(245 days)
Not Found
No
The device description details a mechanical contact lens case with a manual dial for setting reminders. There is no mention of any computational or learning capabilities.
No.
This device is a contact lens case used for storage during chemical disinfection and does not directly restore, replace, or modify a physiological function.
No
Explanation: The device is a contact lens storage case used for chemical disinfection and reminder setting, not for diagnosing any medical condition.
No
The device description clearly outlines a physical contact lens case with molded plastic components, lids, and dials. There is no mention of any software component.
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 function, not a diagnostic test performed on a biological sample in vitro.
- Device Description: The description details a physical case for holding contact lenses and a mechanism for setting reminders. 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 testing, which are relevant to the safety and functionality of a physical 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, tissue, etc.), detecting specific analytes, or providing diagnostic information.
Therefore, the Polaris 'Dial-A-Date' 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
The Polaris Dial-a-Date Contact Lens Case is intended for the storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. Used for storage during chemical disinfection only. Not for use during heat disinfection.
Product codes (comma separated list FDA assigned to the subject device)
LRX
Device Description
The Polaris Dial-a-Date contact lens case is a device for the storage of soft (hydrophilic) and rigid gas permeable contact lenses. Contact lenses can be fully immersed into the chamber and accommodates all lenses currently being sold in the market. The contact lens case consists of a molded dual compartment bottom base and two screwdown lids. The bottom of each compartment is marked with L (left) and R (right). The lids are also labeled with L (left) and R (right), and include a dial with molded-in numbers from 0 to 3 and 0 to 9, respectively. The outer lids are colored to make the molded-in numbers of the dials visible at the 'dialed position'. The dials can be incrementally rotated to let the user set reminders (i.e. day of the month to replace the contact lenses).
The outer lids and number dials do not come into contact with the lens care solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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)
The following testing has been performed to support substantial equivalence:
- Biocompatibility Testing according to the applicable standards, as described in Section 15 Biocompatibility
- Leakage Testing, as described in Section 18 Performance Testing Bench Studies
Biocompatibility Testing:
The Polaris Dial-a-Date contact lens case has been evaluated for biocompatibility in accordance with Part 10993 of the ISO Standard tests, which 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 being exposed for 24 to 48 hours in L929 colorectal carcinoma cells - ISO 10993-10:2006, Biological evaluation of medical devices Part 10: Tests for . irritation and delayed-type hypersensitivity (Skin Sensitization). Under the conditions of this study, the test article extracted by Sodium Chloride 0.9% Inj. showed no evidence of causing delayed dermal contact sensitization in guinea pigs.
- ISO 10993-10:2006, Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (Ocular Irritation). All grades of ocular irritation calculated by maximum average score were zero. Based on the conditions and results of the study, the test article extract administered to NZW rabbits by ocular instillation did not cause any observable irritation response in vivo. All data generated from this study will provide as safety reference for human exposure.
- ISO 10993-11:2006, Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity.
Under the conditions of this study, there was no mortality or evidence of systemic toxicity from the test article extract injected into ICR mice. All data generated from this study will provide as safety criteria for human exposure. - ISO 10993-12:2007, Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials. (Biocompatibility).
Leakage Testing:
Production units of the Polaris Dial-a-Date contact lens case have undergone leakage testing. The Polaris Dial-a-Date contact lens case was tested for leakage following a written test protocol. 192 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 lens cases showed any leakage and all of the Leakage Tests passed successfully. The results were documented.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
Not Found
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
§ 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.”
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Image /page/0/Picture/1 description: The image shows the word "RELIANCE" in bold, sans-serif font. To the left of the word is a logo that appears to be an eagle head inside of a square with a check mark. The logo and the word are both in black. The background is white.
NOV 26 2012 1
510(k) Summary
(per 21 CFR 807.92)
Submission Correspondent
Emergo Group, Inc. www.emergogroup.com/
Address
611 West Fifth Street Third Floor Austin, TX 78701 USA
Phone
(512) 327-9997 Fax (512) 327-9998
Contact
Caroline Tontini to projectmanagement@emergogroup.com
Submission Sponsor
Reliance Design & Manufacture Corp. No.19, Lane 166, Yanhe St., Yongkang Dist. Tainan City 71082, Taiwan R.O.C
FDA Establishment Registration #: 3008388282
Date Prepared
February 10th, 2012
Trade Name
Polaris Dial-a-Date Contact Lens Case
Classification Name
Soft (hydrophilic) contact lens care products
Regulation Number 886.5928
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Image /page/1/Picture/1 description: The image shows the word "RELIANCE" in bold, black letters. To the left of the word is a black square with a white bird-like figure inside. The font of the word is sans-serif and the letters are closely spaced together.
Product Code LRX
Classification Panel Ophthalmic Devices
Device Class Class 2
Predicate Devices
Polaris Contact Lens Case (K093377) from Reliance Design & Manufacture Corp.
Intended Use
The Polaris Dial-a-Date Contact Lens Case is intended for the storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. Used for storage during chemical disinfection only. Not for use during heat disinfection.
Device Description
The Polaris Dial-a-Date contact lens case is a device for the storage of soft (hydrophilic) and rigid gas permeable contact lenses. Contact lenses can be fully immersed into the chamber and accommodates all lenses currently being sold in the market. The contact lens case consists of a molded dual compartment bottom base and two screwdown lids. The bottom of each compartment is marked with L (left) and R (right). The lids are also labeled with L (left) and R (right), and include a dial with molded-in numbers from 0 to 3 and 0 to 9, respectively. The outer lids are colored to make the molded-in numbers of the dials visible at the 'dialed position'. The dials can be incrementally rotated to let the user set reminders (i.e. day of the month to replace the contact lenses).
The outer lids and number dials do not come into contact with the lens care solution.
Image /page/1/Picture/12 description: The image shows an exploded view of a contact lens case and its components. The case itself is a double-sided container, with two circular depressions for holding the lenses. Above each side of the case, there is a lens and a corresponding cap, with dashed lines indicating the alignment and assembly order of the components. The image illustrates how the lens and cap fit together into the case.
Figure 5A Exploded View of the lens case illustrating the coloring of the Outer Lid
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Image /page/2/Picture/1 description: The image shows the word "RELIANCE" in bold, black letters. To the left of the word is a logo that features a white bird head inside of a black square. A black wing extends from the square. The logo and the word are aligned horizontally.
Comparison of Technological Characteristics
The following table compares the Polaris Dial-a-Date to the POLARIS (201) with respect to intended use, technological characteristics and principles of operation.
Table 5A – Comparison of Characteristics | ||
---|---|---|
Manufacturer | Reliance Design & Manufacture Corp. | Reliance Design & Manufacture Corp. |
Product Name | POLARIS (201) Contact Lens Case | Polaris Dial-a-Date (202) |
Contact Lens Case | ||
510(k) Number | K093377 | Pending |
Classification | ||
Advisory | ||
Committee | Ophthalmic | Ophthalmic |
Product Code | LRX | LRX |
Regulation # | 886.5928 | 886.5928 |
Class | 2 | 2 |
Intended Use | For storage of soft (hydrophilic), rigid | |
gas permeable, and hard contact | ||
lenses. | ||
Use for storage during chemical | ||
disinfection only. Not for use during | ||
heat disinfection. | For storage of soft (hydrophilic), rigid | |
gas permeable, and/or hard contact | ||
lenses. | ||
Use for storage during chemical | ||
disinfection only. Not for use during heat | ||
disinfection. | ||
Composition (%) | - Polyolefin > 95% |
- Mixture 95%
- Mixture Trade/Device Name: Polaris Dial-a-Date 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: October 22, 2012 Received: October 31, 2012
Dear Ms. Tontini:
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
6
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 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" (21CFR 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.
Kesia Y. Alexander
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 Statement
510(k) Number (if known): K120904
Device Name: Polaris "Dial-A-Date" Contact Lens Case
Indications for Use:
Polaris 'Dial-A-Date' is a contact lens case for storage of soft (hydrophilic), rigid gas permeable, and hard contact lenses. Use for storage during chemical disinfection only.
Not for use during heat disinfection.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
MARC ROBBOY
sion Sign-O Division of Ophthalmic and Ear, Nose and Throat Devices 510(k) Number