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

Device Description

The Contact Lens Case is a simple device made with a polypropylene base and a polyethylene lid to store soft (hydrophilic), hard, and rigid gas permeable contact lenses during chemical disinfections. This device is manufactured only for chemical disinfections with approved chemical cleaning agents to clean contact lenses.

The physical style is simple with a base volume of 4.8 milliliter and dimensions of 6.25 mm wide and 9.25 mm high. This provides sufficient space to insert and retrieve the contact lenses. It also provides sufficient space to introduce the chemical cleaning solution and adequately cover the lenses for cleaning.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a Contact Lens Case. It outlines the device description, indications for use, and a summary of testing conducted to demonstrate substantial equivalence to a predicate device. However, it does not contain the specific acceptance criteria and detailed study that proves the device meets those criteria, as typically seen for AI-based medical devices.

The information provided describes a physical medical device (contact lens case), not an AI or algorithm-based device. Therefore, the questions related to AI performance metrics (like sample sizes for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and effect size improvements) are not applicable to this document. The provided text details testing for biocompatibility and leakage, which are relevant for a physical contact lens case.

Here's an attempt to answer the questions based only on the provided text, recognizing the mismatch with typical AI/algorithmic device data:

1. Table of Acceptance Criteria and Reported Device Performance

Test/Acceptance Criteria	Reported Device Performance
Biocompatibility:
ISO 10993-5: In Vitro Cytotoxicity	Test article extract did not show potential toxicity to L-929 cells with polar and non-polar extracts.
ISO 10993-10: Ocular Irritation	Test article extracts showed no significant evidence of causing ocular irritation (response of ocular on testing side does not exceed that on the control side; grade 0).
ISO 10993-10: Skin Sensitization	Test article extract showed no significant evidence of causing skin sensitization in the guinea pig (positive rate of all test group animals was 0%).
ISO 10993-11: Systemic Toxicity	Test article extracts showed no significant evidence of causing acute systemic toxicity in the mice (no animals found with abnormal clinical symptoms, all had normal weight change).
Leakage Testing:	None of the tested contact lens cases showed any leakage and all passed the leakage tests successfully.

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

Biocompatibility Testing: The text mentions "L929 mouse fibroblast cells" for cytotoxicity, "guinea pig" for skin sensitization, and "mouse" for systemic toxicity. The specific number of cells or animals used as a "sample size" is not provided.
Leakage Testing: 240 combinations of different tops and bottoms were tested.
Data Provenance: Not explicitly stated, but the tests were conducted according to ISO standards, implying laboratory testing. The manufacturing company is in China, so it's likely the testing was conducted there or by a certified lab. The data is prospective in the sense that the manufacturer conducted these tests specifically for this 510(k) submission.

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

This question is not applicable. The "ground truth" for these tests (cytotoxicity, irritation, systemic toxicity, leakage) is objective biological responses or physical observation, not expert interpretation of medical images or data.

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

This question is not applicable. Adjudication methods are typically used for subjective assessments where multiple experts might disagree (e.g., classifying medical images). The tests performed are objective laboratory and physical tests.

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 or algorithmic device.

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 AI or algorithmic device.

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

The "ground truth" for the biocompatibility tests involved observable biological responses in cells and animals (e.g., cell viability, irritation scores, systemic effects). For leakage testing, the ground truth was the observable absence or presence of liquid leakage.

8. The sample size for the training set

Not applicable. This device is a physical contact lens case, not an AI or algorithmic device that requires a training set.

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

Not applicable. This device is a physical contact lens case, not an AI or algorithmic device that requires a training set.

Summary

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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 arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a symbol that appears to be three stylized human profiles facing to the right, stacked on top of each other.

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

December 9, 2016

Ningbo Yinzhou Zonghai Artware Co., Ltd. c/o Mr. Charles Mack IRC 7808 Rush Creek Drive Pasco. WA 99301

Re: K162869

Trade/Device Name: 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: September 28, 2016 Received: October 13, 2016

Dear Mr. Mack:

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. 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

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the quality systems (OS) 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,

Denise L. Hampton -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) K162869

Device Name 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 disinfection only. DO NOT USE WITH HEAT.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: September 30, 2016

Company and Correspondent making the submission:

Name - Ningbo Yinzhou Zonghai Artware Co., Ltd. Address - Honglianchi, Guangsheng Village, Jishigang Town, Yinzhou District, Ningbo City Zhejiang Province, China 315172 Tel: +86-574-88003277 Fax: +86-574-88003255 Contact - Mr. Weng Changhai General Manager Email – : sales1@zonghai.net

US Correspondent Name- IRC, Charles Mack Address- 2091 Oak Drive, Lake Havasu City, Arizona 86406 Tel: 931-625-4938 Principal Engineer Email- charliemack@irc-us.com

1. Device :

Trade/proprietary name	: Contact Lens Case
Common Name	: Contact Lens Case
Classification Name	: case, contact lens

1. Predicate Devices :

Manufacturer	Predicate Device	510(k)Number	Submitted Device
Ni HauIndustrial Co.,Ltd.	Cat Contact Lens CaseSunglasses Contact LensCase1st Contact Lens CaseGeeky Eye Contact LensCase	K142717	Contact Lens Case

1. Classifications Names & Citations : 21CFR 886.5928, LRX, Contact Lens Case

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Description :

6. Indication for use:

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

7. Testing summary:

Biocompatibility testing was conducted as noted below:

ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity. The purpose of the test is to assess the potential cytotoxicity of test article Contact Lens Case in the In Vitro Cytotoxicity Test using L929 mouse fibroblast cells (From ATCC), which was sensitive to extractable cytotoxic articles. Under the conditions of this study, the test articles Contact Lens Case extract did not show potential toxicity to L-929 cells with polar and non-polar extracts.

ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. The test was designed to evaluate the potential of a test article extract to cause ocular irritation. According to what observed, the response of ocular on testing side does not exceed that on the control side. Thus, it is identified as grade 0. All animals were not found abnormal clinical symptoms. except ocular reactions. All animals were normal weight change. Under the conditions of this study, the test article extracts showed no significant evidence of causing ocular irritation.

ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. The purpose of this test is to evaluate the potential of a test article extract to cause skin sensitization in the guinea pig. All animals were not found abnormal clinical symptoms except skin reactions. All animals were normal weight change. The positive rate of all test group animals was 0%. The positive rate of all negative control animals was 0%. Under the conditions of this study, the test article extract showed no significant evidence of causing skin sensitization in the guinea pig.

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ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity. The purpose of this testing was to evaluate the potential of a test article extract to cause acute systemic toxicity in mouse. No animals were found with any abnormal clinical symptoms.

All animals had normal weight change. Under the conditions of this study, the test article extracts showed no significant evidence of causing acute systemic toxicity in the mice.

Leakage testing was conducted to the contact lens case samples. 240 combinations of different tops and bottoms were filled to 2/3 with liquid. Each set was turned upside down for 15 minutes and the tests were repeated 3 times.

None of the tested contact lens cases showed any leakage and all passed the leakage tests successfully.

The test results show the Contact Lens Case complies with the requirement as defined.

Comparison with predicate device:

Ningbo Yinzhou Zonghai Artware Co., Ltd. believes that the Contact Lens Case is substantially equivalent to the (K142717) Ni Hau Industrial Co., Ltd. Cat Contact Lens Case; Sunglasses Contact Lens Case; 1st Contact Lens Case; Geeky Eye Contact Lens Case.

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Element ofcomparison	Subject Device	Predict Device
Company	Ningbo Yinzhou Zonghai ArtwareCo., Ltd.	Ni Hau Industrial Co., Ltd.
FDA510(K) Number	N/A	K142717
Device Name	Contact Lens Case	Cat Contact Lens CaseSunglasses Contact Lens Case1st Contact Lens CaseGeeky Eye Contact Lens Case
Classification	CFR 886.5928, Class II	CFR 886.5928, Class II
Product Code	LRX	LRX
Indications for Use	For storage of soft (hydrophilic),hard, and rigid gas permeablecontact lenses during chemicaldisinfections. Use for storageduring chemical disinfections only.DO NOT USE WITH HEAT	For storage of soft (hydrophilic),hard, and rigid gas permeablecontact lenses during chemicaldisinfection. Use for storage duringchemical disinfections only. DO NOTUSE WITH HEAT.
Case Dimension	63x32x16mm	Cat: 65 x 37 x 14mmSunglasses: 71 x 31 x 14mm1st Contact: 60 x 39.6 mmGeeky eyes: 80 x 32 x 21mm
Single WellCapacity Volume	4.8ml	Cat: 3mlSunglasses: 2.5ml1st Contact: 3mlGeeky eyes: 2.8ml
Device Material	BASE: Polypropylene(PP)LID: Polyethylene(PE)	Acrylonitrile Butadene Styrene(ABS)
DeviceConstruction	Shaped base with two wells to holdthe fluid and two screw lids for theLeft and Right eyes of contactlenses.	Shaped base with two wells to holdthe fluid and two screw lids for theLeft and Right eyes of contactlenses.
Screw On Caps	Yes	Yes
R/L indicationson chamber bottomsand/or top	Yes	Yes
Biocompatibility	Complying with ISO10993-1:- Cytotoxicity (ISO 10993-5)- Skin sensitization (ISO10993-10)- Ocular Irritation (ISO 10993-10)-SystematicToxicity (ISO10993-11)	PASS the following test:- Cytotoxicity (ISO 10993-5)- Eye Irritation (ISO 10993-10)- Systematic Toxicity (ISO10993-11)
Disinfection Type	Chemical disinfection, not heatdisinfection.	Chemical disinfection, not heatdisinfection.
Sterilization	Not sold sterile	Not sold sterile

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9. Safety and Performance Data:

SerialNumber/Version	Standard and Description	Scope
Performance Standards
ISO10993-5: 2009	Biological evaluation of medical devices -- Part 5: Testsfor In Vitro cytotoxicity	BiocompatibilityTesting
ISO10993-10:	Biological evaluation of medical devices - Part 10: Testsfor irritation and skin sensitization	BiocompatibilityTesting
ISO10993-10:	Biological evaluation of medical devices - Part 10: Testsfor ocular irritation	BiocompatibilityTesting
ISO10993-11:	Biological evaluation of medical devices - Part 11: Testsfor systemic toxicity	BiocompatibilityTesting

1. Clinical: No clinical tests were performed.
  The basic design of the submitted device specifications is substantially the same 11. as the predicate, with differences in the aesthetic design and plastic material. Though the plastic material is different, biocompatibility testing has verified that the submitted device is safe for use.

All the labeling and characteristics of the submitted OTC Contact Lens Case is the same as the predicate devices and most typical OTC contact lens cases currently on the market. The submitted device and predicate both are used for storage and disinfection by chemical solution of soft (hydrophilic), hard, and rigid gas permeable contact lenses.

1. Conclusions:
  In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Ningbo Yinzhou Zonghai Artware Co., Ltd. concludes that the Contact Lens Case is substantially equivalent to predicate devices as described herein.

END

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.”