(19 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of the lens case and neutralization disc, with no mention of AI or ML.
No.
The device is a lens case described for storage and neutralization of hydrogen peroxide, not for treating or diagnosing a medical condition.
No
The device is a lens case designed for the storage and disinfection of contact lenses using hydrogen peroxide. It does not perform any diagnostic function.
No
The device description clearly outlines physical components (transparent cup, screw cap, lens holders, platinum-coated neutralization disc) and performance studies focus on biocompatibility, physicochemical, and design functionality tests of these physical components.
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 disinfection with a specific hydrogen peroxide solution. This is a process related to the care and maintenance of a medical device (contact lenses), not a diagnostic test performed on a biological sample to determine a medical condition.
- Device Description: The device is a lens case with a neutralization disc. Its function is to facilitate the chemical process of neutralizing hydrogen peroxide. This is a physical/chemical process, not a diagnostic measurement or analysis.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing information for diagnosis, monitoring, or screening of a disease or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not fit that description.
N/A
Intended Use / Indications for Use
For storage of soft (hydrophilic), and rigid gas permeable (RGP) hard contact lenses during disinfection with buffered 3% hydrogen peroxide contact lens solution.
Product codes (comma separated list FDA assigned to the subject device)
LPN, LRX
Device Description
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.
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)
The AOCup Lens Case with AODisc and the changed gasket was evaluated in biocompatibility, physicochemical and design functionality tests.
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K003345, K013512, K022687, K023455, K030522, K031521, P820040, S032, K162597
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.”
0
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.
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 Freeway
Fort 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 Case
with 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 care
products; (21 CFR 886.5918) Rigid gas permeable contact lens
care products |
| Product Code: | LPN (Solution), LRX (lens case) |
4
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 as | |
| part of the system) | |
| K013512, 20-Dec- | |
| 2001; | |
| K022687, 19-Nov- | |
| 2002; | |
| K023455, 28-Feb- | |
| 2003; | |
| K030522, 12-Sep- | |
| 2003; | |
| K031521, 27-Jun- | |
| 2003 | |
| Previously | |
| approved in PMA | |
| P820040, | |
| Supplement S032, | |
| 23-Oct-1995 |
(Reclassified to
Class II in 1997) | AOCup Lens Case with AODisc |
| Special 510k
K162597, 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.
5
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.
6
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.