Televere Podiatry Digital Imaging System

{0}------------------------------------------------ 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); {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) n/a K172124 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for TELEVERE SYSTEMS. The word "TELEVERE" is in orange, and the word "SYSTEMS" is in a smaller font size and in gray. The logo is simple and modern. 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 1. 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 2. 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 3. 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 4. 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. 5. 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. {4}------------------------------------------------ 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. 6. 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 System<br>K170975 | 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 {5}------------------------------------------------ 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%<br>(3 cy/mm) for RQA5. | 31% (0 cy/mm), 22% (1 cy/mm), 7% (3<br>cy/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 &<br>EMC | EC 60601-1-2 Edition 3: 2007-03,<br>Medical Electrical Equipment - Part 1-2:<br>Collateral Standard Electromagnetic<br>Compatibility Requirements and Tests<br>IEC 60601-1-2 Edition 4.0 2014-02<br>Medical Electrical Equipment - Part 1-2:<br>General Requirements For Basic Safety<br>And Essential Performance - Collateral<br>Standard: Electromagnetic<br>Disturbances - 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. 8. 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. 9. Summary of Clinical Testing: Sample clinical images from the new device were also provided however they were not necessary to demonstrate substantial equivalence. 10. 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.