(46 days)
Not Found
No
The device description focuses on sensing physical properties of the film (size, location, density) and automatically adjusting light intensity, masking, and other optical properties based on these measurements and known human visual perception limitations. There is no mention of learning from data, complex algorithms beyond simple sensing and adjustment, or any terms associated with AI/ML. The performance study focuses on observer performance with the device, not on the device's internal processing or learning capabilities.
No
A therapeutic device is one that treats or alleviates a disease or condition. This device is an illuminator that enhances the viewing of radiographic films for diagnosis, but it does not directly treat a medical condition.
No
The device is a film illuminator designed to improve the viewing experience of radiographic films, not to diagnose medical conditions or analyze patient data itself. Its function is to optimize film viewing conditions and enhance the ability of a human observer to detect and discern radiographic objects, but it does not perform diagnostic functions independently.
No
The device description explicitly details hardware components such as a back illumination system, faceplate, optical grid, and mechanisms for sensing film size, location, and density, which are not solely software functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The SmartLight Digital Film Viewer System is a radiographic film illuminator. Its purpose is to improve the viewing conditions of existing radiographic films, which are images of the inside of the body. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for "reading radiographic films" and improving the ability to "detect and discern radiographic objects recorded on film." This is about interpreting images, not analyzing biological samples.
- Device Description: The description focuses on how the device illuminates and masks the film to enhance visual perception. It doesn't mention any analysis of biological materials.
The device is a tool to aid in the interpretation of medical images, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Digital Film Viewer is a radiographic film illuminator with the following new indications for use:
- The Digital Film Viewer substantially improves the ability to detect and discern radiographic objects recorded on film compared to unmasked and masked light boxes.
- The Digital Film Viewer substantially improves the ability to detect and discern clinical information recorded on radiographic film compared to unmasked and masked light boxes.
- The Digital Film Viewer mitigates the age-dependent degradation in the ability to detect or discern radiographic objects recorded on film for readers over 30 years of age, as experienced on unmasked and masked light boxes.
The SmartLight Digital Film Viewer System is a radiographic film illuminator designed to automatically adapt film-viewing conditions to compensate for known physical and psychophysical limitations in human visual perception when reading radiographic films.
Product codes
90 IXC
Device Description
The Digital Film Viewer is a radiographic film illuminator designed to automatically adapt film-viewing conditions to compensate for known physical and psychophysical limitations in human visual perception when reading radiographic films.
The device senses the size, location, and density of films mounted on its faceplate and automatically adapts film-viewing conditions, as described below:
- Adaptive Light Intensity The device automatically adapts the intensity of the (a) back illumination system according to film density. Back light intensity ranges from 500-10,000 nits.
- Masking The device enables electro-optical collimation of the back illumination (b) such that those parts of the faceplate covered by films are illuminated, while the rest of the faceplate remains dark, eliminating extraneous glare.
- Film Scatter Suppression The device incorporates an optical grid, which (c) projects light in the forward direction to suppress optical scatter within the film (Callier effect).
- Ambient Light The device reduces the ambient light level when films are (d) mounted on its faceplate.
- Pupil Diameter The device emits a dark blue light from its faceplate to control (e) pupil dilation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The new indications for use relate to device performance and are based on data from a controlled, statistical study of a large number of observers.
The study data demonstrate substantial and significant improvement in observer ability to detect and discern radiographic information recorded on film, when using the Digital Film Viewer compared to either an unmasked or masked light box.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1890 Radiographic film illuminator.
(a)
Identification. A radiographic film illuminator is a device containing a visible light source covered with a translucent front that is intended to be used to view medical radiographs.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
0
510(k) Summary for SmartLight Digital Film Viewer Appendix D
1. Sponsor
Contact:
SmartLight Inc. 241 Main Street Hackensack, NJ 07601 201-487-4544 (T) 201-487-4746 (F)
A. Robert Sohval, PhD
Date Prepared:
April 15, 1999
2. Device Name
SmartLight Digital Film Viewer System Proprietary Name: Common or Usual Name: Radiographic Film Illuminator Radiographic Film Illuminator Classification Name:
3. Predicate Device
Product: ADViewer Company: ADP Ltd. K952188
4. Device Description
The Digital Film Viewer is a radiographic film illuminator designed to automatically adapt film-viewing conditions to compensate for known physical and psychophysical limitations in human visual perception when reading radiographic films.
The device senses the size, location, and density of films mounted on its faceplate and automatically adapts film-viewing conditions, as described below:
- Adaptive Light Intensity The device automatically adapts the intensity of the (a) back illumination system according to film density. Back light intensity ranges from 500-10,000 nits.
- Masking The device enables electro-optical collimation of the back illumination (b) such that those parts of the faceplate covered by films are illuminated, while the rest of the faceplate remains dark, eliminating extraneous glare.
- Film Scatter Suppression The device incorporates an optical grid, which (c) projects light in the forward direction to suppress optical scatter within the film (Callier effect).
- Ambient Light The device reduces the ambient light level when films are (d) mounted on its faceplate.
- Pupil Diameter The device emits a dark blue light from its faceplate to control (e) pupil dilation.
1
5. Intended Use
The Digital Film Viewer is a radiographic film illuminator with the following new indications for use:
- The Digital Film Viewer substantially improves the ability to detect and discern (a) radiographic objects recorded on film compared to unmasked and masked light boxes.
- The Digital Film Viewer substantially improves the ability to detect and discern (b) clinical information recorded on radiographic film compared to unmasked and masked light boxes.
- The Digital Film Viewer mitigates the age-dependent degradation in the ability to (c) detect or discern radiographic objects recorded on film for readers over 30 years of age, as experienced on unmasked and masked light boxes.
6. Technological Characteristics and Substantial Equivalence
There are no significant differences in the technological characteristics of the Digital Film Viewer with the new indications for use and the predicate devices have the same overall intended use and function for the illumination and viewing of radiographic films.
7. Performance Characteristics
The new indications for use relate to device performance and are based on data from a controlled, statistical study of a large number of observers.
The study data demonstrate substantial and significant improvement in observer ability to detect and discern radiographic information recorded on film, when using the Digital Film Viewer compared to either an unmasked or masked light box.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of three human figures, one behind the other, with their heads tilted upwards.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1999 JUN
A. Robert Sohval. Ph.D. Chief Executive Officer SmartLight, Incorporated 241 Main Street Hackensack, New Jersey 07601 Re:
K991302 SmartLight Digital Film Viewer, Models SL 4000Plus and SL 2000 Plus Dated: April 15, 1999 Received: April 16, 1999 Regulatory Class: I 21 CFR 892.1890/Procode: 90 IXC
Dear Dr. Sohval:
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 of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (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 regulatory 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.
If you desire specific advice for your device on our labeling requlation (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,
CAPT Daniel C. Schultz, 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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2. INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K991302 |
|---|---|
| Device Name: | SmartLight Digital Film Viewer System |
| Indications for Use: | The SmartLight Digital Film Viewer System is a |
| radiographic film illuminator designed to automatically | |
| adapt film-viewing conditions to compensate for known | |
| physical and psychophysical limitations in human visual | |
| perception when reading radiographic films. |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Degnan
(Division Sign-Off)
(Division of Reproductive, Abdominal, ENT, and Radiological Deyic 510(k) Number .
Prescription Use
(Per 21 CFR 801.109)