(161 days)
Not Found
No
The device is a contact lens cleaning and disinfecting solution, and the description focuses on its chemical composition and performance in cleaning, disinfection, and compatibility studies. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
A therapeutic device is typically something that diagnoses, treats, or prevents a disease or condition, or affects the structure or function of the body. This device is a contact lens cleaning and disinfecting solution, which maintains the cleanliness and safety of contact lenses rather than directly treating a medical condition of the user.
No
This device is a cleaning and disinfecting solution for contact lenses. Its intended use involves cleaning, daily protein removal, disinfection, and storing of contact lenses, not diagnosing a medical condition.
No
The device is a contact lens cleaning and disinfecting solution, which is a chemical product, not software. The description details the chemical composition, packaging, and a physical lens case.
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 a test performed in vitro (outside the body) on a biological specimen to diagnose a condition.
- Device Description: The device is a sterile solution and a special lens case. It does not involve any components or processes typically associated with IVD tests (e.g., reagents for detecting analytes in biological samples).
- Performance Studies: The performance studies focus on the efficacy of cleaning, disinfection, lens compatibility, and biocompatibility. These are relevant to the safety and effectiveness of a contact lens care product, not the diagnostic accuracy of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting specific substances in the body, or providing diagnostic information.
Therefore, based on the provided description, CLEAR CARE PLUS Cleaning & Disinfecting Solution is a contact lens care product, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CLEAR CARE PLUS Cleaning & Disinfecting Solution is indicated for use in simultaneous cleaning, daily protein removal, disinfection, and storing of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) and rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses, as recommended by your eye care professional.
Product codes (comma separated list FDA assigned to the subject device)
LPN, MRC
Device Description
FID 120947A is a sterile solution containing micro-filtered hydrogen peroxide 3% as the active ingredient. The formulation contains dual surfactants, Pluronic® 17R4 and a novel block copolymer surfactant, EO10BO3. composed of ethylene oxide and butylene oxide (nEOBO), to enhance wettability of contact lens surfaces. The formulation also contains phosphonic acid, a metal chelating agent to stabilize hydrogen peroxide, sodium phosphates as buffering agents, and sodium chloride as a tonicity agent. The sterile solution is aseptically filled and packaged in sterilized plastic bottles [gamma irradiated bottle; ethylene oxide (EtO) snap cap) with a tamper-evident seal and labeling to include the manufacturing lot number and expiration date. A special lens case, consisting of a transparent cup and connected unit of screw cap, lens holders (baskets) and platinum-coated neutralizing disc, is provided with each purchase of FID 120947A. The lens case is the same as that provided with the previously cleared device.
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
Over-The-Counter Use
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)
Residual Hydrogen Peroxide and Area under Curve:
The neutralization profile of FID 120947A was conducted for 100 cycles and found to be equivalent to Clear Care® in terms of residual hydrogen peroxide level, post neutralization and pH and osmolality. In addition, the area under the curve, a measurement of the total peroxide exposure available to kill microorganisms, for FID 120947A demonstrates an effective neutralization rate of peroxide.
Cleaning:
Studies were conducted to demonstrate the cleaning efficacy of FID 120947A with hydrogel and silicone hydrogel soft contact lenses and rigid gas permeable (RGP) lenses. The cleaning efficacy study using an exaggerated in vitro lysozyme demonstrates the ability of FID 120947A to clean protein from all hydrogel and silicone hydrogel soft contact lenses and rigid gas permeable (RGP) contact lenses.
A second in vitro cleaning efficacy study was conducted with three different soft contact lens materials, using physiologically relevant multi-component artificial tear fluid solution. The study further demonstrates the ability of FID 120947A to clean protein from soft contact lenses.
In addition, the ability of cleaning efficacy of the solution was evaluated through the determination of the critical micelle concentration (CMC). The surfactant concentration in the formulation was determined to exceed the CMC value.
Lens Compatibility:
Compatibility studies of FID 120947A were conducted with Groups I, II and IV traditional hydrogel soft contact lenses, Group V silicone hydrogel soft contact lenses and RGP contact lenses. Results demonstrate that FID 120947A is compatible with all hydrogel and silicone hydrogel soft contact lenses and RGP contact lenses.
Microbiology:
A series of studies was performed, based on the May 1997 FDA (510(k)) guidance document for contact lens care products, ANSI Z80.18-2010 (Contact Lens Care Products -Vocabulary, Performance, Specifications and Test Methodology), EN ISO 14729:2001/A1:2010 (Ophthalmic Optics - Contact Lens Care Products -Microbiological Requirements and Test Methods for Products and Regimens for Hygienic Management of Contact Lenses) and EN ISO 14730:2000 (Ophthalmic optics- Contact Lens Care Products - Antimicrobial Preservative Efficacy Testing and Guidance on Determining Discard Date), to demonstrate the microbiological efficacy of FID 120947A. Results demonstrated that the formulation meets the criteria for disinfection and preservative efficacy. In addition, FID 120947A met the requirements of ISO/FDA disinfecting regimen procedure for all nine contact lens materials tested.
Biocompatibility:
A complete battery of pre-clinical safety evaluations was conducted to ensure the safety of FID 120947A. Included in this battery were tests for genotoxicity, sensitization, systemic toxicity and ocular biocompatibility. Testing was conducted according to the May 1997 FDA 510(k) guidance document for contact lens care products and ISO 10993-1:2009/Cor. 1:2010 and related ISO biocompatibility standards. Acceptable results from this comprehensive series of in vitro and in vivo testing support the safety of FID 120947A for its intended use.
Clinical:
Two clinical studies were conducted to evaluate the safety and efficacy of FID 120947A in silicone hydrogel, traditional hydrogel and RGP contact lens wearers. In the first study, the control product was Bausch + Lomb renu® fresh™ multi-purpose solution; and in the second study the control product was Boston Simplus® Multi-Action Contact Lens Solution. Upon review of the clinical results, FID 120947A was found to be at least as safe and effective as renu® fresh " for hydrogel and silicone hydrogel soft contact lenses; and Boston Simplus® for RGP contact lenses.
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, K020802, K024289
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.”
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing to the right, overlapping to create a sense of depth and unity. The emblem is white, set against a dark background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 26, 2015
Alcon Laboratories, Inc. Ms. Alicia M. Plesnarski, RAC Director, Regulatory Affairs, Alcon Vision Care 6201 South Freeway Fort Worth, TX 76134
Re: K142284
Trade/Device Name: CLEAR CARE® PLUS Cleaning & Disinfecting Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LPN, MRC Dated: December 15, 2014 Received: December 17, 2014
Dear Ms. Plesnarski:
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 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
1
device-related 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.
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,
Kesia Y. Alexander -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) K142284
Device Name
CLEAR CARE PLUS Cleaning & Disinfection Solution
Indications for Use (Describe)
CLEAR CARE PLUS Cleaning & Disinfecting Solution is indicated for use in simultaneous cleaning, daily protein removal, disinfection, and storing of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) and rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses, as recommended by your eye care professional.
| 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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510(K) SUMMARY
This summary document is being prepared in accordance with section 21 CFR 807.92.
The submitter of the 510(k) is:
Alicia M. Plesnarski, RAC Director, Regulatory Affairs, Alcon Vision Care Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134 Phone: (678) 415-3924 Fax: (678) 415-3454 email: alicia.plesnarski@alcon.com
Date Summary Prepared: 20-Jan-2015
Device Subject to this 510(k):
| Trade Name: | CLEAR CARE® PLUS Cleaning & Disinfecting Solution |
|---|---|
| Common Name: | Cleaning and Disinfecting Solution |
| Classification Name: | Soft (hydrophilic) contact lens care products (886.5928); |
| Rigid gas permeable contact lens care products (886.5918) | |
| Product Code: | LPN |
Predicate Device(s)
The 510(k) device, Hydrogen Peroxide nEOBO FID 120947A (i.e., FID 120947A), is a modification of the predicate device, Clear Care® Cleaning & Disinfecting Solution, a legally commercialized device in the US per the following US FDA 510(k) clearances: K003345, 26-Mar-2001; K013512, 20-Dec-2001; K022687, 19-Nov-2002; K023455, 28-Feb-2003; K030522, 12-Sep-2003; and K031521, 27-Jun-2003. In addition, other legally marketed devices to which substantial equivalence was demonstrated include Bausch + Lomb renus
4
fresh™ multi-purpose solution [510(k) clearance K020802, 31-May-2002], and Boston Simplus® Multi-Action Solution [510(k) clearance K024289, 02-May-2003].
Device Description
FID 120947A is a sterile solution containing micro-filtered hydrogen peroxide 3% as the active ingredient. The formulation contains dual surfactants, Pluronic® 17R4 and a novel block copolymer surfactant, EO10BO3. composed of ethylene oxide and butylene oxide (nEOBO), to enhance wettability of contact lens surfaces. The formulation also contains phosphonic acid, a metal chelating agent to stabilize hydrogen peroxide, sodium phosphates as buffering agents, and sodium chloride as a tonicity agent. The sterile solution is aseptically filled and packaged in sterilized plastic bottles [gamma irradiated bottle; ethylene oxide (EtO) snap cap) with a tamper-evident seal and labeling to include the manufacturing lot number and expiration date. A special lens case, consisting of a transparent cup and connected unit of screw cap, lens holders (baskets) and platinum-coated neutralizing disc, is provided with each purchase of FID 120947A. The lens case is the same as that provided with the previously cleared device.
Indications for Use
Clear Care Plus Cleaning & Disinfecting Solution is indicated for use in simultaneous cleaning, daily protein removal, disinfection, and storing of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) and rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses, as recommended by your eye care professional.
Brief Summary of Nonclinical Tests and Results
A series of pre-clinical and clinical studies were completed to demonstrate the substantial equivalence of FID 120947A to the predicate device(s). Testing was conducted in consideration of the May 1997 FDA Guidance for Industry: Premarket Notification 510(k) Guidance Document for Contact Lens Care Products and applicable ISO and ANSI standards for contact lens care solutions.
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. Residual Hydrogen Peroxide and Area under Curve
The neutralization profile of FID 120947A was conducted for 100 cycles and found to be equivalent to Clear Care® in terms of residual hydrogen peroxide level, post neutralization and pH and osmolality. In addition, the area under the curve, a measurement of the total peroxide exposure available to kill microorganisms, for FID 120947A demonstrates an effective neutralization rate of peroxide.
Cleaning .
Studies were conducted to demonstrate the cleaning efficacy of FID 120947A with hydrogel and silicone hydrogel soft contact lenses and rigid gas permeable (RGP) lenses. The cleaning efficacy study using an exaggerated in vitro lysozyme demonstrates the ability of FID 120947A to clean protein from all hydrogel and silicone hydrogel soft contact lenses and rigid gas permeable (RGP) contact lenses.
A second in vitro cleaning efficacy study was conducted with three different soft contact lens materials, using physiologically relevant multi-component artificial tear fluid solution. The study further demonstrates the ability of FID 120947A to clean protein from soft contact lenses.
In addition, the ability of cleaning efficacy of the solution was evaluated through the determination of the critical micelle concentration (CMC). The surfactant concentration in the formulation was determined to exceed the CMC value.
. Lens Compatibility
Compatibility studies of FID 120947A were conducted with Groups I, II and IV traditional hydrogel soft contact lenses, Group V silicone hydrogel soft contact lenses and RGP contact lenses. Results demonstrate that FID 120947A is compatible with all hydrogel and silicone hydrogel soft contact lenses and RGP contact lenses.
. Microbiology
A series of studies was performed, based on the May 1997 FDA (510(k)) guidance document for contact lens care products, ANSI Z80.18-2010 (Contact Lens Care Products -Vocabulary, Performance, Specifications and Test Methodology), EN ISO
6
14729:2001/A1:2010 (Ophthalmic Optics - Contact Lens Care Products -Microbiological Requirements and Test Methods for Products and Regimens for Hygienic Management of Contact Lenses) and EN ISO 14730:2000 (Ophthalmic optics- Contact Lens Care Products - Antimicrobial Preservative Efficacy Testing and Guidance on Determining Discard Date), to demonstrate the microbiological efficacy of FID 120947A. Results demonstrated that the formulation meets the criteria for disinfection and preservative efficacy. In addition, FID 120947A met the requirements of ISO/FDA disinfecting regimen procedure for all nine contact lens materials tested.
Biocompatibility .
A complete battery of pre-clinical safety evaluations was conducted to ensure the safety of FID 120947A. Included in this battery were tests for genotoxicity, sensitization, systemic toxicity and ocular biocompatibility. Testing was conducted according to the May 1997 FDA 510(k) guidance document for contact lens care products and ISO 10993-1:2009/Cor. 1:2010 and related ISO biocompatibility standards. Acceptable results from this comprehensive series of in vitro and in vivo testing support the safety of FID 120947A for its intended use.
. Clinical
Two clinical studies were conducted to evaluate the safety and efficacy of FID 120947A in silicone hydrogel, traditional hydrogel and RGP contact lens wearers. In the first study, the control product was Bausch + Lomb renu® fresh™ multi-purpose solution; and in the second study the control product was Boston Simplus® Multi-Action Contact Lens Solution. Upon review of the clinical results, FID 120947A was found to be at least as safe and effective as renu® fresh " for hydrogel and silicone hydrogel soft contact lenses; and Boston Simplus® for RGP contact lenses.
Substantial Equivalence Conclusion .
The cumulative results of all testing demonstrate the safety, efficacy and performance of FID 120947A and, thus, substantial equivalence to the predicate device(s) for cleaning and disinfection of hydrogel and silicone hydrogel soft contact lenses and rigid gas permeable (RGP) contact lenses.