The SOFT PLUG Extended Duration 180 Canalicular Plugs and the SOFT PLUG Extended Duration 180 Tapered Canalicular Plugs are intended to temporarily block tear flow by the occlusion of the canaliculus in order to:

Temporarily treat dry eye syndrome, and the dry eye components of various ocular surface diseases,
Temporarily enhance the efficacy of topical medications or ocular lubricants,
Temporarily treat contact lens intolerance secondary to dry eye,
Temporarily treat dry eye after ocular surgery, and
Determine the potential effectiveness of permanent occlusion.

Device Description

The Oasis Medical SOFT PLUG® Extended Duration 180 Tapered Canalicular Plug is a mid-term duration device designed to be inserted through the punctal opening into the canaliculus in order to block tear drainage through the lacrimal drainage system for approximately 180 days. The plugs are made from degradable polydioxanone monofilament colored violet with D&C No. 2. The plugs are 2.0mm long and have a base diameter of 0.6mm with one end tapered to enable easier placement through the punctal opening.

AI/ML Overview

This is a 510(k) summary for a medical device, the SOFT PLUG® Extended Duration 180 Tapered Canalicular Plug. The document focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel acceptance criteria or a dedicated clinical study with AI or human readers for device performance.

Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not applicable or cannot be extracted from this document, as they pertain to clinical studies or AI performance evaluation, which are not detailed here.

However, based on the provided information, I can offer the following:

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

The document does not explicitly state "acceptance criteria" in a quantitative, measurable way for a primary clinical outcome. Instead, it relies on demonstrating substantial equivalence to a predicate device by showing that the new device is as safe and effective. The "performance" described is primarily related to non-clinical testing confirming that the changes in the device (specifically the tapered geometry) do not negatively impact its fundamental characteristics compared to the predicate.

Criteria Category	Acceptance Criteria (Implied from Substantial Equivalence and Testing)	Reported Device Performance (from Non-Clinical Testing)
Biocompatibility	Demonstrate biocompatibility (no adverse biological reactions).	Biocompatibility testing from predicate (K162361) leveraged, with cytotoxicity testing confirming manufacturing process does not affect toxicology.
Degradation Rate	Maintain similar degradation rate as the predicate device.	Accelerated in-vitro degradation studies confirm manufacturing process does not affect degradation rate.
Sterile Barrier & Packaging Integrity	Maintain sterile barrier and packaging integrity during shipping.	Shipping study (ISO 11607, ASTM D4169, ISTA 2A) supports suitable packaging and unaffected sterile barrier.
Material Composition	Maintain same material as the predicate device.	No differences in material; both use polydioxanone monofilament with D&C Violet Number 2 dye.
Functionality	No differences in function compared to the predicate device.	"No differences in the function of these devices."
Safety and Effectiveness	As safe and effective as the predicate device.	Non-clinical performance tests demonstrate the device is "as safe and effective as the predicate device."

Relevant Study/Testing:

The study that "proves the device meets the acceptance criteria" (in the context of substantial equivalence) is comprised of non-clinical performance tests detailed in the "Summary of Non-clinical Testing" section. These tests were conducted to confirm that the modification (tapered end) did not alter the fundamental safety and performance characteristics from the predicate device.

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

This information is not provided in the document. The document describes non-clinical testing (biocompatibility, degradation, shipping) but does not specify sample sizes for these tests or their provenance. This type of information is typically not included in the public 510(k) summary but would be found in the full submission.

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)

This information is not applicable as the document does not describe a clinical study involving experts establishing ground truth for diagnostic or interventional performance. The testing described is non-clinical.

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

This information is not applicable as the document does not describe a clinical study requiring adjudication of expert interpretations.

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

This information is not applicable. This document is for a physical medical device (canalicular plug) and does not involve AI or human readers for diagnostic or interventional tasks.

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

This information is not applicable. This document is for a physical medical device and does not involve an algorithm or AI.

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

This information is not applicable as the testing is non-clinical and relies on validated laboratory methods (e.g., ISO 10993-5 for cytotoxicity, ASTM F1635 for degradation, ISO 11607/ASTM D4169/ISTA 2A for shipping) rather than clinical ground truth types.

8. The sample size for the training set

This information is not applicable. This document is for a physical medical device and does not involve machine learning or a training set.

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

This information is not applicable. This document is for a physical medical device and does not involve machine learning or a training set.

Summary

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June 3, 2022

Oasis Medical, Inc Ting-Hsuan Wu Regulatory Affairs Specialist 514 S Vermont Avenue Glendora, CA 91741

Re: K213988

Trade/Device Name: SOFT PLUG Extended Duration 180 Tapered Canalicular Plug Regulatory Class: Unclassified Product Code: LZU Dated: April 15, 2022 Received: April 20, 2022

Dear Ting-Hsuan Wu:

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 device-related 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/guidance-regulatory-information/postmarketing-safetyreporting-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-device-safety/medical-devicereporting-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/medicaldevices/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/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-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 Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K213988

Device Name

SOFT PLUG Extended Duration 180 Tapered Canalicular Plug

Indications for Use (Describe)

Temporarily treat dry eye syndrome, and the dry eye components of various ocular surface diseases,
Temporarily enhance the efficacy of topical medications or ocular lubricants,
Temporarily treat contact lens intolerance secondary to dry eye,
Temporarily treat dry eye after ocular surgery, and
Determine the potential effectiveness of permanent occlusion.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

Applicant's Name andAddress:	OASIS Medical, Inc.514 S. Vermont Ave.Glendora, CA 91741
Contact Person:	James ChristensenDirector Research and Development(626) 852-5156
Date Prepared:	May 24, 2022
510(k) Number:	K213988
Device Trade Name:	SOFT PLUG® Extended Duration 180 Tapered Canalicular Plug
Common Name:	Intracanalicular Plug
Regulation Name:	Plug, Punctum
Regulatory Class:	Unclassified
Product Code:	LZU
FDA Panel:	Ophthalmic
Basis for Submission:	Traditional 510(k): Device modification
Predicate Device:	K162361SOFT PLUG® Extended Duration 180 Canalicular Plug
Device DescriptionSummary:	The Oasis Medical SOFT PLUG® Extended Duration 180Tapered Canalicular Plug is a mid-term duration devicedesigned to be inserted through the punctal opening into thecanaliculus in order to block tear drainage through the lacrimaldrainage system for approximately 180 days. The plugs aremade from degradable polydioxanone monofilament coloredviolet with D&C No. 2. The plugs are 2.0mm long and have abase diameter of 0.6mm with one end tapered to enable easierplacement through the punctal opening.
Indications For Use:	The SOFT PLUG® Extended Duration 180 Canalicular Plugsand the SOFT PLUG® Extended Duration 180 TaperedCanalicular Plugs are intended to temporarily block teardrainage by the occlusion of the canaliculus in order to:- Temporarily treat dry eye syndrome, and the dry eyecomponents of various ocular surface diseases,- Temporarily enhance the efficacy of topical medications orocular lubricants,- Temporarily treat contact lens intolerance secondary to dryeye,- Temporarily treat dry eye after ocular surgery, and- Determine the potential effectiveness of permanent occlusion.
Summary of TechnologyCharacteristics:	There are no differences in the material used for this device andthe predicate device. Both devices are formed frompolydioxanone monofilament which is a polymerizedcomposition of p-dioxanone monomer and D&C Violet Number2 dye.
	There are differences in the geometry of this devise compared tothe predicate device. Both style plugs are 2.0mm long. Thetapered style plug has a base diameter of 0.6mm with one end ofthe plug tapered and the other end flat. The predicate device is acylindrical style plug having a range of diameters from 0.3mmto 0.5mm with both ends of the plug flat.
	Both style plugs are designed to be inserted through the punctalopening and reside in the canaliculus until they degrade. Theangle of the tapered end of the tapered style plug approximatesthe angle of a punctal dilator, a device used to enlarge thepunctal opening to ease insertion of a plug.
	There are no differences in the function of these devices. Noadditional questions of safety and effectiveness are raised due tomaterial, design, or function.
Summary of Non-clinicalTesting:	Biocompatibility testing from the predicate device premarket510(k) submission K162361, SOFT PLUG® Extended Duration180 Canalicular Plug, is leveraged as applicable for this device.
	Cytotoxicity testing performed in accordance with ISO 10993-5supports that the manufacturing process to form the tapered endof the plug does not affect the toxicology of the devicecompared to the predicate device
	Accelerated in-vitro degradation studies in accordance withASTM F1635 supports that the manufacturing process to formthe tapered end of the plug does not affect the degradation rateof the device compared to the predicate device
	A shipping study performed in accordance with ISO 11607,ASTM D4169 and ISTA 2A supports that the packaging issuitable for use and the sterile barrier is not affected by therevised product design.
Substantial EquivalenceBasis:	The conclusions drawn from non-clinical performance testsdemonstrate that the SOFT PLUG® Extended Duration 180Tapered Canalicular Plug is as safe and effective as thepredicate device, and is substantially equivalent to the predicatedevice.

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Regulation Number and Section

N/A