquire/ Process/ | ||||
| Display/ Store/ Export radiograph- | ||||
| ic images of all body parts using | ||||
| Radiographic techniques. It is in- | ||||
| tended for use in general radio- | ||||
| graphic applications wherever a | ||||
| conventional film/screen or CR | ||||
| system 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 display | ||||
| radiographic 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. The | ||||
| Yushan X-Ray Flat Panel De- | The Wireless/Wired | |||
| Yushan X-Ray Flat Panel | ||||
| Detector is intended to | ||||
| capture for display radio- | ||||
| graphic images of human | ||||
| anatomy. It is intended | ||||
| for use in general projec- | ||||
| tion radiographic applica- | ||||
| tions including pediatric | ||||
| and neonatal exams | ||||
| wherever conventional | ||||
| film/screen or CR sys- | ||||
| tems may be used. The | ||||
| Yushan 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 applications | ||||
| wherever convention- | ||||
| al film/screen or CR | ||||
| systems may be used. | ||||
| The Yushan X-Ray Flat | ||||
| Panel Detector is not | ||||
| intended for mam- | ||||
| Flat Panel Detectors is not intend- | ||||
| ed for mammography applica- | tector with DROC is not in- | |||
| tended for mammography, | Detector is not intended | |||
| for mammography, | mography, fluorosco- |
K210988, K220510. The comparisons of technological characteristics are listed in the following table.
Allengers Medical Systems Limited - 510(K)
8
Allengers Medical Systems Limited - 510(K)
9
| 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 system | |
| ISO 13485 | ||
| ISO 14971 | ||
| ANSI/AAMI ES60601-1 | ||
| IEC 62220-1-1ISO 20417 | ||
| IEC 60601-1-2 | ||
| IEC 62304 | ||
| IEC 60601-1-6 | ||
| IEC 62366-1 | ||
| ISO 10993-1 | ||
| ISO 10993-5 | ||
| ISO 10993-10 | ||
| ISO 15223-1 | ||
| ANSI AAMI HE75 | FDA Standards 21 CFR 892.1680 for stationary x-ray system | |
| European Medical Devices Directive (93/42/EEC) | ||
| EN ISO 13485 | ||
| ISO 14971 | ||
| ANSI/AAMI ES60601-1 | ||
| CAN/CSA C22.2 No. 60601-1:14 | ||
| IEC 60601-1-2 | ||
| IEC 62304 | ||
| IEC 60601-1-6 | ||
| IEC 62366-1 | ||
| ISO 10993-1 | ||
| ISO 10993-5 | ||
| ISO 10993-10 | ||
| ISO 15223-1 | ||
| ANSI AAMI HE75 |
10
| Feature | Subject Device | Predicate Device | |||
|---|---|---|---|---|---|
| Dimensions (inch.) | G4336RWG: (W)14X(H)17 | ||||
| G4336RWC: (W)14X(H)17 | |||||
| G4343RWG: (W)17X(H)17 | |||||
| G4343RWC: (W)17X(H)17 | |||||
| G4343RG: (W)17X(H)17 | |||||
| T4336RWG: (W)14X(H)17 | |||||
| T4336RWC: (W)14X(H)17 | |||||
| G4343RC: (W)17X(H)17 | V14G: (W)14X(H)17 | ||||
| V14C: (W)14X(H)17 | |||||
| V17G: (W)17X(H)17 | |||||
| V17C: (W)17X(H)17 | |||||
| V17Ge: (W)17X(H)17 | F14G: (W)14X(H)17 | ||||
| F14C: (W)14X(H)17 | V17Ce: (W)17X(H)17 | ||||
| Weight (Kg) | G4336RWG: 2.7 | ||||
| G4336RWC: 2.7 | |||||
| G4343RWG: 3.2 | |||||
| G4343RWC: 3.2 | |||||
| G4343RG: 3.5 | |||||
| T4336RWG: 2.3 | |||||
| T4336RWC: 2.5 | |||||
| G4343RC: 3.6 | V14G: @3 | ||||
| V14C: @3 | |||||
| V17G: @3 | |||||
| V17C: @3 | |||||
| V17Ge: @3 | F14G: @2 | ||||
| F14C: @2 | V17Ce: @3.5 | ||||
| Feature | Subject Device | Predicate Device | |||
| Substrate | G4336RWG | ||||
| G4336RWC | |||||
| G4343RWG | |||||
| G4343RWC | |||||
| G4343RG | |||||
| G4343RC | Glass | ||||
| Non-Glass | Glass | Non-Glass | |||
| (polyethylene tereph- | |||||
| thalate laminate) | Glass | ||||
| T4336RWG | |||||
| T4336RWC | |||||
| Scintillator | G4336RWG | ||||
| G4343RWG | |||||
| G4343RG | |||||
| T4336RWG | |||||
| G4336RWC | ૯૦૮ | V14G: GOS | |||
| V14C: Csl | |||||
| V17G: GOS | |||||
| V17C: Csl | |||||
| V17Ge: GOS | F14G: GOS | ||||
| F14C: Csl | V17Ce: Csl | ||||
| G4343RWC | |||||
| T4336RWC | |||||
| G4343RC | Cal | ||||
| A/D Conversion | 16 bit | 16 bit | 16 bit | 16 bit | |
| Feature | Subject Device | Predicate Device | |||
| Pixels | G4336RWG: 2500 x 3052 | ||||
| G4336RWC: 2500 x 3052 | |||||
| G4343RWG: 3072 x 3072 | |||||
| G4343RWC: 3072 x 3072 | |||||
| G4343RG: 3072 x 3072 | |||||
| T4336RWG: 2500 x 3052 | |||||
| T4336RWC: 2500 x 3052 | |||||
| G4343RC: 3072 x 3072 | V14G: 2500 x 3052 | ||||
| V14C: 2500 x 3052 | |||||
| V17G: 3072 x 3072 | |||||
| V17C: 3072 x 3072 | |||||
| V17Ge: 3072 x 3072 | F14G: 2500 x 3052 | ||||
| F14C: 2500 x 3052 | V17Ce: 3072 x 3072 | ||||
| Interface | Wired: Gigabit Ethernet | ||||
| Wireless: IEEE802.11 ac /a/g/n | Wired: Gigabit Ethernet | ||||
| Wireless: IEEE802.11 ac | |||||
| /a/g/n | Wired: Gigabit Ethernet | ||||
| Wireless: IEEE802.11 ac | |||||
| /a/g/n | Wired: Gigabit Ether- | ||||
| net | |||||
| Power | Rechargeable Lithium Battery | ||||
| *G4343RG, G4343RC Have no | |||||
| Battery | Rechargeable Lithium Bat- | ||||
| tery |
- V17Ge has no Battery | Rechargeable Lithium
Battery | No Battery | |
| 8. Biological | | | | | |
| Biological safety | All material contact with patients
is in accordance with ISO 10993. | All material contact with
patients is in accordance
with ISO 10993. | All material contact with
patients is in accordance
with ISO 10993. | All material contact
with patients is in ac-
cordance with ISO
- | |
| 9. Others | | | | | |
| | Allengers Medical Systems Limited - 510(K)
5-0-10
Section 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 | |
11
Allengers Medical Systems Limited - 510(K)
12
13
14
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
15
Table 1
| Manufacturer | InnoCare Optoelectronics Corp. | Allengers Medical Systems Limited |
|---|---|---|
| Product Name | Yushan X-Ray Flat Panel Detector | |
| with 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-
sensus
Number | Self- De-
clared | Comments/
Deviations |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------------------------|---------------------|--------------------------------|
| Standard | AAMI / ANSI ES60601-
1:2005/(R) 2012 And A1:
2012, C1:2009/(R) 2012 And
A2:2010/ (R) 2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, | Met all
requirements | 19-4 | Yes | No deviations
from 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 And
Essential Performance - Col-
lateral Standard: Electro-
magnetic Compatibility - Re-
quirements And Tests | Met all
require-
ments | 19-8 | Yes | No deviations
from standard |
| Standard | IEC 62304 Edition 1.1 2015-
06 CONSOLIDATED VERSION
Medical device software -
Software life cycle processes | Met all
require-
ments | 13-79 | Yes | No deviations
from standard |
| Standard | IEC 60601-1-6 Edition 3.1
2013-10, Medical Electrical
Equipment - Part 1-6: Gen-
eral Requirements For Basic
Safety And Essential Perfor-
mance - Collateral Standard:
Usability. (General I
(QS/RM)) | Met all
require-
ments | 5-89 | Yes | No deviations
from standard |
| Standard | ANSI AAMI IEC 62366-1 Edi-
tion 1.0 2015-02 Medical de-
vices - Part 1: Application of
usability engineering to med-
ical devices [Including COR-
RIGENDUM 1 (2016)] | Met all
require-
ments | 5-114 | Yes | No deviations
from standard |
| Standard | ISO 10993-1 Fifth edition
2018-08 Biological evalua- | Met all
require-
ments | 2-258 | Yes | No deviations
from standard |
| | tion of medical devices - Part
1: Evaluation and testing
within a risk management
process | ments | | | |
| Standard | ISO 10993-10: Fourth edition
2021-11 Biological evalua-
tion of medical devices --
Part 10: Tests for irritation
and skin sensitization | Met all
require-
ments | 2-174 | Yes | No deviations
from standard |
| Standard | ISO 14971 Third Edition
2019-12 Medical devices -
Application of risk manage-
ment to medical devices | Met all
require-
ments | 5-125 | Yes | No deviations
from standard |
| Standard | ISO 15223-1 Third edition
2016-11-01 Medical de-
vices - Symbols to be used
with information to be sup-
plied by the manufacturer -
Part 1: General requirements | Met all
require-
ments | 5-117 | Yes | No deviations
from standard |
| Standard | ANSI AAMI HE75:2009/
(R)2013 Human factors engi-
neering - Design of medical
devices | Met all
require-
ments | 5-57 | Yes | No deviations
from standard |
| Standard | ISO 10993-5 Third edition
2009-06-01Biological evalua-
tion of medical devices - Part
5: Tests for in vitro cytotoxi-
city | Met all
require-
ments | 2-245 | Yes | No deviations
from standard |
| Standard | IEC 62220-1-1 Edition 1.0
2015-03 Medical electrical
equipment-Characteristics of
digital X-ray imaging devices
Part 1-1: Determination of
the detective quantum effi-
ciency Detectors used in ra-
diographic imaging | Met all
require-
ments | 12-289 | Yes | No deviations
from standard |
| Standard | IEC 62133-2 Edition1.0 2017-
02 Secondary cells and bat-
teries containing alkaline or
other non-acid electrolytes -
Safety requirements for
portable sealed secondary
cells, and for batteries made
from them, for use in porta-
ble applications - Part 2: Lith-
ium systems | Met all
require-
ments | 19-33 | Yes | No deviations
from standard |
| Standard | ISO 20417 First edition 2021-
04 Corrected version 2021-
12 Medical devices -
Information to be supplied
by the manufacturer | Met all
require-
ments | 15-135 | Yes | No deviations
from standard |
| Guidance | Submission of 510(k)s for
Solid State X-ray Imaging De-
vices (issued on September
1, 2016) | Met all
require-
ments | N/A | Yes | No deviations
from guidance |
| Guidance | Content of Premarket Sub-
missions for Management of
Cybersecurity in Medical De- | Met all
require-
ments | N/A | Yes | No deviations
from guidance |
| | vices (issued on October 2,
2014) | ments | | | |
| Guidance | eCopy Program for Medical
Device Submissions (issued
on April 27, 2020) | Met all
require-
ments | N/A | Yes | No deviations
from guidance |
| Guidance | Guidance for the Content of
Premarket Submissions for
Software Contained in Medi-
cal Devices (issued on May
11, 2005) | Met all
require-
ments | N/A | Yes | No deviations
from guidance |
| Guidance | Appropriate Use of Volun-
tary Consensus Standards in
Premarket Submissions for
Medical Devices (issued on
September 14,2018) | Met all
require-
ments | N/A | Yes | No deviations
from guidance |
| Guidance | Use of International Stand-
ard ISO 10993-1, "Biological
evaluation of medical devic-
es - Part 1: Evaluation and
testing within a risk man-
agement process (issued on
September 4, 2020) | Met all
require-
ments | N/A | Yes | No deviations
from guidance |
| Guidance | Information to Support a
Claim of Electromagnetic
Compatibility (EMC) of Elec-
trically-Powered Medical
Devices (issued on July 11,
2016) | Met all
require-
ments | N/A | Yes | No deviations
from guidance |
16
17
18
19
20
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.