(165 days)
No
The summary describes a physical medical device (canalicular plug) and its material properties and performance studies related to biocompatibility and degradation. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended to temporarily treat dry eye syndrome and related conditions by occluding the canaliculus, which directly addresses a medical condition.
No
The canalicular plug is intended to physically block tear flow to treat dry eye symptoms and enhance medication efficacy, not to diagnose a condition. Its use for "determining the potential effectiveness of permanent occlusion" is a step in treatment planning, not a diagnostic act in itself.
No
The device description clearly states the device is a physical plug made from degradable polydioxanone monofilament, designed for insertion into the canaliculus. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
- Device Function: The SOFT PLUG Extended Duration 180 Canalicular Plugs are physical devices inserted into the body (specifically, the canaliculus) to block tear flow. They are a therapeutic device, not a diagnostic one.
- Intended Use: The intended uses listed are all related to treating or managing dry eye and related conditions by physically altering tear drainage. None of the uses involve analyzing samples from the body to diagnose a condition.
Therefore, based on the provided information, this device is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SOFT PLUG® Extended Duration 180 Canalicular Plugs and the SOFT PLUG® Extended Duration 180 Tapered Canalicular Plugs are intended to temporarily block tear drainage 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.
Product codes
LZU
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
canaliculus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Biocompatibility testing from the predicate device premarket 510(k) submission K162361, SOFT PLUG® Extended Duration 180 Canalicular Plug, is leveraged as applicable for this device.
Cytotoxicity testing performed in accordance with ISO 10993-5 supports that the manufacturing process to form the tapered end of the plug does not affect the toxicology of the device compared to the predicate device
Accelerated in-vitro degradation studies in accordance with ASTM F1635 supports that the manufacturing process to form the tapered end of the plug does not affect the degradation rate of 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 is suitable for use and the sterile barrier is not affected by the revised product design.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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)
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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) SUMMARY
| Applicant's Name and
Address: | OASIS Medical, Inc.
514 S. Vermont Ave.
Glendora, CA 91741 |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | James Christensen
Director 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: | K162361
SOFT PLUG® Extended Duration 180 Canalicular Plug |
| Device Description
Summary: | 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. |
| Indications For Use: | The SOFT PLUG® Extended Duration 180 Canalicular Plugs
and the SOFT PLUG® Extended Duration 180 Tapered
Canalicular Plugs are intended to temporarily block tear
drainage 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. |
| Summary of Technology
Characteristics: | There are no differences in the material used for this device and
the predicate device. Both devices are formed from
polydioxanone monofilament which is a polymerized
composition of p-dioxanone monomer and D&C Violet Number
2 dye. |
| | There are differences in the geometry of this devise compared to
the predicate device. Both style plugs are 2.0mm long. The
tapered style plug has a base diameter of 0.6mm with one end of
the plug tapered and the other end flat. The predicate device is a
cylindrical style plug having a range of diameters from 0.3mm
to 0.5mm with both ends of the plug flat. |
| | Both style plugs are designed to be inserted through the punctal
opening and reside in the canaliculus until they degrade. The
angle of the tapered end of the tapered style plug approximates
the angle of a punctal dilator, a device used to enlarge the
punctal opening to ease insertion of a plug. |
| | There are no differences in the function of these devices. No
additional questions of safety and effectiveness are raised due to
material, design, or function. |
| Summary of Non-clinical
Testing: | Biocompatibility testing from the predicate device premarket
510(k) submission K162361, SOFT PLUG® Extended Duration
180 Canalicular Plug, is leveraged as applicable for this device. |
| | Cytotoxicity testing performed in accordance with ISO 10993-5
supports that the manufacturing process to form the tapered end
of the plug does not affect the toxicology of the device
compared to the predicate device |
| | Accelerated in-vitro degradation studies in accordance with
ASTM F1635 supports that the manufacturing process to form
the tapered end of the plug does not affect the degradation rate
of 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 is
suitable for use and the sterile barrier is not affected by the
revised product design. |
| Substantial Equivalence
Basis: | The conclusions drawn from non-clinical performance tests
demonstrate that the SOFT PLUG® Extended Duration 180
Tapered Canalicular Plug is as safe and effective as the
predicate device, and is substantially equivalent to the predicate
device. |
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