Contact Lens Case, Model: A-1, B-1

• K Number: K172925
• Device Name: Contact Lens Case, Model: A-1, B-1
• Manufacturer: P L Overseas Limited
• Date Cleared: 2017-11-30 ( 66 days)
• Product Code: LRX
• Regulation Number: 886.5928

Intended 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.

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.

Predicate Devices

K162869, K140488

Reference Devices

No reference devices were used in this submission.

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and function of a contact lens case for chemical disinfection, with no mention of AI or ML technologies.

Therapeutic

No.
Explanation: The device is a contact lens case used for storage during chemical disinfection, not for treating a disease or condition.

Diagnostic

No

This device is a contact lens storage case used for chemical disinfection of contact lenses, not for diagnosing any medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical product (a contact lens case with a holder and cover) and the performance studies focus on physical properties like biocompatibility and leakage, not software functionality.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for the storage of contact lenses during chemical disinfection. This is a physical storage and containment function, not a diagnostic test performed on a biological sample.
• Device Description: The description details a physical case with wells for holding contact lenses and disinfection solution. There is no mention of reagents, assays, or any components used to analyze biological samples.
• Performance Studies: The performance studies focus on biocompatibility and leakage, which are relevant to the physical integrity and safety of a storage device, not the analytical performance of a diagnostic test.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, or tissue), detecting specific analytes, or providing diagnostic information about a patient's health status.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This contact lens case does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

LRX

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 +/-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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

contact lens wearer or practitioner

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K162869, K140488

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

No reference devices were used in this submission.

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.”

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 ([e-mail]) or phone [phone] 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)

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.

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: [phone] Tax: 00852 2959 0930

Maggie Li Tel: [phone] Email: [e-mail]

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
Ningbo
Yinzhou
Zonghai 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 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 ±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.

1. K1628690, "Contact Lens Case", manufactured by "Ningbo Yinzhou Zonghai Artware Co., Ltd" in Zhejiang, China

2. 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 Case
K162869	Contact Lens Case
K140488
Classification Name	Case, Contact Lens	Case, Contact Lens	Case, Contact Lens
Classification Advisory
Committee	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
Comparison
Statement	The subject device has the same classification as the predicate devices.
2. Intended Use
Intended Use	For storage of soft
(hydrophilic), hard and
rigid gas permeable
(RGP) contact lenses
during chemical
disinfection.
Use for storage during

                                                                                                                                                                                                                   | 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. | For storage of soft
(hydrophilic), hard and
rigid gas permeable
contact lenses during
chemical disinfections.
Use for storage during
chemical disinfection
only. Do not use heat
disinfection. | |
| Comparison
Statement | The subject device has the same intended use as the predicate devices. | | | |
| 3.Design/Material | | | | |
| Disinfection Type | Chemical Disinfection
Not heat-Disinfection | Chemical Disinfection
Not heat-Disinfection | Chemical Disinfection
Not heat-Disinfection | |
| Sterilization | Not sold sterile | Not sold sterile | Not sold sterile | |
| Design | Holder with two wells
to hold fluid and two
covers for the Left and
Right eyes of contact
lenses
The covers are
designed for screwing. | Shaped base with two
wells to hold fluid and
two screw lids for the
Left and Right eyes of
contact lenses | Two adjoining
chambers with screw
top into which contact
lenses are immersed. | |
| Dimension (LWH) | A-1
B-1 | 643116mm
653115mm | 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-
density
Polyethylene
(HDPE) | LID: Polyethylene
(PE) | Butadiene-Styrene
copolymer (ABS) | |
| | B-1
Acrylonitrile-
Butadiene-
Styrene
copolymer
(ABS) | | | |
| Comparison
Statement | The subject device has a similar product design as the predicate device. The
minor difference is material and appearance, which will be discussed and
demonstrated in "Safety Elements" below. | | | |
| 4.Effectiveness | | | | |
| Effectiveness | The capacity is
sufficient for contact
lens to be fully
immersed under use
condition. | The capacity is
sufficient for contact
lens to be fully
immersed under use
condition. | The capacity is
sufficient for contact
lens to be fully
immersed under use
condition. | |
| Comparison
Statement | The subject device has the same performance effectiveness as the predicate
devices. | | | |
| 5.Safety Elements | | | | |
| Biocompatibility | Complying with ISO
10993-1:
-Cytotoxicity
(ISO10993-5)
-Skin Sensitization
(ISO10993-10)
-Ocular Irritation
(ISO10993-10)
-Systematic Toxicity
(ISO10993-11) | Complying with
ISO10993-1:
-Cytotoxicity
(ISO10993-5)
-Skin Sensitization
(ISO10993-10)
-Ocular Irritation
(ISO10993-10)
-Systematic Toxicity
(ISO10993-11) | Unknown | |
| Leakage Test | No Leakage | No Leakage | Unknown | |
| Comparison
Statement | The A-1 Model of the subject device is made of similar materials as the
Predicate Device 1 and B-1 Model of the subject device is made of the same
material as the Predicate Device 2. Meanwhile, the subject device was
tested relevant biocompatibility tests in accordance with Product Guidance
and 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.