(28 days)
No
The document describes standard digital imaging software with basic image adjustment features and exposure control, without mentioning any AI or ML capabilities.
No
The device is an x-ray system intended for imaging (diagnosis), not for treating a condition.
Yes
The device is an x-ray system intended for imaging hands and feet, which aids qualified clinicians in diagnosis.
No
The device description explicitly states it consists of a combination of software, a high frequency X-Ray generator, a PC-based computer, and a power supply. While the software is a key component and provides control and image processing, it is part of a larger system that includes hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. This includes things like blood, urine, tissue, etc.
- This device is an X-ray system. It uses radiation to create images of the internal structures of the body (specifically hands and feet in this case). It does not involve the analysis of biological specimens.
The description clearly states its purpose is for "x-ray of hands and feet" and describes the components of an X-ray system (generator, software for image processing, etc.). This aligns with the definition of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Televere Podiatry X-Ray System HF is intended for use by qualified clinicians for the x-ray of hands and feet. Not for mammography. Not fluoroscopy.
Product codes
KPR
Device Description
The Televere Podiatry X-Ray System HF consists of a combination of previously cleared Tigerview digital imaging software (K061035), a high frequency X-Ray generator (X-CEL MODEL HF 718BD, K160857), a PC-based computer and a power supply. Tigerview software provides an exposure control upgrade of the previously cleared HF x-ray generator by replacing the manual touchscreen of the Predicate Device (K160857) with the Tigerview computer software interface. Tigerview software provides basic image adjustment features as well as x-ray exposure control settings. An image adjustment system 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 software 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 previously cleared x-ray generator (K160857) contained minimal software functionalities and a manual x-ray exposure interface. The Proposed Device seeks to upgrade the manually entered x-ray exposure touchscreen of the Predicte Device with the Tigerview software computer interface. The combination of the digital imaging software and the x-ray generator does not affect the safety or efficacy of either component device alone, or in combination.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
hands and feet
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified clinicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Bench Testing Conducted:
- 21 CFR 1020.30 Diagnostic x-ray systems and their major components.
- 21 CFR 1020.31 Radiographic equipment
- 60601-1 3rd Edition Medical electrical equipment Part 1: General requirements for safety .
- 60601-1-2 3rd Edition Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic compatibility – Requirements and tests
- 60601-1-6 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
- 62304:2006 Medical device software Software life cycle processes
- 60601-2-54:2009 Ed.1.0 Medical electrical equipment Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
- 60601-3:2008-Ed. 2.0 Medical electrical equipment – Part 1-3: General requirements for basic safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray equipment
- EC TR 60878 Graphical symbols for electrical equipment in medical practice
- EN ISO 14971 Application of risk management to medical devices
- ISO 15223-1 Medical devices Symbols to be used with medical device labels, labeling, and information to be supplied.
Summary of ClinicalTesting: Sample clinical images from the new device were also provided however they were not necessary to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and includes the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 20, 2018
Televere Systems, Inc. % Mr. Robert Bakin Regulatory Consultant Technology and Business Law Advisors, LLC 1244 Capuchino Avenue BURLINGAME CA 94010
Re: K180765
Trade/Device Name: Televere Podiatry X-Ray System HF Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: March 21, 2018 Received: March 23, 2018
Dear Mr. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.
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Page 2 - Mr. Robert Bakin
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 mediation-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).
Sincerely,
Michael D. O'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
2
Indications for Use
510(k) Number (if known) -n/a K180765
Device Name
Televere Podiatry X-Ray System HF
Indications for Use (Describe)
The Televere Podiatry X-Ray System HF is intended for use by qualified clinicians for the x-ray of hands and feet. Not for mammography. Not fluoroscopy. 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
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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Image /page/3/Picture/0 description: The image shows the logo for TELEVERE SYSTEMS. The word "TELEVERE" is in large, orange, sans-serif font. Below it, in a smaller, gray, sans-serif font, is the word "SYSTEMS". The logo is simple and modern.
SQUARE STORE SHARE
510(k) Summary:
Televere Systems, 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 March 20, 2018
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Identification of the Device: Proprietary-Trade Name: Televere Podiatry X-Ray System HF Classification Name:Stationary X-ray System Product Code: KPR Common/UsualName:Stationary X-Ray System Device Class/RegulationNumber:Class Il per regulation 21 C.F.R. §892.1680
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Equivalent legally marketed device: Model HF 718BD X-Ray System (K160857), X-CEL X-Ray Corp. Classification Name: Stationary X-ray System Product Code: KPR Common/UsualName:Stationary X-Ray System Device Class/RegulationNumber:Class Il per regulation 21 C.F.R. §892.1680
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Associated legally marketed devices: Tiger View Professional (PACS Software) K061035, Televere Systems, LLC. This is the software used withthisdevice.
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
-
Indications for Use: The Televere Podiatry X-Ray System HF is intended for use by qualified clinicians for the x-ray of hands and feet. Not for mammography. Not fluoroscopy.
-
Description of the Device: The Televere Podiatry X-Ray System HF consists of a combination of previously cleared Tigerview digital imaging software (K061035), a high frequency X-Ray generator (X-CEL MODEL HF 718BD, K160857), a PC-based computer and a power supply. Tigerview software provides an exposure control upgrade of the previously cleared HF x-ray generator by replacing the manual touchscreen of the Predicate Device (K160857) with the Tigerview computer software interface. Tigerview software provides basic image adjustment features as well as x-ray exposure control settings. An image adjustment system 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 software 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 written in a bold, sans-serif font in orange color. Below "TELEVERE", the word "SYSTEMS" is written in a smaller, sans-serif font in gray color. The logo appears to be for a technology or engineering company.
SQUARE STORE VIEW SHARE
The previously cleared x-ray generator (K160857) contained minimal software functionalities and a manual x-ray exposure interface. The Proposed Device seeks to upgrade the manually entered x-ray exposure touchscreen of the Predicte Device with the Tigerview software computer interface. The combination of the digital imaging software and the x-ray generator does not affect the safety or efficacy of either component device alone, or in combination.
Integration-level requirements/restrictions:
The proposed device is compatible with flat panel detectors having AED functionality.
- 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 | X-CEL X-Ray Model HF 718BD X-Ray System | Televere Podiatry X-Ray System HF |
| Indications for Use | The HF 718B X-Ray System is intended for | |
| use by qualified clinicians for the x-ray of | ||
| hands and feet. | The Televere Podiatry X-Ray | |
| System HF is intended for use by | ||
| qualified clinicians for the x-ray | ||
| of hands and feet. Not for | ||
| mammography. Not fluoroscopy. | ||
| Configuration | X-ray generator and Software only. No | |
| digital flat panel. | SAME | |
| X-Ray Tube | Stationary anode | |
| Focal spot 1.0 mm NEMA | ||
| Filtration 3.2 mmAl minimum | ||
| X-ray tube current 10 mA fixed | ||
| Kilovoltage to x-ray tube up to 90 kV | ||
| Tube shielding 1 mm pb equivalent | ||
| minimum | SAME | |
| Waveform | High Frequency (HF) | SAME |
| Exposure Control | Manual Touchscreen | Tigerview Software |
| Power | ||
| Requirements | 105-130 volt AC @ 58-62Hz. Single phase. | |
| Less than 20 Amperes. | SAME | |
| Exposure Factors | Exposure times from 50 to 500 mS | |
| Adjustable kilo-voltage from 50 to 90 kV | ||
| No automatic exposure control or mAs | ||
| settings | SAME |
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Image /page/5/Picture/0 description: The image shows the logo for TELEVERE SYSTEMS. The word "TELEVERE" is in large, orange, sans-serif font. Below that, in a smaller, gray, sans-serif font, is the word "SYSTEMS."
| Exposure Presets | 14 - For repeatedly used techniques. | 37 total (Ankle 10, Foot 9, Calcaneus 9, Other 9) |
|---|---|---|
| Exposure switch | Deadman | SAME |
| Performance | ||
| accuracy | 21 CFR 1020.31 compliant | |
| kVp accuracy at 50-90 kV = +/- 8% | ||
| mA accuracy = +/- 1% | ||
| Timer accuracy = +/- 5%. | ||
| Reproducibility = 0.002cv | ||
| Leakage Radiation = 34mR | SAME | |
| X-ray Beam | ||
| Quality Metrics | "kVp" "HVL" "mR" | |
| 50 1.71 6.38 | ||
| 60 2.40 8.37 | ||
| 70 2.69 14.49 | ||
| 85 3.05 19.95 | ||
| 90 3.31 22.87 | SAME | |
| Electrical Safety & | ||
| EMC | Electrical Safety per IEC 60601-1 | |
| and EMC per IEC 60601-1-2. | SAME |
7. Bench Testing Conducted:
- · 21 CFR 1020.30 Diagnostic x-ray systems and their major components.
- 21 CFR 1020.31 Radiographic equipment
- 60601-1 3rd Edition Medical electrical equipment Part 1: General requirements for safety .
- 60601-1-2 3rd Edition Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic compatibility – Requirements and tests
- . 60601-1-6 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
- · 62304:2006 Medical device software Software life cycle processes
- 60601-2-54:2009 Ed.1.0 Medical electrical equipment Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
- . 60601-3:2008-Ed. 2.0 Medical electrical equipment – Part 1-3: General requirements for basic safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray equipment
- EC TR 60878 Graphical symbols for electrical equipment in medical practice
- · EN ISO 14971 Application of risk management to medical devices
- ISO 15223-1 Medical devices Symbols to be used with medical device labels, labeling, and information to be supplied.
-
Summary of ClinicalTesting: Sample clinical images from the new device were also provided however they were not necessary to demonstrate substantial equivalence.
-
Conclusion: After analyzing bench, clinicalimage, and externallaboratory testing to applicable standards, it is the conclusion of Televere that the Televere Podiatry X-Ray System HF 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.