← Product Code LZU · K222164
# Visant Medical Canalicular Plug (K222164)
_Visant Medical, Inc. · LZU · Dec 23, 2022 · OP · SESE_
**Canonical URL:** https://fda.innolitics.com/device/K222164
## Device Facts
- **Applicant:** Visant Medical, Inc.
- **Product Code:** LZU
- **Decision Date:** Dec 23, 2022
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** OP
- **Attributes:** Therapeutic
## Intended Use
The Visant Medical Canalicular Plug is intended to block tear drainage by occlusion of the canalicular system. It is indicated for use, for up to 6 months, in patients experiencing dry eye symptoms.
## Device Story
Visant Medical Canalicular Plug is a transparent, cross-linked hyaluronic acid hydrogel device designed to temporarily block tear drainage by occluding the canalicular system. The device is supplied in a 0.6 mL gel-filled syringe. A healthcare practitioner inserts 0.2 mL of the gel into the patient's lower canaliculus using a lacrimal cannula. The gelatinous material fills the lumen to maintain surface lubrication. The device is non-degradable and can be removed via irrigation of the canalicular system. It is intended for use in a clinical setting by a physician or qualified healthcare provider. The device provides a mechanical barrier to tear drainage, which helps retain ocular surface moisture and may benefit patients with dry eye syndrome. Clinical decision-making is supported by the practitioner's assessment of dry eye symptoms and lacrimal system patency.
## Clinical Evidence
Prospective, multicenter, randomized, double-masked, controlled trial (n=157). Participants (mean age 62.9) with dry eye syndrome were randomized 2:1 to Visant (n=103) or Oasis Form Fit (n=54). Primary endpoints included Schirmer's test scores and OSDI questionnaire improvement. At Month 3, mean change in Schirmer's score was 3.40±7.54 mm (Visant) vs 1.78±5.44 mm (control). OSDI improvement (≥4.5/7.3 points) was achieved by 83.8% of Visant and 84.6% of control participants. Safety profile was comparable; adverse events were mostly mild.
## Technological Characteristics
Material: Cross-linked, particulated hyaluronic acid hydrogel. Form factor: Gel-filled syringe (0.6 mL). Principle: Mechanical occlusion of the canaliculus via hydrated gel. Connectivity: None. Sterilization: Steam (SAL 10^-6). Biocompatibility: ISO 10993 compliant.
## Predicate Devices
- Oasis Form Fit ([K040912](/device/K040912.md))
## Submission Summary (Full Text)
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December 23, 2022
Visant Medical, Inc. % Lee Kramm, M.D., M.S.E. President, Chief Strategist and Medical Officer Regulatory Pathways Group Inc. 340 S. Lemon Ave Walnut, CA 91789-2706
Re: K222164
Trade/Device Name: Visant Medical Canalicular Plug Regulatory Class: Unclassified Product Code: LZU Dated: November 23, 2022 Received: November 25, 2022
Dear Lee Kramm, M.D., M.S.E.:
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.
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.
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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/guidance-regulatoryinformation/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 titled, "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 mediation-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/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 -S
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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
K222164
Device Name Visant Medical Canalicular Plug
Indications for Use (Describe)
The Visant Medical Canalicular Plug is intended to block tear drainage by occlusion of the canalicular system. It is indicated for use, for up to 6 months, in patients experiencing dry eye symptoms.
| Type of Use (Select one or both, as applicable) |
| | |
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| I. | SUBMITTER | |
|------|-----------------------------------------|-------------------------------------------------------------------------------------------------|
| | APPLICANT: | Visant Medical, Inc. 801 Hermosa Way Menlo Park, CA, 94025 (650) 867-2957 |
| | OFFICIAL CORRESPONDENT: | Lee Kramm Regulatory Pathways Group Inc. (720) 252-8488 lkramm@regulatorypathways.com) |
| | DATE SUMMARY PREPARED: | December 22, 2022 |
| II. | DEVICE | |
| | TRADE NAME: | Visant Medical Canalicular Plug |
| | COMMON NAME: | Canalicular Plug |
| | DEVICE CLASSIFICATION / PRODUCT CODE | Unclassified LZU |
| III. | PREDICATE DEVICE | |
| PREDICATE DEVICE: | Oasis Form Fit |
|--------------------------|--------------------------------|
| | K040912 |
| | Partners in Biomaterials, Inc. |
# IV. DEVICE DESCRIPTION
The Visant Medical Canalicular Plug is designed to temporarily block tear drainage by the occlusion of the canaliculus of one or both eyelids in a given patient, thus maintaining lubricating tears on the surface of the eye. The Visant Plug consists of a transparent hydrogel, manufactured from cross-linked hyaluronic acid, that is designed for insertion into the canaliculus.
The Visant Medical Canalicular Plug is inserted into the lower canaliculus of the patient's eyelid by the healthcare practitioner, using a commercially available lacrimal cannula attached to the 0.6 mL gel-filled syringe which pushes the gel into the lower punctum until the recommended volume of gel (0.2 mL) is inserted.
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#### INTENDED USE AND INDICATIONS FOR USE V.
The Visant Medical Canalicular Plug has the same intended use as the predicate. It is intended to temporarily block tear drainage by the occlusion of the canalicular system. The Visant Medical Canalicular Plug will have the following Indications for Use (IFU) statement:
The Visant Medical Canalicular Plug is intended to block tear drainage by occlusion of the canalicular system. It is indicated for use, for up to 6 months, in patients experiencing dry eye symptoms.
The IFU statement for the Visant Medical Canalicular Plug is not substantially different from that of the predicate device.
# VI. TECHNOLOGICAL CHARACTERISTICS COMPARISON
A comparison of the key characteristics of the subject and predicate devices are presented in the following table.
| | SUBJECT DEVICE | PREDICATE DEVICE |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Visant Medical Canalicular Plug | Form Fit® Hydrogel Canalicular Plug K040912 |
| Manufacturer | Visant Medical | Partners in Biomaterials, Inc. (Oasis Medical) |
| Product Code(s) | LZU | LZU |
| Intended Use | To block tear drainage by the occlusion of the of the canalicular system. | To block tear drainage by the occlusion of the of the canalicular system. |
| IFU statement | The Visant Medical Canalicular Plug is intended to block tear drainage by occlusion of the canalicular system. It is indicated for use, for up to 6 months, in patients experiencing dry eye symptoms | The Hydrogel Canalicular Plug is intended for use in patients experiencing dry eye symptoms such as redness, burning, reflex tearing, itching, or foreign body sensations, which can be relieved by blocking of the punctum.
The Hydrogel Canalicular Plug may be used in the treatment of dry eye syndrome and the dry eye component of various ocular surface diseases.