(141 days)
Model#'s 3543A, 4343A, 2929A and A843B; Solid State X-ray Imager (Flat Panel/Digital Imager) are indicated for use in generating radiographic images of human anatomy. They are intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding dental, fluoroscopic, and mammographic applications. As prescribed by a licensed physician
Our device is used in medical x-ray imaging systems. The product can only be used by trained personnel of medical facilities. The product is only used for single image diagnosis applications. The flat panel detector consists of GOS scintillator screen and thin-film transistors. The scintillator screen converts the x-rays into visible light. Thin-film transistors convert the visible light to an electrical charge. The flat panel detector can then obtain a digital image by analog to digital conversion and associated circuits.
The provided text describes a 510(k) premarket notification for X-ray imagers (Models 3543A, 4343A, 2929A, and A843B). It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria and performance evaluation against those criteria is not explicitly detailed in the way a clinical study report would present it.
Here's an attempt to extract and infer the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly defined as pass/fail metrics in a table. Instead, the document compares the technical characteristics of the applicant's device to those of predicate devices to demonstrate "substantial equivalence." The implicit acceptance criterion is that the applicant's device's performance should be comparable to or better than the predicate devices across several key technical specifications.
| Characteristic | Acceptance Criteria (Predicate Device K152151) | Reported Device Performance (PZMedical) |
|---|---|---|
| Intended Use | General radiographic images of human anatomy. Excludes fluoroscopic, angiographic, and mammographic. | General radiographic images of human anatomy. Excludes dental, fluoroscopic, angiographic, and mammographic. (Slight difference in exclusion of "dental") |
| Configuration | Digital Panel and Software only, no generator or stand. | Digital Panel and Software only, no generator or stand. |
| Scintillator | GOS/CsI | GOS/CsI |
| Pixel Pitch | 139 µm | 140 µm (Very similar) |
| Limiting Resolution | Over 3 lp/mm | 3.6 lp/mm (Better) |
| DQE @ 2 lp/mm (CsI) | 26% | 32% (Better) |
| DQE @ 2 lp/mm (GOS) | Not specified | 15% |
| MTF @ 2 lp/mm (CsI) | 42% | 33% (Lower, but still a performance metric compared to predicate) |
| MTF @ 2 lp/mm (GOS) | Not specified | 24% |
| A/D Conversion | 16 bit | 16 bit |
| Active Area (various models) | 17 x 17 inch | 4343A: 16.9 x 16.9 inch3543A: 13.8 x 16.8 inch2929A: 11.3 x 11.3 inchA843B: 42.3 x 16.9 inch (Varies by model, but within general range of digital imagers) |
| Pixels (various models) | 3072 x 3072 (9.4 Million) | 3543A: 2500 x 3052 (7.6 Million)4343A: 3072 x 3072 (9.4 Million)2929A: 2048 x 2048 (4.2 Million)A843B: 7680 x 3072 (23.6 Million) (Comparable or improved depending on model) |
| Software Outputs | DICOM image | DICOM image |
| SW revision | K152151 | PZDR V2.0.1 (Different version, as expected for different manufacturer) |
2. Sample size used for the test set and data provenance:
- Test set sample size: Not explicitly stated as a number of images or patients. The document mentions "comparison images" were used.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- This information is not provided. The "comparison images" suggest qualitative evaluation rather than a formal ground truth establishment process by experts.
4. Adjudication method for the test set:
- Not applicable/Not provided. There is no mention of an adjudication process.
5. Multi-reader multi-case (MRMC) comparative effectiveness study:
- No, a formal MRMC comparative effectiveness study was not done. The document states: "We have included comparison images using our devices Models 3543A, 4343A, 2929A and A843B and a Atlaim Atal 9 cleared device (K132151) as direct comparison of the image quality of our devices in order to support substantial equivalence." This suggests a visual comparison of image quality rather than a study with human readers evaluating images with and without AI assistance.
- Effect size: Not applicable, as no MRMC study was conducted.
6. Standalone (algorithm only without human-in-the-loop performance) study:
- Yes, in a way. The "Non-Clinical data" section details various technical performance metrics (DQE, MTF, NPS, spatial resolution, etc.) for the device itself, demonstrating its standalone physical and technical capabilities. These are objective measurements of the device's image acquisition properties. The "comparison images" also likely fall under this, as they compare the raw output of the device to a predicate.
7. Type of ground truth used:
- For the non-clinical technical performance data (DQE, MTF, etc.), the ground truth is based on physical phantom measurements and industry standards for evaluating X-ray detector performance.
- For the "comparison images," the ground truth implicitly is the visual quality and diagnostic utility as interpreted by the applicant, compared to images from a predicate device. This is a qualitative assessment rather than a formally established ground truth like pathology or expert consensus.
8. Sample size for the training set:
- Not applicable. This device is an X-ray imager (hardware and associated basic software for image acquisition and viewing), not an AI algorithm that requires a training set in the typical sense for image interpretation. The software aspects mentioned (DICOM, image processing, basic editing) are standard functionalities and not indicative of a deep learning model that needs a training set of labeled images.
9. How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set or AI model that requires ground truth labeling.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a symbol above them that resembles a caduceus without the snake.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Shanghai PZ Medical Technology Co., Ltd. % Jeff Moeller Vice President OrganizeUS. Inc. 8317 Lakeside Drive Downers Grove, Illinois 60516
July 7, 2017
Re: K170480
Trade/Device Name: Models 3543A, 4343A, 2929A and A843B Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MOB Dated: April 30, 2017 Received: May 5, 2017
Dear Jeff Moeller:
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. 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
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael D. O'Hara
For
Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170480
Device Name Models 3543A, 4343A, 2929A and A843B
Indications for Use (Describe)
Model#'s 3543A, 4343A, 2929A and A843B; Solid State X-ray Imager (Flat Panel/Digital Imager) are indicated for use in generating radiographic images of human anatomy. They are intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding dental, fluoroscopic, and mammographic applications. As prescribed by a licensed 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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�rganizeUS, Inc.
8317 Lakeside Drive Downers Grove, IL 60516
510(k) Summary
(Revised 06/30/17)
| Owners name: | Shanghai PZ Medical Technology Co., Ltd.5F, Building 13 No.2 Suide Road200331 Shanghai |
|---|---|
| Contact person / firm: OrganizeUS, Inc. | 8317 Lakeside DriveDowners Grove, IL 60516847-337-3004Jeff Moeller, Vice President |
| Date: | March 17, 2017 |
| Trade name: | Models 3543A, 4343A, 2929A and A843B |
| Common name: | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Classification name: | Stationary X-Ray system, 892.1680, code MQB |
| Predicate devices: | Atlaim's model ATAL 9 - K152151Stationary X-Ray system, 892.1680, code MQB |
| IRAY model 1417 - K161730Stationary X-Ray system, 892.1680, code MQB | |
| CareRay model Care view 1500C & 1500L - K153058Stationary X-Ray system, 892.1680, code MQB | |
| Description: | Our device is used in medical x-ray imaging systems. The product can only beused by trained personnel of medical facilities. The product is only used forsingle image diagnosis applications. The flat panel detector consists of GOSscintillator screen and thin-film transistors. The scintillator screen converts thex-rays into visible light. Thin-film transistors convert the visible light to anelectrical charge. The flat panel detector can then obtain a digital image byanalog to digital conversion and associated circuits. |
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Intended use: Model#'s 3543A, 4343A, 2929A and A843B; Solid State X-ray Imager (Flat Panel/Digital Imager) are indicated for use in generating radiographic images of human anatomy. They are intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding dental, fluoroscopic, angiographic, and mammographic applications. As prescribed by a licensed physician.
Refer to the table below (2 pages) Technological:
| Characteristic | Atlaim ATAL 9 K152151 | PZMedical 4343A,3543A,2929A,A843B |
|---|---|---|
| Intended Use | Indicated for use in generalradiographic images of humananatomy. It is intended to replaceradiographic film/screen systems in allgeneral-purpose diagnostic procedures,excluding fluoroscopic, angiographic,and mammographic applications. | Model#'s 3543A, 4343A, 2929A and A843B;Solid State X-ray Imager (Flat Panel/DigitalImager) are indicated for use in generatingradiographic images of human anatomy. They areintended to replace radiographic film/screensystems in all general-purpose diagnosticprocedures, excluding dental, fluoroscopic,angiographic, and mammographic applications.As prescribed by a licensed physician. |
| Configuration | This submission is for the DigitalPanel and Software only, no generatoror stand provided. | This submission is for the Digital Panel andSoftware only, no generator or stand provided. |
| Digital Panel | Atlaim ATAL 9 | PZMedical 4343A,3543A,2929A,A843B |
| Scintillator | GOS/CsI | GOS/CsI |
| Pixel Pitch | 139 µm | 140 µm |
| LimitingResolution | Over 3 lp/mm | 3.6 lp/mm |
| DOE | 26% at 2 lp/mm (CsI) Not specified forGOS | 32% at 2 lp/mm (CsI) 15% at 2 lp/mm (GOS) |
| MTF | 42% at 2 lp/mm (CsI) Not specified forGOS | 33% at 2 lp/mm (CsI) 24% at 2 lp/mm (GOS) |
| A/D Conversion | 16 bit | 16 bit |
| Active Area | 17 x 17 inch | 4343A: 430.08 x 430.08 mm or 16.9 x 16.9 inch3543A: 350.00 x 427.28 mm or 13.8 x 16.8 inch2929A: 286.72 x 286.72 mm or 11.3 x 11.3 inchA843B: 1075.2 x 430.08 mm or 42.3 x 16.9 inch |
| Dimensions | 460(W)×461(L)×15(H) | 4343A: 460 x 460 x 15 mm3543A: 383 x 460 x 15 mm2929A: 316 x 316 x 15 mmA843B: 1120 x 465 x 20 mm |
| Weights | 2.9kg (2.4kg w/o Battery) (up to 10hours of battery life) | 4343A: 4.3 kg (wireless, w/ batteries) 4.3 kg(wired, w/o batteries)3543A: 3.3 kg (wireless, w/ batteries) 2.9 kg(wired, w/o batteries)2929A: 1.8 kg (wireless, w/ batteries) 1.5 kg(wired, w/o batteries)A843B: 11.6 kg (wireless, w/ batteries) 10.9 kg(wired, w/o batteries) |
| Pixels | 3072 x 3072 (9.4 Million) | 3543A: 2500 x 3052 (7.6 Million)4343A: 3072 x 3072 (9.4 Million)2929A: 2048 x 2048 (4.2 Million)A843B: 7680 x 3072 (23.6 Million) |
| Interface | Wired: Gigabit Ethernet (1000Base-T)Wireless: IEEE802.11ac, backwardcompatible | Wired: Gigabit Ethernet (1000Base-T)Wireless: IEEE802.11ac, backward compatible |
| Power Source | AC Line and/or Rechargeable LithiumBattery (10 hr run time) | AC Line and/or Rechargeable Lithium Battery |
| Electrical safetyand EMC | Electrical Safety per IEC 60601-1 andEMC perIEC 60601-1-2 as well as IEEE802.11ac.Meets FCC requirements. | Electrical Safety per IEC 60601-1 and EMC perIEC 60601-1-2 as well as IEEE 802.11ac.Meets FCC requirements. |
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SOFTWARE RELATED
| Characteristic | Atlaim ATAL 9 K152151 | PZMedical 4343A,3543A,2929A,A843B |
|---|---|---|
| Software | Outputs a DICOM image | Outputs a DICOM image |
| SW revision | K152151 | PZDR V2.0.1 |
| DICOM | Yes | Yes |
| DICOM Image Transmission | Yes | Yes |
| Image Acquisition Interface | Yes | Yes |
| Patient Body Part Selection | Yes | Yes |
| Image Processing | Yes | Yes |
| Basic Image Editing andMarking (pan, zooming,window/level adjusting, textmarking) | Yes | Yes |
| Image Browsing | Yes | Yes |
| Patient Registration andManagement | Yes | Yes |
Non-Clinical data:
Testing results have shown that our devices Models 3543A, 4343A, 2929A and A843B, Solid State X-Ray Imager (Flat Panel/Digital Imager) are substantially equivalent to cleared predicate devices.
Atlaim Corporation, Atal 9, K132151 Careray, Care View 1500C / Care View 1500L, K153058 IRay, Wireless Digital Flat Panel Detertor, K161730
Specifically in relation too; DQE, MTF, Quantum limited performance, Effects of aliasing, Sensitivity linearity, Lag, Change in detection sensitivity, Dose requirement and reciprocity changes, Stability of the device characteristics with time, Uniformity of device characteristics, NPS, spatial resolution, Image Acquisition time and Black level.
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Clinical data:
We have included comparison images using our devices Models 3543A, 4343A, 2929A and A843B and a Atlaim Atal 9 cleared device (K132151) as direct comparison of the image quality of our devices in order to support substantial equivalence. We believe our image quality is substantially equivalent to cleared predicate devices.
Conclusions:
In accordance with 21 CFR, Part 807 and supported by the information provided in this premarket notification (K170480). Shanghai PZ Medical Technology Co., Ltd. 5F, Building 13 No.2 Suide Road 200331 Shanghai concludes that our devices Models 3543A, 2929A and A843B Solid State X-Ray Imager (Flat Panel/Digital Imager) is substantially equivalent to predicate devices in 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.