For storage of soft (hydrophilic), hard, and rigid gas permeable contact lenses during chemical disinfection. Use for storage during chemical disinfections only. DO NOT USE WITH HEAT.

Device Description

The contact lens cases in submission are intended to be used to store soft (hydrophilic) and hard contact lenses during chemical disinfection only. These are not to be used in heat disinfection.

There are 2 parts to each contact lens case, the main body/base with two wells, and two screw-on lids. In order to store contact lenses with disinfection solution, the wells for storage need to be leak-proof, which is designed so by the screw construction of the lids.

The plastic that is used in all four contact lens cases is Acrylonitrile Butadene Styrene (Product Name: Polylac ® PA-707, manufactured by Chi Mei Corporation, please refer MSDS attached: Attachment 1), which is a durable plastic that is insoluble in water and can be used for at least two months continuous use.

The cat contact lens case is black, with white printed on the lids. The color pigment used in the case is PLASBLAK® UN2014 (Supplier: Cabot Plastics, please refer MSDS attached: Attachment 2). This pigment is insoluble in water.

The sunglasses contact lens case is white, with black labels on the lids. The color pigment used in the case is DuPont™ Titanium Dioxide Pigment - Plastics Grade/Type : R-350 (Supplier: DuPont, please refer MSDS attached: Attachment 3). This pigment is insoluble in water.

The 1st contact lens case is green, with clear uncolored lids. There are 2 color pigments used in the green body (1) PV Fast Green GNX (Supplier: Clariant Chemicals (India) Limited, please refer MSDS attached: Attachment 4) and (2) MACROLEX Yellow G Granulate (Supplier: Bayer AG, please refer MSDS attached: Attachment 5). These pigments are insoluble in water.

The Geeky eyes contact lens case is red with black glasses. The color pigment used in the red case is 13575 Orange Color Powder (Supplier: Summit Color Co., Ltd., please refer MSDS attached: Attachment 6). This pigment is insoluble in water.

The individual well capacity of each contact lens are: cat contact lens case 2.8ml, sunglasses contact lens case 2.5ml, 1* contact lens case 3ml, geeky eyes contact lens case 2.8ml. The capacities aforementioned are sufficient for a contact lens to be fully soaked in the disinfection liquid.

At the base of the cat contact lens case and the sunglasses contact lens case, in each well there is L and R embossed to help users differentiate the left and right lenses. The geeky eyes contact lens case also has the L and R markings on the side of the casing outer. The 1d contact lens case does not have L and R markings on it as the two wells are situated one above and one below the disc so it is unlikely to mix up the two wells during use.

Through use, the material of the contact lens case may come into contact with the user's eyes indirectly. The user will need to put contact lenses with chemical disinfecting liquid into the contact lens case for storage. Therefore we have used a plastic material and colorants that are insoluble in water so that it will not come in contact with one's eyes.

These contact lens cases are intended for the storage of soft (hydrophilic) and hard contact lenses. The case should ensure the fluids contained do not leak. These cases are for the storage of chemical disinfecting fluids with contact lenses only, they are not to be used in heat disinfection. These are not sold sterile, so the packaging should have instructions written on them to "Rinse the case thoroughly with clean solution before use".

It is recommended to replace the contact lens case at least every 3 months.

AI/ML Overview

This document describes the premarket notification (510(k)) for several contact lens cases. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, performance studies, sample sizes, expert ground truth, and MRMC studies is not directly applicable or available in this document.

However, I can extract the relevant information and indicate where data is not provided for questions that are typically relevant to AI/diagnostic device submissions.

The Device:

Ni Hau Industrial Co., Ltd. Contact Lens Cases (Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eyes Contact Lens Case)

Acceptance Criteria and Reported Device Performance

The document doesn't define quantitative acceptance criteria in terms of metrics like sensitivity, specificity, accuracy, or other performance characteristics typically associated with AI or diagnostic devices. Instead, the acceptance criteria are based on demonstrating substantial equivalence to a legally marketed predicate device by fulfilling manufacturing, material, and functional requirements.

The "reported device performance" is implicitly that the device meets the same safety and performance characteristics as the predicate device. The comparison focuses on physical properties, intended use, and biocompatibility.

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance (as per document)
Intended Use	For storage during chemical disinfection of soft (hydrophilic), hard, and rigid gas permeable contact lenses. Not for heat disinfection.	Matches predicate device's intended use.
Device Material	Acrylonitrile Butadiene Styrene (ABS)	All 4 devices use ABS (Polylac ® PA-707). Matches predicate.
Device Construction	Shaped base with two wells and two screw-on lids for leak-proof storage.	All 4 devices have shaped base with two wells and two screw lids. Matches predicate.
Biocompatibility	Must pass relevant ISO 10993 tests (Cytotoxicity, Eye Irritation, Systemic Toxicity).	All 4 devices "PASS the following test: Cytotoxicity (ISO 10993-5), Eye Irritation (ISO 10993-10), Systematic Toxicity (ISO 10993-11)." Matches predicate.
Sterilization	Not sold sterile.	Not sold sterile. Matches predicate.
Well Capacity (Sufficiency)	Sufficient volume for contact lenses to be fully soaked in disinfection liquid.	Well capacities range from 2.5ml to 3ml, stated as "sufficient for a contact lens to be fully soaked." Predicate device wells are 4.8ml-5.5ml, also sufficient.
Material Insolubility	Plastic material and colorants used are insoluble in water to prevent contact with eyes.	ABS plastic and all specified color pigments (PLASBLAK® UN2014, DuPont™ Titanium Dioxide, PV Fast Green GNX, MACROLEX Yellow G Granulate, 13575 Orange Color Powder) are stated as insoluble in water.
Leak-proof Design	Wells for storage need to be leak-proof.	Designed with screw construction of the lids to be leak-proof.
Recommended Replacement	Manufacturers recommendation to replace cases every 3 months.	Stated: "It is recommended to replace the contact lens case at least every 3 months."
Labeling	Instructions to "Rinse the case thoroughly with clean solution before use."	Packaging should have these instructions.

Study Information

The document describes a submission for substantial equivalence based on a comparison to a predicate device, not a de novo study demonstrating the clinical performance of a diagnostic or AI device. Therefore, many of the typical study parameters for such devices are not applicable.

Sample size used for the test set and the data provenance: Not applicable. This is not a study assessing diagnostic performance or algorithm output. The "test set" would implicitly refer to the contact lens case prototypes themselves. The provenance of the materials (ABS plastic, pigments) is provided by manufacturer and product name (e.g., Chi Mei Corporation, Cabot Plastics, DuPont), and the manufacturing location is Taiwan.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a diagnostic output is not established here. Compliance with international standards (e.g., ISO 10993 for biocompatibility) is used as evidence of safety, which would be evaluated by qualified testing laboratories.
Adjudication method for the test set: Not applicable. No diagnostic outputs to adjudicate.
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 device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" here is compliance with established device safety and manufacturing standards, and demonstrated equivalence to a legally marketed predicate device. This includes:
- Material specifications (e.g., ABS composition, insolubility of pigments).
- Physical design specifications (e.g., screw lids for leak-proofing, well capacity).
- Biocompatibility test results (passing ISO 10993-5, 10993-10, 10993-11). These lab tests provide objective data as "ground truth" for the material's biological safety.
The sample size for the training set: Not applicable. This is not an AI device.
How the ground truth for the training set was established: Not applicable. This is not an AI device.

Summary

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

May 7, 2015

Ni Hau Industrial Co., Ltd. Ms. Lyn Chiu Sales Manager No. 15. Allev 125. Lane 318. Section 2. An Ho Road Tainan City, Taiwan 70967

Re: K142717

Trade/Device Name: Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LRX Dated: April 10, 2015 Received: April 13, 2015

Dear Ms. Chiu:

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 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 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 -A

for Malvina B. Eydelman, MD 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) K142717

Device Name Cat Contact Lens Case / Sunglasses Contact Lens Case 1st Contact Lens Case Geeky Eyes Contact Lens Case

Indications for Use (Describe)

For storage of soft (hydrophilic), hard, and rigid gas permeable contact lenses during chemical disinfection. Use for storage during chemical disinfections only. DO NOT USE WITH HEAT.

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

_ 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)

Joseph C. Hut

Digitally signed by Joseph C. Hutter -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1300106195, cn=Joseph C. Hutter -S Date: 2015.05.05 10:56:22 -04'00"

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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."

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Image /page/3/Picture/0 description: The image shows the word "Nihau" in a bold, sans-serif font. The word is slightly slanted to the right. A circular shape is behind the word, partially obscuring the top and right portions of the letters. The logo has a simple, clean design.

Ni Hau Industrial Co., Ltd. No. 15, Alley 125, Lane 318, Section 2, An Ho Rd., Tainan City, Taiwan TEL:+886- 6- 355- 7000 FAX:+886- 6- 355- 9000 › 355-0297 E-MAIL:lyn@ni-hau.com.tw,

510(k) Summary

(1) 510(k) Proprietary Details
Date of Summary:	MAY 05, 2015
Company:	Ni Hau Industrial Co., Ltd.
Address:	No. 15, Alley 125, Lane 318, Section 2, An Ho Road, Tainan
	City, TAIWAN. Postal Code: 70967
Telephone:	(886) 6-355 7000 Extension 64
Fax:	(886) 6 – 355 9000
Email:	lyn@ni-hau.com.tw
Contact Person:	Ms. Lyn Chiu

(2) 510(k) Device Details:
Device Name:	Cat Contact Lens CaseSunglasses Contact Lens Case1st Contact Lens CaseGeeky Eyes Contact Lens Case
Device Model #:	K-489 (Cat)K-488 (Sunglasses)K-506 (1st Contact)K-507 (Geeky Eyes)
Device:	Case, Contact Lens
Classification	Soft (hydrophilic) contact lens care products.
Description:
Review Panel:	Ophthalmic
Product Code:	LRX
Submission Type:	510(k)
Regulation Number:	886.5928
Device Class:	II

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Image /page/4/Picture/0 description: The image shows the word "Nihau" in a stylized font, with the letters slightly overlapping each other. A circular shape is positioned above the word, partially enclosing the top portion of the letters. The overall design appears to be a logo or brand mark.

Ni Hau Industrial Co., Ltd. No. 15, Alley 125, Lane 318, Section 2, An Ho Rd., Tainan City, Taiwan TEL: +886- 6- 355- 7000 FAX:+886- 6- 355- 9000 › 355-0297 E-MAIL:lyn@ni-hau.com.tw,

(3) Predicate Device:
Device Name:	Owl Contact Lens CaseDog Contact Lens Case
Device Trade Name:	Owl Contact Lens CaseDog Contact Lens Case
Device Model Number:	MG00-A (Owl)MG37-A (Dog)
Classification Product Code:	LRX
Device Class:	II
510(k) Submitter/ Holder	NINGBO LISHUNDA ELECTRONICS CO., LTD.
510(k) Number	K130930

(4) Device Description:

The contact lens cases in submission are intended to be used to store soft (hydrophilic) and hard contact lenses during chemical disinfection only. These are not to be used in heat disinfection.

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Image /page/5/Picture/0 description: The image shows the word "Nihau" in a bold, sans-serif font. The word is slightly tilted to the right. A curved line, resembling a crescent or a partial circle, arches over the word, adding a dynamic element to the design. The overall impression is a simple yet recognizable logo or brand mark.

Ni Hau Industrial Co., Ltd. No. 15, Alley 125, Lane 318, Section 2, An Ho Rd., Tainan City, Taiwan TEL:+886- 6- 355- 7000 FAX:+886- 6- 355- 9000 › 355-0297 E-MAIL:lyn@ni-hau.com.tw,

These contact lens cases are intended for the storage of soft (hydrophilic) and

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Image /page/6/Picture/0 description: The image shows a logo with the word "Nihau" in a stylized font. The word is in black and appears to be slightly italicized. Above and below the word, there is a curved line that forms a partial circle, creating a frame around the text. The logo is simple and monochromatic.

Ni Hau Industrial Co., Ltd. No. 15, Alley 125, Lane 318, Section 2, An Ho Rd., Tainan City, Taiwan TEL:+886- 6- 355- 7000 FAX:+886- 6- 355- 9000 > 355-0297 E-MAIL:lyn@ni-hau.com.tw,

hard contact lenses. The case should ensure the fluids contained do not leak. These cases are for the storage of chemical disinfecting fluids with contact lenses only, they are not to be used in heat disinfection. These are not sold sterile, so the packaging should have instructions written on them to "Rinse the case thoroughly with clean solution before use".

It is recommended to replace the contact lens case at least every 3 months.

(5) Indications For Use

For storage of soft (hydrophilic), hard, and rigid gas permeable contact lenses during chemical disinfection. Use for storage during chemical disinfections only. DO NOT USE WITH HEAT.

(6) Comparison of Devices in Application & Substantially Equivalent PredicateDevice:
The Device in Submission	Substantially EquivalentPredicate Device
Device Name	Cat Contact Lens CaseSunglasses Contact Lens Case1st Contact Lens CaseGeeky Eyes Contact Lens Case	OWL CONTACT LENS CASESDOG CONTACT LENS CASES
Device Model #:	K-489 (Cat)K-488 (Sunglasses)K-506 (1st Contact)K-507 (Geeky)	MG00-A (Owl)MG37-A (Dog)
DeviceAppearance	Image: Cat contact lens case and sunglasses contact lens case	Image: Owl contact lens case
Image: Green contact lens case	Image: Blue contact lens case
Case Dimension	Cat: 65 x 37 x 14mm	Owl: 71 x 38.5 x 17mm
	Sunglasses: 71 x 31 x 14mm	Dog: 69.5 x 38 x 14mm
	1st Contact: 60 x 39.6 mm
	Geeky eyes: 80 x 32 x 21mm
Single Well	Cat: 3ml	Owl: 5.5ml
Capacity Volume	Sunglasses: 2.5ml	Dog: 4.8ml
	1st Contact: 3ml
	Geeky eyes: 2.8ml
Device Material	All 4: (ABS) AcrylonitrileButadene Styrene	Both: (ABS) AcrylonitrileButadene Styrene
DeviceConstruction	All 4: Shaped base with twowells to hold the fluid and twoscrew lids for the Left andRight eyes of contact lenses.	Both: Shaped base with twowells and two screw lids
Device IntendedUse	All 4: To hold soft and hardcontact lenses. For storingchemical disinfecting fluidonly.	Both: To hold soft and hardcontact lenses. For storingchemical disinfecting fluidonly.
Biocompatibility	PASS the following test:Cytotoxicity (ISO 10993-5)Eye Irritation (ISO 10993-10)Systematic Toxicity (ISO10993-11)	PASS the following test:Cytotoxicity (ISO 10993-5)Eye Irritation (ISO 10993-10)Systematic Toxicity (ISO10993-11)
Sterilization	Not sold sterile	Not sold sterile

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Image /page/7/Picture/0 description: The image shows the logo for Nihau. The logo consists of the word "Nihau" in a stylized font, with a circular shape encompassing the top half of the word. The font is bold and slightly slanted, giving it a dynamic appearance. The logo is presented in black and white.

Ni Hau Industrial Co., Ltd. No. 15, Alley 125, Lane 318, Section 2, An Ho Rd., Tainan City, Taiwan TEL:+886- 6- 355- 7000 FAX:+886- 6- 355- 9000 › 355-0297 E-MAIL:lyn@ni-hau.com.tw,

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Image /page/8/Picture/0 description: The image shows a logo with the word "Nihau" in bold, stylized letters. A curved line arches over the word, creating a semi-circular shape above it. The logo has a simple, black-and-white design, with the word "Nihau" being the most prominent element.

Ni Hau Industrial Co., Ltd. No. 15, Alley 125, Lane 318, Section 2, An Ho Rd., Tainan City, Taiwan TEL: +886- 6- 355- 7000 FAX:+886- 6- 355- 9000 \ 355-0297 E-MAIL:lyn@ni-hau.com.tw,

Since the construction, materials and specifications of the devices in submission are very similar to the substantially predicate devices, which have been safely distributed in the USA market, we can conclude that our Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, and Geeky Eye Contact Lens Case are also safe to be distributed in the U.S.A.

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.”