(237 days)
Not Found
No
The device description and performance studies focus on the material properties and physical function of a canalicular plug, with no mention of AI or ML.
Yes
The device is intended to temporarily block tear drainage to address medical conditions such as dry eye syndrome and to enhance the efficacy of topical medications, which are therapeutic interventions.
No
The device is a medical implant intended to treat certain conditions (e.g., dry eye, enhance medication efficacy) by blocking tear drainage. It is not described as gathering or analyzing data to diagnose a medical condition.
No
The device description clearly states it is a physical implant made from polydioxanone monofilament, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The Soft Plug® Extended Duration 180 Canalicular Plugs are physical implants inserted into the body (specifically, the canaliculus) to block tear drainage. They do not analyze or test any bodily fluids or tissues.
- Intended Use: The intended uses all involve a physical intervention within the body to manage tear drainage, not to diagnose a condition through laboratory testing.
Therefore, based on the provided information, this device is a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LZU
Device Description
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.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Non-clinical Testing:
- Accelerated shelf life testing: showed an average loss of tensile strength of 9% across all plug diameters after two years equivalent storage in foil pouches. A loss of 20% in tensile strength represents an approximate 10-15% shortening of the 120-180 day absorption period in the body.
- Chemical characterization and biocompatibility testing: performed in accordance with ISO 10993-18:2005 and ISO 10993-1:2009. Based on a toxicological risk assessment, the likely exposure level of all compounds found are present at levels that can be considered safe and acceptable.
- Product Adoption Study: performed in accordance with ANSI/AAMI/ISO 11135:2014 to adopt the product into the Product Family currently sterilized by a validated ethylene oxide cycle. Ethylene oxide residuals have been reduced below the levels of concern in accordance with ISO 10993-7:2008.
- Bacterial endotoxin testing: conducted on similar plug products manufactured, packaged and sterilized in a similar manner, has been shown to be below 20 EU/device in accordance with USP in 39-NF34:2016.
- Shipping study: performed in accordance with ISO 11607:2016, ASTM D4169-13 and ISTA 2A 2011. There was some damage to the corrugated outer case and minor damage to some of the chipboard cartons, but there was no damage to the pouched product or loss of plugs from their foam holders.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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.
1
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
2
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)
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 PRAStaff(@fda.hhs.gov
"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
5. 510(k) SUMMARY
| Applicant's Name and
Address: | OASIS Medical, Inc.
514 S. Vermont Ave.
Glendora, CA 91741 |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | James Christensen
New 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 Description
Summary: | 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. |
| 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. |
| Summary of Technology
Characteristics: | There are no differences in the material used for these devices.
The plugs are cut from polydioxanone monofilament which is a
polymerized composition of p-dioxanone monomer and D&C
Violet Number 2 dye.
There are no differences in the design of these devices. The
plugs are 2.0mm long. The plugs are available in four
diameters: 0.2mm, 0.3mm, 0.4mm, and 0.5mm which are based
on USP synthetic absorbable suture diameters.
The plugs are designed to be inserted through the punctal
opening 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 raised
due to material, design, or function. |
| Summary of Non-clinical
Testing: | Accelerated shelf life testing conducted on ethylene oxide
sterilized product showed an average loss of tensile strength of
9% across all plug diameters after two years equivalent storage
in foil pouches. A loss of 20% in tensile strength represents an
approximate 10-15% shortening of the 120-180 day absorption
period in the body.
Chemical characterization and biocompatibility testing were
performed in accordance with ISO 10993-18:2005 and ISO
10993-1:2009. Based on a toxicological risk assessment, the
likely exposure level of all compounds found are present at
levels that can be considered safe and acceptable.
A Product Adoption Study performed in accordance with
ANSI/AAMI/ISO 11135:2014 was performed to adopt the
product into the Product Family currently sterilized by a
validated ethylene oxide cycle. Ethylene oxide residuals have
been reduced below the levels of concern in accordance with
ISO 10993-7:2008.
Bacterial endotoxin testing conducted on similar plug products
manufactured, packaged and sterilized in a similar manner, has
been shown to be below 20 EU/device in accordance with USP
in 39-NF34:2016.
A shipping study was performed in accordance with ISO
11607:2016, ASTM D4169-13 and ISTA 2A 2011. There was
some damage to the corrugated outer case and minor damage to
some of the chipboard cartons, but there was no damage to the
pouched product or loss of plugs from their foam holders |
4
5
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.