(274 days)
The VeraPlug™ Punctal Plug is for use in patients with dry eye syndromes.
The VeraPlug™ Punctal Plug is designed to provide reduction or elimination of tear drainage through the inferior or superior puncta, thus maintaining lubricating tears on the surface of the eye. Each VeraPlug™ Punctal Plug is molded from medical grade silicone. The VeraPlug™ Punctal Plug is available in 3 sizes (small, medium, and large) and is packaged 2 per/box. Each plug is sterile and preloaded on an inserter.
The inserter is manufactured using medical grade ABS (acrylonitrile butadiene styrene), and 304 stainless steel.
Here's the analysis of the provided text regarding the acceptance criteria and supporting study for the VeraPlug™ Punctal Plug:
This document is a 510(k) premarket notification for a medical device called the VeraPlug™ Punctal Plug. It aims to demonstrate substantial equivalence to a predicate device, not necessarily to establish de novo acceptance criteria for a novel device. Therefore, the "acceptance criteria" discussed relate to demonstrating this equivalence rather than setting performance thresholds for a new technological concept.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (VeraPlug™ Punctal Plug) |
|---|---|---|
| Intended Use | "For use in patients with dry eye syndromes," consistent with the predicate device which treats "dry eye" syndrome to enhance tear contact time and make eye drops more effective. | The VeraPlug™ Punctal Plug is for use in patients with dry eye syndromes. (Matches predicate) |
| Material | Medical Grade Silicone | Medical Grade Silicone (Matches predicate) |
| Sterility | Device must be sterile. | Yes (Matches predicate); Sterility testing completed via validated ETO sterilization cycle. |
| Design (Shape) | Similar design shape with a conical shaped nose (distal end), a shaft, and a dome-shaped proximal end, comparable to the predicate. | Has a similar design shape with a conical shaped nose (distal end), a shaft, and a dome shaped proximal end. (Comparable to predicate) |
| Design (Nose Diameter) | Within cleared nose diameter ranges of the predicate device (Small: 0.75mm, Medium: 0.88mm, Large: 1.01mm). | Small: 0.76mm, Medium: 0.89mm, Large: 1.02mm (All within ~0.01mm of predicate, deemed "within cleared nose diameter ranges") |
| Design (Overall Length) | Within cleared overall length ranges of the predicate device (Small: 1.63mm, Medium: 1.80mm, Large: 1.93mm). | Small: 1.65mm, Medium: 1.83mm, Large: 2.00mm (All within ~0.02-0.07mm of predicate, deemed "within cleared overall length ranges") |
| Mechanical Performance | Must pass a simulated implantation stretch test, similar to the predicate device. | Passed (Matches predicate) |
| Biocompatibility | Must be biocompatible for its intended use. | Biocompatibility testing was deemed unnecessary as the material (medical grade silicone) has a long-standing history of biocompatibility for punctal occluders. |
| ETO Residuals | Ethylene Oxide residuals must meet safety standards. | Testing performed and demonstrated safety. |
| Microorganisms | The product must meet standards for the population of microorganisms (bioburden). | Testing performed and demonstrated safety. |
| Packaging Validation | Post-accelerated aging packaging must maintain integrity and sterility (e.g., Bubble Test, Dye Penetration). | Testing performed and demonstrated safety. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not describe a clinical "test set" in the sense of patient data being collected for evaluation of the device. The non-clinical tests involved laboratory and bench testing of the device itself and its manufacturing processes.
- Sample Size: Not specified for individual tests, but implicitly refers to a sufficient number of devices for bench and lab testing (e.g., for sterility, stretch tests, and packaging validation).
- Data Provenance: The data is generated from non-clinical bench and laboratory testing of the manufacturing processes and device properties. It is not derived from human subjects or patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" do not apply.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this submission. The "ground truth" for the non-clinical tests is established by adherence to recognized international standards (ISO, ASTM) and internal validation protocols for manufacturing processes (e.g., ETO sterilization validation). There is no "test set" that requires human expert adjudication for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable. Since there is no "test set" involving human interpretation or subjective evaluation, no adjudication method is described or required.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance?
No, an MRMC comparative effectiveness study was not done. This device is a physical medical implant (a punctal plug), not an AI-powered diagnostic or assistive technology. Therefore, the concept of "human readers improve with AI" is not relevant here.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Established industry standards and regulations: Adherence to ISO and ASTM standards for sterilization, biocompatibility, and packaging.
- Laboratory test results: Objective measurements demonstrating physical and biological properties (e.g., passing a stretch test, meeting ETO residual limits, adequate bioburden reduction, package integrity).
- Substantial equivalence: The comparative data with the legally marketed predicate device regarding materials, dimensions, and intended use serves as a form of "ground truth" for demonstrating safety and effectiveness based on equivalence.
8. The Sample Size for the Training Set
This information is not applicable. Since this is a physical medical device and not an AI algorithm, there is no concept of a "training set" in this context. The manufacturing processes are validated, and devices are tested, but not in the sense of training a model.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no training set for this device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 13, 2014
Krishna Imports Inc. Dba Stephens Instruments c/o Ms. Archna Johnson Vice President 2500 Sandersville Rd. Lexington, KY 40511
Re: K140352
Trade/Device Name: VeraPlug" Punctal Plug Regulation Number: Preamendment Regulation Name: Preamendment Regulatory Class: Unclassified Product Code: LZU Dated: October 3, 2014 Received: October 6, 2014
Dear Ms. Johnson,
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.
Kesia Y. Alexander -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140352
Device Name VeraPlug
Indications for Use (Describe)
The VeraPlug™ Punctal Plug is for use in patients with dry eye syndromes.
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
69
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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| Date Prepared | November 5, 2014 |
|---|---|
| 510K #: | K140352 |
| Applicant: | Krishna Imports Inc dba Stephens Instruments2500 Sandersville Rd.Lexington, KY 40511 |
| Contact Person: | Archna Johnson |
| Phone No.: | 855-857-0518, 859-259-4926 (fax) |
| Device Name: | VeraPlug™ Punctal Plug (Punctal Occluder) |
| Common/Usual Name: | Plug, Punctum |
| Type of Submission: | Traditional, Original |
| Product Code: | LZU |
| Regulatory Class: | Unclassified |
Indications for Use:
The VeraPlug™ Punctal Plug is for use in patients with dry eye syndromes.
Device Description:
The VeraPlug™ Punctal Plug is designed to provide reduction or elimination of tear drainage through the inferior or superior puncta, thus maintaining lubricating tears on the surface of the eye. Each VeraPlug™ Punctal Plug is molded from medical grade silicone. The VeraPlug™ Punctal Plug is available in 3 sizes (small, medium, and large) and is packaged 2 per/box. Each plug is sterile and preloaded on an inserter.
The inserter is manufactured using medical grade ABS (acrylonitrile butadiene styrene), and 304 stainless steel.
Predicate Devices/Substantial Equivalence:
The Lacrivera VeraPlug™ is equivalent to the predicate device listed below:
Predicate Device:
Odyssey Medical
Punctal Occluder (#K972523)
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Predicate product Comparison Table
| Parameter | Stephens Instruments | Odyssey Medical | Comment |
|---|---|---|---|
| 510(k)Number | K140352 | K972523 | |
| Indications forUse | The VeraPlug™Punctal Plug is for usein patients with dry eyesyndromes. | Punctal Occluders (plugs) are indicated for thetreatment of "dry eye" syndrome. Dry eye beinga condition where there is sufficient lubrication inthe eye and the conjunctive becomes much lessmoist than normal. This produces pain anddiscomfort in the eyes. This may occur in anycondition that causes scars of the cornea, such aserythema multiforme, trachoma, or corneal burns,etc. Other patients that may benefit are: cataractpatients, patiens with arthritis, patients medicatedfor hypertension, contact wearers of any age,seasonal allergy sufferers, patients who liver indry climates, or spend extended periods in airconditioning, and any others who suffer from dryeye irritatio. Treatment is to stop tear outflow viaa specific punctum to enhance tear contact timein certain dry eye conditions. It is also reasonablethat eyes drops of many kinds would be moreeffective if retained on the surface of the eye,rather than drained into the sinus. | Both are intendedfor use withpatients sufferingfrom dry eyesyndromes |
| Shape Design | Image: [shape design] | Image: [shape design] | Plugs arecomparable in nosediameter, overalllength, and shapedesign |
| Material | Medical Grade Silicone | Medical Grade Silicone | Same |
| Sterile | Yes | Yes | Same |
| NoseDiameter | |||
| Small | 0.76mm | 0.75mm | Within cleared |
| Medium | 0.89mm | 0.88mm | nose diameterranges |
| Large | 1.02mm | 1.01mm | |
| OverallLength | |||
| Small | 1.65mm | 1.63mm | |
| Medium | 1.83mm | 1.80mm | Within clearedoverall lengthranges |
| Large | 2.00mm | 1.93mm | |
| Stretch TestComparisonStudy Results | Passed | Passed | Same |
| PatientPopulation | Patients suffering fromdry eye syndromes | Patients suffering from dry eye symptoms | Same |
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Discussion of Technological Characteristics
The VeraPlug™ Punctal Plug and the predicate device are both intended for use with patients suffering from dry eye syndromes. There are slight design differences between the Odyssey and Stephens Instruments punctal plugs. Both have a similar design shape with a conical shaped nose (distal end), a shaft, and a dome shaped proximal end, with comparable nose diameters and overall lengths. Both are manufactured of medical grade silicone and packaged 2 per/box. Each plug is sterile, preloaded on an inserter.
Non-Clinical Tests
The non-clinical testing performed on the Lacrivera VeraPlug™ included sterility testing which was completed via a validated ETO (Ethylene oxide) sterilization cycle and bench testing that included a simulated implantation stretch test. Biocompatibility testing for the plug was determined to be unnecessary as the material utilized in the plug, medical grade silicone, has a long standing history of being biocompatible for use for the manufacture of punctal occluders. The processes utilized by manufacturers in the forming of the plug are also common throughout the industry.
Standards utilized for testing include:
- . ISO 11135-1:2007 Sterilization of Health Care Products – Ethylene Oxide – Part 1: Requirements for the Development, Validation, and Routine Control of a Sterilization Process for medical devices
- . ISO 11737-1:2006 Sterilization of Medical Devices – Microbiological Methods Part 1: Determination of the Population of Microorganisms on Product (Bioburden Testing)
- ASTM F-1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical . Devices
- ISO 11607-1 ISO Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems (Bubble Test, Dye Penetration)
- . ISO 11607-2 Packaging for terminally Sterilized medical Devices – Part 2: Validation Requirements for Forming, Sealing and Assembly Processes
- . ISO 10993-7:2008 Biological Evaluation of medical devices - Part 7: Ethylene Oxide Sterilization residuals (ETO Residuals)
Conclusion
The Lacrivera VeraPlug™ is substantially equivalent to the predicate device in intended use, material, design and device specifications. Safety and performance testing was performed on the sterilization method, ethylene oxide residuals, microorganisms on the product and postaccelerated aging package validation. The results of which have demonstrated that the device
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does not introduce significant questions of safety or effectiveness and therefore, is substantially equivalent to the predicate device.
N/A