(118 days)
The Televere Podiatry Digital Imaging System is intended for digital image capture use in podiatry radiographic examinations, wherever conventional screen-film systems may be used. Not for mammography. Not for fluoroscopy.
The Televere Podiatry 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 PC based computer, x-ray generator and the power-supply are necessary for a the subject device. The imaging software has previously been cleared by FDA (i.e., K061035, TigerView Professional) and is being used unchanged in the subject device. This previously cleared software provides basic image adjustment features - an image management system allowing 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 PC-compatible 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 (VarexPaxScan2530C) has not been previously cleared by FDA as an individual component. 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 component. 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. A gigabit Ethernet port allows for tethered, non-wireless data transmission.
The provided document is a 510(k) premarket notification for the Televere Podiatry Digital Imaging System. It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence. However, this document does not describe a study involving AI for image analysis.
Instead, it focuses on the physical and performance characteristics of a digital X-ray imaging system component (Flat Panel Display or FPD) and its integration with existing software. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and performance specifications of the imaging system and comparison to a legally marketed predicate device, rather than the performance of an AI algorithm against clinical ground truth.
Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance for AI, training set details) are not applicable for a 510(k) submission that doesn't involve an AI component that performs image analysis.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in the format of pass/fail thresholds for clinical performance. Instead, it presents a "Substantial Equivalence Chart" which compares specifications of the new device to a predicate device. The implicit acceptance criteria are that the new device's performance metrics are "substantially equivalent" to the predicate.
| Characteristic | Predicate Device (Televere Digital Imaging System K170975) | Device Seeking Clearance (Televere Podiatry Digital Imaging System) | Implicit Acceptance Criteria (based on "Substantial Equivalence Conclusion") | Reported Performance for Device Seeking Clearance (relative to Predicate) |
|---|---|---|---|---|
| Device Name | Televere Digital Imaging System K170975 | Televere Podiatry Digital Imaging System | Substantially Equivalent | Matches |
| Flat Panel Device | XRpadTM 4343F-N | PaxScanTM 2530C | Substantially Equivalent | Different model, but deemed equivalent overall |
| Intended Use | General radiographic exams (skull, chest, shoulders, spine, abdomen, pelvis, extremities). Not for mammography. | Podiatry radiographic exams. Not for mammography. Not for fluoroscopy. | Substantially Equivalent (more specific for podiatry, but similar application) | More specific for podiatry, "substantially equivalent" per conclusion. |
| Configuration | Digital Panel and Software only, no generator or stand provided | SAME | Substantially Equivalent | Matches |
| Digital Panel Pixels | 4318 x 4320 | 1792 x 2176 | Substantially Equivalent | Different (fewer), but deemed equivalent for intended use. |
| Digital Panel Pitch | 100μm | 139μm | Substantially Equivalent | Different, but deemed equivalent for intended use. |
| Internal Image Storage | 1 GB DDR3, 4 GB SDHC card (e.g., 500 images for 10mb) | none | Substantially Equivalent (implies lack of storage is not a safety/efficacy issue) | Different (none), but deemed equivalent. |
| Image Acquisition Time | < 5 seconds | 1 second | Substantially Equivalent (implies faster is okay/better) | Faster (1 second) |
| DICOM 3 | YES via software cleared in K061035 | SAME | Substantially Equivalent | Matches |
| A/D Conversion | 16 Bit | SAME | Substantially Equivalent | Matches |
| Scintillator | Gadolinium Oxysulfide (GadOx) | SAME | Substantially Equivalent | Matches |
| MTF (RQA5) | 55% (1 cy/mm), 25% (2cy/mm), 5% (4 cy/mm) | 55% (1 cy/mm), 23% (2cy/mm), 5% (4 cy/mm) | Substantially Equivalent (differences are minor) | Slightly lower at 2cy/mm (23% vs 25%) but stated as "similar enough not to make a notable difference" and "substantially equivalent". |
| DQE (RQA5) | 40% (0 cy/mm), 30% (1 cy/mm), 10% (3 cy/mm) | 31% (0 cy/mm), 22% (1 cy/mm), 7% (3 cy/mm) | Substantially Equivalent (differences are present but deemed acceptable) | Lower across all points (e.g., 31% vs 40% at 0 cy/mm) but stated as "similar enough not to make a notable difference" and "substantially equivalent". |
| Interface | Gigabit Ethernet Port | SAME | Substantially Equivalent | Matches |
| Panel Size | 460 mm (w) × 460 mm (l) × 15 mm (h) | 249 mm (w) x 302 mm (l) x 49 mm (h) | Substantially Equivalent (implies different physical dimensions are acceptable for podiatry use) | Different, smaller. |
| Power Source | External Power Supply 100-240 VAC | SAME | Substantially Equivalent | Matches |
| Electrical Safety & EMC | IEC 60601-1-2 Ed 3:2007-03, IEC 60601-1-2 Ed 4.0 2014-02 | SAME | Substantially Equivalent | Matches |
2. Sample sized used for the test set and the data provenance:
- The document states "clinical images from the new device were also provided however they were not necessary to demonstrate substantial equivalence."
- This suggests that formal, quantitative clinical performance testing with a 'test set' as one would define for an AI algorithm was not the primary method for demonstrating equivalence.
- The focus was on bench testing (MTF, DQE, electrical safety, EMC) and comparison of specifications to the predicate device. Therefore, sample size and data provenance for a "test set" in the context of clinical image analysis are not provided or applicable for this type of submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for clinical conditions based on expert consensus is not described as a part of this submission framework. The "ground truth" here is the performance of the predicate device and relevant engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no clinical test set requiring adjudication in the context of diagnostic accuracy is described.
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 submission is for an imaging system (hardware and associated software for image management), not an AI diagnostic algorithm. No human reader studies for diagnostic improvement are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" or reference standard for this submission appears to be:
- Performance metrics of the legally marketed predicate device (K170975).
- International Electrotechnical Commission (IEC) Standards for Electrical Safety and Electromagnetic Compatibility (IEC 60601-1-2).
- FDA guidance documents for solid-state digital X-ray panels.
- "Clinical image inspection" by Televere, noting "Professional evaluation of imaging samples were of excellent quality, high resolution, clinically acceptable." This implies some internal review, but not a blinded, rigorous clinical study designed to establish diagnostic accuracy against a separate ground truth.
8. The sample size for the training set:
- Not applicable. This is not an AI algorithm that requires a training set. The "imaging software" (TigerView Professional K061035) was previously cleared and "is being used unchanged in the subject device," implying it was already "trained" or developed prior to this submission.
9. How the ground truth for the training set was established:
- Not applicable, as it's not an AI training set for this submission.
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November 9, 2017
Image /page/0/Picture/1 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
Televere Systems LLC % Robert Bakin Regulatory Consultant Technology and Business Law Advisors, LLC 1244 Capuchino BURLINGAME, CA 94010
Re: K172124
Trade/Device Name: Televere Podiatry Digital Imaging System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MOB Dated: October 10, 2017 Received: October 12, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Robert Oaks
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) n/a
Device Name Televere Podiatry Digital Imaging System
Indications for Use (Describe)
The Televere Podiatry Digital Imaging System is intended for digital image capture use in podiatry radiographic examinations, wherever conventional screen-film systems may be used. Not for mammography.
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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COURSE STORE LESSON SHARE
510(k) Summary:
Televere Svstems, LLC 1160 Cavalier Road Arnold, MD 21012 Email: rquaal@tigerview.com Establishment Registration Number: 2954358
CONTACT: Robert E. Bakin Email: rbakin@tblawadvisors.com Technology & Business Law Advisors, LLC 1244 Capuchino Avenue, Burlingame, CA 94010 Phone: 571-215-3507 Prepared July 12, 2017
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Identification of the Device: Proprietary-Trade Name: Televere Podiatry 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 21 C.F.R. §892.1680
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Equivalent legally marketed device: Televere Digital Imaging System (K170975). 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 21 C.F.R. §892.1680
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Associated legally marketed devices: 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 21 C.F.R. §892.2050
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Indications for Use: The Televere Podiatry Digital Imaging System is intended for digital image capture use in podiatry radiographic examinations, wherever conventional screen-film systems may be used. Not for mammography. Not for fluoroscopy.
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Description of the Device: The Televere Podiatry 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 PC based
computer, x-ray generator and the power-supply are necessary for a the subject device. The imaging software has previously been cleared by FDA (i.e., K061035, TigerView
Professional) and is being used unchanged in the subject device. This previously cleared software provides basic image adjustment features - an image management system allowing 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 PC-compatible 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.
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Image /page/4/Picture/0 description: The image contains the logo for TELEVERE SYSTEMS. The word "TELEVERE" is in large, bold, orange letters. Below it, in smaller, gray letters, is the word "SYSTEMS."
TOURARE STORE UNISEX SHARE
TheFPD component seeking clearance (VarexPaxScan2530C) has not been previously cleared by FDA as an individualcomponent. TheFPD usesalarge-areaamorphous silicon sensorarraywith a gadolinium oxysulfide(GadOx) scintillator for displayinghigh qualityimagesoverawiderangeofdosesettingsand 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 component. The combination of the digital imaging software and the FPD does not affectthesafetyorefficacyofeithercomponent device alone,orin combination. A gigabit Ethernet port allows for tethered, non-wireless data transmission.
Integration-level requirements/restrictions: High-frequency X-ray generators that support AED enabled digital flat panel displays are compatible with the Televere Podiatry Digital Imaging System. Synchronization withthegeneratorisachievedthroughthe interface power unit,supplied. Alternately the panelhasautomatic exposure detection (AED). Ifthis mode isused, the precautions listed in the panel user manual must be observed. The user should confirm that the generator/tubestand combination proposed employsonly Electronic Product Radiation Control certified components. Theuser should useonlytrained serviceengineersduringtheintegration process and fully test the system prior to use on patients.
- Safety and Effectiveness, Comparison to predicate device. The results of clinical image inspection, bench, and laboratory test results demonstrate that the new device is as safe and effective as the predicate device. Clinical images highlight equal or better image quality as compared to the predicate.
| 7. Substantial Equivalence Chart | ||
|---|---|---|
| Predicate Device | Device Seeking Clearance | |
| Device Name | Televere Digital Imaging SystemK170975 | Televere Podiatry Digital Imaging System |
| Flat Panel Device | XRpadTM 4343F-N | PaxScanTM 2530C |
| 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. | The Televere Podiatry Digital Imaging System is intended for digital image capture use in podiatry radiographic examinations, wherever conventional screen-film systems may be used. Not for mammography. Not for fluoroscopy. |
| Configuration | Digital Panel and Software only, no generator or stand provided | SAME |
| Digital Panel Pixels | 4318 x 4320 | 1792 x 2176 |
| Digital Panel Pitch | 100μm | 139μm |
| Internal Image Storage | 1 GB DDR3, 4 GB SDHC card, image number depends on image size (e.g., for 10 mb image there would be room for 500 images). | none |
| Image Acquisition Time | < 5 seconds | 1 second |
| DICOM 3 | YES via software cleared in K061035 | SAME |
| A/D Conversion | 16 Bit | SAME |
| Scintillator | Gadolinium Oxysulfide (GadOx) | SAME |
| MTF | 55% (1 cy/mm), 25% (2cy/mm), 5% (4 | 55% (1 cy/mm), 23% (2cy/mm), 5% (4 |
7. Substantial Equivalence Chart
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Image /page/5/Picture/0 description: The image contains the logo for TELEVERE SYSTEMS. The word "TELEVERE" is in a bold, sans-serif font and is colored orange. Below "TELEVERE" is the word "SYSTEMS" in a smaller, gray, sans-serif font. The logo is simple and modern.
NCOURE STORE VIEW SHARE
| cy/mm) for RQA5. | cy/mm) for RQA5. | |
|---|---|---|
| DQE | 40% (0 cy/mm), 30% (1 cy/mm), 10%(3 cy/mm) for RQA5. | 31% (0 cy/mm), 22% (1 cy/mm), 7% (3cy/mm) for RQA5. |
| Interface | Gigabit Ethernet Port | SAME |
| Panel Size | 460 mm (w) × 460 mm (l) × 15 mm (h) | 249 mm (w) x 302 mm (l) x 49 mm (h) |
| Power Source | External Power Supply 100-240 VAC | SAME |
| Electrical Safety &EMC | EC 60601-1-2 Edition 3: 2007-03,Medical Electrical Equipment - Part 1-2:Collateral Standard ElectromagneticCompatibility Requirements and TestsIEC 60601-1-2 Edition 4.0 2014-02Medical Electrical Equipment - Part 1-2:General Requirements For Basic SafetyAnd Essential Performance - CollateralStandard: ElectromagneticDisturbances - Requirements And Tests | SAME |
Substantial Equivalence Conclusion: The comparison table reveals there are no new technical issues of safety or effectiveness raised by substitution of the digitalx-ray panel. Professional evaluation of imaging samples were of excellent quality, high resolution, clinically acceptable and substantially equivalent to the predicate device.
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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 substantially equivalent. 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 Podiatry Digital Imaging System is as safe and effective as the predicate device K170975, 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.