(173 days)
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No
The summary does not mention AI, ML, or any related concepts, and the device description and intended use are consistent with traditional confocal microscopy.
No.
The device is a confocal microscope used to view and evaluate ocular images, not to treat disease or infection.
Yes
The device is described as being used to "evaluate ocular disease and infections in patients," which indicates a diagnostic purpose.
No
The device description explicitly states "CON-S LTD. CONFOCAL MICROSCOPE," which is a hardware device. The intended use also refers to viewing ocular images, which is a function of a microscope.
Based on the information provided, it is highly likely that this device is an IVD (In Vitro Diagnostic). Here's why:
- Intended Use: The intended use is to "view ocular images, and evaluate ocular disease and infections in patients." While viewing images is a general function, the key phrase is "evaluate ocular disease and infections." This strongly suggests the device is used to aid in the diagnosis or assessment of a patient's condition.
- Anatomical Site: The device is used on the "Ocular" site, which is a part of the human body.
- Predicate Devices: The predicate devices are the Tandem Scanning Instrument and the Tomey Confocal microscope. These are known medical devices used for examining the eye, often in a diagnostic context.
Why it fits the definition of an IVD:
An In Vitro Diagnostic (IVD) device is defined as a medical device that is intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes.
While this device uses confocal microscopy to view the eye directly (which might seem "in vivo"), the purpose of the viewing is to "evaluate ocular disease and infections." This evaluation is a diagnostic process. The images captured are essentially "specimens" in the context of being analyzed to understand the patient's condition.
In summary: The device's intended use to evaluate disease and infections, combined with its function of viewing ocular images for this purpose, aligns strongly with the definition and purpose of an IVD.
However, it's important to note:
- The provided information is limited. A definitive determination would require a more complete understanding of the device's specific functionalities and how the "evaluation" is performed.
- Regulatory classification is complex. The final determination of whether a device is an IVD rests with regulatory bodies like the FDA.
Based on the provided text, the strong indication is that this device is intended for diagnostic purposes and therefore likely falls under the category of an IVD.
N/A
Intended Use / Indications for Use
Our device has the same indications for use as both the Tandem Scanning Instrument and as the Tomey Confocal microscope. These indications are to view ocular images, and evaluate ocular disease and infections in patients.
Product codes
86 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
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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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 15 1997
Herbert E. Kaufman, M.D. Con-S Ltd. The Galleria One Galleria Boulevard Suite 912 Metairie, LA 70002
Re: K970414 Trade Name: Confocal Microscope Regulatory Class: II Product Code: 86 HJO Dated: May 8, 1997 Received: May 19, 1997
Dear Dr. Kaufman:
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 to 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 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.
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Page 2 - Herbert E. Kaufman, M.D.
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 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/dsmamain.html".
Sincerely yours,
A Roerl lorenttal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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CON-S LTD. 10K Application nfocal Microscop ary 1997
510(k) Number (If Known):
K970414
CON-S LTD. CONFOCAL MICROSCOPE Device Name:
Indications for Use: Our device has the same indications for use as both the Tandem Scanning Instrument and as the Tomey Confocal microscope. These indications are to view ocular images, and evaluate ocular disease and infections in patients.
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Bruce Drum
Division Sign-Off
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K970414*
Prescription Use Over-The-Counter Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)