(38 days)
The VIDAR TeleradPRO film digitizer is used for making digital copies of medical x-ray films.
The TeleradPRO film digitizer is intended for making digital copies of medical xray films.
The device consists of a film digitizer with single-film or multi-film feeder, external power adapter, and Windows driver software. The film digitizer will convert the X-ray film into digital data representing the X-ray film, and the windows driver software is used to import the digital data into a compatible software application. The Digitizer is connected to a PC through a USB 2.0 interface. The digitizer utilizes rollers driven by a stepper motor to feed the X-ray film past the scan optics. The scan optics consists of a white LED illuminator, a lens, mirrors, and a CCD linear array detector.
The provided text describes the TeleradPRO X-Ray Film Digitizer and its substantial equivalence to a predicate device (TeleRADPro Film Digitizers, K993597). However, it does not contain detailed information about specific acceptance criteria or an in-depth study that proves the device meets those criteria in a quantitative manner as typically expected for medical device performance studies.
The document primarily focuses on establishing substantial equivalence to a predicate device, which often relies on demonstrating similar technological characteristics and intended use, rather than presenting a novel clinical study with detailed performance metrics against predefined acceptance criteria.
Based on the provided text, here's the information that can be extracted, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Optical Resolution | 300 dpi |
| Grayscale Depth | 16-bit |
| Optical Density Sensitivity (DMAX) | 4.8 OD |
| Medical OD Range | 0.2 - 3.2 (incorporates noise and linearity measurements) |
| Intended Use | Making digital copies of medical x-ray films (met by design) |
| Function, Safety, Operating Environmental Conditions, Effectiveness | Determined to be substantially equivalent to predicate device |
Missing Information: Specific quantitative acceptance thresholds for DMAX, medical OD range linearity, and noise are not provided, nor are detailed test results demonstrating compliance against these thresholds. The document states "VIDAR conducts extensive performance testing and the test results demonstrate the device meets the requirements for its intended use" but does not elaborate on the specific tests or their outcomes beyond the summary characteristics.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document refers to "extensive performance testing" and "Bench Testing" (Section 22, which is not included in the provided text), but it does not specify any test set sample sizes or the provenance of any data (e.g., country of origin, retrospective/prospective). It suggests that the testing was primarily to demonstrate the device's technical specifications and substantial equivalence, not necessarily a clinical or reader study with a specific test set of images.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. As no clinical or reader study with a "test set" and "ground truth" established by experts is described, this information is not applicable. The device is a digitizer, not an AI diagnostic tool, so "ground truth" would relate to the fidelity of the digitization process itself, not an interpretation of medical images.
4. Adjudication Method for the Test Set
This information is not provided in the document. See point 3 above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No MRMC study was done, nor is it relevant given the device is an X-ray film digitizer, not an AI diagnostic tool designed to assist human readers. The document does not mention any AI components.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
The document describes "Performance Testing" and "Bench Testing" which would likely be standalone evaluations of the digitizer's technical specifications (e.g., resolution, DMAX, linearity). However, details of these studies are not provided beyond the summary characteristics listed in Section 1.
7. The Type of Ground Truth Used
Given that the device is a digitizer, the "ground truth" for its performance would typically involve comparing the digitized image to the original film's characteristics or a known standard. The document mentions "incorporates noise and linearity measurements" for the medical OD range, implying that instrumental measurements were used to verify the fidelity of the digitization process. There is no mention of "expert consensus, pathology, or outcomes data" as ground truth, as those would be relevant for diagnostic interpretation, not for a digitizing device.
8. The Sample Size for the Training Set
This information is not provided and is not applicable. The device is a film digitizer, which typically does not involve machine learning "training sets." Its operation is based on optical and electronic principles, not learned algorithms.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable. See point 8 above.
{0}------------------------------------------------
K 102476
page 1/2
Image /page/0/Picture/1 description: The image shows the logo for VIDAR systems corporation. The logo is black and white and features the company name in a bold, sans-serif font. Below the company name is the tagline "The Image of Reliability". The logo is simple and professional, and it conveys a sense of quality and dependability.
510(k) Summary
Submitter: VIDAR Systems Corporation 365 Herndon Parkway Herndon, VA 20170 U.S.A. 703-471-7070 (phone) 703-471-1165 (fax)
7 2019
Official Correspondent: Carrie L. Brancart Date of Submittal: August 23, 2010
Trade Name: TeleradPRO
X-Ray Film Digitizer Common Name:
Classification Name: Medical Image Digitizer (21 CFR 892.2030) Product Code: LMA Predicate Device: Trade Name: TeleRADPro Film Digitizers 510(k): K993597
Manufacturer: VIDAR Systems Corporation
Device Description:
The device consists of a film digitizer with single-film or multi-film feeder, external power adapter, and Windows driver software. The film digitizer will convert the X-ray film into digital data representing the X-ray film, and the windows driver software is used to import the digital data into a compatible software application
The Digitizer is connected to a PC through a USB 2.0 interface. The digitizer utilizes rollers driven by a stepper motor to feed the X-ray film past the scan optics. The scan optics consists of a white LED illuminator, a lens, mirrors, and a CCD linear array detector.
Intended Use:
The VIDAR TeleradPRO film digitizer is used for making digital copies of medical x-ray films.
The intended use of the modified device, as described in its labeling, has not changed as a result of the modifications.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for VIDAR systems corporation. The logo is black and white and features the company name in a bold, sans-serif font. Below the company name is the tagline "The Image of Reliability". The logo is simple and professional, and it conveys a sense of trust and quality.
Technological Characteristics:
The VIDAR TeleradPRO film digitizer offers a high optical resolution of 300 dpi; 16-bit grayscale, optical density sensitivity (DMAX) of 4.8 OD, and a medical OD range of 0.2 - 3.2 (incorporates noise and linearity measurements).
Performance Testing:
VIDAR conducts extensive performance testing and the test results demonstrate the '' ' . . device meets the requirements for its intended use. Please see Section 22 Bench Testing.
Substantial Equivalence to Predicate Device:
The TeleradPRO is substantially equivalent to TeleRADPro film digitizer. The comparison table of the principal characteristics of the two devices is shown in Section 14 and specification data for the TeleradPRO is included in Section 13.
Conclusion:
In terms of intended use, function, safety, operating environmental conditions and effectiveness of the TeleradPRO it is determined to be substantially equivalent to the predicate device used for this application.
8 - 2
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Carrie L. Brancart Director, Quality Assurance and Regulatory Affairs Vidar Systems Corporation 365 Herndon Parkway HERNDON VA 20170
DCT 7 2010
Re: K102476
Trade/Device Name: TeleradPRO Regulation Number: 21 CFR 892.2020 Regulation Name: Medical image communications device Regulatory Class: II Product Code: LMA Dated: August 23, 2010 Received: August 30, 2010
Dear Ms. Brancart:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
{3}------------------------------------------------
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
VIDAR Systems Corporation
K 102476
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: TeleradPRO
Indications for Use:
The TeleradPRO film digitizer is intended for making digital copies of medical xray films.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
7 - 1
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office affer and sation (ODE) OJU
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K162476
§ 892.2030 Medical image digitizer.
(a)
Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.