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.

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.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Televere Podiatry X-Ray System HF. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove the device meets specific acceptance criteria for diagnostic performance.

Therefore, the document does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance as it would for a new AI/CAD device. Specifically:

No specific acceptance criteria for diagnostic performance are stated. The submission focuses on regulatory compliance and technical specifications.
No numerical performance metrics (e.g., sensitivity, specificity, AUC) are reported for diagnostic tasks. The "device performance" mentioned refers to electrical and safety aspects.
No information on sample size for test sets, data provenance, number or qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or ground truth types (pathology, outcomes data) is provided. These are typical for studies assessing diagnostic accuracy.
No information on training set sample size or how training ground truth was established is provided. This is because the device is an X-ray system, not a machine learning algorithm requiring a training set for diagnostic tasks.

The document states:

"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." (Page 4, Section 6)
"Sample clinical images from the new device were also provided however they were not necessary to demonstrate substantial equivalence." (Page 5, Section 8)

This indicates that clinical images were reviewed, but a formal study with detailed acceptance criteria and quantitative diagnostic performance metrics was not conducted or deemed necessary for this 510(k) submission, which primarily addresses hardware and software integration.

The "Acceptance Criteria" provided in the document relate to the technical performance of the X-ray system itself (e.g., kVp accuracy, mA accuracy, timer accuracy, reproducibility, leakage radiation) and compliance with various electrical safety and radiation standards. These are listed under "Performance Accuracy" and "X-ray Beam Quality Metrics" in the Substantial Equivalence Chart on Page 5.

Summary of available information related to performance/acceptance criteria:

Category	Acceptance Criteria (Predicate)	Reported Device Performance (Televere Podiatry X-Ray System HF)
Performance Accuracy	21 CFR 1020.31 compliant:kVp accuracy at 50-90 kV = +/- 8%mA accuracy = +/- 1%Timer accuracy = +/- 5%.Reproducibility = 0.002cvLeakage Radiation = 34mR	SAME (The document explicitly states "SAME" for all these parameters, indicating the new device meets or performs equivalently to the predicate's stated performance and compliance.)
X-ray Beam Quality Metrics	"kVp" "HVL" "mR"50 1.71 6.3860 2.40 8.3770 2.69 14.4985 3.05 19.9590 3.31 22.87	SAME (The document explicitly states "SAME" for all these parameters, indicating the new device meets or performs equivalently to the predicate's stated performance.)
Electrical Safety & EMC	Electrical Safety per IEC 60601-1and EMC per IEC 60601-1-2.	SAME (The document explicitly states "SAME", indicating compliance with these standards.)
Other Standards	Compliance with: 21 CFR 1020.30, 21 CFR 1020.31, 60601-1 3rd Ed, 60601-1-2 3rd Ed, 60601-1-6, 62304:2006, 60601-2-54:2009, 60601-3:2008, EC TR 60878, EN ISO 14971, ISO 15223-1.	The Bench Testing Conducted section (Page 5) lists these standards, implying that the Televere Podiatry X-Ray System HF was tested against and found compliant with them. The conclusion states: "After analyzing bench, clinical image, and external laboratory 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..."

Missing Information (as per your request, not available in the document):

Sample size used for the test set and the data provenance: Not applicable for a diagnostic performance study as described in the prompt. Clinical images were inspected, but details like sample size or origin for that inspection are not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no formal diagnostic performance study is presented.
Adjudication method for the test set: Not applicable.
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, as this is solely an X-ray system, not an AI/CAD diagnostic aid.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For technical performance, the ground truth would be precise measurements and compliance with regulatory standards. For the "clinical image inspection," the ground truth would be expert visual assessment, but details are not provided.
The sample size for the training set: Not applicable, as this is an X-ray system, not a machine learning model.
How the ground truth for the training set was established: Not applicable.

In essence, the document serves as a regulatory submission demonstrating technical and safety equivalence, not a publication detailing a diagnostic performance study for a machine learning or CAD device.

Summary

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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

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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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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

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
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
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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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 foruse by qualified clinicians for the x-ray ofhands and feet.	The Televere Podiatry X-RaySystem HF is intended for use byqualified clinicians for the x-rayof hands and feet. Not formammography. Not fluoroscopy.
Configuration	X-ray generator and Software only. Nodigital flat panel.	SAME
X-Ray Tube	Stationary anodeFocal spot 1.0 mm NEMAFiltration 3.2 mmAl minimumX-ray tube current 10 mA fixedKilovoltage to x-ray tube up to 90 kVTube shielding 1 mm pb equivalentminimum	SAME
Waveform	High Frequency (HF)	SAME
Exposure Control	Manual Touchscreen	Tigerview Software
PowerRequirements	105-130 volt AC @ 58-62Hz. Single phase.Less than 20 Amperes.	SAME
Exposure Factors	Exposure times from 50 to 500 mSAdjustable kilo-voltage from 50 to 90 kVNo automatic exposure control or mAssettings	SAME

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Exposure Presets	14 - For repeatedly used techniques.	37 total (Ankle 10, Foot 9, Calcaneus 9, Other 9)
Exposure switch	Deadman	SAME
Performanceaccuracy	21 CFR 1020.31 compliantkVp accuracy at 50-90 kV = +/- 8%mA accuracy = +/- 1%Timer accuracy = +/- 5%.Reproducibility = 0.002cvLeakage Radiation = 34mR	SAME
X-ray BeamQuality Metrics	"kVp" "HVL" "mR"50 1.71 6.3860 2.40 8.3770 2.69 14.4985 3.05 19.9590 3.31 22.87	SAME
Electrical Safety &EMC	Electrical Safety per IEC 60601-1and 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.

Regulation Number and Section

§ 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.