(19 days)
For storage of soft (hydrophilic), and rigid gas permeable (RGP) hard contact lenses during disinfection with buffered 3% hydrogen peroxide contact lens solution.
The device is a specialized lens case consisting of a transparent cup with a connected unit of screw cap, lens holders (baskets) and platinum-coated neutralization disc. The platinum catalyst coating and shape of the plastic disc are designed to effectively neutralize hydrogen peroxide in the lens care system to harmless water and oxygen gas.
The provided text describes a 510(k) premarket notification for a medical device called "Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc." This submission is for a modification to an existing device, specifically a change in the silicone material of a gasket and its coating within the lens case.
The document does not contain the kind of detailed acceptance criteria and study information typically associated with AI/ML-based medical devices or diagnostic tools. Instead, it focuses on the safety and efficacy of a contact lens care product and its components. Therefore, many of the requested fields related to AI/ML study design will not be applicable.
Here's an attempt to answer the questions based on the available information, noting where information is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Standard ISO 10993 subparts for new silicone and new coating material. (Implicitly, the criteria would be to pass these tests, demonstrating non-toxicity and compatibility with human tissue). | "Toxicological safety has been tested and confirmed in a battery of tests of the new silicone as well as the new coating material in accordance with the subparts of standard ISO 10993." (Successful) |
| Physicochemical Properties | USP and EP requirements for extractable and leachable testing of coated and uncoated gaskets. (Implicitly, the criteria would be to meet these requirements, ensuring no harmful substances leach from the materials). | "Furthermore, extractable and leachable testing of the coated and uncoated gaskets has been conducted in accordance with USP and EP requirements." (Implicitly successful, as the conclusion states substantial equivalence and safety.) |
| Design Functionality | - Coating adhesion to silicone material. - No negative effect on functionality characteristics of the gasket in the lens case assembly. (Implicitly, the criteria would be acceptable adhesion and no degradation of the gasket's designed function). | "Design functionality tests were conducted to confirm that the coating adheres reliably to the silicone material and does not affect negatively any functionality characteristics of the gasket in the lens case assembly." (Implicitly successful, as the conclusion states substantial equivalence and safety.) |
| Overall Safety & Efficacy | The modified device must be "substantially equivalent" to predicate devices, ensuring continued safety and efficacy for its intended use (storage of soft and RGP contact lenses during disinfection with 3% hydrogen peroxide solution). The modifications should not change the indications for use or the basic technical principle of the device. | "Successful results of all nonclinical testing supported the substantial equivalence and therefore safety and efficacy of the modified AOCup Lens Case with AODisc to the existing product for its intended use." (Met) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for the tests conducted (biocompatibility, physicochemical, and design functionality). It also does not provide details on data provenance beyond indicating the submitter (Alcon Laboratories, Inc., USA, with a contact in Germany) and the FDA's review process. These types of tests are typically bench tests or laboratory assessments of materials, not clinical studies with human subjects or retrospective/prospective data collection in the sense of an AI/ML diagnostic.
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 question is not applicable to the scope of this regulatory submission. The "ground truth" here is established by adherence to recognized international standards (ISO, USP, EP) and internal engineering design specifications for material properties and device function. There were no human experts establishing a "ground truth" for a diagnostic outcome.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The tests described are laboratory and bench tests, not assessments requiring human adjudication of diagnostic outcomes.
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/ML device or a diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" or reference standards used are:
- International Standards: Subparts of ISO 10993 (for biocompatibility).
- Pharmacopeia Standards: USP (United States Pharmacopeia) and EP (European Pharmacopoeia) requirements (for extractable and leachable testing).
- Engineering Design Specifications: Related to coating adhesion and overall functionality of the gasket within the lens case.
8. The sample size for the training set
Not applicable. This is not an AI/ML device and does not involve a "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device and does not involve a "training set."
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 4, 2017
Alcon Laboratories, Inc. Ralf Finke Senior Regulatory Specialist Ciba Vision GmbH Industriering 1 Grosswallstadt, Bavaria 63868, Germany
Re: K173538
Trade/Device Name: Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AQDisc Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LPN, LRX Dated: November 10, 2017 Received: November 15, 2017
Dear Ralf Finke:
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. Iisting 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.
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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 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.
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) K173538
Device Name
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
Indications for Use (Describe)
For storage of soft (hydrophilic), and rigid gas permeable (RGP) hard contact lenses during disinfection with buffered 3% hydrogen peroxide contact lens solution.
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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AOCup Lens Case with AODisc - Parylene
510(k) Summary
This 510(k) summary document has been prepared in accordance with section 21 CFR 807.92.
I. Submitter of the 510(k)
| Company: | Alcon Laboratories, Inc.6201 South FreewayFort Worth, TX 76134-2099, USA |
|---|---|
| Primary Contact Person: | Ralf Finke |
| Phone: | (Germany) +49 (6022) 240.515 |
| Fax: | (Germany) +49 (6022) 240.512 |
| Email: | ralf.finke@alcon.com |
| Back up Contact Person: | Katryna Warren |
| Phone: | (USA, Fort Worth, TX) 817-615-5076 |
| Fax: | (USA, Fort Worth, TX) 817-551-4630 |
| Email: | katryna.warren@alcon.com |
| Date Prepared: | November 10, 2017 |
II. Devices Subject to this 510(k)
| Trade Names: | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Casewith AODisc |
|---|---|
| Common Name: | Cleaning and Disinfecting Solution, Contact lens case |
| Classification Name: | Ophthalmic |
| Device Classification: | Class II (21 CFR 886.5928) Soft (hydrophilic) contact lens careproducts; (21 CFR 886.5918) Rigid gas permeable contact lenscare products |
| Product Code: | LPN (Solution), LRX (lens case) |
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AOCup Lens Case with AODisc - Parylene
III. Predicate Device
The legally marketed device(s) to which we are claiming substantial equivalence are:
| 510(k) Number | Device |
|---|---|
| K003345, 26-Mar-2001; | Clear Care Cleaning & Disinfecting Solution(contains the AOCup Lens Case with AODisc aspart of the system) |
| K013512, 20-Dec-2001; | |
| K022687, 19-Nov-2002; | |
| K023455, 28-Feb-2003; | |
| K030522, 12-Sep-2003; | |
| K031521, 27-Jun-2003 | |
| Previouslyapproved in PMAP820040,Supplement S032,23-Oct-1995(Reclassified toClass II in 1997) | AOCup Lens Case with AODisc |
| Special 510kK162597, 19-Oct-2016 |
IV. Device Description
The AOCup Lens Case with AODisc is equivalent to the predicate device except change to the silicone material of a gasket and the coating of this silicone gasket. The gasket has O-ring form and is included in the screw cap assembly of the lens case.
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AOCup Lens Case with AODisc - Parylene
The device is a specialized lens case consisting of a transparent cup with a connected unit of screw cap, lens holders (baskets) and platinum-coated neutralization disc. The platinum catalyst coating and shape of the plastic disc are designed to effectively neutralize hydrogen peroxide in the lens care system to harmless water and oxygen gas.
The modifications of gasket material and coating do not change any indications for use nor the basic technical principle of the device functions.
Indications for Use V.
For storage of soft (hydrophilic), and rigid gas permeable (RGP) hard contact lenses during disinfection with buffered 3% hydrogen peroxide contact lens solution.
VI. Comparison to Technological Characteristics with the Predicate Device
The silicone material and its coating of an o-ring gasket in the screw cap of predicate device AOCup Lens Case cleared in 510k K162597 has been changed to a different silicone material and different coating. Dimensions and technical function of the gasket are unchanged.
VII. Performance Data
The AOCup Lens Case with AODisc and the changed gasket was evaluated in biocompatibility, physicochemical and design functionality tests.
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AOCup Lens Case with AODisc - Parylene
Toxicological safety has been tested and confirmed in a battery of tests of the new silicone as well as the new coating material in accordance with the subparts of standard ISO 10993. Furthermore, extractable and leachable testing of the coated and uncoated gaskets has been conducted in accordance with USP and EP requirements.
Design functionality tests were conducted to confirm that the coating adheres reliably to the silicone material and does not affect negatively any functionality characteristics of the gasket in the lens case assembly.
VIII. Conclusions
Successful results of all nonclinical testing supported the substantial equivalence and therefore safety and efficacy of the modified AOCup Lens Case with AODisc to the existing product for its intended use.
§ 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.”