For storage of soft (hydrophilic), hard and rigid gas permeable (RGP) contact lenses during chemical disinfection. Use for storage during chemical disinfection only. Do not use during heat disinfection.

Device Description

The Contact Lens Case is a lens case product to be used by the contact lens wearer or practitioner for storing soft (hydrophilic), hard and rigid gas permeable contact lenses during chemical disinfection. The Case is to be designed during chemical disinfection only. No designed for heat disinfecting system.

The Contact Lens Case includes A-1 and B-1 two models. Both have adopted the same structure design, consisting of two parts: holder and cover. The holder is based with adjoining dual wells for the containment of fluid, and two covers are designed for screwing. At the same time, the bottom of each well is marked with L (left) and R (right) letters, and the covers are also labeled with L (left) and R (right) letters.

The Contact Lens Case is simple with a well volume of 4.2mL $\pm$0.15. This volume capacity can provide sufficient space to insert and retrieve the contact lenses. It also provides sufficient space to introduce the chemical cleaning solution and adequately over the lenses for cleaning.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a Contact Lens Case, Model: A-1, B-1. The primary focus of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing novel safety and effectiveness through extensive clinical trials for a new medical device. Therefore, the information regarding acceptance criteria and studies will be different from what might be found for a device requiring more comprehensive performance validation (e.g., AI algorithms or complex medical devices).

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely based on demonstrating equivalence in product design, material biocompatibility, and functional performance (leakage) to existing, approved predicate devices.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Requirement	Reported Device Performance
I. Biocompatibility	Must comply with ISO 10993-1, specifically tests for:	All tests were passed (see details below).
Cytotoxicity	ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity	Passed
Skin Sensitization	ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization	Passed
Ocular Irritation	ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Ocular Irritation	Passed
Systemic Toxicity	ISO 10993-11:2006/(R)2010, Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity	Passed
II. Leakage Testing	No leakage when filled to 2/3 with liquid, turned upside down for 15 minutes, repeated 3 times.	None of the tested contact lens cases showed any leakage and all passed the leakage tests successfully. (120 combinations of different tops and bottoms were tested).
III. Effectiveness (Volume)	The capacity must be sufficient for the contact lens to be fully immersed under use conditions. (Predicate devices had volumes of 4.2mL ± 0.15 and 4.8mL, and "over 3.0mL"). Subject device has a well volume of 4.2mL ± 0.15.	The capacity is sufficient for contact lens to be fully immersed under use conditions. (Stated in the comparison table and device description, implicitly meeting the criterion by matching/exceeding predicate volume).
IV. Material Equivalence	The subject device materials should be similar to or have demonstrated equivalent safety profile to predicate devices. (A-1: Polypropylene (holder), High-density Polyethylene (HDPE) (cover); B-1: Acrylonitrile-Butadiene-Styrene copolymer (ABS))	A-1 Model is made of similar materials as Predicate Device 1 (Polypropylene holder, Polyethylene lid). B-1 Model is made of the same material as Predicate Device 2 (Acrylonitrile-Butadiene-Styrene copolymer (ABS)). Relevant biocompatibility tests were conducted and met all requirements, demonstrating comparability.
V. Design & Intended Use	Similar design (holder with two wells, screw covers, L/R markings) and identical intended use (storage of soft, hard, RGP contact lenses during chemical disinfection, not heat disinfection) to predicate devices.	The subject device has the same classification, intended use, and similar product design as the predicate devices. Minor differences in material and appearance were addressed by safety testing. The subject device has "the same performance effectiveness as the predicate devices." (Stated in comparison tables).

Study Details

Given the nature of a 510(k) for a contact lens case, the "study" is primarily a set of non-clinical tests to demonstrate safety and performance equivalence.

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

Biocompatibility Testing: The specific sample sizes for each individual biocompatibility test (cytotoxicity, sensitization, ocular irritation, systemic toxicity) are not explicitly stated in the provided text. These tests are typically performed on extracts from a representative number of device components or material samples under controlled laboratory conditions, not on a "test set" in the sense of clinical cases.
Leakage Testing:
- Sample Size: 120 combinations of different tops and bottoms.
- Data Provenance: Not explicitly stated but implied to be conducted by the manufacturer or a contracted testing lab as part of the device's validation.

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

This information is not applicable or not provided for this type of device and submission. "Ground truth" established by experts is typically relevant for diagnostic devices or AI algorithms where human interpretation is being evaluated or augmented. For a contact lens case, the "ground truth" for performance is defined by adherence to physical and biological testing standards.

3. Adjudication method for the test set:

This information is not applicable or not provided. Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies in expert interpretations of data, usually in diagnostic imaging or clinical trials. For a non-clinical device like a contact lens case, the test results are usually measured objectively against predefined pass/fail criteria.

4. 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:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices involving human readers. The contact lens case is a physical medical device, not an AI diagnostic tool.

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

No, a standalone algorithm performance study was not done. This device does not involve an algorithm.

6. The type of ground truth used:

The "ground truth" for this device's performance is established by objective measurements against recognized international standards and specifications:
- Biocompatibility: Adherence to ISO 10993 standards for cytotoxicity, sensitization, ocular irritation, and systemic toxicity.
- Leakage: Absence of visible liquid escape under specified test conditions.
- Volume/Effectiveness: Physical measurement of fluid capacity compared to the functional requirement (sufficient immersion) and predicate devices.

7. The sample size for the training set:

Not applicable / Not provided. This device is not an AI algorithm that requires a "training set." The testing performed (biocompatibility, leakage) is for validation against established standards.

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

Not applicable / Not provided. As there is no "training set" for an AI algorithm, this question is irrelevant to this device submission.

Summary

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November 30, 2017

P L Overseas Limited % Rain Yip Official Correspondent Feiying Drug & Medical Consulting Technical Service Group Rm. 3005 Area B. Bldg.1, Southward Ruifeng Business Center Guimiao Road Shenzhen, Guangdong 518000 P.R. China

Re: K172925

Trade/Device Name: Contact Lens Case, Model: A-1, B-1 Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LRX Dated: September 16, 2017 Received: September 25, 2017

Dear Rain Yip:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality svstems (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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

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) K172925

Device Name Contact Lens Case

Indications for Use (Describe)

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)

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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: 16/09/2017

I. Submitter

P L Overseas Limited RM.A 4/F Alexandra Indl. Bldg. Blk.A, 1064-1066 Tung Chau West ST., Cheung Sha Wan, Kowloon, HongKong

Phone: 00852 2959 3013 Tax: 00852 2959 0930

Maggie Li Tel: 86 138 2888 2233 Email: maggie@mghkltd.com

II. Device

Name of Device: Contact Lens Case Common or Usual Name: Contact Lens Case Classification Name: Case, Contact Lens Regulatory Class: II Product Code: LRX Regulation Number: 21 CFR 886.5928

III. Predicate Device

1 ) The predicate devices are listed as below:

Manufacturer	Predicate Device	510(k) Number	Approval Date
NingboYinzhouZonghai Artware Co.,Ltd	Contact Lens Case	K162869	December 9, 2016
MACA Plastics Inc	Contact Lens Case	K140488	September 10, 2014

2 ) No reference devices were used in this submission.

IV. Device Description

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The Contact Lens Case is simple with a well volume of 4.2mL ±0.15. This volume capacity can provide sufficient space to insert and retrieve the contact lenses. It also provides sufficient space to introduce the chemical cleaning solution and adequately over the lenses for cleaning.

V. Indications for Use

For storage of soft (hydrophilic), hard and rigid gas permeable (RGP) contact lenses during chemical disinfection.

Use for storage during chemical disinfection only. Do not use during heat disinfection.

VI. Comparison of Technological Characteristics With the Predicate Device

The Contact Lens Case is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance.

K1628690, "Contact Lens Case", manufactured by "Ningbo Yinzhou Zonghai Artware Co., Ltd" in Zhejiang, China
K140488, "Contact Lens Case", manufactured by "MACA Plastics Inc" in Ohio, U.S.A

The following table shows similarities and differences of use, design, material, safety and effectiveness between the subject device and predicate devices.

Comparison Elements	Subject Device	Predicate Device 1	Predicate Device 2
1.Classification
Device Name	Contact Lens Case	Contact Lens CaseK162869	Contact Lens CaseK140488
Classification Name	Case, Contact Lens	Case, Contact Lens	Case, Contact Lens
Classification AdvisoryCommittee	Ophthalmic	Ophthalmic	Ophthalmic
Class	II	II	II
Comparison Elements	Subject Device	Predicate Device 1	Predicate Device 2
Regulation Number	21CRF 886.5928	21CRF 886.5928	21CRF 886.5928
Product Code	LRX	LRX	LRX
ComparisonStatement	The subject device has the same classification as the predicate devices.
2. Intended Use
Intended Use	For storage of soft(hydrophilic), hard andrigid gas permeable(RGP) contact lensesduring chemicaldisinfection.Use for storage during	For storage of soft(hydrophilic), hard andrigid gas permeablecontact lenses duringchemical disinfection.Use for storage duringchemical disinfectiononly. DO NOT USEWITH HEAT.	For storage of soft(hydrophilic), hard andrigid gas permeablecontact lenses duringchemical disinfections.Use for storage duringchemical disinfectiononly. Do not use heatdisinfection.
ComparisonStatement	The subject device has the same intended use as the predicate devices.
3.Design/Material
Disinfection Type	Chemical DisinfectionNot heat-Disinfection	Chemical DisinfectionNot heat-Disinfection	Chemical DisinfectionNot heat-Disinfection
Sterilization	Not sold sterile	Not sold sterile	Not sold sterile
Design	Holder with two wellsto hold fluid and twocovers for the Left andRight eyes of contactlensesThe covers aredesigned for screwing.	Shaped base with twowells to hold fluid andtwo screw lids for theLeft and Right eyes ofcontact lenses	Two adjoiningchambers with screwtop into which contactlenses are immersed.
Dimension (LWH)	A-1B-1	643116mm653115mm	633216mm	Unknown
Volume (Each well)		4.2mL $\pm$ 0.15	4.8mL	Over 3.0mL
Materials	A-1	Holder:Polypropylene	BASE: Polypropylene(PP)	Polypropylene (PP)and Arcylonitrile-
Comparison Elements	Subject Device	Predicate Device 1	Predicate Device 2
	(PP)Cover: High-densityPolyethylene(HDPE)	LID: Polyethylene(PE)	Butadiene-Styrenecopolymer (ABS)
	B-1Acrylonitrile-Butadiene-Styrenecopolymer(ABS)
ComparisonStatement	The subject device has a similar product design as the predicate device. Theminor difference is material and appearance, which will be discussed anddemonstrated in "Safety Elements" below.
4.Effectiveness
Effectiveness	The capacity issufficient for contactlens to be fullyimmersed under usecondition.	The capacity issufficient for contactlens to be fullyimmersed under usecondition.	The capacity issufficient for contactlens to be fullyimmersed under usecondition.
ComparisonStatement	The subject device has the same performance effectiveness as the predicatedevices.
5.Safety Elements
Biocompatibility	Complying with ISO10993-1:-Cytotoxicity(ISO10993-5)-Skin Sensitization(ISO10993-10)-Ocular Irritation(ISO10993-10)-Systematic Toxicity(ISO10993-11)	Complying withISO10993-1:-Cytotoxicity(ISO10993-5)-Skin Sensitization(ISO10993-10)-Ocular Irritation(ISO10993-10)-Systematic Toxicity(ISO10993-11)	Unknown
Leakage Test	No Leakage	No Leakage	Unknown
ComparisonStatement	The A-1 Model of the subject device is made of similar materials as thePredicate Device 1 and B-1 Model of the subject device is made of the samematerial as the Predicate Device 2. Meanwhile, the subject device wastested relevant biocompatibility tests in accordance with Product Guidanceand ISO10993 standards as recognized by FDA; the test results met all
Comparison Elements	Subject Device	Predicate Device 1	Predicate Device 2
	relevant requirements in test standards, and are comparable to the predicate device.
	The subject device has the same performance effectiveness as the predicate devices.

Comparison Table

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VII.Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Non-Clinical Data:

1) Biocompatibility Testing

The biocompatibility evaluation for the Contact Lens Case was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on June 16, 2016", as recognized by FDA. The battery of testing included the following tests:

ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices -Par t 5: Tests for In Vitro Cytotoxicity
ISO 10993-10:2010, Biological Evaluation of Medical Devices -Par t 10: Tests for Irritation and Skin Sensitization
ISO 10993-10:2010, Biological Evaluation of Medical Devices -Par t 10: Tests for Ocular Irritation
ISO 10993-11:2006/(R)2010, Biological Evaluation of Medical Devices -Par t 11: Tests for Systemic Toxicity

All tests were passed.

2) Leakage Testing

Leakage testing was conducted to the Contact Lens Case samples. 120 combinations of different tops and bottoms were filled to 2/3 with liquid. Each set was turned upside down for 15 minutes and the test 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.

Clinical Data

Clinical studies were unnecessary for this application. Lens case solutions used with this contact lens case are already cleared for use as cleaning, rinsing, disinfection and storage solutions for soft (hydrophilic), hard and rigid gas permeable (RGP) contact lenses.

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Summary

Based on the above performance as documented in this application, Contact Lens Case was found to have a safety and effectiveness profile that is similar to the predicate device.

Conclusions VIII.

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design, materials and performance, the Contact Lens Case is to be concluded substantial equivalent to its predicate devices.

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.”