OPAQUE HERRICK LACRIMAL PLUG by LACRIMEDICS, INC.

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.

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) plug is composed of any one of the following: (1) a copolymer of L-lactide and epsilon -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.

AI/ML Overview

The provided text describes a Summary of Safety and Effectiveness for the Lacrimedics Dissolvable Opaque Herrick Lacrimal Plug® device and a 510(k) clearance letter. It does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or reader improvement.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices already on the market, which is the basis for 510(k) clearance. This means the new device shares similar technological characteristics and intended uses with a legally marketed device.

Therefore, many of the requested categories for a study's acceptance criteria and performance cannot be directly extracted from this document, as a formal performance study with these elements is not presented.

Here's a breakdown of what can be inferred or stated based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. The "performance" described is in terms of its intended use and compliance with manufacturing standards, assuming equivalence to predicate devices.

Acceptance Criteria	Reported Device Performance
Not explicitly defined as quantitative performance metrics. The primary "acceptance criterion" for 510(k) clearance is Substantial Equivalence to legally marketed predicate devices.	The device provides temporary occlusion of the tear drainage system for its intended uses. It is composed of similar materials as predicate devices. Manufacturing and QC testing are in substantial compliance with current FDA guidelines and 21 CFR 820 regulations.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document does not describe a clinical study with a test set of subjects/patients to evaluate performance. The 510(k) clearance is primarily based on a comparison of technological characteristics and intended use to predicate devices, not on new clinical trial data that would require a "test set" in the context of device performance metrics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No test set requiring expert-established ground truth is described in the provided documents for device performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is not an AI-assisted diagnostic tool or an imaging device, so an MRMC study is irrelevant to its premarket notification.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device (lacrimal plug), not an algorithm or software requiring standalone performance evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. There is no performance study described that would involve establishing a "ground truth" for diagnostic accuracy or similar metrics. The "ground truth" for 510(k) substantial equivalence relies on regulatory compliance and the established safety and effectiveness of predicate devices.

8. The sample size for the training set

Not applicable. No training set is described as this is not a machine learning/AI device.

9. How the ground truth for the training set was established

Not applicable. No training set is described.

Summary

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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 Henderson310 Prune AlleyEastsound, 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.

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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.

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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

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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

Regulation Number and Section

N/A