(51 days)
Indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding fluoroscopic, angiographic, and mammographic applications.
The Prudent 1717, Prudent 1417, Prudent 1212 are digital radiography systems, featuring an integrated flat panel digital detector (FPD). It is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the updated panels are the same as our previous panel retaining the Wi-Fi wireless features and rechargeable battery operation. The Prudent 1717 is available in 3 pixel sizes: 100/140/168 um whereas the Prudent 1417, Prudent 1212 are available in two pixel sizes: 100/140 µm. The available resolutions vary according to the comparison table below. All of the models are Wi-Fi wired) and rechargeable battery (or AC line) operated. The device employs the same software as cleared in the predicate with only minor changes made.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the PIXXGEN Corporation's Prudent digital x-ray detector panels:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the comparison to predicate devices and adherence to established standards. The reported device performance is presented in comparison to these predicates.
| Acceptance Criterion (Implicit) | Reported Device Performance (Prudent series) |
|---|---|
| Image Quality (Quantitative) | |
| DQE (CSI) at 2 lp/mm (compared to K201932 alternate predicate: 45%) | 60%, 44%, 47% (for 100/140/168 um pixel sizes respectively). Same or better than alternate predicate. |
| MTF (CSI) at 1 lp/mm (compared to K201932 alternate predicate: 35%) | 70%, 53%, 55% (for 100/140/168 um pixel sizes respectively). Better than alternate predicate. |
| DQE (GOS) at 1 lp/mm (compared to K202995 alternate predicate: 20%) | 36%, 27%, 30% (for 100/140/168 um pixel sizes respectively). Better than alternate predicate. |
| MTF (GOS) at 1 lp/mm (compared to K202995 alternate predicate: 50%) | 56%, 55%, 54% (for 100/140/168 um pixel sizes respectively). Better than alternate predicate. |
| Limiting Resolution (compared to K182533 predicate: 3 lp/mm) | 5.0 lp/mm, 3.6 lp/mm, 3.0 lp/mm. Equal or better. |
| Image Quality (Qualitative) | |
| Diagnostic Quality of Clinical Images (compared to predicate device) | Excellent diagnostic quality. (As evaluated by a Board Certified Radiologist). |
| Safety & Performance (Bench Testing & Other) | |
| Electrical Safety (IEC/UL 60601-1) | Standards met. |
| Electromagnetic Compatibility (IEC 60601-1-2) | Standards met. |
| Battery Safety (IEC 62133) | Standards met. |
| Risk Analysis (ISO 14971) | Conducted in accordance with ISO 14971:2012. |
| Software Validation (EN 62304) | Software Validation Report for Revision 5 produced. The software remains essentially the same as in the predicate but moved from Revision 4 to Revision 5. |
| Battery Life | 6-8 hours / 480-600 images. (Confirmed by testing, improved from predicate's 5 hours/300 images). |
| Usability (IEC 62366-1) | Evaluation concluded that the intended user can safely use the device in the intended environment without use error. |
| Cybersecurity Labeling (FDA guidance) | Cybersecurity precautionary labeling added. |
| General Equivalence to Predicate (K182533) and Alternate Predicates (K202995, K201932) | The results of clinical image inspection, bench, and test laboratory results indicates that the new device is as safe and effective as the predicate device. Clinical images collected demonstrate equal or better image quality as compared to our predicate. "Thus rendering them substantially equivalent to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a numerical sample size for the "clinical images" test set. It only states "Clinical images collected."
- Data Provenance: The document does not explicitly state the country of origin. It does not explicitly state if the data was retrospective or prospective. However, the term "Clinical images collected" typically implies prospective collection for such validation, but this is not explicitly confirmed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: "a Board Certified Radiologist" (singular, implying one).
- Qualifications of Experts: "Board Certified Radiologist." No specific experience level (e.g., "10 years of experience") is provided.
4. Adjudication Method for the Test Set
- Adjudication Method: The document states that the images were "evaluated by a Board Certified Radiologist." This suggests a single reader evaluation, which means no multi-reader adjudication method (like 2+1, 3+1) was explicitly performed or mentioned for the clinical image evaluation.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned. The study described is an evaluation of the device's image quality by a single radiologist, not a comparison of human readers' performance with and without AI assistance. This device is a digital x-ray detector panel, not an AI-powered image analysis tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- The document primarily describes a standalone performance evaluation of the imaging device itself (the detector panel) in terms of objective image quality metrics (DQE, MTF, limiting resolution) and a qualitative assessment of clinical images. Since the device is a detector, it intrinsically operates "standalone" in providing the image data. The "algorithm" here refers to the device's inherent image acquisition and processing capabilities, not an AI algorithm acting on those images. The evaluation by the radiologist is an assessment of the output of the standalone device.
7. The Type of Ground Truth Used
- For Quantitative Metrics (DQE, MTF, Limiting Resolution): These are objective physical measurements governed by established scientific and engineering standards (e.g., Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices). The "ground truth" for these is the measurement itself, verified against the alternate predicate devices' published specifications.
- For Clinical Images: The ground truth was established by expert consensus/evaluation by a "Board Certified Radiologist." The assessment was subjective, stating the images were "of excellent diagnostic quality." It is not directly pathology or outcomes data.
8. The Sample Size for the Training Set
- This document describes a medical device (digital x-ray detector panel), not an AI algorithm that requires a separate "training set" in the machine learning sense. Therefore, there is no mention of a training set sample size. The device's "training" refers to its design and engineering to meet specific technical specifications.
9. How the Ground Truth for the Training Set Was Established
- As a digital x-ray detector panel, the concept of a "training set" and establishing ground truth for it (in the AI/machine learning context) does not apply. The device's performance is driven by its physical components and embedded firmware/software, which are developed and verified through engineering principles and adherence to standards rather than algorithm training on a dataset.
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Image /page/0/Picture/10 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health and Human Services emblem. To the right of the emblem is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue font. The word "FDA" is in a larger font size than the rest of the text.
PIXXGEN Corporation % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114
Re: K211108
Trade/Device Name: Prudent 1717, Prudent 1417, Prudent 1212 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: April 14, 2021 Received: April 15, 2021
Dear Mr. Kamm:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
June 4, 2021
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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.
For
Thalia T. Mills, Ph.D. Director 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) K211108
Device Name Prudent 1717, Prudent 1417, Prudent 1212
Indications for Use (Describe)
Indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding fluoroscopic, angiographic applications.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ----------------------------------------------------------------------------------------------------- |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|
| ----------------------------------------------- |
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510(k) Summary 510(k) Number K211108 PIXXGEN Corporation 5F, SMART BAY, 123, Beolmal-ro, Dongan-gu, Anyang-si, Gyeonggi-do, 431804, Korea Tel +82.70.4846.8888 Date Prepared: April 29, 2021 Contact: Young Kim, President
1. Identification of the Device:
Proprietary-Trade Names: Prudent 1717, Prudent 1417, Prudent 1212 Classification Name: Solid State X-Ray Imager (Flat Panel/Digital Imager), Common/Usual Name: Digital X-Ray Receptor Panel Device Class/Regulation Number: Class II per regulation 892.1680 Product Code: MQB
-
- Equivalent legally marketed device: K182533 PIXX 1717; PIXX 1212; Digital Diagnostic X-Ray Receptor Panels Classification Name: Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB,
Common/Usual Name: Digital X-Ray Receptor Panel
- Equivalent legally marketed device: K182533 PIXX 1717; PIXX 1212; Digital Diagnostic X-Ray Receptor Panels Classification Name: Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB,
Device Class/Regulation Number: Class II per regulation 892.1680
Product Code: MQB
Alternate Predicate Device 1: (for MTF/DQE comparison) K202995, CareRay Digital Medical Technology Co., Ltd
Proprietary-Trade Name: CareView 3600RF, CareRay Digital Medical Technology Co., Ltd.
Classification Name: Solid State X-Ray Imager (Flat Panel/Digital Imager),
Common/Usual Name: Digital X-Ray Receptor Panel
Device Class/Regulation Number: Class II per regulation 892.1680
Product Code: MQB
Alternate Predicate Device 2: (for MTF/DQE comparison) K201932, CareRay Digital Medical Technology Co., Ltd
Proprietary-Trade Name: CareView 1800Cw, CareRay Digital Medical Technology Co., Ltd.
Classification Name: Solid State X-Ray Imager (Flat Panel/Digital Imager),
Common/Usual Name: Digital X-Ray Receptor Panel
Device Class/Regulation Number: Class II per regulation 892.1680 Product Code: MQB
-
- Indications for Use (intended use) Indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding fluoroscopic, angiographic, and mammographic applications.
4. Description of the Device:
The Prudent 1717, Prudent 1417, Prudent 1212 are digital radiography systems, featuring an integrated flat panel digital detector (FPD). It is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the updated panels are the same as our previous panel retaining the Wi-Fi wireless features and rechargeable battery operation. The Prudent 1717 is
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available in 3 pixel sizes: 100/140/168 um whereas the Prudent 1417, Prudent 1212 are available in two pixel sizes: 100/140 µm. The available resolutions vary according to the comparison table below. All of the models are Wi-Fi wired) and rechargeable battery (or AC line) operated. The device employs the same software as cleared in the predicate with only minor changes made.
-
- Safety and Effectiveness, comparison to predicate device. The results of clinical image inspection, bench, and test laboratory results indicates that the new device is as safe and effective as the predicate device. Clinical images collected demonstrate equal or better image quality as compared to our predicate.
| K182533, PIXX 1717, PIXX 1417, PIXX 1212 | Prudent 1717, Prudent 1417, Prudent 1212 | |
|---|---|---|
| Intended Use | Indicated for use in general radiographicimages of human anatomy. It is intended toreplace radiographic film/screen systems inall general-purpose diagnostic procedures,excluding fluoroscopic, angiographic, andmammographic applications | UNCHANGED |
| Configuration | This submission is for the Digital Panel andSoftware only, no generator or standprovided. | UNCHANGED |
| Pixel Pitch | 140 μm | Prudent 1717: 100/140/168 μm (3 availablepixel sizes)Prudent 1417: 100/140 μm (2 available pixelsizes)Prudent 1212:100/140 μm (2 availablepixel sizes) |
| LimitingResolution | 3 lp/mm | 5.0 lp/mm, 3.6 lp/mm 3.0 lp/mm(Equal or better) |
| A/D Conversion | 16 bits | SAME |
| Active Area | 17 x 17 inch14 x 17 inch12 x 12 inch | SAME |
| Dimensions(mm)/Weights(Kg) | 460(W)x461(L)x15(H)/3.0Kg385(W) x 460(L) x 15(H)/ 2.8Kg308.5(W) x 319.5(L) x 15(H)/ 1.9Kg | 460(W)X460(L)X15(H)/ 3.9Kg382(W)X460(L)X15(H)/ 3.3Kg372(W)X315(L)X15(H)/ 2.0KgComparable sizes |
| Pixels | 3,072 x 3,0722,560 x 3,0722,048 x 2,048 | 1717: 3072x3072/2560x2560/4302x43021417: 2500x3052 / 3534x43021212: 2048x2048 / 2864x2864Similar resolutions |
| Software | Outputs a DICOM image | SAME |
| DICOM | Yes | Yes |
| Scintillator | Csl or GOS | SAME |
| K182533, PIXX 1717, PIXX 1417, PIXX 1212 | Prudent 1717, Prudent 1417, Prudent 1212 | |
| Interface | Wired: Gigabit Ethernet(1000BASE-T)Wireless:IEEE802.11ac, backward compatible | SAME |
| Power source | AC Line and/or Rechargeable LithiumBattery; 5 hours/300 images | AC Line and/or Rechargeable LithiumBattery;6 |
| Standards | Electrical Safety per IEC 60601-1:2012 andEMC per IEC 60601-1-22007+AC:2010 as wellas IEEE802.11ac. Meets FCC requirementsplus IEC 62133 Battery safety. | SAME |
6. Substantial Equivalence Chart
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| Alternate predicates | Prudent 1717, Prudent 1417, Prudent 1212 | |
|---|---|---|
| DQE(CSI) | K201932 Alternate predicate At 2 lp/mm 45% | At 2 lp/mm 60 % / 44% / 47%(@100/140/168 um respectively)Same or better than alternate predicate |
| MTF(CSI) | K201932 Alternate predicate at 1 lp/mm:35% | At 1 lp/mm 70%, 53%, 55%(@100/140/168 um respectively)Better than alternate predicate |
| DOE(GOS) | K202995 Alternate predicate at 1 lp/mm 20% | At 1 lp/mm 36%, 27%, 30%(@100/140/168 um respectively)Better than alternate predicate |
| MTF(GOS) | K202995 Alternate predicate at 1 lp/mm: 50% | At 1 lp/mm 56%, 55%, 54%(@100/140/168 um respectively)Better than alternate predicate |
-
- Summary of Bench Testing Conducted: IEC Standards were employed for: Electrical Safety and Electromagnetic Compatibility, and Battery Safety Tests. Standards met: Electrical safety per: IEC/UL 60601-1, Medical Electrical Equipment – Part 1: General Requirements for Safety. (General) Electromagnetic Compatibility per IEC 60601-1-2, Collateral Standard: Electromagnetic compatibility Requirements and tests. IEC 62133 Edition 2.0 2012-12 Secondary cells and batteries containing alkaline or other non-acid
electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
- Summary of Bench Testing Conducted: IEC Standards were employed for: Electrical Safety and Electromagnetic Compatibility, and Battery Safety Tests. Standards met: Electrical safety per: IEC/UL 60601-1, Medical Electrical Equipment – Part 1: General Requirements for Safety. (General) Electromagnetic Compatibility per IEC 60601-1-2, Collateral Standard: Electromagnetic compatibility Requirements and tests. IEC 62133 Edition 2.0 2012-12 Secondary cells and batteries containing alkaline or other non-acid
Risk Analysis was conducted in accordance with ISO 14971:2012 and EN 62304. The software remains essentially the same as in K182533 but moved from Revision 4 to Revision 5. A Software Validation Report for Revision 5 was produced.
MTF and DQE measurements were made in accordance with Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices Guidance for Industry and Food and Drug Administration Staff Document issued on: September 1, 2016
Battery life testing was conducted to confirm that the Prudent panels run for 6-8 hours/480-600 images.
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The panels were evaluated for Usability according to IEC 62366-1:2015 Medical devices — Part 1: Application of usability engineering to medical devices. The evaluation concluded that the intended user can safely use the device in the intended environment without use error.
Cybersecurity precautionary labeling was added per the FDA guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff, Document Issued on: October 2, 2014.
-
- Summary of Clinical Testing: Clinical images obtained in accordance with Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices 1 Guidance for Industry and Food and Drug Administration Staff Document issued on: September 1, 2016. The images were evaluated by a Board Certified Radiologist and found to be of excellent diagnostic quality.
-
- Conclusion: After analyzing bench, clinical image, and external laboratory testing to applicable standards, it is the conclusion of Pixxgen that the Prudent 1417, Prudent 1417, Prudent 1212 Digital Diagnostic X-Ray Receptor Panels are as safe and effective as the predicate device, have few technological differences, and has the identical indications for use, thus rendering them substantially equivalent to the predicate device.
§ 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.