(43 days)
No
The device is a chemical solution for cleaning contact lenses and the summary does not mention any computational or data-driven components.
No.
The device is a cleaning and disinfecting solution for contact lenses, not a substance applied to the body to prevent or treat a disease.
No
This device is a cleaning and disinfecting solution for contact lenses, not a diagnostic device. Its purpose is to clean and disinfect, not to diagnose a condition or disease.
No
The device description clearly states it is an aqueous solution, which is a chemical substance, not software. The performance studies also focus on the chemical and biological properties of the solution and its interaction with contact lenses.
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 diagnosing a disease or condition based on in vitro examination of specimens derived from the human body.
- Device Description: The description details a solution for contact lens care, not a reagent or instrument used for in vitro testing.
- Lack of IVD Characteristics: The document 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 prognosis of a disease or condition.
- Performance Studies: The performance studies focus on the efficacy of the solution in cleaning and disinfecting contact lenses, biocompatibility, and microbiological efficacy against organisms relevant to contact lens care. They do not involve diagnostic performance metrics like sensitivity, specificity, or AUC related to diagnosing a medical condition.
Therefore, the AOSEPT Clear Care Cleaning and Disinfecting Solution is a medical device intended for the care of contact lenses, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
AOSept Clear Care Cleaning and Disinfecting Solution is indicated for use in simultaneous cleaning, daily protein removal, disinfecting, and storing of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner.
Product codes (comma separated list FDA assigned to the subject device)
LPN
Device Description
The AOSEPT Clear Care Cleaning and Disinfecting Solution is an aqueous solution contains hydrogen peroxide 3% (stabilized with phosphonic acid), sodium chloride, a phosphate buffer system and a non-ionic surfactant. The solution is indicated for use in simultaneous cleaning and disinfecting, daily protein removal, and storing of soft (hvdrophilic) contact lenses as recommended by your eve care practitioner.
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)
A series of preclinical and clinical studies have been completed on this product and were previously submitted under submission K003345 and K013512. The non-clinical and clinical studies were completed to demonstrate the substantial equivalence of AOSEPT Clear Care Cleaning and Disinfecting Solution to other currently marketed solutions. All testing was conducted in accordance with and in conformance to applicable device regulations. Results demonstrate the solution is non-toxic and biocompatible, and is comparable to other currently marketed soft contact lens solutions.
Silicone Hydrogel Lens Compatibility Data
A study was conducted to verify that Lotrafilcon A (silicone hydrogel) lenses are compatible with AOSEPT Clear Care Cleaning and Disinfecting Solution. The study showed there was no significant difference between AOSEPT Clear Care Cleaning and Disinfecting Solution and the saline control solution, with respect to optical and physical changes in the measured properties of the lenses. AOSEPT Clear Care Cleaning and Disinfecting Solution meets the guidelines set forth in FDA's May 1, 1997 Guidance for Industry, Premarket Notification 510(k) Guidance Document for Contact Lens Care products.
In Vitro Cleaning Efficacy
Results of the study showed that AOSEPT Clear Care is substantially equivalent to SOLO-Care Multipurpose Solution in terms of daily protein removal. This data was previously submitted and reviewed in original 510(k) submission - K003345..
Cytotoxicity
A series of cytotoxicity studies were previously conducted to demonstrate the safety of AOSEPT Clear Care. Results of the testing demonstrated that AOSEPT Clear Care is non-cytotoxic and is a non-irritant. This data was previously submitted and reviewed in original 510(k) submission - K003345.
Microbiology
A series studies were previously completed to demonstrate the microbiological efficacy of AOSEPT Clear Care. These studies were previously submitted under 510(k) K003345. These studies demonstrate that AOSEPT Clear Care meets the stand-alone criteria of the disinfection efficacy test of the FDA May 1, 1997 Guidance for Industry: Premarket Notification 510(k) Guidance Document for Contact Lens Care Products.
Clinical Testing
A series of clinical studies have been conducted, submitted and reviewed in 510(k) submissions K003345 and K013512. Data from the clinical studies supported the substantial equivalence of AOSEPT Clear Care.
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.
Not Found
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.
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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510(k) SUMMARY PART IX.
In response to the requirements addressed by the Safe Medical Devices Act (SMDA) of 1990, a summary follows with the safety and effectiveness information upon which the substantial equivalence determination is based.
510(k) SUMMARY FOR AOSEPT Clear Care Cleaning and Disinfecting Solution
1. Submitter Information
CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia 30097 Contact Person: Telephone No.
Steven Dowdley 678-415-3897
2. Device Name
Classification Name: Proprietary Name:
Soft (hydrophilic) Contact Lens Solution AOSEPT Clear Care Cleaning and Disinfecting Solution
3. Predicate Device(s)
AOSEPT Clear Care Cleaning and Disinfecting Solution
4. Description of the Device
The AOSEPT Clear Care Cleaning and Disinfecting Solution is an aqueous solution contains hydrogen peroxide 3% (stabilized with phosphonic acid), sodium chloride, a phosphate buffer system and a non-ionic surfactant. The solution is indicated for use in simultaneous cleaning and disinfecting, daily protein removal, and storing of soft (hvdrophilic) contact lenses as recommended by your eve care practitioner.
5. Indications for Use
AOSept Clear Care Cleaning and Disinfecting Solution is indicated for use in simultaneous cleaning, daily protein removal, disinfecting, and storing of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) as recommended by your eve care practitioner.
6. Description of Safety and Substantial Equivalence
A series of preclinical and clinical studies have been completed on this product and were previously submitted under submission K003345 and K013512. The non-clinical and clinical studies were completed to demonstrate the substantial equivalence of AOSEPT Clear Care Cleaning and Disinfecting Solution to other currently marketed solutions. All testing was conducted in accordance with and in conformance to applicable device regulations. Results demonstrate the solution is non-toxic and biocompatible, and is comparable to other currently marketed soft contact lens solutions.
Silicone Hydrogel Lens Compatibility Data
A study was conducted to verify that Lotrafilcon A (silicone hydrogel) lenses are compatible with AOSEPT Clear Care Cleaning and Disinfecting Solution. The study showed there was no significant difference between AOSEPT Clear Care Cleaning and
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Disinfecting Solution and the saline control solution, with respect to optical and physical changes in the measured properties of the lenses. AOSEPT Clear Care Cleaning and Disinfecting Solution meets the guidelines set forth in FDA's May 1, 1997 Guidance for Industry, Premarket Notification 510(k) Guidance Document for Contact Lens Care products.
In Vitro Cleaning Efficacy
Results of the study showed that AOSEPT Clear Care is substantially equivalent to SOLO-Care Multipurpose Solution in terms of daily protein removal. This data was previously submitted and reviewed in original 510(k) submission - K003345..
Cytotoxicity
A series of cytotoxicity studies were previously conducted to demonstrate the safety of AOSEPT Clear Care. Results of the testing demonstrated that AOSEPT Clear Care is non-cytotoxic and is a non-irritant. This data was previously submitted and reviewed in original 510(k) submission - K003345.
Microbiology
A series studies were previously completed to demonstrate the microbiological efficacy of AOSEPT Clear Care. These studies were previously submitted under 510(k) K003345. These studies demonstrate that AOSEPT Clear Care meets the stand-alone criteria of the disinfection efficacy test of the FDA May 1, 1997 Guidance for Industry: Premarket Notification 510(k) Guidance Document for Contact Lens Care Products.
Clinical Testing
A series of clinical studies have been conducted, submitted and reviewed in 510(k) submissions K003345 and K013512. Data from the clinical studies supported the substantial equivalence of AOSEPT Clear Care.
7. Substantial Equivalence
The data provided in this 510(k) submission concludes that AOSEPT Clear Cleaning and Disinfecting Solution is substantially equivalent to AOSEPT Clear Care Cleaning and Disinfecting Solution for cleaning, rinsing, chemical (not heat) disinfecting, protein removal, and storing soft (hydrophilic) contact lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 2003
CIBA Vision Corporation c/o Steven Dowdley, RAC CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, GA 30097
Re: K031521
Trade/Device Name: AOSEPT Clear Care Cleaning and Disinfecting Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LPN Dated: May 12, 2003 Received: May 28, 2003
Dear Mr. Dowdley:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
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Page 2 - Steven Dowdley, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A kalgi Rosenthal
A. Ralph Rosenthal, 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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PART III. INDICATIONS FOR USE STATEMENT
510(k) Number: (Number to be assigned)
AOSept Clear Care Cleaning and Disinfecting Solution Device Name:
Indications for Use:
AOSept Clear Care Cleaning and Disinfecting Solution is indicated for use in simultaneous cleaning, daily protein removal, disinfecting, and storing of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: | or | over-the-counter: | ||
---|---|---|---|---|
------------------- | -------------------------- | ---- | ------------------- | -------------------------------------------- |
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K03/52/