(237 days)
The Soft Plug® Extended Duration 180 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.
The OASIS Medical SOFT PLUG® Extended Duration 180 Canalicular Plug is a mid-term implant 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 absorbable polydioxanone monofilament colored violet with D&C No. 2. The plugs are 2.0mm long and available in 0.2mm, 0.3mm, 0.4mm, and 0.5mm diameters.
The provided text is a 510(k) premarket notification for a medical device called "Soft Plug Extended Duration 180 Canalicular Plug." This document focuses on demonstrating substantial equivalence to an already legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria for a novel technology through a clinical study with defined endpoints like accuracy, sensitivity, or specificity.
Therefore, the information typically requested in your prompt regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, is not present in this type of regulatory submission.
This 510(k) summary primarily discusses:
- Device Description: What the device is (a mid-term absorbable plug for tear drainage), its material (polydioxanone monofilament), dimensions, and how it's used.
- Intended Use: The temporary treatment of dry eye, enhancement of topical medications, treatment of contact lens intolerance, treatment of dry eye after ocular surgery, and determination of potential effectiveness of permanent occlusion.
- Comparison to Predicate Device: It states "There are no differences in the material used for these devices," "There are no differences in the design of these devices," and "There are no differences in the function of these devices." This is the core of its claim for substantial equivalence.
- Non-Clinical Testing: This section details engineering and biocompatibility testing rather than clinical performance metrics. These tests include:
- Shelf life testing: Demonstrated 9% loss of tensile strength after two years equivalent storage, noting a 20% loss would shorten absorption time by 10-15%.
- Chemical characterization and biocompatibility testing: Performed according to ISO 10993-18:2005 and ISO 10993-1:2009, concluding that exposure levels of compounds are safe.
- Product adoption study: For sterilization according to ANSI/AAMI/ISO 11135:2014, with ethylene oxide residuals reduced per ISO 10993-7:2008.
- Bacterial endotoxin testing: Below 20 EU/device.
- Shipping study: In accordance with ISO 11607:2016, ASTM D4169-13, and ISTA 2A 2011, showing no damage to pouched product despite minor carton damage.
In summary, the provided document does not contain the information required to fill out your requested table or answer most of your detailed questions because it's a 510(k) summary for a substantial equivalence claim, relying on non-clinical testing and direct comparison to a predicate device, not on a clinical performance study with AI or diagnostic accuracy metrics.
Therefore, I cannot provide the requested table or answer the specific questions about clinical performance, AI, or human reader studies. The document states that "No additional questions of safety and effectiveness are raised due to material, design, or function," and that non-clinical performance tests "demonstrate that the SOFT PLUG® Extended Duration 180 Canalicular Plug is as safe and effective as the predicate device, and is substantially equivalent to the predicate device." This is the "proof" provided within this type of regulatory submission.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 17, 2017
Oasis Medical, Inc. % James Christensen New Product Development 514 S. Vermont Avenue Glendora, CA 91741
Re: K162361
Trade/Device Name: Soft Plug Extended Duration 180 Canalicular Plug Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: LZU Dated: March 6, 2017 Received: March 10, 2017
Dear James Christensen:
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 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 devicerelated 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" (21 CFR 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,
Denise L. Hampton -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) K162361
Device Name
Soft Plug® Extended Duration 180 Canalicular Plug
Indications for Use (Describe) Indications for Use:
The Soft Plug® Extended Duration 180 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.
Type of Use (Select one or both, as applicable)
| For Transportation (49 CFR 390 Subpart E) |
|---|
| For On-Site Construction (49 CFR 390 Subpart F) |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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5. 510(k) SUMMARY
| Applicant's Name andAddress: | OASIS Medical, Inc.514 S. Vermont Ave.Glendora, CA 91741 |
|---|---|
| Contact Person: | James ChristensenNew Product Development(626) 852-5156 |
| Date Prepared: | March 6, 2017 |
| Device Trade Name: | SOFT PLUG® Extended Duration 180 Canalicular Plug |
| Common Name: | Intracanalicular Plug |
| Regulation Number: | Unclassified |
| Regulation Name: | Plug, Punctum |
| Regulatory Class: | Unclassified |
| Product Code: | LZU |
| FDA Panel: | Ophthalmic |
| Predicate Device: | K150288 – PDO Absorbable Punctal Plug |
| Device DescriptionSummary: | The OASIS Medical SOFT PLUG® Extended Duration180 Canalicular Plug is a mid-term implant designed to beinserted through the punctal opening into the canaliculus inorder to block tear drainage through the lacrimal drainagesystem for approximately 180 days. The plugs are made fromabsorbable polydioxanone monofilament colored violet withD&C No. 2. The plugs are 2.0mm long and available in 0.2mm,0.3mm, 0.4mm, and 0.5mm diameters. |
| Indications For Use: | The SOFT PLUG® Extended Duration 180 Canalicular Plugsare intended to temporarily block tear drainage by the occlusionof the canaliculus in order to - Temporarily treat dry eyesyndrome, and the dry eye components of various ocular surfacediseases, - Temporarily enhance the efficacy of topicalmedications or ocular lubricants, - Temporarily treat contactlens intolerance secondary to dry eye, - Temporarily treat dryeye after ocular surgery, and - Determine the potentialeffectiveness of permanent occlusion. |
| Summary of TechnologyCharacteristics: | There are no differences in the material used for these devices.The plugs are cut from polydioxanone monofilament which is apolymerized composition of p-dioxanone monomer and D&CViolet Number 2 dye.There are no differences in the design of these devices. Theplugs are 2.0mm long. The plugs are available in fourdiameters: 0.2mm, 0.3mm, 0.4mm, and 0.5mm which are basedon USP synthetic absorbable suture diameters.The plugs are designed to be inserted through the punctalopening and reside in the canaliculus until these are absorbed.There are no differences in the function of these devices.No additional questions of safety and effectiveness are raiseddue to material, design, or function. |
| Summary of Non-clinicalTesting: | Accelerated shelf life testing conducted on ethylene oxidesterilized product showed an average loss of tensile strength of9% across all plug diameters after two years equivalent storagein foil pouches. A loss of 20% in tensile strength represents anapproximate 10-15% shortening of the 120-180 day absorptionperiod in the body.Chemical characterization and biocompatibility testing wereperformed in accordance with ISO 10993-18:2005 and ISO10993-1:2009. Based on a toxicological risk assessment, thelikely exposure level of all compounds found are present atlevels that can be considered safe and acceptable.A Product Adoption Study performed in accordance withANSI/AAMI/ISO 11135:2014 was performed to adopt theproduct into the Product Family currently sterilized by avalidated ethylene oxide cycle. Ethylene oxide residuals havebeen reduced below the levels of concern in accordance withISO 10993-7:2008.Bacterial endotoxin testing conducted on similar plug productsmanufactured, packaged and sterilized in a similar manner, hasbeen shown to be below 20 EU/device in accordance with USP<85> in 39-NF34:2016.A shipping study was performed in accordance with ISO11607:2016, ASTM D4169-13 and ISTA 2A 2011. There wassome damage to the corrugated outer case and minor damage tosome of the chipboard cartons, but there was no damage to thepouched product or loss of plugs from their foam holders |
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Substantial Equivalence The conclusions drawn from non-clinical performance tests demonstrate that the SOFT PLUG® Extended Duration 180 Basis: Canalicular Plug is as safe and effective as the predicate device, and is substantially equivalent to the predicate device.
N/A