(344 days)
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Not Found
No
The summary describes a standard electrophysiology device that measures electrical responses to visual stimuli. There is no mention of AI, ML, or any related concepts in the intended use, device description, or other sections.
No
The device is used for diagnosis and management of glaucoma by measuring electrophysiologic potentials and does not provide any treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "as an aid in the diagnosis and management of Glaucoma."
No
The device description explicitly mentions the use of electrodes placed on the patient's face and eye to measure the electrical response, indicating the presence of hardware components beyond just software.
Based on the provided information, the GLAID device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- GLAID's function: The GLAID device measures electrical responses directly from the patient's eye and face using electrodes. It does not analyze specimens taken from the body.
Therefore, the GLAID device falls under the category of a medical device used for physiological measurement, not an IVD.
N/A
Intended Use / Indications for Use
The GLAID device is indicated for use in the measurement of visual electrophysiologic potentials, including the electroretinogram (ERG), pattern electroretinogram (PERG), visual evoked potential (VEP) and electrooculogram (EOG), as an aid in the diagnosis and management of Glaucoma when used in conjunction with other established methods of diagnosis and disease management.
Product codes (comma separated list FDA assigned to the subject device)
GWE
Device Description
The GLAID Ocular Electrophysiology Device generates a display of photic stimuli which the patient observes as a pattern of alternating dark and white bars or checks. The electrical response of the patients' eye is monitored and recorded. The patients' response is measured using electrodes placed on the patients' face and eve.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
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
Not Found
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.
Not Found
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
§ 882.1890 Evoked response photic stimulator.
(a)
Identification. An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.(b)
Classification. Class II (performance standards).
0
K043367 510(K) SUMMARY
Date: 19 June 2003
Submission Correspondent: Emergo Group, Inc.
Address: 2519 McMullen Booth Road Suite 510-295 Clearwater, Florida 33761
Phone: (727) 797-4727 Fax: (727) 797-4757
Contact: Mr. Rene van de Zande
Submission Sponsor: LACE Elettronica s.r.l.
| Trade Name: | GLAID Ocular Electrophysiology Device |
|---|---|
| Common Name: | Photostimulator |
| Classification: | Ophthalmology |
The GLAID Ocular Electrophysiology Device generates a display of photic stimuli Description: which the patient observes as a pattern of alternating dark and white bars or checks. The electrical response of the patients' eye is monitored and recorded. The patients' response is measured using electrodes placed on the patients' face and eve
Intended Use: The GLAID device is indicated for use in the measurement of visual electrophysiologic potentials, including the electroretinogram (ERG), pattern electroretinogram (PERG), visual evoked potential (VEP) and electrooculogram (EOG), as an aid in the diagnosis and management of Glaucoma when used in conjunction with other established methods of diagnosis and disease management.
Predicate Devices: The predicate devices referenced in this submission are: the Electro-Diagnostic Imaging, Inc. VERIS System, the Doran Instruments Inc. Maculoscope, and the LKC Technologies Inc. Electroretinograph.
Summary and Conclusions Regarding Substantial Equivalence:
By definition, a device is substantially equivalent when the device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the device is as safe and effective as the predicate device and the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device.
The differences between the GLAID Ocular Electrophysiology Device and the predicate devices cited do not raise any different questions regarding safety and effectiveness. The differences in the technological characteristics are minimal, and the associated procedures are nearly identical. The Intended use is identical to the intended use of the previously cleared predicate devices, and the indications are equivalent.
The device, as designed, is as safe and effective as the predicate devices, and the device is substantially equivalent to the referenced predicate devices.
1
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Image /page/1/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 image of an eagle.
NOV 1 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
LACE Elettronica s.r.l. c/o Ian P. Gordon Emergo Group, Incorporated 2519 McMullen Booth Road Suite 510-295 Clearwater, FL 33761
Re: K043367
Trade/Device Name: GLAID Ocular Electrophysiology Device Regulation Number: 21 CFR 882.1890 Regulation Name: Evoked Response Photic Stimulator Regulatory Class: Class II Product Code: GWE Dated: October 19, 2005 Received: October 24, 2005
Dear Mr. Gordon:
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 such 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); 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.
2
This letter will allow you to begin 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), please contact the Office of Compliance at (301) 827-8910. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
David M. Whipple
Acting 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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Page 1 of 1
510(k) Number (if known): K 043367
Device Name: GLAID Ocular Electrophysiology Device
Indications for Use:
The GLAID device is indicated for use in the measurement of visual electrophysiologic potentials, including the electroretinogram (ERG), pattern electroretinogram (PERG), visual evoked potential (VEP) and electrooculogram (EOG), as an aid in the diagnosis and management of Glaucoma when used in conjunction with other established methods of diagnosis and disease management.
Jac Callaway
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
K043367 510(k) Number _
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
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