(236 days)
The Wireless(V14 CLARITY, V14 HC, V17 CLARITY, V17 HC, F14 CLARITY, F14 HC)/Wired(V14 CLARITY, V14 HC, V17 CLARITY, V17 HC, F14 CLARITY, F14 HC, W17 Clarity, W17 HC) PRORAD X-Ray Flat Panel Detector with DROC is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The PRORAD X-Ray Flat Panel Detector with DROC is not intended for mammography, 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.
PRORAD X-Ray Flat Panel Detector with DROC is the similar product to the predicate, Yushan X-Ray Flat Panel Detector with DROC, K201528, K210988, K220510. There are 8 models in this submission, V14 Clarity, V14 HC, V17 Clarity, V17 HC, W17 HC, F14 Clarity, F14 HC, W17 Clarity are a portable(wireless)/nonportable(wired) digital detector. The PRORAD X-Ray Flat Panel Detector with DROC 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 non-grid 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.
The PRORAD X-Ray Flat Panel Detector with DROC sensor can automatically collects x-ray images from an x-ray source. It collects x-rays and digitizes the images for their transfer and display to a computer. 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.
PRORAD series is working by using DROC. This is a software running on a Windows PC as an user interface for radiologist to perform a general radiography exam. The function include:
- Detector status update
- Xray exposure workflow
- Image viewer and measurement.
- Post image process and DICOM file I/O
- Image database: DROC support the necessary DICOM Services to allow a smooth integration into the clinical network
This submission for the PRORAD X-Ray Flat Panel Detector with DROC (K240771) indicates that no new performance data was generated to demonstrate substantial equivalence. Instead, the device is deemed substantially equivalent to its predicate devices (Yushan X-Ray Flat Panel Detector with DROC, K201528, K210988, K220510) due to minimal changes in product name, appearance, and labeling, implying that the performance of the device is identical to the predicates. Therefore, the acceptance criteria and study details would be those established for the predicate devices.
However, based solely on the provided document, which states "no clinical study has been performed" and that "the performance data is the same and need no extra validation," it explicitly does not include a study directly proving the device meets new acceptance criteria. It relies on the substantial equivalence argument, meaning the predicate devices' performance data is referenced implicitly.
Since the document explicitly states "No clinical study has been performed" and "Therefore the performance data is the same and need no extra validation", there isn't a direct study described in this document that proves the device meets (new) acceptance criteria. Instead, the device is deemed substantially equivalent to the predicate devices and thus relies on the predicate devices' performance data. The document does not provide details of any specific acceptance criteria or performance study results for the PRORAD device itself.
However, based on the non-clinical performance data section, it states that "the image quality evaluation confirmed that the image quality of the PRORAD X-Ray Flat Panel Detector with DROC is substantially equivalent to that of the predicate device." While this isn't a detailed study, it implies a comparison.
Here's an attempt to answer the questions based on the limited information regarding this specific device's performance, highlighting the reliance on predicate device information:
1. A table of acceptance criteria and the reported device performance
Based on the provided document, no specific acceptance criteria for the PRORAD X-Ray Flat Panel Detector with DROC itself are listed, nor is new device performance data reported. The document states that the device's technical characteristics, design, functional, and performance characteristics are similar to the predicate devices. The assumption is that the new device meets the same performance characteristics as the predicate. The comparison table of technical characteristics (from page 8-14 of the original document) contains performance-related metrics that are presented as identical or nearly identical between the subject device and the predicates.
| Acceptance Criteria (Implied from Predicate/Comparison) | Reported Device Performance (PRORAD) |
|---|---|
| Technical Characteristics | |
| Pixel Pitch | 140 μm |
| DQE (GOS, at 1 lp/mm, RQA5) | 0.27 |
| DQE (CsI, at 1 lp/mm, RQA5) | 0.50 (V14/V17 Clarity & F14 Clarity) |
| MTF (GOS, at 1 lp/mm, RQA5) | 0.52 |
| MTF (CsI, at 1 lp/mm, RQA5) | 0.69 (V14/V17 Clarity & W17 Clarity) |
| Max. Resolution (GOS) | 3.57 lp/mm |
| Max. Resolution (CsI) | 3.57 lp/mm |
| A/D Conversion | 16 bit |
| Safety and Standards Compliance | |
| Compliance with 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. | Confirmed (through non-clinical tests) |
| Compliance with FDA's Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices | Followed |
| Compliance with Guidance for the Content of Premarket Submissions for Device Software Functions (Software Level of Concern: Basic) | Followed |
| Compliance with Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | Followed (risks addressed, controls implemented) |
| Load-bearing characteristics | Tested and Passed |
| Protection against ingress of water | Tested and Passed |
| EMC emission testing (IEC60601-1-2) | Satisfactory |
| Biocompatibility (ISO 10993 series) | Demonstrated (materials safe and effective) |
| Image Quality | Substantially equivalent to predicate device |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states, "No clinical study has been performed." For non-clinical tests (e.g., electrical safety, EMC, mechanical, biocompatibility), sample sizes are not specified. The "image quality evaluation" also does not mention a sample size or data provenance. The assessment relies on the inherent similarity of the new device to the previously cleared predicate devices.
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)
Not applicable, as no new clinical study was performed for this 510(k) submission. The document relies on "image quality evaluation" that confirmed substantial equivalence, but details on experts or ground truth establishment for this comparison are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new clinical study involving adjudication was performed for this 510(k) submission.
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
Not applicable. This device is a digital X-ray flat panel detector, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an imaging hardware component, not an algorithm for standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no new clinical study requiring ground truth was performed for this 510(k) submission. The "image quality evaluation" for substantial equivalence would likely rely on quantitative technical metrics rather than clinical ground truth for diagnostic accuracy.
8. The sample size for the training set
Not applicable, as no machine learning algorithm development (which would require a training set) is described for this device in the document.
9. How the ground truth for the training set was established
Not applicable, as no machine learning algorithm development is described.
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November 12, 2024
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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Prognosys Medical Systems Private Limited % Giridhar Tumba Management Representative & Assistant General Manager 168/1, Machohalli, Dasanapura Hobli, Bangalore North, Bangalore 560091 INDIA
Re: K240771
Trade/Device Name: PRORAD X-Ray Flat Panel Detector with DROC Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: October 15, 2024 Received: October 16, 2024
Dear Giridhar Tumba:
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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
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assistance/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, Gabriela M.
Rodal -S
Digitally signed by Gabriela M. Rodal -S
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
for
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Indications for Use
510(k) Number (if known) K240771
Device Name PRORAD X-Ray Flat Panel Detector with DROC
Indications for Use (Describe)
The Wireless(V14 CLARITY, V14 HC, V17 CLARITY, V17 HC, F14 CLARITY, F14 HC/Wired(V14 CLARITY, V14 HC, V17 CLARITY, V17 HC, F14 CLARITY, F14 HC, W17 Clarity, W17 HC) PRORAD X-Ray Flat Panel Detector with DROC is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The PRORAD X-Ray Flat Panel Detector with DROC is not intended for mammography, 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.
| 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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Image /page/4/Picture/0 description: The image shows the logo for Prognosys Medical Systems. The word "Prognosys" is in a large, bold, red font. Below that, the words "Medical Systems" are in a smaller, black font. Behind the text are three light blue, stylized arrows pointing upwards and to the right.
510(k) Summary K240771
I. SUBMITTER
PROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITED
168/1, Machohalli, Dasanapura Hobli, Bangalore North, Bangalore, India. PIN: 560091. TEL: +91-80-49325700 Email: giri.tumba@prognosysmedical.com Contact Person: GIRIDHAR TUMBA
II. DEVICE
Trade name: PRORAD X-Ray Flat Panel Detector with DROC Regulation description: Stationary x-ray system. Review panel: Radiology Product code: MQB Regulation number: 21 CFR 892.1680 Device class: Class II
III. PREDICATE DEVICE
Substantial equivalence to the following predicate device is as follows: Trade/Device Name: Yushan X-Ray Flat Panel Detector with DROC 1. FDA 510(k) clearance number: K201528 Manufacturer: InnoCare Optoelectronics Corp. Decision Date: 10/11/2020 Regulation description: Stationary x-ray system. Review panel: Radiology Product code: MQB Regulation number: 21 CFR 892.1680 Device class: Class II Trade/Device Name: Yushan X-Ray Flat Panel Detector with DROC 2. FDA 510(k) clearance number: K210988
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Image /page/5/Picture/0 description: The image shows the logo for Prognosys Medical Systems. The word "Prognosys" is written in blue, with the "g" slightly overlapping the "o". Below "Prognosys" are the words "Medical Systems" in a smaller font. Behind the text are three light blue arrows pointing to the right.
Manufacturer: InnoCare Optoelectronics Corp. Decision Date: 4/21/2021 Regulation description: Stationary x-ray system. Review panel: Radiology Product code: MQB Regulation number: 21 CFR 892.1680 Trade/Device Name: Yushan X-Ray Flat Panel Detector with DROC 3. FDA 510(k) clearance number: K220510 Manufacturer: InnoCare Optoelectronics Corp. Decision Date: 4/14/2022 Regulation description: Stationary x-ray system. Review panel: Radiology Product code: MQB Regulation number: 21 CFR 892.1680
IV. DESCRIPTION OF THE DEVICE SUBJECT TO PREMERKET NOTIFI-CATION
PRORAD X-Ray Flat Panel Detector with DROC is the similar product to the predicate, Yushan X-Ray Flat Panel Detector with DROC, K201528, K210988, K220510. There are 8 models in this submission, V14 Clarity, V14 HC, V17 Clarity, V17 HC, W17 HC, F14 Clarity, F14 HC, W17 Clarity are a portable(wireless)/nonportable(wired) digital detector. The PRORAD X-Ray Flat Panel Detector with DROC 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 non-grid 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.
The PRORAD X-Ray Flat Panel Detector with DROC is currently indicated for gen-
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Image /page/6/Picture/0 description: The image shows the logo for Prognosys Medical Systems. The logo features the word "Prognosys" in a blue, sans-serif font, with the "g" slightly overlapping a series of three light blue, stylized arrows pointing to the right. Below "Prognosys" are the words "Medical Systems" in a smaller, sans-serif font, also in blue.
eral projection radiographic applications and the scintillator material is using cesium iodide (Csl) or gadolinium oxysulfide (GOS).
The PRORAD X-Ray Flat Panel Detector with DROC sensor can automatically collects x-ray images from an x-ray source. It collects x-rays and digitizes the images for their transfer and display to a computer. 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.
PRORAD series is working by using DROC. This is a software running on a Windows PC as an user interface for radiologist to perform a general radiography exam. The function include:
-
- Detector status update
-
- Xray exposure workflow
-
- Image viewer and measurement.
-
- Post image process and DICOM file I/O
-
- Image database: DROC support the necessary DICOM Services to allow a smooth integration into the clinical network
The software documentation level for the PRORAD X-Ray Flat Panel Detector with DROC has been determined Basic based on the "Guidance for the Content of Premarket Submissions for Device Software Functions", and the software for the Prorad X-Ray detectors is unchanged from the predicate.
The cybersecurity risks of the PRORAD X-Ray Flat Panel Detector with DROC 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.
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Image /page/7/Picture/0 description: The image shows the logo for Prognosys Medical Systems. The word "Prognosys" is written in a blue, sans-serif font, with the "g" slightly overlapping the "o". Below "Prognosys" are the words "Medical Systems" in a smaller, red, sans-serif font. Behind the text are three light blue arrows pointing to the right.
V. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
PRORAD X-Ray Flat Panel Detector with DROC have the same Indications for Use, and similar design, functional and technical requirements as the models in K201528, K220510. The comparison of technological characteristics is listed in the following table.
| Subject Device | Predicate Device | |||
|---|---|---|---|---|
| Manufacturer | PROGNOSYS MEDICAL SYS-TEMS PRIVATE LIMITED | InnoCare Optoelectronics Corp. | ||
| Product name | PRORAD X-Ray Flat Panel De-tector with DROC | Yushan X-Ray Flat Panel Detector with DROC | ||
| FDA Cleared | - | K201528 | K210988 | K220510 |
| Model name | V14 Clarity | V14C | - | - |
| V14 HC | V14G | - | - | |
| V17 Clarity | V17C | - | - | |
| V17 HC | V17G | - | - | |
| W17 HC | V17Ge | - | - | |
| F14 Clarity | - | F14C | - | |
| F14 HC | - | F14G | - | |
| W17 Clarity | - | - | V17Ce |
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Image /page/8/Picture/0 description: The image shows the logo for Prognosys Medical Systems. The logo features the word "Prognosys" in a bold, blue font, with the word "Medical" in a smaller font below and to the left, and the word "Systems" in a smaller font below and to the right. Behind the text is a series of light blue arrows pointing to the right, creating a sense of forward movement.
| Clinical | ||||
|---|---|---|---|---|
| Indications for Use | The Wireless(V14 CLARITY, V14 HC, V17 CLARITY, V17 HC, F14 CLARITY, F14 HC)/Wired(V14 CLARITY, V14 HC, V17 CLARI-TY, V17 HC, F14 CLARITY, F14 HC, W17 Clarity, W17 HC)PRORAD X-Ray Flat Panel Detector with DROC is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The PRORAD X-Ray Flat Panel Detector with DROC is not intended for mammography, fluoroscopy, tomography, and angiography ap- | The Wireless(V14C, V14G, V17C, V17G)/Wired(V14C, V14G, V17C, V17G, V17Ge) Yushan X-Ray Flat Panel Detector with DROC is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The Yushan X-Ray Flat Panel Detector with | The Wireless/Wired Yushan X-Ray Flat Panel Detector is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. The Yushan X-Ray Flat Panel Detector is not intended for | The Wired Yushan X-Ray Flat Panel Detector is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The Yushan X-Ray Flat Panel Detector is not intended for mammography, fluoroscopy, tomography, and angiography applications. The use of this |
| plications. The use of this productis not recommended for pregnantwomen and the risk of radioactivi-ty must be evaluated by a physi-cian. | DROC is not intendedfor mammography,fluoroscopy, tomogra-phy, and angiographyapplications. | mammography, fluor-oscopy,tomography, and angi-ography applications.Yushan series provideeither raw X ray imageor corrected image forsystem integrator to dofurtherimage process. | product is not recom-mended for pregnantwomen and the risk ofradioactivity must beevaluated by a physi-cian. | |
| Compliancestandard | - FDA Standards 21 CFR892.1680 for stationary x-raysystem- European Medical DevicesDirective (93/42/EEC)- EN ISO 13485- ISO 14971- ANSI/AAMI ES60601-1- CAN/CSA C22.2 No. 60601-1:14 | - 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 | ||
| - 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 | - ISO 10993-1- ISO 10993-5- ISO 10993-10- ISO 15223-1 | |||
| Technical | ||||
| Dimensions(mm) | V14 HC:460(W)×383(L)×15(H)V14 Clarity:460(W)×383(L)×15(H)V17 HC:460(W)×460(L)×15(H)V17 Clarity:460(W)×460(L)×15(H)W17 HC:460(W)×460(L)×15(H)F14 HC: | V14G:460(W)×383(L)×15(H)V14C:460(W)×383(L)×15(H)V17G:460(W)×460(L)×15(H)V17C:460(W)×460(L)×15(H)V17Ge:460(W)×460(L)×15(H) | F14G:460(W)×383(L)×15(H)F14C:460(W)×383(L)×15(H) | V17Ce:460(W)×460(L)×15(H) |
| 460(W)×383(L)×15(H)F14 Clarity:460(W)×383(L)×15(H)W17 Clarity:460(W)×460(L)×15(H) | ||||
| Weight (Kg) | V14 HC: 2.7V14 Clarity: 2.7V17 HC: 3.2V17 Clarity: 3.2W17 HC: 3.5F14 HC: 2.3F14 Clarity: 2.5W17 Clarity: 3.6 | V14G: 2.7V14C: 2.7V17G: 3.2V17C: 3.2V17Ge: 3.5 | F14G: 2.3F14C: 2.5 | V17Ce: 3.6 |
| Substrate | V14 HC: GlassV14 Clarity: GlassV17 HC: GlassV17 Clarity: GlassW17 HC: GlassF14 HC: Non-GlassF14 Clarity: Non-Glass | Glass | Non-Glass(polyethylene tereph-thalate laminate) | Glass |
| W17 Clarity: Glass | ||||
| Scintillator | V14 HC: GOSV14 Clarity: CsIV17 HC: GOSV17 Clarity: CsIW17 HC: GOSF14 HC: GOSF14 Clarity: CsIW17 Clarity: CsI | V14G: GOSV14C: CsIV17G: GOSV17C: CsIV17Ge: GOS | F14G: GOSF14C: CsI | V17Ce: CsI |
| Pixel Pitch | 140 μm | 140 μm | 140 μm | 140 μm |
| DQE | GOS: at 1 lp/mm, RQA5 is 0.27CsI: at 1 lp/mm, RQA5 is 0.50 | GOS: at 1 lp/mm,RQA5 is 0.27CsI: at 1 lp/mm, RQA5is 0.48 | GOS: at 1 lp/mm,RQA5 is 0.27CsI: at 1 lp/mm, RQA5is 0.50 | CsI: at 1 lp/mm, RQA5is 0.48 |
| MTF | GOS: at 1 lp/mm, RQA5 is 0.52CsI: at 1 lp/mm, RQA5 is 0.69 | GOS: at 1 lp/mm,RQA5 is 0.52CsI: at 1 lp/mm, RQA5is 0.69 | GOS: at 1 lp/mm,RQA5 is 0.52CsI: at 1 lp/mm, RQA5is 0.63 | CsI: at 1 lp/mm, RQA5is 0.69 |
| Max. | GOS: 3.57 lp/mm | GOS: 3.57 lp/mm | GOS: 3.57 lp/mm | CsI: 3.57 lp/mm |
| resolution | CsI: 3.57 lp/mm | CsI: 3.57 lp/mm | CsI: 3.57 lp/mm | CsI: 3.57 lp/mm |
| A/D Conver-sion | 16 bit | 16 bit | 16 bit | 16 bit |
| Pixels | V14 HC: 2500 x 3052V14 Clarity: 2500 x 3052V17 HC: 3072 x 3072V17 Clarity: 3072 x 3072W17 HC: 3072 x 3072F14 HC: 2500 x 3052F14 Clarity: 2500 x 3052W17 Clarity: 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 Ethernet(100BASE-TX or 10BASE-T)Wireless: IEEE802.11 ac /a/g/n* W17 HC, W17 Clarity are notapplicable for wireless function. | Wired: Gigabit Ethernet(100BASE-TX or10BASE-T)Wireless: IEEE802.11ac /a/g/n* V17Ge is not appli-cable for wireless func-tion. | Wired: Gigabit Ethernet(100BASE-TX or10BASE-T)Wireless: IEEE802.11ac /a/g/n | Wired: Gigabit Ethernet(100BASE-TX or10BASE-T) |
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Image /page/9/Picture/0 description: The image shows the logo for Prognosys Medical Systems. The word "Prognosys" is written in a blue, sans-serif font, with the "g" extending below the other letters. Below "Prognosys" are the words "Medical Systems" in a smaller, lighter font. Behind the text are three blue arrows pointing to the right, with each arrow slightly offset from the others.
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Image /page/10/Picture/0 description: The image shows the logo for Prognosys Medical Systems. The word "Prognosys" is written in a bold, sans-serif font, with the "g" slightly overlapping the "o". Below "Prognosys" are the words "Medical Systems" in a smaller, lighter font. Behind the text are three light blue, angled shapes that resemble arrows pointing to the right, creating a sense of forward movement or progress.
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Image /page/11/Picture/0 description: The image shows the logo for Prognosys Medical Systems. The word "Prognosys" is written in blue, with the "g" slightly overlapping the "o". Below "Prognosys" is the phrase "Medical Systems" in a smaller font. Behind the text are three light blue arrows pointing to the right, creating a sense of forward movement.
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Image /page/12/Picture/0 description: The image shows the logo for Prognosys Medical Systems. The word "Prognosys" is in a large, bold, sans-serif font, with the word "Medical Systems" in a smaller font below it. To the right of the text is a graphic of three blue arrows pointing to the right, with each arrow slightly offset from the others.
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Image /page/13/Picture/0 description: The image shows the logo for Prognosys Medical Systems. The word "Prognosys" is written in a blue, sans-serif font, with the "g" slightly larger than the other letters. Below "Prognosys" are the words "Medical Systems" in a smaller, sans-serif font. Behind the text is a blue arrow pointing to the right, which is slightly transparent.
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Image /page/14/Picture/0 description: The image shows the logo for Prognosys Medical Systems. The word "Prognosys" is in a blue, sans-serif font, with the "g" slightly overlapping the "o". Below "Prognosys" is the phrase "Medical Systems" in a smaller, sans-serif font. Behind the text are three light blue arrows pointing to the right, creating a sense of forward movement.
| Power Source | Rechargeable Lithium Battery* W17 HC, W17 Clarity are notapplicable | Rechargeable LithiumBattery* V17Ge is not appli-cable | Rechargeable LithiumBattery | No Battery |
|---|---|---|---|---|
| Biological | ||||
| Biologicalsafety | All material contact with patientsare in accordance with ISO 10993. | All material contactwith patients are in ac-cordance with ISO10993. | All material contactwith patients are in ac-cordance with ISO10993. | All material contactwith patients are in ac-cordance with ISO10993. |
| Others | ||||
| Accessories | - Battery (Optional) * W17- HC, W17 Clarity are not ap-plicable- Power supply (Adapter)- SE cable (Back-up cable)- Power Cord (Optional)- Charger (Optional)- Charger Adapter (Optional) | - Battery (Option-al)* V17Ge is notapplicable- Power supply(Adapter)- SE cable (Back-up cable)- Power Cord | - Battery (Optional)- Power supply(Adapter)- SE cable (Back-up cable)- Power Cord (Op-tional)- Charger (Option- | - Power supply(Adapter)- SE cable (Back-upcable)- Power Cord |
| - | DROC Dongle (Optional) | al) | ||
| - | Charger Adapter(Optional) | |||
| - | DROC Dongle(Optional) |
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Image /page/15/Picture/0 description: The image shows the logo for Prognosys Medical Systems. The word "Prognosys" is in a blue sans-serif font, with the "g" slightly overlapping the "o". Below that, in a smaller font, are the words "Medical Systems". Behind the text are three light blue arrows pointing to the right, arranged in a diagonal line.
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Image /page/16/Picture/0 description: The image shows the logo for Prognosys Medical Systems. The word "Prognosys" is written in a blue, sans-serif font, with the "g" slightly larger than the other letters. Below "Prognosys" are the words "Medical Systems" in a smaller font. Behind the text are three light blue, stylized arrows pointing to the right.
VI. PERFORMANCE DATA
Non-clinical Performance Data: PRORAD X-Ray Flat Panel Detector with DROC 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 AN-SI/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 Device Software Functions (issued on June 14, 2023) was followed to evaluate the level of concern as basic; Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (issued on September 27, 2023) 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: IEC60601-1-2 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 PRORAD X-Ray Flat Panel Detector with DROC 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, V14 Clarity, V14 HC, V17 Clarity, V17 HC, W17 HC, F14 Clarity, F14 HC, W17 Clarity, which are similar to the predicate devices 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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Image /page/17/Picture/0 description: The image contains the logo for Prognosys Medical Systems. The logo features the word "Prognosys" in a blue, sans-serif font, with the "g" slightly larger than the other letters. Below "Prognosys" are the words "Medical Systems" in a smaller font. Behind the text are three light blue, stylized arrows pointing to the right, creating a sense of forward movement.
| Manufacturer | InnoCare Optoelectronics Corp. | PROGNOSYS MEDICALSYSTEMS PRIVATE LIM-ITED |
|---|---|---|
| ProductName | Yushan X-Ray Flat Panel Detectorwith DROC | PRORAD X-Ray Flat PanelDetector with DROC |
| Model Name | FDA Cleared Device: K201528V14C | PRORAD V14 Clarity |
| V14G | PRORAD V14 HC | |
| V17C | PRORAD V17 Clarity | |
| V17G | PRORAD V17 HC | |
| V17Ge | PRORAD W17 HC | |
| FDA Cleared Device: K210988F14C | PRORAD F14 Clarity | |
| F14G | PRORAD F14 HC | |
| FDA Cleared Device: K220510V17Ce | PRORAD W17 Clarity |
Error! Reference source not found. Product Name/Model Name Difference
VII. CONCLUSIONS
PRORAD X-Ray Flat Panel Detector with DROC 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.
PRORAD X-Ray Flat Panel Detector with DROC is 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.