(51 days)
The intended use of the P111, TeleRADPRO, and VXR-12 plus is to produce digital copies of medical x-ray films.
The VIDAR P111, TeleRADPRO, and VXR-12 plus x-ray film digitizers are intended for producing digital copies of medical x-ray films.
The VIDAR P 111, TeleRADPRO, and VXR-12 plus film digitizers are intended for making digital copies of medical x-ray films.
The x-ray film digitizer is an electronic device used to convert analog x-ray films to digital images.
This 510(k) summary (K993597) for the VIDAR P111, TeleRADPRO, and VXR-12 plus x-ray film digitizers does not include detailed information about specific acceptance criteria, device performance studies, or clinical trials with human readers. The submission primarily focuses on establishing substantial equivalence to a predicate device (MedScan 12, K933632).
Therefore, I cannot fulfill all parts of your request as the information is not present in the provided document.
Here's what can be extracted based on the provided text, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the 510(k) summary. The document states that "Technical differences between the devices and the predicate raise [sic] of safety and effectiveness," implying a comparison, but it doesn't detail specific performance metrics or acceptance criteria for the new devices or the predicate.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided. The document makes no mention of a test set, study design, or data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided. Since there's no mention of a test set or ground truth establishment, this detail is absent.
4. Adjudication Method for the Test Set:
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not provided. The document does not mention any studies involving human readers or comparative effectiveness with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study:
Since the device is an "x-ray film digitizer" which converts analog films to digital images, its "performance" would likely relate to image quality parameters (resolution, density accuracy, signal-to-noise ratio, etc.) rather than an "algorithm only" performance in the sense of a diagnostic AI. The document does not detail any standalone performance studies using specific metrics.
7. Type of Ground Truth Used:
This information is not provided.
8. Sample Size for the Training Set:
This information is not provided. The document does not describe a training set for an AI algorithm. The devices are digitizers, not AI diagnostic tools.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided.
Summary of Device and its Purpose (from the provided text):
- Device Trade Name: P111, TeleRADPRO, and VXR-12 plus x-ray film digitizers.
- Common Name: X-ray film digitizer.
- Intended Use: To produce digital copies of medical x-ray films.
- Classification: Class II (per 21 CFR 892.2030, but the initial 510(k) summary states "Class 11 per CFR 892.2040 (proposed)"). The FDA response clarifies it as Class II, 21 CFR 892.2030.
- Predicate Device: MedScan 12 (K933632).
- Substantial Equivalence: Claimed based on similarities to the MedScan 12, with acknowledgement of "Technical differences... [that] raise [of] safety and effectiveness." (The wording "raise of safety and effectiveness" seems like a grammatical error and likely implies "raise issues of safety and effectiveness" that need to be addressed, which the submission presumably does, or "do not raise concerns of safety and effectiveness.")
Conclusion based on the provided document:
This 510(k) summary is very high-level and characteristic of submissions for devices seeking substantial equivalence rather than approval based on extensive clinical performance data or AI model validation. It focuses on the device's function as a digitizer and its comparison to an existing predicate. Detailed performance metrics, study designs, or AI-specific validation details are not included in this particular summary.
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K99 3597
DEC 1 5 1999
510 (k) Summary As required by 807.92 For the P111, TeleRADPRO, and VXR-12 plus x-ray film digitizers Prepared on August 3, 1999
| Submitted by: | VIDAR Systems Corporation460 Spring Park PlaceHerndon, VA 20170Telephone: (703) 471-7070Fax: (703) 471-1165 |
|---|---|
| Contact Person: | Mary "Pennie" DrinkardMedical Business Line Program Manager |
| Device Trade Name: | P111, TeleRADPRO, and VXR-12 plus x-ray film digitizers. |
| Common Name: | X-ray film digitizer |
| Classification: | Medical image digitizers were reviewed by the Radiology panel and areclassified in Class 11 per CFR 892.2040 (proposed). |
| Predicate Device: | MedScan 12 (K933632) |
| Manufactured by: | VIDAR Systems Corporation, 460 Spring Park Place, Herndon, VA 20170 |
| Description of Device: | The x-ray film digitizer is an electronic device used to convert analog x-rayfilms to digital images. |
| Intended use for the device: |
The intended use of the P111, TeleRADPRO, and VXR-12 plus is to produce digital copies of medical x-ray films.
The VIDAR P111, TeleRADPRO, and VXR-12 plus x-ray film digitizers are intended for producing digital copies of medical x-ray films.
Substantial Equivalence to Predicate Device:
The P111, TeleRADPRO, and VXR-12 plus are substantially equivalent to the MedScan 12 (K933632) film digitizer manufactured by VIDAR Systems Corporation, 460 Spring Park Place, Herndon, VA 20170. Technical differences between the devices and the predicate raise of safety and effectiveness.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three overlapping profiles facing to the right. The profiles are rendered in black and white. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC | 5 |999
Mary "Pennie" Drinkard Medical Business Line Program Manager Vidar Systems Corporation 460 Spring Park Place Herndon, VA 20170
Re:
K993597 Vidar Sierra, TeleRADPRO and VXR-12 plus Film Digitizers Dated: July 29, 1999 Received: October 25, 1999 Regulatory class: II 21 CFR 892.2030/90 LMA
Dear Ms. Drinkard:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
BART D. JACOBS, M.D.
APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K99 3597 510 k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: P 111, TeleRADPRO, and VXR-12 plus.
Indications for use:
The VIDAR P 111, TeleRADPRO, and VXR-12 plus film digitizers are intended for making digital copies of medical x-ray films.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Neyman
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devic 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-counter Use __
§ 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.