COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST

K140026 · Lacrimedics, Inc. · LZU · Jun 3, 2014 · OP

Device Facts

• Record ID: K140026
• Device Name: COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST
• Applicant: Lacrimedics, Inc.
• Product Code: LZU · OP
• Decision Date: Jun 3, 2014
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

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 Story

VisiPlugST is a synthetic, absorbable punctum plug designed for temporary occlusion of the lacrimal drainage system. The device is a small, cylindrical monofilament (1.75-2.00mm length; 0.3-0.5mm diameter) inserted by a practitioner into the horizontal canaliculus. It restricts tear drainage to increase ocular surface moisture. The plug is composed of Glycoprene MG23 (poly(glycolide-co-trimethylene carbonate-co-caprolactone)) and contains Green D & C 6 dye and titanium dioxide for visibility. The device is used in clinical settings to aid diagnosis of dry eye, manage post-surgical complications, or enhance medication efficacy. Practitioners use the device's opacity to confirm placement. The device provides a temporary benefit by retaining tears on the ocular surface, assisting in clinical decision-making regarding long-term treatment options.

Clinical Evidence

Bench testing only. Performance data compared the strength retention and mass loss degradation rates of Glycoprene MG23 to gut suture material. Results showed Glycoprene MG23 has a 40% strength retention at 4-5 days (vs 3 days for gut) and 46% mass loss at 30 days (vs 45% for gut). Biocompatibility studies confirmed the safety of the device materials.

Technological Characteristics

Cylindrical punctum plug; 1.75-2.00mm length; 0.3mm, 0.4mm, 0.5mm diameters. Material: Glycoprene MG23 (poly(glycolide-co-trimethylene carbonate-co-caprolactone)). Additives: Green D & C 6 dye (CAS# 128-80-3) and titanium dioxide for opacity. Mechanical insertion by practitioner. Synthetic, absorbable polymer.

Indications for Use

Indicated for patients requiring temporary occlusion of the tear drainage system for diagnostic assessment of long-term occlusion, enhancement of topical medication/lubricant efficacy, post-surgical dry eye prevention, contact lens-related dryness, or evaluation of dry eye components of ocular surface diseases.

Predicate Devices

• Collagen Plugs for the Lacrimal Efficiency Test (K895342)

Reference Devices

• Maxon, Sterile Synthetic Absorbable Sutures (K990951)
• CaproSyn Suture (K032586)

Submission Summary (Full Text)

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### Section 5

JUN 0 3 2014 K140026

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

| Submitted by:<br>Telephone:<br>Fax: | Lacrimedics, Inc.<br>PO Box 1209<br>434 Prune Alley<br>Eastsound, WA 98245-1209<br>360-376-7095<br>360-376-7085 |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Rebecca Cyd Dutton<br>360-376-7095, ext. 201<br>[e-mail] |
| 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 Test<br>510(k): K895342 |
| Device Description: | The proposed device is an ophthalmic device<br>commonly referred to as a punctum plug. It is<br>designed to be placed by a practitioner into the<br>horizontal canaliculus to restrict the natural<br>lubricating tears from being pumped off the eye.<br><br>VisiPlugST provides temporary occlusion of the<br>tear drainage system. The device may be used as<br>a diagnostic aid to determine the potential<br>effectiveness of long-term occlusion, to<br>temporarily enhance the efficacy of topical<br>medications or ocular lubricants, after surgery to<br>prevent complications due to dry eyes, to evaluate<br>treatment of ocular dryness secondary to contact<br>lens use, and to evaluate the dry eye component<br>of ocular surface diseases (OSD).<br><br>VisiPlugST plugs are cylindrical in shape,<br>approximately 1.75-2.00mm in length, and<br>available in three sizes: 0.3mm, 0.4mm and<br>0.5mm. Each plug is cut from a monofilament<br>strand of Glycoprene® MG23, a synthetic surgical<br>grade polymer composed of poly(glycolide-co-<br>trimethylene carbonate-co-caprolactone). |
| 510(k) Summary - | VisiPlugST for the Lacrimal Efficiency Test |
| | The monofilament is dyed with an approved color<br>additive, Green D & C 6 (CAS# 128-80-3; 0.1%<br>by weight). Titanium dioxide is added to the<br>polymer to make the plugs opaque, providing a<br>satisfactory means with which to determine the<br>plug's presence or absence following insertion by a<br>practitioner. |
| Indications for Use: | VisiPlugST provide temporary occlusion of the<br>tear drainage system. VisiPlugST may be used as<br>a diagnostic aid to determine the potential<br>effectiveness of long-term occlusion, to<br>temporarily enhance the efficacy of topical<br>medication or ocular lubricants, after surgery to<br>prevent complications due to dry eyes, to evaluate<br>treatment of ocular dryness secondary to contact<br>lens use, and to evaluate the dry eye component<br>of ocular surface diseases (OSD). |
| Differences: | The VisiPlugST Indications for Use do not name<br>the specific ocular surface diseases; the listed<br>conditions in the Predicate Device Indications for<br>Use are representative only, not all inclusive.<br>VisiPlugST plugs are for short-term (temporary)<br>occlusion. |
| Technological Characteristics: | The proposed device has the same design as the<br>Primary Predicate Device. |
| | Reference Devices:<br>Maxon, Sterile Synthetic Absorbable Sutures<br>510(k): K990951 |
| | CaproSyn Suture<br>510(k): K032586 |
| Differences: | The Primary Predicate Device is comprised of<br>animal tissue. The proposed device is comprised of<br>a copolymer similar to the Referenced Predicate<br>Devices which have been approved for soft tissue<br>approximation and ophthalmic surgeries. |
| Nonclinical Tests: | Performance Data testing was conducted to<br>compare the strength and mass loss degradation<br>rates of Glycoprene® MG23 to that of gut suture<br>(material used for the Primary Predicate Device). |
| | The material used for the proposed device,<br>Glycoprene® MG23, has a similar strength<br>retention and mass loss profile as that of the<br>Primary Predicate Device. Glycoprene® MG23 has<br>a 40% strength retention rate at 4-5 days |
| 510(k) Summary - | VisiPlug®ST for the Lacrimal Efficiency Test |
| Nonclinical Tests:<br>(continued) | compared to 40% strength retention at 3 days for<br>gut suture. Mass loss profiles at 30 days are 46%<br>and 45% respectively. |
| | Results of biocompatibility studies for VisiPlug®ST<br>for the Lacrimal Efficiency Test indicate the<br>proposed device is safe. |
| Conclusions: | The proposed device has the same design,<br>performance and safety profile as that of the<br>Primary Predicate Device and is therefore<br>substantially equivalent. |

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and the control control control of the control of the controlled

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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.

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#### 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 [phone] or [phone] 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 [phone] or [phone] 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

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## 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)

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