(42 days)
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Not Found
No
The summary does not mention AI, ML, or any related terms, and the description of the device's function is limited to standard corneal measurement and analysis.
No
The device is used for measuring, recording, and analyzing corneal curvature, which is an diagnostic and analytical function, not therapeutic.
Yes
The device "specifically measures, records, and corneal arolyzes corneal curvature" and is used for "patient screening," "operative corneal surgery portu defermination and follow-up," and "assisting in the and follow-up lenses. of contact." These are all diagnostic or pre-diagnostic activities.
Unknown
The provided text does not contain a "Device Description" section, which is crucial for determining if the device is software-only. The "Intended Use" describes the function of the device (measuring and analyzing corneal curvature) but doesn't specify the form factor (hardware, software, or a combination). Without a device description, it's impossible to definitively say if it's software-only.
Based on the provided information, the Eyesys Uista is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Eyesys Uista Function: The description clearly states that the Eyesys Uista "specifically measures, records, and corneal arolyzes corneal curvature in a non-invasive manner." This involves directly interacting with the patient's eye, not analyzing a sample taken from the body.
- Intended Use: The intended use describes its application in ophthalmic and optometric offices for patient screening, documentation, surgical planning, and contact lens fitting. These are all procedures performed directly on the patient.
Therefore, the Eyesys Uista is a medical device used for diagnostic purposes, but it falls under the category of in vivo (within the living body) diagnostics, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Eyesys Uista has the Same intended use as other analysis and topography sustems. It specifically measures, records, and corneal arolyzes corneal curvature in a non-invasive manner.
Product codes
86 HLQ, 86 HJA
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
corneal
Indicated Patient Age Range
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Intended User / Care Setting
The EyeSys Vista will be operated by dostors and technicians in ophtholmic and optometric offices.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 886.1350 Keratoscope.
(a)
Identification. A keratoscope is an AC-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device includes the photokeratoscope which records corneal curvature by taking photographs of the cornea.(b) The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9. The battery-powered device is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 1997
Ms. Beth A. Soper Premier Laser Systems, Inc. 3 Morgan Irvine, CA 92618
Re: K973756 Trade Name: Eye Sys Vista TM Regulatory Class: I Product Code: 86 HLQ, 86 HJA Dated: September 30, 1997 Received: October 2, 1997
Dear Ms. Soper:
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 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.
1
Page 2 - Ms. Soper
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 Rosenthal
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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Q001
P. 2
Page _ of _
510 (k) Number (if known): K 973 756 Indications For Use
The Eyesys Uista has the Same intended use as other analysis and topography sustems. It specifically measures, records, and corneal arolyzes corneal curvature in a non-invasive manner.
The EyeSys Vista will be operated by dostors and technicians in ophtholmic and optometric offices . Corners topogital pho for potient screening become the standard of care documentation, corneal operative corneal surgery portu defermination and follow- up, as well as assisting in the and follow-up lenses. of contact
(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
Counter Use
(Optional Formar 1-2-56)
Am Williams
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number