(91 days)
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No
The summary describes an LED lamp replacement for a slit lamp, which is a hardware component and does not mention any software or processing capabilities that would involve AI/ML.
No
The device is an accessory for a diagnostic tool (slit lamp biomicroscope) and is not intended for treating eye conditions.
No
The device is an LED lamp accessory for replacement of a bulb in a slit lamp biomicroscope. While the biomicroscope itself is indicated for examination and diagnosis of eye conditions, the LED lamp is simply a light source accessory and does not perform any diagnostic function.
No
The device is described as "LED lamps for slit lamp biomicroscope," which are hardware components intended to replace a tungsten bulb.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as a replacement light source for a slit lamp biomicroscope. The slit lamp itself is used for examining the eye, which is a diagnostic process, but the LED lamp is simply an accessory providing illumination.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. This device does not interact with any bodily samples.
- Device Description: It's described as an LED lamp, not a diagnostic test kit or instrument that analyzes biological samples.
The device is an accessory for a diagnostic instrument (the slit lamp), but it is not a diagnostic device itself, and certainly not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Vivid Light™ LED lamps for slit lamp biomicroscope are intended to be used as accessories for replacement of the 6V Tungsten bulb for Haag Streit's BM900, BQ900, BX900 and BP900 slit lamp biomicroscopes. Haag Streit's slit lamp biomicroscopes are indicated as noninvasive aid to the examination and diagnosis of eye conditions and in fitting of contact lenses.
Product codes
HJO
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
eye
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
IntraVista Medical Systems. Inc. c/o Wei Su, Ph.D. Chairman and CEO 1567 Samedra Street Sunnyvale, CA 94087
DEC 1 8 2009
Re: K092883
Trade/Device Name: Vivid Light™ LED lamp Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slitlamp Bio-microscope Regulatory Class: II Product Code: HJO Dated: November 16, 2009 Received: November 23, 2009
Dear Dr. Su:
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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Kenia Alexander Jr.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K092883
Vivid Light™ LED lamps for slit lamp biomicroscope Device Name:
Indications For Use: The Vivid Light™ LED lamps for slit lamp biomicroscope are intended to be used as accessories for replacement of the 6V Tungsten bulb for Haag Streit's BM900, BQ900, BX900 and BP900 slit lamp biomicroscopes. Haag Streit's slit lamp biomicroscopes are indicated as noninvasive aid to the examination and diagnosis of eye conditions and in fitting of contact lenses.
Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
the 1
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
K092883 510(k) Number.