(28 days)
The Televere Digital Imaging System is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used. Allows imaging of the skull, chest, shoulders, pelvis, and extremities. Not for mammography.
The Televere Digital Imaging System consists of a combination of digital imaging software, a flat panel display (FPD), a PC-based computer and a power supply. The imaging software has previously been cleared by FDA (i.e., K061035, TigerView Professional). This previously cleared software provides basic image adjustment features: An image management system that allows the physician to acquire, display, edit (e.g., resize, adjust contrast, crop, etc.), review, store, print, and distribute medical images within a Picture Archiving and Communication System (PACS) environment. TigerView Professional runs on standard PCcompatible computers and is compatible with capture devices which attach to the computer using a Network Adaptor, USB port, PCI slot, parallel port, memory card, S-video port on a video capture card, or SCSI card. The FPD component seeking clearance (PerkinElmer Model XRPad 4343F N) has not been previously cleared by FDA. The FPD uses a large-area amorphous silicon sensor array with a gadolinium oxysulfide (GadOx) scintillator for displaying high quality images over a wide range of dose settings and is intended to be integrated into a complete X-ray system. This premarket notification seeks clearance for a combination finished device consisting of the combination of the previously cleared digital imaging software and the FPD. The combination of the digital imaging software and the FPD does not affect the safety or efficacy of either component device alone, or in combination.
The provided document is a 510(k) premarket notification for the Televere Digital Imaging System. It describes the device, its intended use, and proposes it as substantially equivalent to a predicate device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a numeric fashion other than stating the new device is "as safe and effective as the predicate device" and that "Clinical images collected demonstrate equal or better image quality as compared to our predicate." However, it does provide a comparative table with performance specifications of the new device against the predicate.
| Characteristic | Predicate Device (Viztec LLC: ViZion + DR, Digital Flat Panel X-Ray Detector System K123644) | Televere Digital Imaging System K162521 (Using XRpad 4343F-N panel) | Compliance/Comparison |
|---|---|---|---|
| Pixel Data | 3072×3072 pixels with 139µm pitch | 4318 × 4320 100 µm Pixel Pitch | Better Resolution |
| Internal image storage | 200 images | 1 GB DDR3, 4 GB SDHC card (Example: 500 images for 10mb image) | Quantitative difference, potentially better |
| Image acquisition time | ≤ 5 Seconds | ≤ 5 Seconds (SAME) | Equivalent |
| DICOM 3 | YES | YES via our software cleared in K061035 | Equivalent |
| A/D Conversion | 12 Bit | 16 Bit | Better |
| Scintillator | Gadolinium Oxysulfide (GadOx) | Gadolinium Oxysulfide (GadOx) | Equivalent |
| MTF (1 cy/mm, RQA5) | 54% | 55% | Better |
| MTF (2 cy/mm, RQA5) | 23% | 25% | Better |
| MTF (4 cy/mm, RQA5) | Not measured | 5% | Better |
| DQE (0 cy/mm, RQA5) | 30% | 40% | Better |
| DQE (1 cy/mm, RQA5) | 18% | 30% | Better |
| DQE (3 cy/mm, RQA5) | 3% | 10% | Better |
| Interface | Gigabit Ethernet Port | Gigabit Ethernet Port (SAME) | Equivalent |
| Panel Dimensions | 495 (w) x 510 (l) x 38 mm (h) | 460 mm (w) × 460 mm (l) × 15 mm (h) | Different physical size |
| Power Source | External Power Supply 100-240 Vac | External Power Supply 100-240 Vac (SAME) | Equivalent |
| Electrical safety and EMC | Electrical Safety per IEC 60601-1 and EMC per IEC 60601-1-2. UL Listed | Electrical Safety per IEC 60601-1 and EMC per IEC 60601-1-2. UL Listed (SAME) | Equivalent |
2. Sample size used for the test set and the data provenance
The document mentions "Sample clinical images from the new device were also provided however they were not necessary to demonstrate substantial equivalence." It does not specify a sample size for these clinical images, nor does it provide data provenance (country of origin, retrospective/prospective). The primary basis for substantial equivalence seems to be bench testing and comparison of technical specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The substantial equivalence relies on physical and performance characteristic comparisons, not on expert-adjudicated clinical image interpretations for a test set to establish ground truth in the context of device performance metrics like sensitivity/specificity. The statement "Clinical images collected demonstrate equal or better image quality as compared to our predicate" suggests a qualitative assessment, but details about who made this assessment, how many, or their qualifications are absent.
4. Adjudication method for the test set
This information is not provided. Given that quantitative clinical ground truth was not the primary method for demonstrating substantial equivalence, formal adjudication methods are not detailed.
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 done. The Televere Digital Imaging System is a digital X-ray receptor, not an AI-powered diagnostic tool. The purpose of the submission is to demonstrate substantial equivalence to a predicate X-ray system, primarily through technical specifications and bench testing, for image capture. There's no mention of AI or human reader improvement with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is an X-ray imaging system, not an algorithm, and does not operate independently in a diagnostic capacity without human interpretation.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the technical performance metrics (MTF, DQE), the ground truth is established by physical measurements and standardized testing according to IEC standards and FDA guidance documents for solid-state digital X-ray panels. For the qualitative assessment of "clinical images," the type of ground truth and method of establishment is not explicitly stated, but it likely refers to a visual comparison of image quality, not a formal disease presence/absence ground truth.
8. The sample size for the training set
This information is not applicable as the Televere Digital Imaging System is a hardware device (digital X-ray receptor) and not a machine learning or AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is not an AI algorithm and does not use a training set.
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Image /page/0/Picture/1 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 an abstract symbol that resembles three stylized human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 1, 2017
Televere Systems % Robert Bakin Regulatory Consultant Technology & Business Law Advisors, LLC 1244 Capuchino Avenue Burlingame, California 94010
Re: K170975
Trade/Device Name: Televere Digital Imaging System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MQB Dated: March 21, 2017 Received: April 3, 2017
Dear Robert Bakin:
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 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
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the quality systems (OS) 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 yours,
Michal D.'Hara
For
Robert 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) K170975
Device Name Televere Digital Imaging System
Indications for Use (Describe)
The Televere Digital Imaging System is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used. Allows imaging of the skull, chest, shoulders, pelvis, and extremities. Not for mammography.
| 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 K170975
Image /page/3/Picture/1 description: The image shows the logo for TELEVERE SYSTEMS. The word "TELEVERE" is in orange, and the word "SYSTEMS" is in gray. To the right of the logo are the words "ACQUIRE, STORE, VIEW, SHARE" in gray.
Televere Systems, LLC 1160 Cavalier Road Arnold, MD 21012 Email: rquaal@tigerview.com Establishment Registration Number: 2954358 Phone: 571-215-3507 CONTACT: Robert E. Bakin Email: rbakin@tblawadvisors.com Technology & Business Law Advisors, LLC
1244 Capuchino Avenue, Burlingame, CA 94010 Prepared April 26, 2017
1. Identification of the Device:
Proprietary-Trade Name: Televere Digital Imaging System Classification Name: Stationary X-ray System Product Code MQB, Common/Usual Name: Digital X-Ray Receptor Panel Device Class/Regulation Number: Class II per regulation 892.1680
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- Equivalent legally marketed device: ViZion + DR, Digital Flat Panel X-Ray Detector System K123644 Classification Name: Stationary X-ray System Product Code MQB, Common/Usual Name: Digital X-Ray Receptor Panel Device Class/Regulation Number: Class II per regulation 892.1680
3. Associated legally marketed devices:
The Software, TigerView Professional (PACS Software) K061035. This is the software used with this device.
Classification Name: System, Image Processing, Radiological, Code LLZ Common/Usual Name: Picture Archiving and Communications System Device Class/Regulation Number: Class II per regulation 892.2050. Similar Flat Panel Detector: XRpad 4343F MED Flat Panel Detector, K142698 Product Code MQB Classification Name: Stationary X-ray System Common/Usual Name: Digital X-Ray Receptor Panel Device Class/Regulation Number: Class II per regulation 892.1680
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- Indications for Use (intended use) The Televere Digital Imaging System is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used. Allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities. Not for mammography.
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- Description of the Device: The Televere Digital Imaging System consists of a combination of digital imaging software, a flat panel display (FPD), a PC-based computer and a power supply. The imaging software has previously been cleared by FDA (i.e., K061035, TigerView Professional). This previously cleared software provides basic image adjustment features: An image management system that allows the physician to acquire, display, edit (e.g., resize, adjust contrast, crop, etc.), review, store, print, and distribute medical images within a Picture Archiving and Communication System (PACS) environment. TigerView Professional runs on standard PCcompatible computers and is compatible with capture devices which attach to the computer using a Network Adaptor, USB port, PCI slot, parallel port, memory card, S-video port on a video capture card, or SCSI card. The FPD component seeking clearance (PerkinElmer Model XRPad 4343F N) has not been previously cleared by FDA. The FPD uses a large-area amorphous silicon sensor array with a gadolinium oxysulfide (GadOx) scintillator for displaying high quality images over a wide range of dose settings and is intended to be integrated into a complete X-ray system. This premarket notification seeks clearance for a combination finished device consisting of the combination of the previously cleared digital imaging software and the FPD. The combination of the digital imaging software and the FPD does not affect the safety or efficacy of either component device alone, or in combination.
Integration-level requirements/restrictions: This device will work with most modern highfrequency X-ray generators currently on the market. Sync with the generator is achieved through the interface power unit, supplied. Alternately the panel has automatic exposure detection (AED). If this mode is used, the precautions listed in the panel user manual must be observed. The user should confirm that the generator/tubestand combination proposed employs only Electronic Product Radiation Control certified components. The user should use only trained service engineers during the integration process and fully test the system prior to use on patients.
- Description of the Device: The Televere Digital Imaging System consists of a combination of digital imaging software, a flat panel display (FPD), a PC-based computer and a power supply. The imaging software has previously been cleared by FDA (i.e., K061035, TigerView Professional). This previously cleared software provides basic image adjustment features: An image management system that allows the physician to acquire, display, edit (e.g., resize, adjust contrast, crop, etc.), review, store, print, and distribute medical images within a Picture Archiving and Communication System (PACS) environment. TigerView Professional runs on standard PCcompatible computers and is compatible with capture devices which attach to the computer using a Network Adaptor, USB port, PCI slot, parallel port, memory card, S-video port on a video capture card, or SCSI card. The FPD component seeking clearance (PerkinElmer Model XRPad 4343F N) has not been previously cleared by FDA. The FPD uses a large-area amorphous silicon sensor array with a gadolinium oxysulfide (GadOx) scintillator for displaying high quality images over a wide range of dose settings and is intended to be integrated into a complete X-ray system. This premarket notification seeks clearance for a combination finished device consisting of the combination of the previously cleared digital imaging software and the FPD. The combination of the digital imaging software and the FPD does not affect the safety or efficacy of either component device alone, or in combination.
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- 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.
| Viztec LLC: ViZion + DR, Digital Flat Panel X-RayDetector System K123644 | Televere Digital Imaging System K162521Using XRpad 4343F-N panel | |
|---|---|---|
| Intended Use: | ViZion + DR is intended for digital imagecapture use in general radiographicexaminations, wherever conventional screen-film systems may be used, excludingfluoroscopy, angiography and mammography.ViZion + allows imaging of the skull, chest,shoulders, spine, abdomen, pelvis, andextremities. | The Televere Digital Imaging System isintended for digital image capture use ingeneral radiographic examinations,wherever conventional screen-film systemsmay be used. Allows imaging of the skull,chest, shoulders, spine, abdomen, pelvis,and extremities. Not for mammography.(Essentially identical) |
| Configuration | Digital Panel and Software only, no generatoror stand provided. | SAME |
| Digital Panel | 3072×3072 pixels with 139µm pitch | 4318 × 4320 100 µm Pixel Pitch. BetterResolution |
| Internalimage storage | 200 images | 1 GB DDR3, 4 GB SDHC card, number ofimages depends on image size. Example for10 mb image there would be room for 500images. |
7. Substantial Equivalence Chart
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| Viztec LLC: ViZion + DR, Digital Flat Panel X-RayDetector System K123644 | Televere Digital Imaging System K162521Using XRpad 4343F-N panel | |
|---|---|---|
| Imageacquisitiontime | ≤ 5 Seconds | SAME |
| DICOM 3 | YES | YES via our software cleared in K061035 |
| A/DConversion | 12 Bit | 16 Bit |
| Scintillator | Gadolinium Oxysulfide (GadOx) | Gadolinium Oxysulfide (GadOx) |
| MTF | 54% (1 cy/mm), 23% (2 cy/mm) (not measuredat 4 cy/mm) for RQA5 | 55% (1 cy/mm), 25% (2 cy/mm) 5% (4cy/mm) for RQA5. Better than predicate |
| DQE | 30% (0 cy/mm), 18% (1 cy/mm), 3% (3 cy/mm)for RQA5. | 40% (0 cy/mm), 30% (1 cy/mm), 10% (3cy/mm) for RQA5. Better than predicate |
| Interface | Gigabit Ethernet Port | SAME |
| PanelDimensions | 495 (w) x 510 (l) x 38 mm (h) | 460 mm (w) × 460 mm (l) × 15 mm (h) |
| Power Source | External Power Supply 100-240 Vac | SAME |
| Electricalsafety andEMC | Electrical Safety per IEC 60601-1 and EMC perIEC 60601-1-2. UL Listed | SAME |
The comparison table reveals there are no new issues of safety or effectiveness raised by the modification to the scintillator of the digital x-ray panel.
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- Summary of Bench Testing Conducted: IEC Standards have been employed for: Electrical Safety and Electromagnetic Compatibility. The panel power supply is UL Listed. We compared MTF and DQE measurements for the original and modified scintillator versions of the panel and found them to be similar enough not to make a notable difference in acquired images. As compared to the predicate panel the MTF and DQE performance of the new panel is superior. The digital panel manufacturer conducted performance testing according to the FDA guidance document for solid state digital x-ray panels. Risk Analysis and System operation verification tests were conducted in accordance with FDA guidance documents. Since no software modifications were required, confirmation testing was performed. Labeling was developed to comply with the FDA solid state panel guidance document.
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- Summary of Clinical Testing: Sample clinical images from the new device were also provided however they were not necessary to demonstrate substantial equivalence.
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- Conclusion: After analyzing bench, clinical image, and external laboratory testing to applicable standards, it is the conclusion of Televere that the Televere Digital Imaging System K162521 is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device. The new and predicate devices provide values for MTF and DQE that are substantially equivalent.
§ 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.