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. Do not use during heat disinfection.

Device Description

The contact lens cases are designed for storage of contact lenses. The Color Case Contact Lens Case has 2 adjoining wells that have screw top caps. The Flip N Slide Contact Lens Case model has 2 adjoining wells with integral hinged, self-sealing caps in which contact lenses are immersed. The devices are not sterile and are not for heat disinfection. They are made of polypropylene plastic. The volume capacity is 5.91 ml on each well of both lens cases.

AI/ML Overview

This is not an AI software/device. No AI or Machine Learning algorithm is mentioned in the provided text. Therefore, the questions related to AI/ML device performance, training sets, test sets, and expert adjudication are not applicable.

The document describes a submission for contact lens cases (Color Case Contact Lens Case and Flip N Slide Contact Lens Case) which are physical devices used for storage of contact lenses during chemical disinfection.

Regarding the non-clinical testing performed for these physical devices:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly detailed in numerical values, but stated as "no leachable organic compounds above the pre-determined detection limit" for extraction testing and "met acceptance criteria" for biocompatibility testing.
- Reported Device Performance:
  - Extraction Testing: "demonstrated there were no leachable organic compounds above the pre-determined detection limit."
  - Biocompatibility Testing: "has been conducted on the materials and met acceptance criteria."
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not provided in the document. The text only states that "Extraction testing was conducted" and "Biocompatibility testing has been conducted," without specifying sample sizes, data provenance, or study design (retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable as this is not an AI/ML device, and no "ground truth" in the context of expert review for diagnostic accuracy is being established. The testing appears to be laboratory-based analytical and biological testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is not an AI/ML device and no human adjudication process for a test set is described.
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 is not an AI/ML device. "Clinical Testing" is explicitly stated as "Not Applicable".
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the context of AI/ML. For the non-clinical tests, the "ground truth" would be established by standard laboratory methods and control values for extraction and biocompatibility testing according to relevant ISO or ASTM standards, which are not detailed in this summary.
The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no training set.
How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device, so there is no training set or ground truth in this context.

Summary

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K 130 75 3

8 510(k) Summary

Submitter:	WatchDog Group, LC7800 Forsyth Blvd 8th FloorSt. Louis, MO 63105
Contact Persons:	Primary Contact: John O'HaraWatchDog Group, LC7800 Forsyth Blvd 8th Floor, St. Louis, MO 63105Phone: 314-721-5367; Fax: 314-725-5873, email: LensAlert@aol.comSecondary Contact: Maggie Genovese (Same address as above)Phone: 314-721-5367; Fax: 314-725-5873; email: MaggieLensAlert@aol.com
Date Prepared:	June 12, 2013
Trade Names:	Color Case Contact Lens Case; Flip N Slide Contact Lens Case
Classification:	21 CFR 886.5928; Soft (hydrophilic) contact lens care products, Class II
Product Code:	LRX
Predicate Device:	Contact lens cases by Ningbo Kaida Rubber & Plastic Technology Co., LT (K071081)
Device Description:	The contact lens cases are designed for storage of contact lenses. The ColorCase Contact Lens Case has 2 adjoining wells that have screw top caps. TheFlip N Slide Contact Lens Case model has 2 adjoining wells with integralhinged, self-sealing caps in which contact lenses are immersed. The devices arenot sterile and are not for heat disinfection. They are made of polypropyleneplastic. The volume capacity is 5.91 ml on each well of both lens cases.
Intended Use:	Intended for the storage of soft (hydrophilic), rigid gas permeable (RGP), orhard contact lenses during chemical disinfection. For use in storage duringchemical disinfection only. Do not use during heat disinfection.
Comparison ofTechnologicalCharacteristics:	Similar to the predicate, both the Color Case Contact Lens Case and the Flip NSlide Contact Lens Case have 2 adjoining wells with top caps designed to holdcontact lenses and their chemical disinfectant solutions. Similar to several ofthe contact lens cases encompassed by the predicate premarket notification(K071081), both the Color Case Contact Lens Case and the Flip N Slide ContactLens Case are composed of polypropylene plastic. The new Color Case ContactLens Case uses separate screw caps, as does the predicate. The Flip N SlideContact Lens Case model differs from the predicate in that it has integral, self-sealing caps instead of separate screw top caps. This difference does not posenew questions of safety and effectiveness, as the integral cap design achievesthe same outcome of securing the contact lenses and disinfectant solutions in thewells.
Non-Clinical Testing:	Extraction testing was conducted and demonstrated there were no leachableorganic compounds above the pre-determined detection limit. Biocompatibilitytesting has been conducted on the materials and met acceptance criteria.
Clinical Testing	Not Applicable
Conclusion:	The physical design, materials and intended use of the new devices aresubstantially equivalent to those of the predicate device and any differences do

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The caduceus is a common symbol associated with healthcare and medicine, and its presence in the logo signifies the department's role in promoting and protecting the health of Americans.

June 13, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Mr. John O'Hara President Watchdog Group, LC 7800 Forsyth Blvd., 8th Floor Clayton, MO 63105

Re: K130753

Trade/Device Name: Color Contact Lens Case; Flip n Slide Contact Lens Case Regulation Number: 21 CFR 886.5928 Regulation Name: Contact Lens Case Regulatory Class: Class II Product Code: LRX Dated: May 7, 2013 Received: May 10, 2013

Dear Mr. O'Hara:

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. Ilisting 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. John O'Hara

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/Resourcesfor You/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 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Kesia YAlexander -S

for Malvina Eydelman 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: K130753

Device Names:

· Color Contact Lens Case
· Flip N Slide Contact Lens Case

Indications for Use:

Prescription Use
(part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use	X
(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Leoni 2013.06 04'00'

(Division Sign-Off) Division of Ophthalmic and Ear, Nose, and Throat Devices 510(k) Number:________________________________________________________________________________________________________________________________________________________________ K130753

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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.”