(145 days)
Focus HD 43 Detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in all generalpurpose diagnostic procedures. The device is not intended for mammography or dental applications.
Focus HD 43 Detector is a kind of wireless digital flat panel detector. It supports the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 42.67cm×42.67cm. The sensor plate of Focus HD 43 Detector is direct-deposited with CsI scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the user interface. The major function of the Focus HD 43 Detector is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. Both kinds of detectors are the key component of DR system, enable to complete the digitalization of the medical X-ray imaging with the DR system software. SDK(include iDetector) is intended to supply API interface for DR system manufacturers. DR system manufacturer control the detector by SDK interface. SDK is not intend to be used directly by other users beside DR system manufacturers.
The provided text is a 510(k) summary for the iRay Technology Taicang Ltd. Focus HD 43 Detector. It states that the device is substantially equivalent to a predicate device (Mars1717X Wireless Digital Flat Panel Detector, K210314).
Crucially, the document does NOT contain information about a study proving the device meets acceptance criteria derived from a performance study with human readers or AI algorithms. Instead, it focuses on demonstrating substantial equivalence through non-clinical testing and comparison of technical specifications with a previously cleared predicate device.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as typically seen in performance claims for AI/CADe devices or new clinical functionalities. The information given indicates a different pathway to market clearance for this type of device (a digital X-ray detector).
However, I can extract the information provided about the device's technical specifications and the comparison to its predicate, which implicitly serves as the "acceptance criteria" for demonstrating substantial equivalence for this type of hardware device.
Here's an attempt to structure the available information relevant to the prompt, acknowledging the absence of a "study" in the typical sense of AI/clinical performance, and focusing on the technical equivalence:
Acceptance Criteria and Study for Focus HD 43 Detector (Based on Substantial Equivalence to Predicate Device)
The "acceptance criteria" for the Focus HD 43 Detector are primarily its substantial equivalence in performance characteristics to the legally marketed predicate device, the Mars1717X Wireless Digital Flat Panel Detector (K210314). The "study" proving this equivalence is a series of non-clinical tests and direct comparison of specifications.
1. Table of Acceptance Criteria and Reported Device Performance
For a device like an X-ray detector, acceptance criteria are generally based on meeting or exceeding the technical specifications of a predicate device, along with demonstrating safety and electromagnetic compatibility. The following table showcases the comparison provided in the 510(k) summary:
| Characteristic | Acceptance Criterion (Predicate: Mars1717X) | Reported Device Performance (Proposed: Focus HD 43) |
|---|---|---|
| Intended Use | Digital imaging solution for general radiographic diagnosis, human anatomy (adult & pediatric), replacement for film/screen systems. Not for mammography or dental. | Same |
| Indications for Use | Same as Intended Use | Same |
| Classification Name | Stationary X-ray system | Same |
| Product Code | MQB | Same |
| Regulation Number | 21 CFR 892.1680 | Same |
| Device Class | Class II | Same |
| X-Ray Absorber (Scintillator) | CsI | Same |
| Installation Type | Wireless, Portable | Same |
| Readout Mechanism | Thin Film Transistor | Same |
| Image Matrix Size | 4267 × 4267 pixels | Same |
| Pixel Size | 100μm | Same |
| ADC Digitization | 16 bit | Same |
| Effective Imaging Area | 426.7 mm × 426.7mm | Same |
| Spatial Resolution | Min. 4.3 lp/mm | 5.0 lp/mm (Better than predicate) |
| Detective Quantum Efficiency (DQE) | 0.54 at 1 lp/mm (RQA5, 2.5μGy) | Same |
| Power Consumption | Max. 19W | Max. 42W (Different, but likely within acceptable limits for safety regulations/power supply) |
| Communications (Wireless) | Wired (for service): Gigabit Ethernet; Wireless: IEEE 802.11a/b/g/n/ac (2.4 GHz/5 GHz) | Same |
| Imaging Protect Plate | Carbon Fiber Plate | Same |
| Cooling | Air cooling | Same |
| Dimensions | 460 mm × 460 mm × 15mm | Same |
| Detector IP grade | IP56 | Same |
| Power Input Port | 4 pin port | 10 pin port (Different, noted as main modification, likely handled by non-clinical tests) |
| Surface Pressure (Uniform load) | 300 kg over whole area | Same |
| Surface Pressure (Local load) | 150 kg on 4 cm diameter area | 100 kg on 4 cm diameter area (Inferior to predicate, but may still meet a minimum standard for safety and durability) |
| Operation Temperature | +10 ~ +35°C | +5 ~ +35°C (Broader range) |
| Operation Humidity | 5 ~ 90% (Non-Condensing) | Same |
| Operation Atmospheric Pressure | 70 ~ 106 kPa | Same |
| Operation Altitude | Max. 3000 meters | Same |
| Storage & Transport Temperature | -20 ~ +55°C | Same |
| Storage & Transport Humidity | 5 ~ 95% (Non-Condensing) | Same |
| Storage & Transport Atmospheric Pressure | 60 ~ 106 kPa | 70 ~ 106 kPa (Slightly narrower range than predicate) |
| Storage & Transport Altitude | Max. 3000 meters | Same |
| Software | SDK (include iDetector) providing API for DR system manufacturers | Same |
| Battery | Model: Battery-KX, Rated Voltage: 11.55V | Same |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of a clinical test set with patient data for performance evaluation. The "tests" were non-clinical engineering and safety tests.
- Data Provenance: The 510(k) summary explicitly states that "Non-clinical studies have been performed," and "All test results are meet the standard requirements." The testing was conducted by the manufacturer, iRay Technology Taicang Ltd. (China). The data refers to engineering and safety performance data, not patient-specific clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. Ground truth as typically defined for clinical/AI performance studies (e.g., expert radiological reads, pathology) was not established for this device's premarket clearance, as it's a hardware device demonstrating substantial equivalence through non-clinical testing.
4. Adjudication Method for the Test Set
- Not applicable. There was no human "adjudication" of images for clinical ground truth. Non-clinical tests typically adhere to defined protocols and measurement standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is relevant for assessing human reader performance, often with and without AI assistance, or comparing different imaging modalities/interpretations. This 510(k) is for a digital X-ray detector hardware, not an AI or CADe device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No. This is not an algorithmic device in the sense of AI/CADe. Its performance is demonstrated through its physical characteristics and image acquisition capabilities, which are then used by human readers and integrated into existing DR systems.
7. Type of Ground Truth Used
- The "ground truth" for this device's acceptance is based on engineering specifications, safety standards compliance (e.g., IEC/ES 60601-1, IEC 60601-1-2, ISO 10993-1), and direct comparison to the technical characteristics of a legally marketed predicate device. There is no clinical or pathological "ground truth" derived from patient outcomes involved in this specific premarket notification.
8. Sample Size for the Training Set
- Not applicable. This device is a hardware component (digital flat panel detector) and does not involve AI or machine learning that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this device.
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March 29, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
iRay Technology Taicang Ltd. % Junjie Qian Registration & Regulation Affairs Engineer No. 33 Xinggang Rd., Taicang Port Economic Technological Development Zone Taicang, Jiangsu 215434 CHINA
Re: K213529
Trade/Device Name: Focus HD 43 Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: October 20, 2021 Received: November 4, 2021
Dear Junjie Oian:
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 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, Ph.D. Assistant Director Diagnostic X-ray Systems Team Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213529
Device Name Focus HD 43 Detector
Indications for Use (Describe)
Focus HD 43 Detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in all generalpurpose diagnostic procedures. The device is not intended for mammography or dental applications.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
(As Required by 21 CFR 807.92) K213529
-
- Date Prepared [21 CFR 807.92(a)(1)]
October 13, 2021
- Date Prepared [21 CFR 807.92(a)(1)]
2. Submitter's Information [21 CFR 807.92(a)(1)]
| Company Name: | iRay Technology Taicang Ltd. |
|---|---|
| Company Address: | No.33 Xinggang Road, Taicang Port Economic andTechnological Development Zone, Jiangsu, China 215434- |
| Contact Person: | Junjie. Qian |
| Phone: | 0512-53690872 |
| Fax: | 0512-53690872 |
| Email: | junjie.qian@iraygroup.com |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name: | Focus HD 43 Detector |
|---|---|
| Common Name: | Solid State X-Ray Imager |
| Model Name: | Focus HD 43 |
| Classification Name: | Stationary X-Ray System |
| Product Code: | MQB |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
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4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[
The identification predicates within this submission are as follows:
| Manufacturer: | iRay Technology Taicang Ltd. |
|---|---|
| Trade Name: | Wireless Digital Flat Panel Detector |
| Model Name: | Mars1717X |
| Product Code: | MQB |
| Classification Name: | Stationary X-Ray System |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
| FDA 510 (k) #: | K210314 |
5. Description of the Device [21 CFR 807.92(a)(4)]
Focus HD 43 Detector is a kind of wireless digital flat panel detector. It supports the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 42.67cm×42.67cm.
The sensor plate of Focus HD 43 Detector is direct-deposited with CsI scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the user interface. The major function of the Focus HD 43 Detector is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. Both kinds of detectors are the key component of DR system, enable to complete the digitalization of the medical X-ray imaging with the DR system software.
SDK(include iDetector) is intended to supply API interface for DR system manufacturers. DR system manufacturer control the detector by SDK interface. SDK is not intend to be used directly by other users beside DR system manufacturers.
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6. Intended Use [21 CFR 807.92(a)(5)]
6.1. Indications for use
Focus HD 43 Detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in all generalpurpose diagnostic procedures. The device is not intended for mammography or dental applications.
6.2. Suitable patient
It is suitable for providing digital X-ray imaging for DR system to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients, but not intended for mammography or dental applications. The remaining notes depend on the DR system.
6.3. Processing of input and output
When Focus HD 43 Detector works continuously, it can automatically distinguish X-ray and output an imaging for diagnosis of disease, injury, or of any applicable health problem.
| Item | Predicate Device:Mars1717X Wireless DigitalFlat Panel Detector | Proposed Device:Focus HD 43 Detector |
|---|---|---|
| 510(K) Number | K210314 | |
| Intended Use | The Mars1717X WirelessDigital Flat Panel Detector isindicated for digital imagingsolution designed for providinggeneral radiographic system inall general-purpose diagnosticprocedures. | Same |
| Item | Predicate Device:Mars1717X Wireless DigitalFlat Panel Detector | Proposed Device:Focus HD 43 Detector |
| Indications forUse | Mars1717X wireless digitalflat panel detector is indicatedfor digital imaging solutionsdesigned to provide generalradiographic diagnosis forhuman anatomy including bothadult and pediatric patients. Itis intended to replacefilm/screen systems in allgeneral-purpose diagnosticprocedures. The device is notintended for mammography ordental applications. | Same |
| ClassificationName | Stationary X-ray system | Same |
| Product Code | MQB | Same |
| RegulationNumber | 21 CFR 892.1680 | Same |
| Panel: | Radiology | Same |
| Classification: | II | Same |
| X-Ray Absorber(Scintillator): | CsI | Same |
| Installation Type: | Wireless, Portable | Same |
| ReadoutMechanism: | Thin Film Transistor | Same |
| Item | Predicate Device:Mars1717X Wireless DigitalFlat Panel Detector | Proposed Device:Focus HD 43 Detector |
| Image MatrixSize: | 4267 ×4267 pixels | Same |
| Pixel Size: | 100μm | Same |
| ADC Digitization | 16 bit | Same |
| Effective ImagingArea: | 426.7 mm × 426.7mm | Same |
| SpatialResolution: | Min. 4.3lp/mm | 5.0 lp/mm |
| DetectiveQuantumEfficiency(DQE) | 0.54 at 1 lp/mm (RQA5,2.5μGy) | Same |
| PowerConsumption: | Max. 19W | Max.42W |
| Communications:(Wirelessfunctionality) | a) Wired (only forservice) : GigabitEthernet (1000BASE-T)b) Wireless: IEEE802.11a/b/g/n/ac (2.4 GHz/ 5 GHz) | Same |
| Imaging protectPlate: | Carbon Fiber Plate | Same |
| Cooling: | Air cooling | Same |
| Dimensions: | 460 mm × 460 mm × 15mm | Same |
| Detector IP grade | IP56 | Same |
| Item | Predicate Device:Mars1717X Wireless DigitalFlat Panel Detector | Proposed Device:Focus HD 43 Detector |
| Power input port | 4 pin port | 10 pin port |
| Surface pressure | Uniform load: 300 kg over thewhole area of the surface;Local load: 150 kg on an area4 cm diameter of center | Uniform load: 300 kg over thewhole area of the surface;Local load: 100 kg on an area 4cm diameter of center |
| Operation: | Temperature: +10 ~ +35°CHumidity: 5 ~ 90%(Non-Condensing)Atmospheric pressure: 70 ~106 kPaAltitude: Max. 3000 meters | Temperature: +5 ~ +35°CHumidity: 5 ~ 90%(Non-Condensing)Atmospheric pressure: 70 ~ 106kPaAltitude: Max. 3000 meters |
| Storage andTransportation:( detector ) | Temperature: -20 ~ +55°CHumidity: 5 ~ 95%(Non-Condensing)Atmospheric pressure: 60 ~106 kPaAltitude: Max. 3000 meters | Temperature: -20 ~ +55°CHumidity: 5 ~ 95%(Non-Condensing)Atmospheric pressure: 70 ~ 106kPaAltitude: Max. 3000 meters |
| Software | SDK(include iDetector) isintend to supply API interfacefor DR system manufacturers.DR system manufacturercontrol the detector by SDKinterface. SDK is not intend touse directly by other usersbeside DR systemmanufacturers. | same |
| Item | Predicate Device:Mars1717X Wireless DigitalFlat Panel Detector | Proposed Device:Focus HD 43 Detector |
| Utilized FDAguidancedocuments | 1. Guidance for theSubmission of 510(k)'s forSolid State X-ray ImagingDevices;2. The 510(k) Program:Evaluating SubstantialEquivalence in PremarketNotifications[510(k)];3. Content of PremarketSubmissions forManagement ofCybersecurity in MedicalDevices;4. Radio Frequency WirelessTechnology in MedicalDevices.5. Guidance for “PremarketAssessment of PediatricMedical Devices”;6. Guidance for “PediatricInformation for X-rayImaging Device PremarketNotifications”.7. Design Control GuidanceFor Medical DeviceManufacturers | same |
| Item | Predicate Device:Mars1717X Wireless DigitalFlat Panel Detector | Proposed Device:Focus HD 43 Detector |
| 8. Appropriate Use ofVoluntary ConsensusStandards in PremarketSubmissions for MedicalDevices.9. The Special 510(k)Program | ||
| Battery | Model: Battery-KXRated Voltage:11.55V | same |
7. Technological Characteristic [21 CFR 807.92(a)(6)]
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8. System requirements to operate with other radiographic system components
-
- Recommended Generator Specification:
Energy range: 40~150kVp
- Recommended Generator Specification:
mA range: 10~1000mA (depending on the generator power)
ms range: 106300ms to produce 0.11000mAs (depending on the generator power) Note: To our best knowledge, the detector is compatible with the X-ray generators with the specifications described above. If you have any questions regarding the compatibility issue for other generators, please contact the distributor or manufacturer's service office.
-
- Application Program Interface (API) for system integration manufacturer Minimum configuration: Focus HD 43 Detector connected via wireless communication.
| Operating System: | Windows embedded |
|---|---|
| CPU: | Intel Core i3- 8100 3.6GHz 4C 65W |
| Memory: | 16GB (2x8GB) DDR4 2666 DIMM |
| Hard Disk: | 1TB |
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3) X-ray exposure mode
The AED trigger module is a unit can connect X-ray signal in the Focus HD 43 Detector. Once there is X-ray generator exposure exist, the AED trigger module will detect the X-ray radiation and output signal to the detector. Until the exposure finished, the detector will receive a signal which represent the end of exposure from the inner trigger module and begin to acquire the image.
Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)] 9.
-
- Electrical Safety and EMC testing:
Electrical, mechanical, environmental safety according to IEC/ES 60601-1 was performed, and EMC testing was also conducted in accordance with IEC 60601-1-2. All test results are meet the standard requirements.
- Electrical Safety and EMC testing:
-
- Biological Evaluation:
The materials of the detector which contact operators' or patient's skin have been evaluated with the ISO 10993-1. And the evaluation results and test result assured the safety the same as the predicate device.
- Biological Evaluation:
-
- Non-clinical Considerations:
Main modification from the predicate device is DC input port change(from 4 pin port to 10 pin port ) . This DC input port is only designed and applicable for DR system manufacturer.
- Non-clinical Considerations:
The non-clinical studies have been performed and the results have shown that sections of the non-clinical consideration mentioned in the 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices' are substantially equivalent to the non-clinical consideration of predicate device on the Market (Mars1717X, K210314).
-
- Clinical Consideration:
Intended use, fundamental scientific technology, regulatory requirement, non-clinical performance, labeling, quality-assurance program and software keep the same with
- Clinical Consideration:
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those of predicate device. There is no any change about clinical performance from predicate device
10. Conclusion [21 CFR 807.92(b)(3)]
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, iRay Technology Taicang Ltd. concludes that Focus HD 43 is substantially equivalent to predicate device with regards to safety and effectiveness.
§ 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.