VisiPlugST provide temporary occlusion of the tear drainage system. VisiPlugST may be used as a diagnostic aid to determine the potential effectiveness of long-term occlusion, to temporarily enhance the efficacy of topical medication or ocular lubricants, after surgery to prevent complications due to dry eyes, to evaluate treatment of ocular dryness secondary to contact lens use, and to evaluate the dry eye component of ocular surface diseases (OSD).

Device Description

The proposed device is an ophthalmic device commonly referred to as a punctum plug. It is designed to be placed by a practitioner into the horizontal canaliculus to restrict the natural lubricating tears from being pumped off the eye.

VisiPlugST provides temporary occlusion of the tear drainage system. The device may be used 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 surgery to prevent complications due to dry eyes, to evaluate treatment of ocular dryness secondary to contact lens use, and to evaluate the dry eye component of ocular surface diseases (OSD).

VisiPlugST plugs are cylindrical in shape, approximately 1.75-2.00mm in length, and available in three sizes: 0.3mm, 0.4mm and 0.5mm. Each plug is cut from a monofilament strand of Glycoprene® MG23, a synthetic surgical grade polymer composed of poly(glycolide-co-trimethylene carbonate-co-caprolactone). The monofilament is dyed with an approved color additive, Green D & C 6 (CAS# 128-80-3; 0.1% by weight). Titanium dioxide is added to the polymer to make the plugs opaque, providing a satisfactory means with which to determine the plug's presence or absence following insertion by a practitioner.

AI/ML Overview

The VisiPlugST is a punctum plug designed for temporary occlusion of the tear drainage system.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the VisiPlugST were based on comparing its material properties to an existing predicate device (Collagen Plugs for the Lacrimal Efficiency Test, K895342) and referenced predicate devices (Maxon, Sterile Synthetic Absorbable Sutures K990951 and CaproSyn Suture K032586). The primary performance characteristics evaluated were strength retention and mass loss degradation rates.

Performance Metric	Predicate Device (Gut Suture) Performance	Acceptance Criteria (Implicit: Substantial Equivalence to Predicate)	Reported VisiPlugST Performance (Glycoprene® MG23)	Conclusion
Strength Retention Rate (at 3-5 days)	40% strength retention at 3 days	Similar strength retention profile	40% strength retention at 4-5 days	Meets
Mass Loss Profile (at 30 days)	45% mass loss	Similar mass loss profile	46% mass loss	Meets
Biocompatibility	Safe	Safe	Safe	Meets

2. Sample Size and Data Provenance

The document does not explicitly state a separate "test set" and a "training set" in the context of an algorithm or image analysis. The data provided refers to nonclinical tests conducted to assess the material properties of the VisiPlugST (Glycoprene® MG23) against its predicate device (gut suture).

Sample Size for Test Set: Not explicitly stated for each test, but studies were conducted to compare strength and mass loss degradation rates.
Data Provenance: The studies were nonclinical tests comparing material properties. The country of origin and whether it was retrospective or prospective is not specified, but it refers to laboratory testing of materials.

3. Number of Experts and Qualifications for Ground Truth Establishment

This device is not an AI/ML device that requires expert review for ground truth establishment. The performance data is based on laboratory physical and chemical testing of the device material.

4. Adjudication Method for Test Set

Not applicable as this is not a diagnostic device requiring human reader adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI-assisted diagnostic device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the nonclinical tests was established through laboratory measurements and scientific analysis of the material properties (strength retention, mass loss) and biocompatibility of the Glycoprene® MG23 material, compared against established values and properties of the predicate device's material (gut suture).

8. Sample Size for the Training Set

Not applicable, as this device does not involve a "training set" in the context of an algorithm.

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

Not applicable.

Summary

{0}------------------------------------------------

Section 5

JUN 0 3 2014 K140026

510(k) Summary - VisiPlug - for the Lacrimal Efficiency Test

Submitted by:Telephone:Fax:	Lacrimedics, Inc.PO Box 1209434 Prune AlleyEastsound, WA 98245-1209360-376-7095360-376-7085
Contact Person:	Rebecca Cyd Dutton360-376-7095, ext. 201rdutton@lacrimedics.com
Date Summary Prepared:	June 2, 2014
Device Trade Name:	VisiPlugST for the Lacrimal Efficiency Test™
Device Common Name:	Punctum plug
Classification Name:	Punctum Plug
Product Code:	LZU
Primary Predicate Devices:	Collagen Plugs for the Lacrimal Efficiency Test510(k): K895342
Device Description:	The proposed device is an ophthalmic devicecommonly referred to as a punctum plug. It isdesigned to be placed by a practitioner into thehorizontal canaliculus to restrict the naturallubricating tears from being pumped off the eye.VisiPlugST provides temporary occlusion of thetear drainage system. The device may be used asa diagnostic aid to determine the potentialeffectiveness of long-term occlusion, totemporarily enhance the efficacy of topicalmedications or ocular lubricants, after surgery toprevent complications due to dry eyes, to evaluatetreatment of ocular dryness secondary to contactlens use, and to evaluate the dry eye componentof ocular surface diseases (OSD).VisiPlugST plugs are cylindrical in shape,approximately 1.75-2.00mm in length, andavailable in three sizes: 0.3mm, 0.4mm and0.5mm. Each plug is cut from a monofilamentstrand of Glycoprene® MG23, a synthetic surgicalgrade polymer composed of poly(glycolide-co-trimethylene carbonate-co-caprolactone).
510(k) Summary -	VisiPlugST for the Lacrimal Efficiency Test
	The monofilament is dyed with an approved coloradditive, Green D & C 6 (CAS# 128-80-3; 0.1%by weight). Titanium dioxide is added to thepolymer to make the plugs opaque, providing asatisfactory means with which to determine theplug's presence or absence following insertion by apractitioner.
Indications for Use:	VisiPlugST provide temporary occlusion of thetear drainage system. VisiPlugST may be used asa diagnostic aid to determine the potentialeffectiveness of long-term occlusion, totemporarily enhance the efficacy of topicalmedication or ocular lubricants, after surgery toprevent complications due to dry eyes, to evaluatetreatment of ocular dryness secondary to contactlens use, and to evaluate the dry eye componentof ocular surface diseases (OSD).
Differences:	The VisiPlugST Indications for Use do not namethe specific ocular surface diseases; the listedconditions in the Predicate Device Indications forUse are representative only, not all inclusive.VisiPlugST plugs are for short-term (temporary)occlusion.
Technological Characteristics:	The proposed device has the same design as thePrimary Predicate Device.
	Reference Devices:Maxon, Sterile Synthetic Absorbable Sutures510(k): K990951
	CaproSyn Suture510(k): K032586
Differences:	The Primary Predicate Device is comprised ofanimal tissue. The proposed device is comprised ofa copolymer similar to the Referenced PredicateDevices which have been approved for soft tissueapproximation and ophthalmic surgeries.
Nonclinical Tests:	Performance Data testing was conducted tocompare the strength and mass loss degradationrates of Glycoprene® MG23 to that of gut suture(material used for the Primary Predicate Device).
	The material used for the proposed device,Glycoprene® MG23, has a similar strengthretention and mass loss profile as that of thePrimary Predicate Device. Glycoprene® MG23 hasa 40% strength retention rate at 4-5 days
510(k) Summary -	VisiPlug®ST for the Lacrimal Efficiency Test
Nonclinical Tests:(continued)	compared to 40% strength retention at 3 days forgut suture. Mass loss profiles at 30 days are 46%and 45% respectively.
	Results of biocompatibility studies for VisiPlug®STfor the Lacrimal Efficiency Test indicate theproposed device is safe.
Conclusions:	The proposed device has the same design,performance and safety profile as that of thePrimary Predicate Device and is thereforesubstantially equivalent.

{1}------------------------------------------------

{2}------------------------------------------------

Section 5 (continued)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. .

and the control control control of the control of the controlled

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings or feathers. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-00002

June 3, 2014

Lacrimedies, Inc. Ms. Rebecca Dutton Director of Operations 434 Prune Allev Eastsound. WA 98245

Re: K140026

Trade/Device Name: VisiPlug" gr for the Lacrimal Efficiency Test (Models 1813, 1814, and 1815) Regulation Number: Preamendment

Regulation Name: Preamendment Regulatory Class: Unclassified Product Code: LZU Dated: April 21, 2014 · Received: April 24, 2014

Dear Ms. Dutton:

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. 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 cither 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.

{4}------------------------------------------------

Page 2 - Ms. Rebecca Dutton

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); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Deborah L. Falls -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): K140026

Device Name: VisiPlugg

Indications for Use:

VisiPlugg, provide temporary occlusion of the tear drainage
system. VisiPlugs, may be used 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 surgery to prevent complications due to dry eyes, .
to evaluate treatment of ocular dryness secondary to contact . lens use,
and to evaluate the dry eye component of ocular surface ● diseases (OSD).

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Page 10

Claudine H. Krawczyk -S 2014.06.03 16:29:45 -04'00'

Regulation Number and Section

N/A