The Voguestrap Contact Lens Cases are intended for the storage of soft (hydrophilic), rigid gas permeable (RGP), or hard contact lenses during chemical disinfection. For use in storage during chemical disinfection only. Not to be used with hydrogen peroxide disinfection systems.

Device Description

The Voguestrap Contact Lens Cases are plastic cases designed such that thev are flat storage cases that have either screw top caps or flip top caps. The cases are labeled with an 'R' or 'L' to distinguish right and left lenses. The cases also come in different colors. The screw top model may also have a magnifying glass.

AI/ML Overview

The provided text describes a 510(k) summary for the Voguestrap Contact Lens Cases. However, it does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and a study proving a device meets those criteria. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria and detailed methodology.

Here's a breakdown of what can and cannot be extracted from the given text:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated in terms of quantitative metrics or thresholds.
Reported Device Performance: The document only states, "Biocompatibility testing performed by third party laboratory demonstrated the materials are safe for use in contact lens storage and disinfection." This is a qualitative statement of safety rather than a performance metric against a specific acceptance criterion.

Acceptance Criteria	Reported Device Performance
Not available	Not available
(e.g., Biocompatibility safety limits)	Materials demonstrated safe for use in contact lens storage and disinfection.

2. Sample size used for the test set and the data provenance:

The document does not specify a sample size for any test set or the provenance of any data beyond indicating "third party laboratory" for biocompatibility testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There is no mention of a test set requiring expert ground truth establishment for this type of device (contact lens case).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No test set involving human interpretation and adjudication is mentioned.

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:

Not applicable. This device is a physical contact lens case, not an AI software or system that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical contact lens case, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not explicitly defined. For the biocompatibility testing, the "ground truth" would implicitly be the established safety standards and regulations for materials in contact with biological tissues, interpreted by the third-party laboratory.

8. The sample size for the training set:

Not applicable. No machine learning or AI training set is involved.

9. How the ground truth for the training set was established:

Not applicable. No machine learning or AI training set is involved.

Summary of available information:

The provided 510(k) summary for the Voguestrap Contact Lens Cases focuses on demonstrating substantial equivalence to a predicate device (Bonasse Contact Lens case K991206). The primary "test" mentioned is "Biocompatibility testing performed by third party laboratory," which concluded that "the materials are safe for use in contact lens storage and disinfection." This type of submission relies on showing that the new device is as safe and effective as a legally marketed predicate device, rather than providing detailed performance metrics from a de novo study with specific acceptance criteria as might be seen for more complex diagnostic or therapeutic devices.

Summary

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FEB 2-7 2009

EXHIBIT #1

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the reguirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: K 090362

1. Manufacturer and Sponsor Contact Information

Voquestrap 31-00 47th Ave Long Island City, NY 11101 Phone: 718-706-8700 x 127 Fax: 718-706-8978 Contact Name: Sy Greenwald

Date Summary Prepared: December 29, 2008

' 'ﺗﺠ

1. Name of the Device:
  Classification: Product Code: Voguestrap Contact Lens Cases, Models: IMAG, IPOD, EZ-Find, ISLIDE Class II, 21 CFR 886.5928 LRX

3. Common or Usual Name: Contact Lens Case

Predicate Device Information: বঁ

Bonasse Contact Lens case K991206

5. Device Description:

The Voquestrap Contact Lens Cases are plastic cases designed such that thev are flat storage cases that have either screw top caps or flip top caps. The cases are labeled with an 'R' or 'L' to distinguish right and left lenses. The cases also come in different colors. The screw top model may also have a magnifying glass.

· 6. Intended Use:

The Voquestrap Contact Lens Cases are intended for the storage of soft (hydrophilic), rigid gas permeable (RGP), or hard contact lenses during chemical disinfection. For use in storage during chemical disinfection only. Not to be used with hydrogen peroxide disinfection systems.

Page 1 of 2

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7. Comparison to Predicate Devices:

The Voguestrap device has the same intended use, similar materials and design as the predicate device.

Discussion of Non-Clinical Tests Performed in Determination of Substantial 8. Equivalence:

Biocompatibility testing performed by third party laboratory demonstrated the materials are safe for use in contact lens storage and disinfection.

9. Conclusions:

The Voguestrap Contact Lens Cases are safe and effective for their intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 image of an eagle or other bird with outstretched wings, rendered in a simple, graphic style.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 7 2009

Underwriters Laboratories, Inc c/o Mr. Casey Conry Sr. Project Engineer 1285 Walt Whitman Rd. Melville, NY 11747

Re: K090362

Trade/Device Name: Voguestrap Contact Lens Cases, Models: IMAG, IPOD, EZ-Find, ISLIDE

Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LRX Dated: February 12, 2009 Received: February 13, 2009

Dear Mr. Conry:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. 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); good manufacturing practice requirements as set forth in the quality systems (08) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M. B. Eubanks, m.D.

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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Exhibit 3

Indications for Use

Page 1 of of 1

510(k) Number (if known): _ k 090362

Device Name: Voguestrap Contact Lens Cases, Models: IMAG, IPOD, EZ-Find, ISLIDE

Indications For Use:

Prescription Use (Per 21 CFR 801 Subpart D)

Over-The Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mig-chun Shui

(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices

K ogo362 510(k) 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.”