(116 days)
SmartPlug™ is intended for use in patients experiencing dry eye symptoms such as redness, burning, reflex tearing, itching or foreign body sensations which can be relieved by blocking of the punctum.
SmartPlug™ may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases.
When indicated, SmartPlug™ may be used after surgery of the eye to prevent complications due to dry eye and to enhance the retention of ocular medications on the eye. Patients experiencing dry eye related contact lens problems may also be aided by SmartPlug™.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA to Medennium Inc. regarding their SmartPlug™ Model 500 device. This document primarily focuses on the FDA's determination of substantial equivalence to a predicate device and does not contain information about acceptance criteria, performance studies, or details relevant to artificial intelligence/machine learning (AI/ML) device evaluation.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria from this specific document. The document confirms the FDA clearance for marketing but does not detail the technical performance evaluation or clinical study results that would typically include the requested metrics.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 18 2002
Medennium Inc. c/o Julian Abadia, Vice President Ouality Assurance & Regulatory Affairs 15350 Barranca Parkway Irvine; CA 92618
Re: K022043
Trade/Device Name: SmartPlug™ Model 500 Regulation Name: Punctum Plug Regulatory Class: Unclassified Product Code: LZU Dated: September 17, 2002 Received: September 18, 2002
Dear Mr. Abadia:
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.
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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 and additionally 21 CFR 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
K 022043 510(k) Number (if known):
Device Name: SmartPlug™ Model 500
Indications for Use:
SmartPlug™ is intended for use in patients experiencing dry eye symptoms such as redness, burning, reflex tearing, itching or foreign body sensations which can be relieved by blocking of the punctum.
SmartPlug™ may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases.
When indicated, SmartPlug™ may be used after surgery of the eye to prevent complications due to dry eye and to enhance the retention of ocular medications on the eye. Patients experiencing dry eye related contact lens problems may also be aided by SmartPlug™.
(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
(Optional Format 1-1-96)
lose and Throat Devises
510(k) Number K022043
N/A