(16 days)
The Eye Cup Sterile I 's and the Eye Cup Non Sterile are each a cup that holds liquids, such as eye wash solution, used to flush out the eye.
a) Eye Cup Sterile 1's b) Eye Cup Non Sterile
The provided text is a 510(k) premarket notification letter from the FDA for an "Eye Cup Sterile 1's and Eye Cup Non Sterile" device. This document does not contain information typically found in a study or a description of acceptance criteria for an AI/CADe (Computer-Aided Detection) device.
The letter explicitly states that the device is an "Eye Cup" used to "flush out the eye." It pertains to a physical medical device, not a software algorithm. Therefore, the requested information about acceptance criteria for an AI device, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies is not applicable and cannot be extracted from this document.
The letter is a regulatory approval, confirming that the device is substantially equivalent to legally marketed predicate devices, and outlines general regulatory compliance. It does not include any performance data or study details for the device itself.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three diagonal lines that curve and converge at the bottom. The caduceus is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 6 2005
TOLLOT PTY, LTD c/o Kevin Walls, RAC Principal Consultant Regulatory Insight, Inc. 13 Red Fox Lane Littleton, CO 80127
Re: K051414
Trade/Device Name: Eye Cup Sterile 1's and Eye Cup Non Sterile Regulation Number: None Regulation Name: Eye Cup Regulatory Class: Unclassified Product Code: LXQ Dated: May 26, 2005 Received: June 1, 2005
Dear Mr. Walls:
We have reviewed your Section 510(k) premarket notification of intent to market the device w & nowed your 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 for association to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner be provisions 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 r ou may, aterer or visions 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 If your de rioe 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 than + Federal statutes and regulations administered by other Federal agencies. You must or any I 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.
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Page 2 - Kevin Walls, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w yours of substantial equivalence of your device to a legally prematics notification: "The Pro 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 If you desire specific arropliance 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 other general 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
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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Indications for Use
510(k) Number (if known): K051414
Device Name: a) Eye Cup Sterile 1's b) Eye Cup Non Sterile
Indications for Use: The Eye Cup Sterile I 's and the Eye Cup Non Sterile are each a cup that
s of the Eye Cup and and solution, used to flush out the eve Indications for Use: The Eye Cap Stories For and the exerces of the eye.
holds liquids, such as eye wash solution, used to flush out the eye.
Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (Part 21 CFK 801 Subpart D)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel W. Brown, Ph.D.
Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
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510(k) Number_K051414
N/A