(30 days)
Not Found
No
The device description and performance studies focus on the physical design and chemical neutralization process, with no mention of AI or ML.
No
The device is a contact lens case used for cleaning, disinfecting, and storage of contacts. While essential for hygiene and safe contact lens use, it does not directly treat or diagnose a disease or condition, which is the definition of a therapeutic device.
No
This device is a lens case designed for cleaning, disinfecting, and storing contact lenses, not for diagnosing medical conditions.
No
The device description clearly outlines a physical lens case with a neutralization disc, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for cleaning, disinfecting, and storing contact lenses. This is a direct interaction with a medical device (contact lenses) and not for the purpose of examining specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a lens case with a neutralization disc. Its function is to neutralize hydrogen peroxide, a cleaning and disinfecting agent, into harmless substances. This is a chemical process applied to the contact lens, not a diagnostic test performed on a biological sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly intended to maintain the cleanliness and safety of contact lenses, which are medical devices themselves.
N/A
Intended Use / Indications for Use
For use in simultaneous cleaning, daily protein removal, disinfecting, and storage of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) or rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses as recommended by your eye care practitioner.
Product codes (comma separated list FDA assigned to the subject device)
LPN
Device Description
The two color AOCup Lens Case with AODisc is equivalent to the predicate device except modifications of colorants and minor modifications to basket geometry.
It 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 the strong oxidizing agent hydrogen peroxide to harmless water and oxygen gas.
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 two color AOCup Lens Case with AODisc was evaluated in biocompatibility, physicochemical, design functionality and microbiological tests. 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.
PMA P820040, K003345, K013512, K022687, K023455, K030522, K031521
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 19, 2016
Alcon Laboratories, Inc. % Mr. Ralf Finke Senior Regulatory Specialist, Alcon Vision Care CIBA Vision GmbH Industriering 1 Grosswallstadt, Bavaria, DE 63868
Re: K162597
Trade/Device Name: Clear Care Cleaning & Disinfecting Solution, 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: LPN Dated: September 16, 2016 Received: September 19, 2016
Dear Mr. 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, 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
1
Page 2 - Mr. Ralf Finke
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Kesia Alexander
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) K162597
Device Name
AOSEPT Clear Care Cleaning and Disinfecting Solution (AOCup Lens Case with AODisc)
Indications for Use (Describe)
For use in simultaneous cleaning, daily protein removal, disinfecting, and storage of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) or rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses as recommended by your eye care practitioner.
| 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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8 510(K) SUMMARY
This summary document is being prepared in accordance with section 21 CFR 807.92(c).
Submitter Information: A.
| 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: | Sherri Lakota |
| Phone: | (USA, Fort Worth, TX) 817-615-5472 |
| Fax: | (USA, Fort Worth, TX) 817-551-4630 |
| Email: | sherri.lakota@alcon.com |
| Date Prepared: | September 2016 |
B. Device Name:
| Trade Names: | AOSEPT Clear Care Cleaning and Disinfecting Solution
(AOCup Lens Case with AODisc) |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Contact Lens Accessory |
| 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) |
4
C. Predicate Devices:
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 |
-
| 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) |
Device Description: D.
The two color AOCup Lens Case with AODisc is equivalent to the predicate device except modifications of colorants and minor modifications to basket geometry.
It 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 the strong oxidizing agent hydrogen peroxide to harmless water and oxygen gas.
5
The modifications of colorants and basket geometry do not change any indications for use nor the basic technical principle of the device functions.
E. Indications for Use:
For use in simultaneous cleaning, daily protein removal, disinfecting, and storage of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) or rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses as recommended by your eye care practitioner.
F. Brief Summary of Nonclinical Test and Results:
The two color AOCup Lens Case with AODisc was evaluated in biocompatibility, physicochemical, design functionality and microbiological tests. 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.