(155 days)
Not Found
No
The device description and performance studies focus on the physical properties and clinical efficacy of a hydrogel plug for tear drainage occlusion. There is no mention of AI or ML in the text.
Yes
The device is intended to treat dry eye symptoms by blocking tear drainage, which is a therapeutic purpose.
No.
The device is intended to block tear drainage and maintain tears on the eye surface, which is a treatment for dry eye symptoms, not a diagnostic function.
No
The device is a physical canalicular plug made of hydrogel, designed for insertion into the eyelid. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "block tear drainage by occlusion of the canalicular system" to treat dry eye symptoms. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical plug inserted into the canaliculus. It does not analyze biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, detection of substances, or providing information about a disease state based on in vitro testing.
The device is a medical device used for treatment, not for diagnosis.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LZU
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
canaliculus
Indicated Patient Age Range
age 22 or older
Intended User / Care Setting
healthcare practitioner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A. NON-CLINICAL TESTING
Non-clinical investigations included biocompatibility and physicochemical testing, as well as in vivo studies to establish the safety of the device.
The following battery of tests were conducted on the Visant Medical Canalicular Plug:
Cytotoxicity: ISO 10993-5: 2009, Non-cytotoxic
Genotoxicity: ISO 10993-3: 2014: Ames Mutagenicity, Non-mutagenic . Chromosomal Aberration, Non-mutagenic
Systemic Toxicity: ISO 10993-11: 2017. No acute toxicity .
Material Mediated Pyrogenicity: ISO 10993-11:2017, USP , Non-pyrogenic ●
Guinea Pig Maximization Skin Sensitization: ISO 10993-10: 2010/(R)2014, Non-● sensitizing
Intracutaneous Reactivity: ISO 10993-10: 2010/(R)2014. Saline extract caused skin ● irritation, similar to that observed with other commercially available crosslinked HA products, below a level of concern
Ocular Irritation: ISO 10993-10: 2010/(R)2014, Non-irritating ●
Pre-sterilization Bioburden Determination, ISO 11737-1:2018
Endotoxin (Limulus Amoebocyte Lysate, LAL): USP , AAMI ST72, meets ● the
N/A
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
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.
1
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
Image /page/1/Picture/9 description: The image shows the letters FDA in a light blue color. The letters are large and take up most of the image. The background is white.
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
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) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
3
| 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.
4
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.
When indicated, the Hydrogel
Canalicular Plug may be used after
surgery of the eye to prevent
complications due to dry eye and to
enhance the retention of ocular
medications on the eye. Patients |
VISANT MEDICAL, INC. CANALICULAR PLUG 510(K) SUBSTANTIAL EQUIVALENCE COMPARISON
5
| SUBJECT DEVICE | PREDICATE DEVICE | |
|---|---|---|
| Visant Medical Canalicular Plug | Form Fit® Hydrogel Canalicular | |
| Plug | ||
| K040912 | ||
| experiencing dry eye related contact | ||
| lens problems may also be aided by the | ||
| Hydrogel Canalicular Plug. | ||
| Principle of Operation | Inserted into the canalicular system as a | |
| hydrated, cross-linked, particulated | ||
| hydrogel plug. The gelatinous material | ||
| fills the lumen in order to block tear | ||
| drainage through the lacrimal drainage | ||
| system. | Inserted into the canalicular system as a | |
| dry hydrogel plug and swells to form a | ||
| gelatinous material when it contacts tear | ||
| film. The gelatinous material fills the | ||
| lumen in order to block tear drainage | ||
| through the lacrimal drainage system. | ||
| Plug Material | Hydrogel (Cross-linked, particulated | |
| hyaluronic acid gel) | Hydrogel (semi-rigid rod of polyvinyl | |
| pyrrolidone based hydrogel) | ||
| Biocompatibility | ||
| Established | Yes | Yes |
| Preloaded (Yes/No) | Yes (prefilled syringe) | Yes (preloaded on an inserter) |
| Removable (Yes/No) | Yes, particulated, gelatinous, non- | |
| degradable material can be removed via | ||
| irrigation of the canalicular system | Yes, gelatinous, non-degradable | |
| material can be removed via irrigation | ||
| of the canalicular system | ||
| Sizes | No need for individual sizing. Upon | |
| insertion, it fills the lumen. | No need for individual sizing. | |
| In its dry state, measures 0.3 mm in | ||
| diameter by 2.5 mm long. In its | ||
| hydrated state, it fills the lumen. | ||
| Sterilization | Steam | Gamma |
The Visant Medical Canalicular Plug and the predicate device do not share identical technological characteristics, however, those differences do not raise different types of questions of safety and effectiveness.
The Visant Canalicular Plug and the predicate device share the same mechanism of action and are made from gelatinous material that fills the lumen in order to block tear drainage through the lacrimal drainage system. Both plugs are composed of biocompatible, sterilized, non-degradable hydrogel materials that do not require individualized sizing and that can be removed via irrigation of the canaliculus.
6
VII. PERFORMANCE DATA
A. NON-CLINICAL TESTING
Non-clinical investigations included biocompatibility and physicochemical testing, as well as in vivo studies to establish the safety of the device.
The following battery of tests were conducted on the Visant Medical Canalicular Plug:
- . Cytotoxicity: ISO 10993-5: 2009, Non-cytotoxic
- Genotoxicity: ISO 10993-3: 2014: Ames Mutagenicity, Non-mutagenic . Chromosomal Aberration, Non-mutagenic
- Systemic Toxicity: ISO 10993-11: 2017. No acute toxicity .
- Material Mediated Pyrogenicity: ISO 10993-11:2017, USP , Non-pyrogenic ●
- Guinea Pig Maximization Skin Sensitization: ISO 10993-10: 2010/(R)2014, Non-● sensitizing
- Intracutaneous Reactivity: ISO 10993-10: 2010/(R)2014. Saline extract caused skin ● irritation, similar to that observed with other commercially available crosslinked HA products, below a level of concern
- Ocular Irritation: ISO 10993-10: 2010/(R)2014, Non-irritating ●
- Pre-sterilization Bioburden Determination, ISO 11737-1:2018
- Endotoxin (Limulus Amoebocyte Lysate, LAL): USP , AAMI ST72, meets ● the