The Contactspod is a sterile single-use temporary storage case and contains multi-purpose contact lens solution for use with soft contact lenses. It is not a replacement for your normal contact lens rub and rinse cleaning and disinfecting care regime. It is a clear solution and should not be used, if cloudy or discoloured. Use for storage during chemical disinfection only. DO NOT USE WITH HEAT.

Device Description

The Contactspod is a sterile single use temporary storage case and contains multi-purpose contact lens solution for use with soft contact lenses. The Contactspod comprises an injection mouided medical grade polypropylene case and medical grade TPE basket seal. The contactspod is pre filled with 5ml of multi-purpose solution. The MPS solution is supplied inside the moulded PP case with an aluminium / PE heatseal which is removed by the user. Once lenses are inserted into the solution a secondary seal is used to seal the case.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study details for the Viopti Ltd. Contactspod, based on the provided document:

The document does not explicitly state "acceptance criteria" for specific performance metrics in a clear, quantitative table as one might expect for a typical diagnostic device. Instead, it describes various tests performed to ensure the device's safety and performance and to demonstrate substantial equivalence to a predicate device. The "acceptance criteria" are implied by the successful completion and positive outcomes of these tests, leading to the conclusion of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

As explicit quantitative acceptance criteria are not provided in the document for each test with corresponding reported device performance values, I will summarize the tests conducted and the implied successful outcome, which serves as the "reported performance" (i.e., the device met the objective of each test).

Test Name	Implied Acceptance Criterion	Reported Device Performance
Stand Alone Report (Sterility and Antimicrobial Activity)	Demonstrate sterility and effective antimicrobial activity over shelf life, challenging with standard microorganisms per EN-ISO 14729:2001.	The study aimed to investigate and presumably confirmed the sterility and possible antimicrobial activity in a shelf-life study of six different lots. (Implied successful outcome)
Design Verification Testing	Verify and validate product design and characterize performance across various mechanical and environmental stresses (hinge flexing, air pressure, temperature extremes, latch force, crush resistance).	Various tests were carried out to verify and validate the product design and characterize performance. (Implied successful outcome, e.e., no failures reported)
Microbial Load Comparison between Contact Lens Cases	Demonstrate the Contactspod's effectiveness as a one-use storage environment for contact lenses compared to other cases.	Concluded that the Contactspod would be an effective one-use storage environment for contact lenses. (Implied successful outcome)
Review of ISO 14534 - Ophthalmic Optics - Contact lenses and contact lens care products	Ensure compliance with applicable aspects of ISO 14534.	Contactspod is deemed to be compliant with applicable sections of the standard. (Implied successful outcome)
Usability - ISO 62366: 2008/ IEC 62366:2007 - Application of Usability Engineering to Medical Devices	Assess usability for compliance with ISO 62366/IEC 62366.	The Contactspod was assessed with regards to usability for compliance. (Implied successful outcome)
ISO 10993-1: Biological evaluation of medical devices – Guidance on selection of tests	Demonstrate biological safety in compliance with ISO 10993-1.	Testing and analysis demonstrated compliance to ISO 10993-1. (Implied successful outcome)
Overall Safety and Effectiveness	No adverse indications or results and performance within design specifications, demonstrating substantial equivalence to predicate devices.	The Contactspod indicated no adverse indications or results, performs within design specifications, and is substantially equivalent to the predicate device. (Overall successful conclusion)

2. Sample Size Used for the Test Set and Data Provenance

Stand Alone Report: "six different lots of the Contactspods" were tested. The provenance is not explicitly stated but is implied to be laboratory testing ("tested in the lab"). The study type is interventional/in-vitro product testing.
Other tests (Design Verification, Microbial Load, Usability, ISO compliance): No specific sample sizes (number of devices or cases tested) are provided for these tests within the summary.
Data Provenance: The studies were conducted by Viopti Ltd., implying in-house or contracted laboratory testing, likely in the UK (company location). The data is retrospective in the sense that it was collected prior to this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This type of information is generally not applicable to the assessment of a physical medical device like a contact lens case. The tests are primarily laboratory-based physical, chemical, and microbiological evaluations against established standards and protocols, not subjective human interpretations requiring expert consensus. For example, sterility is measured quantitatively, not by expert opinion.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the evaluation of a contact lens case involves objective physical, chemical, and microbiological testing, not subjective human judgment that would require an adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance, to assess the impact of AI on reader performance. This is not applicable to a physical contact lens storage case.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the "Stand Alone Report" described directly evaluates the device's intrinsic characteristics (sterility and antimicrobial activity) independent of human interaction. Other tests like "Design Verification Testing" also fall under standalone testing of the device itself.

7. The Type of Ground Truth Used

The "ground truth" for the various performance tests is established by:

Established laboratory tests and protocols: For sterility and antimicrobial activity, the ground truth is defined by the methods and standards outlined in EN-ISO 14729:2001 and other relevant microbiology standards.
Engineering specifications and standards: For design verification tests, the ground truth is the pass/fail criteria defined by engineering and performance specifications (e.g., specific force tolerance, temperature limits, seal integrity).
International Standards: For compliance reviews (ISO 14534, ISO 10993-1, ISO 62366), the ground truth is the set of requirements and guidelines specified within those international standards.

8. The Sample Size for the Training Set

Not applicable. The Contactspod is a physical medical device, not an AI/Machine Learning algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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Viopti Ltd. Traditional 510(k) — K131783

For the Contactspod

510(k) Summary

This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92. .

Submitter's Name:

Viopti Ltd

Submitter's Address:

Polaroid Building Vale of Leven Industrial Estate Dumbarton G82 3PW Telephone

+44 (0) 1389 714021

Establishment Registration Number:

Still to be established

Contact Person:

Edwin Lindsay

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Telephone +44 (0) 7917 134922 .

Date Prepared:

13" January 2014

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Viopti Ltd. Traditional 510(k) - K131783 For the Contactspod

Device Classification Information:

RegulationNumber	Device	DeviceClass	ProductCode	ClassificationPanel
886.5928	Case, contact lens	Class 2	LRX	Ophthalmic

Device Trade Name:

Polaroid Contactspod (and other non-Polaroid branded versions)

Device Common Name:

Contactspod

Intended/ Indications Use:

The Contactspod is a sterile single-use temporary storage case and contains multi-purpose contact lens solution for use with soft contact lenses

It is not a replacement for your normal contact lens rub and rinse cleaning and disinfecting care regime.

It is a clear solution and should not be used, if cloudy or discoloured.

Use for storage during chemical disinfection only. DO NOT USE WITH HEAT.

Summary of Substantial Equivalence:

The Viopti Device is substantially equivalent to WatchDog Group LC - Flip N Slide Contact Lens Case (K130753).

The predicate device table has been prepared to compare the Contactspod with other medical devices already on the market

Property	New Device:Contactspod	Predicate 1
Device Manufacturer	Viopti Ltd	WatchDog Group LC
Device Trade Name	Contactspod	Flip N Slide Contact Lens Case
510(K) Number	K131783 (Pending)	K130753
Property	New Device:Contactspod	Predicate 1
Device Common Name	Polaroid Contactspod	Flip N Slide Contact Lens Case
Device Product Code	LRX	LRX
Device ClassificationFDA	Class II	Class II
Intended/ Indications Use	The Contactspod is a sterilesingle-use temporary storagecase and contains multi-purposesolution for use with soft contactlenses.	Intended for the storage of soft(hydrophilic), rigid gaspermeable (RGP), or hardcontact lenses during chemicaldisinfection. For use in storageduring chemical disinfection only.Do not use during heatdisinfection.
Storage case material	Medical grade Polypropylene	Medical grade Polypropylene
Peel off lid material	Aluminium / PE heatseallaminate	Screw Tops Caps
Fluid used for storage of contact lenses	Multi-Purpose Solution- abuffered aqueous solutioncontaining disinfectants /preservatives, buffers, asurfactant, a chelating agent,other ancillary agents andpurified water.	Not Supplied with Contact LensCase
Preservative used	Polyhexamethylene Biguanide(0.0001%)	Not Supplied with Contact LensCase
Volume of liquid for storage of eachlens.	2.5ml	Not Supplied with Contact LensCase
Method of Sterilization	Gamma Irradiation	Non Sterile
SAL level	10-6 or better	Non Sterile
Intended storage of lenses	Up to 24 hours (temporarystorage)	Not Specified
Property	New Device:	Predicate 1
Intended number of uses	Single use	Re-usableReplace case at least every month
OTC or Prescription Device	OTC	OTC
Device Description	The Contactspod is a sterilesingle use temporary storagecase and contains multi-purposecontact lens solution for use withsoft contact lenses.The Contactspod comprises aninjection mouided medical gradepolypropylene case and medicalgrade TPE basket seal. Thecontactspod is pre filled with 5mlof multi-purpose solution.The MPS solution is suppliedinside the moulded PP case withan aluminium / PE heatsealwhich is removed by the user.Once lenses are inserted into thesolution a secondary seal isused to seal the case.	The contact lens cases aredesigned for storage of contactlenses.The Colour Contact Lens Casehas 2 adjoining wells that havescrew top caps. The Flip N Slidecontact lens case model has 2adjoining wells with integralhinged, self-sealing caps inwhich contact lenses areimmersed.The devices are not sterile andare not sterile and are not forheat disinfection. They are madeof polypropylene plastic.The volume capacity is 5.91mlon each well of both les cases

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Viopti Ltd. Traditional 510(k) — K131783

For the Contactspod

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Viopti Ltd. Traditional 510(k) — K131783

For the Contactspod

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Viopti Ltd. Traditional 510(k) - K131783

For the Contactspod

Device Description:

The Polaroid Contactspod is a single use, pre-filled contact lens storage case. The product comprises four components:

. A polypropylene storage case, an aluminium foil seal, two TPE baskets and contact lens solution.
The hinged polypropylene case contains the multipurpose contact lens solution stored under an aluminium foil primary seal. Inside the foil seal are two compartments (one for left lens storage and one for right lens storage).

Each compartment has a min 2.4ml of contact lens solution and a TPE basket. The TPE basket has two purposes. The first is to safely hold the lens in the soft TPE material. The second is to provide the secondary seal when the lid is hinged closed and locked with the latch.

The Polaroid Contactspod are sold both as an individual unit and also packaged in conjunction with other eye care and travel products.

Image /page/4/Picture/8 description: The image shows a contact lens case. The case is open, revealing two compartments labeled "L" and "R" for left and right lenses, respectively. A lens is visible in one of the compartments, and a package of lens solution is partially opened next to the case.

Page 5 of 7

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Viopti Ltd. Traditional 510(k) - K131783

For the Contactspod

Technological Characteristics:

A comparative review of the Contactspod with the predicate devices found that the materials/solution used in the Viopti Contactspod for the temporary storage of Contact Lenses have similar principles of operation and technological characteristics as the previously cleared predicates and thus do not raise any new questions with regards to safety or efficacy.

Performance/Physical Data:

. .

The Contactspod was tested to ensure performance of the system, to verify and validate the product design and to characterize the performance and safety of the Contactspod. ﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻘﺮﻥ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ

The table outlines the features of the system that were evaluated through testing completed by Viopti.

Test Name	Test Description
Stand Alone Report	The aim of this study was to investigate the sterility and possible antimicrobialactivity in a shelf life study of six different lots of the Contactspods prefilled withMultifunctional Solution and radiated by gamma sterilization.The products were tested in the lab using established tests and also by challenging with a standard inoculum of a representative range of microorganisms according to EN-ISO 14729:2001.
Design VerificationTesting	The aim of this was to carry out various tests on the Contactspod to verify andvalidate the product design and to characterize the performance of the ContactspodThis included hinge flexing tests, negative air pressure tests to simulate aircraftcabin pressure on both the primary foil seal and the secondary TPE seal, use ofproduct at extremes of indicated temperature, latch opening force both with the foilremoved (correct operation) and with the foil in place (misuse), crush force testing ofsecondary seal, crush force puncture resistance testing with the foil in place,temporary storage of contactspod at extremely high and low temperature.
Microbial loadcomparison betweencontact lens cases	Study of the effectiveness of various contact lens cases and concluded that theContactspod would be an effective one use storage environment for contact lenses.
Review of ISO 14534 -Ophthalmic Optics-Contact lenses andcontact lens careproducts	A review of ISO 14534 - Ophthalmic Optics- Contact lenses and contact lens careproducts - Fundamental requirements was performed with regards to theContactspod to ensure compliance. All aspects of the standards were addressed/reviewed and Contactspod is deemed to be compliant, with the sections applicableto the Contactspod.

Page 6 of 7

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Viopti Ltd. Traditional 510(k) – K131783

For the Contactspod

Test Name	Test Description
Usability - ISO 62366:2008/ IEC 62366:2007 -Application of UsabilityEngineering to MedicalDevices	The Contactspod was assessed with regards to usability for compliance with ISO62366: 2008/ IEC 62366:2007 - Medical devices - Application of usability engineeringto medical devices

In addition, testing and analysis of the Contactspod has demonstrated compliance to ISO 10993-1: Biological evaluation of medical devices – Guidance on selection of tests and Design Verification Testing was performed to verify the Contactspod.

Safety and Effectiveness:

e 7 of 7

The Contactspod utilises similar technology currently found in legally marketed predicate devices. Based on testing and comparison with the predicate devices, the Contactspod indicated no adverse indications or results. It is our determination that the Contactspod is safe, effective and performs within its design specifications and is substantially equivalent to the predicate device.

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Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 21, 2014

Viopti Ltd. % Mr. Edwin Lindsay, Quality & Regulatory Consultant Polaroid Building Vale of Leven Industrial Estate Dumberton G82 3PW United Kingdom

Re: K131783

Trade/Device Name: Contactspod Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LRX Dated: December 30, 2013 Received: January 8, 2014

Dear Mr. Lindsay:

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.

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.

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Page 2 - Mr. Edwin Lindsay

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); 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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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Indications for Use

510(k) Number (if known) K131783

Device Name Contactspod

Indications for Use (Describe)

The Contactspod is a sterile single-use temporary storage case and contains multipurpose contact lens solution for use with soft contact lenses. It is not a replacement for your normal contact lens rub and disinfecting care regimen. It is a clear solution and should not be used if cloudy or discolored. Use for storage during chemical disinfection only. DO NOT USE WITH HEAT.

Type of Use (Select one or both, as applicable)

[ Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Joseph C. 2014.02.11 14:19

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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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."

Regulation Number and Section

§ 886.5928 Soft (hydrophilic) contact lens care products.

(a)
Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”