(126 days)
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Not Found
No
The summary describes a physical medical device (punctum plugs) and does not mention any software, image processing, AI, or ML capabilities.
Yes
The device is indicated for the "treatment of dry eye disorder" and aims to "increase tear flow on the surface of the eye," which are therapeutic actions.
No
Explanation: The device, 'Punctum plugs', is indicated for the treatment of dry eye disorder by stopping the outflow of tears. It is a therapeutic device, not one used for diagnosis.
No
The device description clearly states "MOIST Punctal Plug System," which is a physical medical device (punctum plugs) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device description and intended use: The description clearly states that the device is a "Punctum Plug System" and its intended use is for the "treatment of dry eye disorder" by physically blocking the outflow of tears. This is a physical intervention applied directly to the eye, not a test performed on a sample outside the body.
Therefore, the MOIST Punctal Plug System is a medical device, but it falls under a different category than in vitro diagnostics.
N/A
Intended Use / Indications for Use
Punctum plugs are indicated for the treatment of dry eye disorder. A condition caused by insufficient moisture in the eye. As a result, one may experience some irritation and discomfort to the eyes. Patients that may benefit from the use of punctum plugs are: sufferers of allergies, cataracts, dry eye secondary to contact lens use, and others who experience dry eye disorders. Specific treatment to stop the outflow of tears via a punctal opening (upper/lower) in order to increase tear flow on the surface of the eye.
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
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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
N/A
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized emblem. The emblem is a symbol that resembles a bird or a wing-like shape, composed of three curved lines. The text is arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 6 2002
MOIST Medical, Inc. c/o Mr. George W. Murray General Manager 2180 Wickersham Lane Germantown, Tennessee 38139
Re: K021936
Trade Name: MOIST Punctal Plug System Classification Regulation Number: Unclassified Regulatory Class: II Product Code: LZU Dated: September 10, 2002 Received: September 12, 2002
Dear Mr. Murray:
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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Page 1 of 1
510(k) Number (if known):
MOIST Punctal Plug System Device Name:
Indications For Use:
Punctum plugs are indicated for the treatment of dry eye disorder. A condition caused by insufficient moisture in the eye. As a result, one may experience some irritation and discomfort to the eyes. Patients that may benefit from the use of punctum plugs are: sufferers of allergies, cataracts, dry eye secondary to contact lens use, and others who experience dry eye disorders. Specific treatment to stop the outflow of tears via a punctal opening (upper/lower) in order to increase tear flow on the surface of the eye.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rusanand Jms
Division Sign-Off
ision of Onhthalmir. Far
510(k) Number K021936
Prescription Use
(Per 21 CFR 801.109)