SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS

K991302 · Smartlight, Inc. · IXC · Jun 1, 1999 · Radiology

Device Facts

• Record ID: K991302
• Device Name: SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS
• Applicant: Smartlight, Inc.
• Product Code: IXC · Radiology
• Decision Date: Jun 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1890
• Device Class: Class 1

Intended 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.

Device Story

Radiographic film illuminator; senses size, location, and density of films on faceplate. Automatically adjusts back illumination intensity (500-10,000 nits) based on film density; performs electro-optical collimation (masking) to eliminate glare; uses optical grid to suppress Callier effect (scatter); reduces ambient light; emits blue light to control pupil dilation. Used in clinical settings by radiologists/clinicians to view radiographic films. Improves detection/discernment of clinical information; mitigates age-related visual perception decline in readers over 30.

Clinical Evidence

Controlled statistical study of a large number of observers. Results demonstrate significant improvement in observer ability to detect and discern radiographic information on film using the SmartLight Digital Film Viewer compared to unmasked or masked light boxes.

Technological Characteristics

Radiographic film illuminator. Features: adaptive back illumination (500-10,000 nits), electro-optical collimation, optical grid for scatter suppression, ambient light reduction, and blue light emission for pupil control. Standalone system.

Indications for Use

Indicated for use as a radiographic film illuminator to improve detection and discernment of radiographic objects and clinical information on film. Mitigates age-dependent degradation in detection/discernment for readers over 30 years of age compared to standard light boxes.

Regulatory Classification

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.

Predicate Devices

• ADViewer (K952188)

Submission Summary (Full Text)

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#### 510(k) Summary for SmartLight Digital Film Viewer Appendix D

K991302

#### 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.

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# 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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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<br>radiographic film illuminator designed to automatically<br>adapt film-viewing conditions to compensate for known<br>physical and psychophysical limitations in human visual<br>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)