(221 days)
Not Found
Not Found
No
The summary describes a simple, disposable device for eye irrigation and does not mention any computational or analytical capabilities, let alone AI/ML.
No
The device is intended to relieve discomfort by irrigating the eye, which is a supportive rather than a therapeutic function.
No
The device is described as an "EYESHOWER" intended for irrigating the eye to relieve discomfort, not for diagnosing any condition.
No
The device description clearly states it is a "single-use, disposable device" intended for use with a physical bottle of eye wash, indicating it is a physical hardware device, not software.
Based on the provided information, the Vista EYESHOWER is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for irrigating the eye to relieve discomfort caused by foreign material, air pollutants, or chlorinated water. This is a direct application to the body (in vivo) for a physical purpose (irrigation), not for examining specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The description reinforces the intended use of irrigating the eye.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Vista EYESHOWER does not fit this description.
N/A
Intended Use / Indications for Use
The Vista EYESHOWER is a single-use, disposable device intended for use with Iriqate, sterile, isotonic, buffered eye wash (Optopics Laboratories Corp., Fairton, N.J.), supplied in a 1-ounce Boston round bottle for irrigating the eye to help relieve discomfort caused by foreign material, air pollutants, or chlorinated water. For Over-The-Counter use.
Product codes
LXO
Device Description
Vista EYESHOWER (Single-use, Disposable)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter use.
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 1, 2021
John Branch Grace Holland Regulatory Consultant 3722 Ave. Sausalito Irvine, California 92606
Re: K971134 Trade/Device Name: Vista Eyeshower Regulatory Class: Unclassified Product Code: LXQ
Dear Grace Holland:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated November 4, 1997. Specifically, FDA is updating this SE Letter as an administrative correction. There was a typo in the product code; the correct product code is LXO.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact J. Angelo Green, OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Devices, 301-796-6484, Angelo.Green@fda.hhs.gov.
Sincerely,
J Angelo Green -S
J. Angelo Green, Ph.D. Assistant Director for Contact Lenses and Dry Eye Devices DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 4 1997
Mr. John Branch c/o Ms. Grace Holland Holland & Associates 3722 Ave. Sausalito Irvine, CA 92606
K971134 Re: Trade Name: Vista EYESHOWER (Single-use, Disposable) Regulatory Class: Unclassified Product Code: 86 LXO · Dated: September 4, 1997 Received: September 5, 1997
Dear Mr. Branch:
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.
2
Page 2 - Mr. John Branch
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
3
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Vista EYESHOWER is a single-use, disposable device intended for use with Iriqate, sterile, isotonic, buffered eye wash (Optopics Laboratories Corp., Fairton, N.J.), supplied in a 1-ounce Boston round bottle for irrigating the eye to help relieve discomfort caused by foreign material, air pollutants, or chlorinated water.
For Over-The-Counter use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Savinto. (Division Sign-Off) Division of Ophthalmic Devices 510(k) Number_K971134
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
The-Counter Use 1
(Optional Format 1-2-96)