(100 days)
Not Found
Not Found
No
The device description and intended use are purely mechanical and material-based, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to treat Dry Eye Syndrome and enhance the efficacy of topical medications or ocular lubricants, which are therapeutic uses.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "may be used: As a diagnostic aid to determine the potential effectiveness of Occlusion Therapy with non-dissolvable plugs."
No
The device description clearly indicates it is a physical plug made of dissolvable materials, intended for insertion into the canaliculus. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to block the canaliculus for the relief of dry eye syndrome and as a diagnostic aid for occlusion therapy. This is a therapeutic or diagnostic procedure performed directly on the patient, not a test performed on a sample taken from the patient.
- Device Description: The device is a physical plug inserted into the tear drainage system. It is not a reagent, instrument, or system intended for use in the examination of specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory testing.
IVD devices are used to perform tests on samples like blood, urine, tissue, etc., to diagnose diseases or conditions. This device is a physical implant used to treat a condition or aid in a diagnostic procedure performed directly on the patient's body.
N/A
Intended Use / Indications for Use
Intended Use: The Lacrimedics Dissolvable Opaque Herrick Lacrimal Plug® is intended to block the canaliculus for the relief of dry eye syndrome.
Indications: Dissolvable Opaque Herrick Lacrimal Plug® may be used:
- . As a diagnostic aid to determine the potential effectiveness of Occlusion Therapy with non-dissolvable plugs.
- To temporarily enhance the efficacy of topical medications or ocular lubricants .
- . After ocular surgery to prevent complications due to dry eyes.
- To evaluate treatment of ocular dryness secondary to contact lens use
- In the treatment of Dry Eye Syndrome and the dry eye components of varying . Ocular Surface Diseases.
Product codes (comma separated list FDA assigned to the subject device)
LZU
Device Description
The Lacrimedics Dissolvable Opaque Herrick Lacrimal Plug® provides temporary occlusion of the tear drainage system. The plug is supplied in various sizes ranging from 0.2 mm to 0.5mm in diameter. The length is approximately 1.75 mm. The dissolvable (suture material) pluq is composed of any one of the following: (1) a copolymer of L-lactide and ε -caprolactone (PCL); (2) polydioxanone (PDO); (3) copolymers of glycolic acid and trimethylene carbonate.
The proposed device is supplied as a single use component for use in treatment of dry eye syndrome. The device is supplied sterile and is intended for SINGLE USE ONLY.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
canaliculus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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): 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
Image /page/0/Picture/0 description: The image shows the handwritten text "KO3O300". The text appears to be written with a dark pen or marker on a white background. The characters are slightly slanted and have a rough, uneven texture, suggesting they were written quickly or with a worn writing instrument.
MAY - 9 2003
Summary of Safety and Effectiveness (Updated)
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the proposed Lacrimedics Dissolvable Opaque Herrick Lacrimal Plug® device.
| Manufacturer: | Lacrimedics |
|---|---|
| Contact Person: | Jerry Henderson |
| 310 Prune Alley | |
| Eastsound, WA 98245-1209 | |
| Device Name: | |
| Trade Name: | Dissolvable Opaque Herrick Lacrimal Plug® |
Intracanalicular Plug/Punctum Plug Common Name:
Proprietary name: TBD
Classification: LZU; Ophthalmic
Date Prepared: May 1, 2003
Device Description: The Lacrimedics Dissolvable Opaque Herrick Lacrimal Plug® provides temporary occlusion of the tear drainage system. The plug is supplied in various sizes ranging from 0.2 mm to 0.5mm in diameter. The length is approximately 1.75 mm. The dissolvable (suture material) pluq is composed of any one of the following: (1) a copolymer of L-lactide and & -caprolactone (PCL); (2) polydioxanone (PDO); (3) copolymers of glycolic acid and trimethylene carbonate.
The proposed device is supplied as a single use component for use in treatment of dry eye syndrome. The device is supplied sterile and is intended for SINGLE USE ONLY.
Intended Use: The Lacrimedics Dissolvable Opaque Herrick Lacrimal Plug® is intended to block the canaliculus for the relief of dry eye syndrome.
Indications: Dissolvable Opaque Herrick Lacrimal Plug® may be used:
- . As a diagnostic aid to determine the potential effectiveness of Occlusion Therapy with non-dissolvable plugs.
- To temporarily enhance the efficacy of topical medications or ocular lubricants .
- . After ocular surgery to prevent complications due to dry eyes.
- To evaluate treatment of ocular dryness secondary to contact lens use
- In the treatment of Dry Eye Syndrome and the dry eye components of varying . Ocular Surface Diseases.
Comparison of Technological Characteristics: The proposed device, the Dissolvable Opaque Herrick Lacrimal Plug®, comprises the same or similar material as the predicate devices. Manufacture of this device, and QC testing, is in substantial compliance with current FDA guidelines and 21 CFR 820 regulations.
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal are three stylized human profiles facing to the right, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 9 2003
Lacrimedics c/o Jerry Henderson RA / QA Specialist P.O. Box 1209 310 Prune Alley Eastsound, WA 98245-1209
Re: K030300
Trade/Device Name: Dissolvable OPAOUE Herrick Lacrimal Plug@ Regulatory Class: Unclassified Product Code: LZU Dated: April 10, 2003 Received: April 17, 2003
Dear Mr. Henderson:
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.
2
Page 2 - Jerry Henderson
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), please contact the Office of Compliance at (301) 594-4613. 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 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. Paepke 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
Enclosure
3
Pagel of l
KU3U300
510(k) Number (if known): K030300
Device Name: Dissolvable Opaque Herrick Lacrimal Plug≤
Indications for Use:
Dissolvable Opaque Herrick Lacrimal Plugs may be used:
- As a diagnostic aid to determine the potential effectiveness of Occlusion Therapy with non-ర్ dissolvable plugs.
- To temporarily enhance the efficacy of topical medications or ocular lubricants డ్
- After ocular surgery to prevent complications due to dry eyes. డ్
- డ్ To evaluate treatment of ocular dryness secondary to contact lens use
- In the treatment of Dry Eye Syndrome and the dry eye components of varying Ocular Surface ర్ల Diseases.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
Dune A. Vachner
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
(Optional Format 3-10-98)
510(k) Number K030300