(28 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.
This looks like a 510(k) summary for a medical device with a minor modification (change in silicone material of a gasket). Generally, devices with such minor changes do not contain extensive studies as they are not typically required for demonstrating substantial equivalence. The document confirms this in Section VII, "Performance Data," stating that the device was evaluated in "biocompatibility, physicochemical and design functionality tests."
Given the information provided in the 510(k) summary:
- No extensive clinical study was conducted or is reported for the device. The primary purpose of this 510(k) (K191795) is to demonstrate substantial equivalence to a legally marketed predicate device after a change in a gasket material.
- The "performance data" mentioned refers to nonclinical testing, which is generally not a clinical trial involving human subjects or AI algorithm performance as you might expect in more complex device submissions.
- The information you are asking for (e.g., sample size for training set, MRMC study, number of experts for ground truth) is typical for AI/ML-driven devices or devices requiring extensive clinical validation. This device (AOCup Lens Case with AODisc) is a contact lens case, which falls under a different regulatory pathway and testing requirements.
Therefore, I cannot provide the detailed information you requested about acceptance criteria and study particulars in the format you specified, as those types of studies and criteria are not described in this 510(k) submission for this specific device. The provided text outlines a regulatory submission for a contact lens case after a material change, not an AI or imaging-based diagnostic device.
However, I can interpret the "Performance Data" section to infer general acceptance criteria and the "study" (nonclinical testing) that proves the device meets them:
General Acceptance Criteria and "Study" (Nonclinical Testing) for AOCup Lens Case with AODisc (K191795)
The primary acceptance criterion for this 510(k) submission is to demonstrate that the modified device (with the new silicone gasket material) maintains the same safety and effectiveness as the predicate device. This is achieved through nonclinical testing to ensure the material change does not negatively impact the device's intended function or biocompatibility.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|---|
| Biocompatibility | The new gasket material must be biocompatible (e.g., non-cytotoxic, non-irritating, non-sensitizing) and not leach harmful substances. | "The AOCup Lens Case with AODisc and the changed gasket was evaluated in biocompatibility... tests." (Implicitly, these tests were successful as the submission concludes substantial equivalence and safety.) |
| Physicochemical Properties | The new gasket material must maintain appropriate physical and chemical properties (e.g., durability, chemical stability) for its function as a seal in the lens case, particularly in contact with hydrogen peroxide solution. | "The AOCup Lens Case with AODisc and the changed gasket was evaluated in... physicochemical... tests." (Implicitly, these tests were successful, indicating the material change did not compromise the physical or chemical integrity of the gasket or its interaction with the solution.) |
| Design Functionality | The device, with the new gasket, must continue to function as intended (e.g., seal properly, prevent leaks, accommodate lenses, allow neutralization). | "The AOCup Lens Case with AODisc and the changed gasket was evaluated in... design functionality tests." "Dimensions and technical function of the gasket are unchanged." "The modifications of gasket material does not change any indications for use nor the basic technical principle of the device functions." (Implicitly, these tests were successful, confirming the gasket still performs its sealing role and the overall lens case maintains its designed function for storage and disinfection.) |
| Substantial Equivalence (Overall) | The modified device must be as safe and effective as the predicate device, and the material change must not raise new questions of safety or effectiveness. | "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." |
Regarding the other points in your request:
- 2. Sample sized used for the test set and the data provenance: Not applicable. These were nonclinical (bench) tests, not involving a "test set" in the context of clinical data or AI algorithms.
- 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for nonclinical tests is based on established testing standards and specifications, not expert interpretation of data.
- 4. Adjudication method: Not applicable.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not an imaging or diagnostic device that would require such a study.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This device does not involve an algorithm.
- 7. The type of ground truth used: For biocompatibility, physicochemical, and design functionality tests, the "ground truth" would be defined by the established industry standards, test methods (e.g., ISO standards for biocompatibility), and internal product specifications for the performance of the gasket and the lens case.
- 8. The sample size for the training set: Not applicable. There is no training set for this type of device.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, the provided document describes a regulatory submission for a physical medical device (contact lens case) with a minor material change. The "study" refers to nonclinical laboratory and bench testing rather than clinical trials or AI performance evaluations, therefore, most of your requested information is not relevant to this specific type of device and submission.
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July 31, 2019
Alcon Laboratories, Inc. Dr. Ralf Finke Senior Regulatory Specialist Alcon Vision Care Industriering 1 Grosswallstadt, DE 63868 Bavaria
Re: K191795
Trade/Device Name: AOCup Lens Case with AODisc Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LRX, LPN Dated: July 2, 2019 Received: July 3, 2019
Dear Dr. 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketingsafety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K191795
Device Name
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) | Over-The-Counter Use (21 CFR 801 Subpart C) | |
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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 |
| Email: | katryna.warren@alcon.com |
| Date Prepared: | June 24, 2019 |
II. Devices Subject to this 510(k)
| Trade Names: | AOCup Lens Case with AODisc(part of the Clear Care Cleaning & Disinfecting Solution systemand the Clear Care Plus Cleaning & Disinfecting Solution system) |
|---|---|
| Common Name: | 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: | LRX (lens case)LPN (Solution) |
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III. Predicate Device
The legally marketed device(s) to which we are claiming substantial equivalence are:
| 510(k) Number | Device |
|---|---|
| Previously approved in PMA P820040, Supplement S032, 23-Oct-1995(Reclassified to Class II in 1997)Special 510k K162597, 19-Oct-2016Special 510k K173538, 04-Oct-2017 | AOCup Lens Case with AODisc |
| K003345, 26-Mar-2001;K013512, 20-Dec-2001;K022687, 19-Nov-2002;K023455, 28-Feb-2003;K030522, 12-Sep-2003;K031521, 27-Jun-2003 | Clear Care Cleaning & Disinfecting Solution (contains the AOCup Lens Case with AODisc as part of the system) |
| K142284, 26-Jan-2015 | Clear Care Plus Cleaning & Disinfecting Solution (contains the AOCup Lens Case with AODisc as part of the system) |
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IV. Device Description
The AOCup Lens Case with AODisc is equivalent to the predicate device except change to the silicone material of a gasket. The gasket has O-ring form and is included in the screw cap assembly of the lens case.
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 does 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 of an o-ring gasket in the screw cap of predicate device AOCup Lens Case cleared in 510k K162597 and K173538 has been changed to a different silicone material. Dimensions and technical function of the gasket are unchanged.
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VII. Performance Data
The AOCup Lens Case with AODisc and the changed gasket was evaluated in biocompatibility, physicochemical and design functionality tests.
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.”