(180 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a contact lens storage case, with no mention of AI or ML.
No
This device is for the storage of contact lenses during chemical disinfection, not for treating a condition or disease.
No
This device is a contact lens case intended for storage and chemical disinfection of contact lenses, not for diagnosing any medical condition.
No
The device description clearly states it is a physical product made of specific materials (ST757M, PT231M, Polymer 27A55) and has defined dimensions and volumes. It is a physical container for contact lenses, not a software application.
Based on the provided text, 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 function related to the care of a medical device (contact lenses), not a diagnostic test performed in vitro (outside the body) on biological samples to diagnose a condition or provide information about a physiological state.
- Device Description: The description focuses on the materials, dimensions, and function of a container for contact lenses. It does not mention any reagents, assays, or procedures for analyzing biological samples.
- Performance Studies: The performance studies described are biocompatibility tests (cytotoxicity, irritation, systemic toxicity) and leakage tests. These are relevant to the safety and functionality of a physical device that comes into contact with a medical device and potentially the user, but not to the performance of a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the Polaris Contact Lens Case is a medical device, but it falls under a different classification than an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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.
Product codes
LRX
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.
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.
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
Not Found
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
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
1
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.
2
| Items
Company | Reliance Design & Manufacture Corp. | Ningbo Kaida Rubber & Plastic
Technology Co., Ltd. | Result |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Name | Polaris Contact Lens Case | Contact Lens Case (Multiple Brand
Names) (K071081) | |
| Classification
Advisory
Committee | Ophthalmic | Ophthalmic | Same |
| Regulation Number | 886.5928 | 886.5928 | Same |
| Product Code | LRX | LRX | Same |
| Intended Use | For storage of soft (hydrophilic), rigid gas
permeable or hard contact lenses. Used
for storage during chemical disinfection
only. Do not use during heat disinfection. | The Applicant contact lens case is a lens
care product to be used by the contact
lens wearer or practitioner for storing
contact lenses while not being worn.
The applicant device is not designed for
heat disinfecting system. Use only with
chemical disinfection. | Same |
| Indications | For storage of soft (hydrophilic), rigid gas
permeable or hard contact lenses. Use for
storage during chemical disinfection only.
Do not use during heat disinfection. | Storage and Disinfection of Soft, Rigid
Gas 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 (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number_K093337