K Number

Device Name

Manufacturer

AlphaMed Inc

Date Cleared

2019-10-24

(262 days)

Product Code

LZU

Regulation Number

N/A

Type

Traditional

Panel

Ophthalmic

Reference & Predicate Devices

K030300

Predicate For

N/A

Intended Use

Tear Pool Dissolvable Punctum Plugs are designed to provide for temporary occlusion of the tear drainage system.

Punctum Plugs are indicated for:

- As a diagnostic aid to determine the potential effectiveness of long term occlusion
- 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
- To evaluate the dry eye component of ocular surface diseases

Device Description

The Tear Pool Dissolvable Punctum Plug is an ophthalmic device commonly referred to as a punctum plug. It is designed to be inserted by a practitioner into the canaliculus to temporarily restrict the natural lubricating tears from draining off the surface of the eye.

This treatment is prescribed for temporary occlusion in the treatment of certain eye conditions collectively referred to as dry eye disease, as well as the dry eye component of ocular surface diseases and other conditions of tear insufficiency.

Tear Pool Dissolvable Punctum Plugs are cylindrical in shape. Approximately 2.0mm in length and are available in two sizes: 0.4mm and 0.5mm. Each plug is composed of polydioxanone(PDO). The plug is dyed with an approved color additive, D & C Violet No. 2.

A Tear Pool Dissolvable Punctum Plug is mounted on a specially designed insertion tool and placed into a plastic tray then sealed with a Tyvek® cover. The primary package is sent to the sterilizer for Ethylene Oxide sterilization. Two sterile trays, one IFU, two chart labels and one silica gel packet are sealed in a pouch and placed in a shelf box.

The Pre-Loaded Tear Pool Dissolvable Punctum Plugs are available in the following models and diameters and are 2.0mm in length
Model# 20-5304 0.4mm
Model# 20-5305 0.5mm

The device is make from Polydioxanone(PDO). The plugs are violet in color.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Tear Pool Dissolvable Punctum Plugs." This document focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical performance studies typical for novel or higher-risk devices. As such, the information needed to answer many of your questions regarding acceptance criteria and study detailed performance evaluation for an AI/CAD-like device is not present in this document.

The document primarily discusses:

Device Description: What the punctum plugs are, their materials (polydioxanone), sizes, and sterilization method (Ethylene Oxide).
Indications for Use: Temporary occlusion of the tear drainage system for various dry eye-related conditions.
Technological Characteristics: Highlighting similarities to the predicate device and the absence of software, energy sources, biologics, drugs, coatings, or additives.
Performance Data (Non-clinical): Biocompatibility testing (cytotoxicity, irritation, sensitization, material testing), sterilization validation (EO residuals, bacterial endotoxin), and insertion tool testing (simulated use deployment).

There is no mention of an AI/CAD device, or any kind of software component that would require acceptance criteria related to AI performance metrics (like sensitivity, specificity, AUC). The device is a physical, dissolvable punctum plug.

Therefore, for most of your questions, the answer will be "Not Applicable" or "Information Not Provided in this Document" because the context of your questions (AI/CAD performance, ground truth establishment, MRMC studies) does not align with the type of device and regulatory submission described in the FDA letter.

However, I can extract the non-clinical performance data and frame it in a way that resembles acceptance criteria based on the information provided, even though it's not for an AI device.

Here's an attempt to answer your questions based only on the provided text, acknowledging its limitations for an AI/CAD context:

Device: Tear Pool Dissolvable Punctum Plugs

Purpose of the Submission: 510(k) Premarket Notification to demonstrate substantial equivalence to a legally marketed predicate device (Dissolvable Opaque Herrick Lacrimal Plug, K030300).

Based on the provided document, the "acceptance criteria" and "study" are focused on demonstrating the safety and effectiveness of a physical medical device (punctum plugs) by showing equivalence to a predicate device, primarily through non-clinical testing. This is not a study of an AI/CAD system.

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a physical device and not an AI, the "acceptance criteria" are based on meeting specific biological, chemical, and functional standards for medical devices. The "reported device performance" indicates whether these standards were met.

Acceptance Criterion (Category)	Specific Test/Standard	Acceptance Threshold (Expected Outcome)	Reported Device Performance (Result)
Biocompatibility	L929 Neutral Red Uptake Test (ISO 10993-5)	Requirements of the standard met (non-cytotoxic)	"The requirements of the standard were met."
	Kligman Maximization Test (ISO 10993-10)	Requirements of the standard met (non-sensitizing)	"The requirements of the standard were met."
	Intracutaneous Injection Test (ISO 10993-10)	Requirements of the standard met (non-irritating)	"The requirements of the standard were met."
	Physicochemical Test for Plastic Material (USP 42, NF 37)	Requirements of the standard met	"The requirements of the standard were met."
Sterilization	EO Sterilization Validation (ISO 11135)	Requirements of the standard met (sterile)	"The requirements of the standard were met."
	EO Residual (ISO 10993-7)	Requirements of the standard met (acceptable residual levels)	"The requirements of the standard were met."
	Bacterial Endotoxin Test (USP 41, ANSI/AAMI ST72)	Requirements of the standard met (low endotoxin levels)	"The requirements of the standard were met."
Insertion Tool Functionality	Simulated Use Deployment Test (in gel)	Plug not damaged, retained, delivered easily; successful multiple deployments	"The insertion tool performs as intended."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified for any of the non-clinical tests. The tests are typically performed on a statistically justified sample of the device or its materials, but the exact number isn't in this summary.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This would typically be laboratory test data rather than patient data. For in vitro and animal (e.g., skin sensitization in guinea pigs/mice) biocompatibility tests, standardized lab conditions are used. It's safe to assume these are prospective laboratory tests specifically performed for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. For a physical medical device, "ground truth" for biocompatibility and sterilization is established by adherence to recognized international standards (e.g., ISO, USP) and validated laboratory testing protocols, rather than expert consensus on interpretive data (which applies to AI/CAD). The "experts" would be the qualified laboratory personnel conducting the tests and the personnel overseeing the quality system.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication (e.g., 2+1, 3+1 for discordant reads) is relevant for human interpretation of imaging data or clinical endpoints. For laboratory tests, the results either meet the specified standard/criteria or they do not.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The device is a physical punctum plug for tear drainage occlusion.

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

No. As there is no algorithm or software component for this medical device, a standalone performance study is not relevant.

7. The Type of Ground Truth Used

For Biocompatibility/Sterilization: Ground truth is defined by the objective results of validated laboratory tests conducted according to established international and national standards (e.g., ISO 10993 series, USP monographs). This could be considered "laboratory standard" or "validated assay results."
For Insertion Tool: Ground truth is functional performance (e.g., successful deployment without damage), verified by a "Simulated Use Deployment Test."

8. The Sample Size for the Training Set

Not Applicable. This device does not have a "training set" as it is not an AI/machine learning product. The design and manufacturing are based on established engineering principles and prior knowledge of the predicate device.

9. How the Ground Truth for the Training Set was Established

Not Applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with a stylized image of a human figure, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" in a larger font size than the rest of the text.

October 24, 2019

AlphaMed, Inc. Mr. James Gubachy VP - Ouality Assurance 3912 Mountain Ave El Paso, TX 79930

Re: K190210

Trade/Device Name: Tear Pool Dissolvable Punctum Plugs Regulatory Class: Unclassified Product Code: LZU Dated: September 25, 2019 Received: September 26, 2019

Dear Mr. Gubachy:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidanceregulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-devicesafety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-andconsumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190210

Device Name Tear Pool Dissolvable Punctum Plugs

Indications for Use (Describe)

Tear Pool Dissolvable Punctum Plugs are designed to provide for temporary occlusion of the tear drainage system.

Punctum Plugs are indicated for:

- As a diagnostic aid to determine the potential effectiveness of long term occlusion
- 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
- To evaluate the dry eye component of ocular surface diseases

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Submitter's Name:	AlphaMed Inc.
Submitter's Address:	3912 Mountain AveEl Paso, TX 79930
Submitter's Telephone:	915-595-2020
Submitter's Contact:	James Gubachy915-595-2020jgubachy@alphamedco.com
Date 510 (k) Summary Prepared:	October 24, 2019
Device Trade Name:	Tear Pool Dissolvable Punctum Plugs
Device Common Name:	Punctum Plug
Classification Name:	Unclassified
Product Code:	LZU
Predicate Device:	Dissolvable Opaque Herrick Lacrimal Plug
Predicate Device 510(k) No .:	K030300

Description of Device

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Device Description (continued)

The Pre-Loaded Tear Pool Dissolvable Punctum Plugs are available in the following models and diameters and are 2.0mm in length

Model# 20-5304	0.4mm
Model# 20-5305	0.5mm

The device is make from Polydioxanone(PDO). The plugs are violet in color.

Differences: The Tear Pool Dissolvable Punctum Plug and the Predicate Device are identical except the Tear Pool Dissolvable Punctum Plug uses an insertion tool. The results of performance testing on the insertion tool and biocompatibility studies with the addition of an insertion tool demonstrate that it does not impact the safety and effectiveness of the Device.

Indications for Use: Tear Pool Dissolvable Punctum Plugs are designed to provide for temporary occlusion of the tear drainage system.

Punctum Plugs are indicated for:

米 As a diagnostic aid to determine the potential effectiveness of long term occlusion
米 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
- To evaluate the dry eye component of ocular surface diseases

Differences: There is no content difference between the Indication for Use for the Predicated Device and the Tear Pool Dissolvable Punctum Plug.

Technological Characteristics

The Tear Pool Dissolvable Punctum Plug has the same design as the Predicate Device. Both devices are made with Polydioxanone(PDO).

Neither the Tear Pool Dissolvable Punctum Plug nor the Predicate Device us software or an energy source, contain biologics or drugs, and do not use coatings or additives.

Differences: There are no technological differences.

Performance Data

Non-clinical performance data includes biocompatiblity testing, sterilization validation, insertion tool testing, package validation and environment of use.

Biocompatibility Testing:

L929 Neutral Red Uptake Test per ISO 10993-5 Biological Evaluatio of Medical Devices -Part 5: Tests for In Vitro Cytotoxicity.