(180 days)
For storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. Use for storage during chemical disinfection only. Do not use during heat disinfection.
Polaris Contact Lens Case is a product for the storage of soft (hydrophilic) and rigid gas permeable contact lenses. This device is intended for use with a contact lens solution to store the contact lenses, This product is not to be used in heat disinfection. This device is manufactured in two variations: #101 and #201. The variants follow the same design principles and have the same intended use. The only differences are the dimensions and appearance between the two models. These variations do not affect the safety or effectiveness of the products' intended use. The primary materials which compose the applicant device are ST757M and PT231M; they are produced by Taiwan Polypropylene Co., Ltd. ST757M is a translucent raw material and PT231M is an opaque white raw material. The Polymer 27A55 is produced by Kraton Polymers UK Ltd. The volume of each of the two chambers in the applicant device #101 contact lens case is 4.5ml. The volume of each of the two chambers in the applicant device #201 contact lens case is 3ml. Contact lenses can be fully immersed into the chamber; both models can accommodate all lenses currently on the market.
This submission describes the Polaris Contact Lens Case (models #101 and #201), a device intended for the storage of soft (hydrophilic), rigid gas permeable, or hard contact lenses with chemical disinfectants. The acceptance criteria and the study that proves the device meets them are summarized below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-5:1999 (In vitro cytotoxicity - no cytotoxic effects) | The test article did not induce cytotoxic effects and did not inhibit cell proliferation after exposure for 24 to 48 hours in L929 colorectal carcinoma cells. |
| ISO 10993-10:2002 (Irritation and Delayed-Type Hypersensitivity - no delayed dermal contact sensitization) | There was no evidence of delayed dermal contact sensitization in guinea pigs after injection with 0.9% extracted Sodium Chloride. No deviation from protocol or adverse problems. | |
| ISO 10993-11:2006 (Systemic Toxicity - data for safety criteria for human exposure) | All data generated from this study will be used as safety criteria for human exposure (implies acceptable systemic toxicity profile based on the standard). | |
| Functional Equivalence | Able to fully immerse all contact lenses on the market | Models #101 (4.5 ml per chamber) and #201 (3ml per chamber) can fully immerse all contact lenses currently on the market (max 1.4 cm diameter x 0.35 cm height). |
| Leakage | Not explicitly stated, but implied as part of overall safety and effectiveness for a contact lens case | Leakage tests were performed on each variant. The result of testing supports the claim of substantial equivalence. |
| Intended Use | Same as predicate: Storage of soft, rigid gas permeable, or hard contact lenses with chemical disinfectants only, no heat disinfection. | Polaris Contact Lens Case has the same intended use. |
| Materials | Suitable for intended use and comparable to predicate. | Constructed from ST757M and PT231M (Taiwan Polypropylene Co., Ltd.) and Polymer 27A55 (Kraton Polymers UK Ltd.). Deemed comparable by the FDA as part of substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided document does not specify a "test set" in the context of typical clinical or performance studies with separate training and testing data for an algorithm. Instead, the testing relates to biocompatibility and functional assessment.
- Biocompatibility Tests: The document details specific ISO standards used.
- ISO 10993-5:1999 (Cytotoxicity): Tested on L929 colorectal carcinoma cells. The sample size for the test article (the contact lens case materials) would be determined by the standard's methodology for preparing extracts from the device for cell culture exposure. The specific number of cell cultures or replicates is not stated.
- ISO 10993-10:2002 (Irritation and Delayed-Type Hypersensitivity): Tested on guinea pigs. The specific number of guinea pigs used for this test is not stated, but these studies typically involve a defined number of animals per group (e.g., 5-10 per group).
- ISO 10993-11:2006 (Systemic Toxicity): The specific animal model and sample size for systemic toxicity are not stated, but similar to hypersensitivity, these studies involve a defined number of animals.
- Functional Assessment (Volume and Lens Immersion): This was a qualitative assessment based on physical dimensions of the device and known dimensions of contact lenses. No "sample size" in the statistical sense is applicable here.
- Leakage Tests: Performed on "each variant" (#101 and #201). The specific number of units tested is not provided.
Data Provenance: The studies were conducted by or on behalf of Reliance Design & Manufacture Corp., located in Taiwan. The data is prospective for the specific tests performed on the Polaris Contact Lens Case.
3. 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)
This device is not an AI/ML device, and therefore, no experts were used to establish ground truth in the context of clinical interpretation or diagnosis. The "ground truth" for the performance criteria (biocompatibility, functional equivalence, leakage) is established by the international standards (ISO 10993 series) themselves and accepted scientific methodologies for assessing material safety and device function.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device involving human interpretation of results. The assessment of test results (e.g., cytotoxicity, allergic reactions in animals) is typically performed by trained laboratory personnel following established protocols and criteria defined by the ISO standards.
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 is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on:
- Established scientific methodologies and criteria defined by the ISO 10993 series of standards for biocompatibility (e.g., absence of cytotoxicity, irritation, sensitization).
- Physical measurements and known specifications for functional aspects (e.g., device chamber volume, typical contact lens dimensions).
- Predicate device's established safety and effectiveness: The primary pathway for approval is substantial equivalence to a legally marketed predicate device (Ningbo Kaida Rubber & Plastic Technology Co., Ltd. Contact Lens Case K071081). The fundamental "ground truth" for safety and effectiveness is that it performs comparably to a device already deemed safe and effective by the FDA.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. Since there is no training set, there is no ground truth established for one.
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510(k) Summary
This 510(k) Summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21CFR807.92.
The Assigned 510(k) is: K093377
Applicant Information
Submitter's Name and Address:
Reliance Design & Manufacture Corp. 19, Lane 166, Yen-Ho St., Yung-Kang City, Tainan County(71082) Taiwan R.O.C.
Contact Person:
Ms. Vicky Lu Sales Manager Tel: +886-6-2424626 Fax: +886-6-2424605 E-mail: vickylu@reliance-tnpc.com
Summary Prepared: 07/06/2009
| Trade Name: | Polaris Contact Lens Case |
|---|---|
| Common Name: | Contact Lens Case |
| Classification Name: | Soft (hydrophilic) contact lens care products (886.5928) |
| Classification: | Class II |
Contact Lens Case (Multiple Brand Names) Predicate Device: Ningbo Kaida Rubber & Plastic Technology Co., Ltd. Applicant: Classification Name: Soft (hydrophilic) contact lens care products (886.5928) Classification: Class II 510(k) Number: K071081
Device Description
Polaris Contact Lens Case is a product for the storage of soft (hydrophilic) and rigid gas permeable contact lenses. This device is intended for use with a contact lens solution to store the contact lenses, This product is not to be used in heat disinfection.
This device is manufactured in two variations: #101 and #201. The variants follow the same design principles and have the same intended use. The only differences are the dimensions and appearance between the two models. These variations do not affect the safety or effectiveness of the products' intended use.
The primary materials which compose the applicant device are ST757M and PT231M; they are produced by Taiwan Polypropylene Co., Ltd. ST757M is a translucent raw material and PT231M is an opaque white raw material. The Polymer 27A55 is produced by Kraton Polymers UK Ltd.
APR 2 7 2010
1
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The volume of each of the two chambers in the applicant device #101 contact lens case is 4.5ml. The volume of each of the two chambers in the applicant device #201 contact lens case is 3ml. Contact lenses can be fully immersed into the chamber; both models can accommodate all lenses currently on the market.
Intended Use
Polaris Contact Lens Case is for the storage of soft (hydrophilic), rigid gas permeable, or hard contact lenses. It is to be used with chemical disinfectants only. It is not to be used in heat disinfection.
Technology Characteristics
Polaris Contact Lens Cases #101 & #201 are products for the storage of soft (hydrophilic) and rigid gas permeable contact lenses. They were manufactured in formulation with Ningbo Kaida Rubber & Plastic Technology Co., Ltd Contact Lens Case (FDA 510(k) K071081 -- currently in commercial distribution).
Non-Clinical Performance Data
Biocompatibility Tests
Polaris Contact Lens Cases have been evaluated in accordance with Part 10993 of the International Standard Organization (ISO). Standard tests administered include:
- . ISO 10993-5:1999 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity. The test article did not induce cytotoxic effects and did not inhibit cell proliferation after exposed for 24 to 48 hours in L929 colorectal carcinoma cells.
- ISO10993-10 (2002) Biological Evaluation of Medical Devices Tests of . Irritation and Delayed-Type Hypersensitivity.
- O Under the conditions of this study, the test article was injected with 0.9% extracted Sodium Chloride; there was no evidence of delayed dermal contact sensitization in guinea pigs.
- There was no deviation from the approved study protocol and no adverse problems that would affect the integrity of the results or the interpretation of our conclusion.
- ISO 10993-11:2006 Biological evaluation of medical devices Tests for . Systemic Toxicity. All data generated from this study will be used as safety criteria for human exposure.
Clinical Performance Data
Polaris Contact Lens Cases have not been studied in a clinical setting.
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| ItemsCompany | Reliance Design & Manufacture Corp. | Ningbo Kaida Rubber & PlasticTechnology Co., Ltd. | Result |
|---|---|---|---|
| Product Name | Polaris Contact Lens Case | Contact Lens Case (Multiple BrandNames) (K071081) | |
| ClassificationAdvisoryCommittee | Ophthalmic | Ophthalmic | Same |
| Regulation Number | 886.5928 | 886.5928 | Same |
| Product Code | LRX | LRX | Same |
| Intended Use | For storage of soft (hydrophilic), rigid gaspermeable or hard contact lenses. Usedfor storage during chemical disinfectiononly. Do not use during heat disinfection. | The Applicant contact lens case is a lenscare product to be used by the contactlens wearer or practitioner for storingcontact lenses while not being worn.The applicant device is not designed forheat disinfecting system. Use only withchemical disinfection. | Same |
| Indications | For storage of soft (hydrophilic), rigid gaspermeable or hard contact lenses. Use forstorage during chemical disinfection only.Do not use during heat disinfection. | Storage and Disinfection of Soft, RigidGas Permeable or Hard | Same |
| Materials | Taiwan Polypropylene Co.,LTD.Polypropylene ST775M & PT231M | SK Corporation Polypropylene (PP)R370 Y with certificated quality | Same |
| Composition(%) | - Polyolefin > 95%- Mixture < 5% | Unknown | N/A |
| Comparison | Composition of predicate device was not listed in predicate 510(k) Summary. | ||
| Size | #101 Length: 63.77mmWeigh: 33.31mmHeight: 16.00mm#201 Length: 67.97mmWeigh: 31.97mmHeight: 21.50mm | Length: 62.96mmWeigh: 30.90mmHeight: 16.38mm | Different |
| Volume | #101 4.5 ml each side#201 3.0 ml each side | 4.2 ml each side | Different |
| Comparison | Although the volumes of #101 & #201 contact lens cases are different than the predicate, the sizesof all contact lenses on the market are no larger than 1.4 cm diameter x 0.35 cm height, thus, anycontact lens on the markets can be fully immersed into the chambers. These differences are notcritical nor do they affect the safety or effectiveness of the devices. | ||
| BiocompatibilityTests Performed | ISO 10993-5:1999 - In vitrocytotoxicity ISO10993-10:2002 - Tests of Irritationand Delayed-Type Hypersensitivity. ISO 10993-11:2006 - Tests forSystemic Toxicity. | In Vitro Cyto-toxicity Delayed-type Hypersensitivity Eye Irritation Systemic Toxicity | Same |
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Table I - Technological Characteristics Summary
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Conclusion
After comparison, it has been determined that Polaris Contact Lens Cases #101 & #201 have the same intended use, effectiveness, safety, and biocompatibility as the Ningbo Kaida Rubber & Plastic Technology Co., Ltd. Contact Lens Case (Multiple Brand Names) (K071081).
The size and volume are different than the predicate. The volume of each chamber in applicant device #101 contact lens case is 4.5 ml (2.3 cm square x 0.85 cm depth). The volume of each chamber in #201 contact lens case is 3 ml (2.1 cm diameter x 0.86 cm depth). Although the volumes of #101 & #201 contact lens cases are different than the predicate, the sizes of all contact lenses on the market are no larger than 1.4 cm diameter x 0.35 cm height, thus, any contact lens on the markets can be fully immersed into the chambers. These differences are not critical nor do they affect the safety or effectiveness of the devices.
The applicant performed biocompatibility testing based on ISO 10993 standards for contact lens cases. Additionally, the applicant performed leakage tests on each variant of the contact lens case. The result of testing and evaluation supports the claim of Polaris Contact Lens Case as the substantial equivalent of Ningbo Kaida Rubber & Plastic Technology Co., Ltd's. Contact Lens Case (Multiple Brand Names) (K071081).
End Summary
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Image /page/4/Picture/11 description: The image shows the logo for the Department of Health & Human Services (HHS) in the United States. The logo features a stylized eagle with three overlapping wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Reliance Design & Manufacturing Corp. c/o Underwriters Laboratories, Inc. Mr. Marc M. Mouser 2600 NW Lake Rd. Camas, Washington 98607-9526
APR 2 7 2010
Re: K093377
Trade/Device Name: Polaris 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 9, 2010 Received: April 12, 2010
Dear Mr. Mouser:
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
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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 yours.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K0933377
Device Name: POLARIS CONTACT LENS CASE Indication for Use :
For storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. Use for storage during chemical disinfection only. Do not use during heat disinfection.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page_1_of_1_(Posted Sep 29, 2009
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number_K093337
§ 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.”