(272 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related terms, and there is no description of training or test sets which are typically associated with AI/ML development.
No
The device is described as a microscope used to examine the cornea of the eye, which indicates a diagnostic rather than therapeutic function.
No
The device is intended to be used to examine the cornea, which implies observation rather than providing a diagnosis.
No
The device description explicitly states "Clinical Specular Microscope, Model HAI CL-1000xyz," which is a hardware device used for examining the cornea. The summary does not mention any software-only component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "examine the cornea of the eye." This is a direct examination of a living tissue within the body (in vivo).
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside the body (in vitro).
- Device Description: The device is a "Clinical Specular Microscope," which is a tool used for direct visualization of the cornea.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting biomarkers, or performing tests on bodily fluids or tissues outside the body.
Therefore, the Clinical Specular Microscope Model HAI CL-1000xyz, as described, is an in vivo diagnostic device used for direct examination of the eye, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Clinical Specular Microscope Model HAI CL-1000xyz is intended to be used to examine the cornea of the eye.
Product codes
NQE
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
cornea of the eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician or practitioner
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 886.1570 Ophthalmoscope.
(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 6 2004
HAI Laboratories. Inc. c/o Mr. Richard C. Lanzillotto 30 Northpoint Road South Beach, NY 117891
Re: K994340
Trade/Device Name: Clinical Specular Microscope, Model HAI CL-1000xyz Regulation Number: CFR 886.1850 Regulation Name: AC-powered slitlamp biomicroscope Regulatory Class: Class II Product Code: NQE Dated: September 20, 2000 Received: December 23, 1999
Dear Mr. Lanzillotto:
This letter updates our substantially equivalent letter of September 20, 2000 regarding the product code and classification regulation of your device. Specular microscopes are now regulated under §886.1850 (AC-powered slitlamp biomicroscope) and are listed under a new product code (NQE). This letter is for informational purposes. No further action is required on your part at this time.
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 (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
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Page 2 - Mr. Richard C. Lanzillotto
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 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 Part 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. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Alard M. Wiggle
J. A. Ralph Rosenthal, M.D.
A. Ralph Rosenthal. Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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HAI Laboratories, Inc. HAI CL-1000xyz
Abbreviated 510K 12/21/99
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Clinical Specular Microscope Model HAI CL-1000xyz
Indications for Use:
The Clinical Specular Microscope Model HAI CL-1000xyz is intended to be used to examine the cornea of the eye.
Contraindications: Warnings and Precautions
CAUTION "Federal Law restricts this device to sale by or on the order of a physician or practitioner"
Also, see attached.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
==============================================================================================================================================================================
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
Dennis L. McCarthy
(Division Sign-Off)
Division of Ophthalmic 510(k) Number