(116 days)
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No
The provided 510(k) summary describes a physical medical device (a punctal plug) and contains no mention of AI, ML, image processing, or any other computational technology typically associated with AI/ML in medical devices.
Yes
The device is intended to relieve dry eye symptoms, treat dry eye syndrome, prevent complications after eye surgery, and enhance retention of ocular medications, all of which are therapeutic applications.
No
The device, SmartPlug™, is described as being used for the treatment of dry eye symptoms and conditions by blocking the punctum, and for preventing complications after eye surgery and enhancing medication retention. Its intended use focuses on providing therapeutic relief and support, not on diagnosing or identifying medical conditions.
No
The 510(k) summary describes a "SmartPlug™" which is intended to block the punctum. This strongly suggests a physical device (a plug) rather than software. The lack of any mention of software, image processing, AI, or data analysis further supports this conclusion.
Based on the provided information, the SmartPlug™ is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of the SmartPlug™ is to be inserted into the punctum (part of the eye) of a patient to treat dry eye symptoms. It is a physical device used in the body, not a test performed on a sample taken from the body.
- The description focuses on a physical device for treatment. The intended use describes a therapeutic intervention (blocking the punctum) to alleviate symptoms. This is characteristic of a medical device, not an IVD.
- There is no mention of analyzing biological samples. The description does not involve any analysis of blood, urine, tissue, or any other bodily fluid or substance.
Therefore, the SmartPlug™ is a medical device, but it does not fit the definition of an In Vitro Diagnostic.
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Intended Use / 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™.
Product codes
LZU
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
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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
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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N/A
0
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 eagle with three curved lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
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