(207 days)
BAUSCH + LOMB EZS05 Disinfecting Solution is indicated for disinfecting, protein removal, and storage of soft (hydrophilic) contact lenses, as recommended by your eye care practitioner.
BAUSCH + LOMB EZS05 Disinfecting Solution is a sterile, buffered 3% hydrogen peroxide solution with a phosphonic acid stabilizer, sodium chloride and phosphate buffers. A special lens case containing a platinum coated neutralizing disc is provided with the EZS05 Disinfecting Solution. The sterile solution is packaged in a plastic bottle with a tamper evident seal and labelled with a lot number and expiration date
The document describes the acceptance criteria and supporting studies for the BAUSCH + LOMB EZS05 3% Hydrogen Peroxide Disinfecting Solution. This is a contact lens care product, and the studies are primarily pre-clinical (in vitro and laboratory-based) to demonstrate safety and effectiveness for its intended use.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a contact lens solution, the performance isn't measured in typical diagnostic metrics (like sensitivity/specificity). Instead, it's evaluated against specific quality and efficacy standards for contact lens care products. The acceptance criteria are implied by the standards referenced and the statement of meeting those criteria.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility | FDA Guidance for Contact Lens Solutions and Accessory Products (May 1997), GLP requirements, recognized testing Standards for cytotoxicity, ocular irritation, and sensitization. | Non-cytotoxic, not an ocular irritant, not a sensitizing agent. |
| Microbiology (Disinfection) | EN ISO 14729:2001 (Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods). | Meets criteria for disinfection. |
| Microbiology (Preservative Efficacy) | EN ISO 14730:2000 (Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date). | Meets criteria for preservative efficacy. |
| Lens Compatibility | Compatibility with soft contact lenses including silicone hydrogel contact lenses. (No specific standard cited, but implied by need for compatibility) | Compatible with soft contact lenses including silicone hydrogel contact lenses. |
| Protein Removal | Efficacy statistically equivalent to predicate device (Ciba Clear Care Cleaning and Disinfecting Solution) on various lens types (Polymacon, Etafilcon A, Galyfilcon A, Balafilcon A) for lysozyme removal. | Statistically equivalent to the predicate device, Ciba Clear Care Cleaning and Disinfecting Solution. |
2. Sample Size Used for the Test Set and Data Provenance
- Biocompatibility, Microbiology, Lens Compatibility: No specific sample sizes for these studies are provided in terms of "test set" and "training set" as these are not machine learning models. These are laboratory-based, pre-clinical studies where samples would refer to test reagents, lens materials, microbial cultures, and animal models or in-vitro cell cultures. No country of origin for the data is mentioned, but testing was performed under Good Laboratory Practice requirements and adhered to international ISO standards. These were likely retrospective analyses of laboratory test results.
- Protein Removal: The study involved in vitro deposition of lysozyme on Polymacon, Etafilcon A, Galyfilcon A, and Balafilcon A Soft Contact Lenses. The exact number of lenses used for each type is not specified but implies multiple lenses to achieve statistical equivalence. The data provenance is from in vitro testing, not human subjects, so geographic origin is not directly relevant. It is a laboratory-based study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The "ground truth" for these pre-clinical studies is established by standardized laboratory methods, physical/chemical measurements, and microbiological assays, not by human expert interpretation of images or clinical cases.
4. Adjudication Method for the Test Set
Not applicable. There's no human interpretation or subjective assessment involved that would require adjudication. The outcomes are objective laboratory measurements.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is a contact lens solution, and its effectiveness is determined through laboratory and in vitro testing, not by human readers interpreting clinical cases. The document explicitly states that "Clinical Studies are not warranted" given the market history of peroxide solutions and the FDA guidance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is geared towards AI/ML devices. Since this is a chemical preparation (contact lens solution), the concept of "standalone (algorithm only)" performance does not apply. The device itself is the "standalone" product that performs its function without human intervention during the disinfection process.
7. The Type of Ground Truth Used
- Biocompatibility: In-vitro cell assays for cytotoxicity, animal models or in vitro tests for ocular irritation and sensitization.
- Microbiology: Standardized microbiological culture methods to determine microbial reduction and preservative efficacy.
- Lens Compatibility: Laboratory assessment of lens material integrity and optical properties after exposure to the solution.
- Protein Removal: Quantitative chemical analysis (HPLC assay for total protein) of lysozyme remaining on contact lenses after treatment.
8. The Sample Size for the Training Set
Not applicable. These are pre-clinical laboratory studies, not machine learning or AI algorithm development, so there isn't a "training set" in that context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set." The methodology involves adherence to established international and FDA standards for laboratory testing.
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KI11877
JAN 2 4 2012
510(k) SUMMARY
BAUSCH + LOMB EZS05 3% Hydrogen Peroxide Disinfecting Solution
1. Submitter Information
Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14609
Contact Person Heather Michaels Specialist Global Regulatory Affairs
Telephone Number (585) 338-8493
2. Device Name
| Common Name: | Contact Lens Disinfection Solution | |
|---|---|---|
| Trade Name: | TBD | |
| Classification: | Soft (hydrophilic) contact lens care products | |
| Device classification: | Class II (21 CFR §886.5928) | |
| Product Code: | LPN |
3. Predicate Devices
Ciba AOSEPT Disinfecting Solution (K003345, K013512) Ciba Clear Care Cleaning and Disinfecting Solution (K022687)
4. Description of the Device
BAUSCH + LOMB EZS05 Disinfecting Solution is a sterile, buffered 3% hydrogen peroxide solution with a phosphonic acid stabilizer, sodium chloride and phosphate buffers. A special lens case containing a platinum coated neutralizing disc is provided with the EZS05 Disinfecting Solution. The sterile solution is packaged in a plastic bottle with a tamper evident seal and labelled with a lot number and expiration date
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5. Intended Use
BAUSCH + LOMB EZS05 Disinfecting Solution is indicated for disinfecting. protein removal, and storage of soft (hydrophilic) contact lenses, as recommended by your eye care practitioner.
6. Description of Safety and Substantial Equivalence
A series of preclinical testing was performed to demonstrate the safety and effectiveness of BAUSCH + LOMB EZS05 Disinfecting Solution. A summary of the test results is provided below:
Biocompatibility
EZS05 Disinfecting Solution was evaluated for non-clinical safety in accordance with FDA Guidance for Contact Lens Solutions and Accessory Products, May 1997, as well as referencing several recognized testing Standards which were performed under Good Laboratory Practice requiations. Cytotoxicity, ocular irritation, and sensitization studies were completed for BAUSCH + LOMB EZS05 Disinfecting Solution. The test results demonstrated that BAUSCH + LOMB EZS05 Disinfecting Solution is non-cytotoxic, and not an ocular irritant or sensitizing agent.
Microbiology
A series of studies were conducted according to EN ISO 14729:2001 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. The testing demonstrated BAUSCH + LOMB EZS05 Disinfecting Solution meets the criteria for disinfection and preservative efficacy.
Lens Compatibility
The results of lens compatibility studies demonstrate BAUSCH + LOMB EZS05 Disinfecting Solution is compatible with soft contact lenses including silicone hydrogel contact lenses.
Protein Removal
The protein removal ability of EZS05 and predicate device Ciba Clear Care was evaluated with Polymacon (38.6% water), Etafilcon A (55% water), Galyfilcon A (47% water), and Balafilcon A (36% water) Soft Contact Lenses. The study evaluated the efficacy of the test products' on lenses deposited in vitro with lysozyme and subjected to a single cleaning / disinfection regimen. The amount of lysozyme remaining on the lenses was quantitated by extraction and HPLC assay for total protein. The results demonstrated that EZS05 was statistically equivalent to the predicate device, Ciba Clear Care Cleaning and Disinfecting Solution.
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Clinical Study
EZS05 Disinfecting Solution contains 3% hydrogen peroxide as the active ingredient, which is the same active ingredient within marketed concentrations of peroxide disinfecting solutions currently marketed in the Bausch & Lomb assessed the market history of peroxides, the U.S. ingredients compared to marketed product and, the applicability of the US FDA's "Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products" and determined that further Clinical Studies are not warranted.
Substantial Equivalence
The cumulative results of laboratory, in vitro and in vivo testing sponsored by Bausch & Lomb demonstrate that the safety, efficacy and performance of BAUSCH + LOMB EZS05 Disinfecting Solution are substantially equivalent to Ciba AOSEPT Disinfecting Solution, and Ciba Clear Care Cleaning and Disinfecting Solution for soft contact lenses.
| Feature | BAUSCH + LOMBEZS05 Disinfecting Solution | Ciba Clear CareCleaning andDisinfecting Solution K022687 | Ciba AOSEPTDisinfecting Solution K003345,K013512 |
|---|---|---|---|
| Indicated for softlenses | Yes | Yes | Yes |
| Indicated for theremoval ofProtein | Yes | Yes | No |
| Rub Regimen | No | Yes, only for RigidGas PermeableLenses | No |
| Lens Case | Designed forsystem | Designed forsystem | Designed forsystem |
| MinimumDisinfection Time | 6 hours | 6 hours | 6 hours |
| Post disinfectionsaline rinse prior towear | Optional | Optional | Yes |
| Hydrogen PeroxideContent | 3% | 3% | 3% |
| Buffer System | Phosphate Buffer | Phosphate Buffer | Phosphate Buffer |
| Stabilizer | Phosphonic Acid | Phosphonic Acid | Phosphonic Acid |
| Lens StoragePeriod | 7 days | 7 days | 24 hours |
SUBSTANTIAL EQUIVALENCE SUMMARY TABLE
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Image /page/3/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 figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird figure. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 2 4 2012
Bausch & Lomb, Inc. c/o Ms. Heather Michaels Specialist Global Regulatory Affairs 1400 North Goodman Street Rochester, NY 14609
Re: K111877
Trade/Device Name: Bausch & Lomb EZS05 Disinfecting Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LPN Dated: January 17, 2012 Received: January 18, 2012
Dear Ms. Michaels:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined 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 commerce prior to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, uevices that have been recuire approval of a premarket approval application (PMA). alla Cosmetic Act (Fiel) that to her required to the general controls provisions of the Act. The T ou may, therefore, market the act include requirements for annual registration, listing of general controls provide of tractice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adultcrainon. Treasonote. OD142 801 at 11:15 am the truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (bee acove). Existing major regulations affecting your device can be may be subject to additions, 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 I 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 Or any 1 occurated and survivements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Of it I ar o 7), ideese events) (21 CFR 803); good manufacturing practice requirements as set de rice-related daverse overley (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 11 you actual open fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely vours.
Kesia Alexander
vina B. Evdelman. M.D. Director Division of Ophthalmic, Neurological, 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):
BAUSCH + LOMB EZS05 Disinfecting Solution Device Name:
Indications for Use:
BAUSCH + LOMB EZS05 Disinfecting Solution is indicated for disinfecting, protein removal, and storage of soft (hydrophilic) contact lenses, as recommended by your eye care practitioner.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter-Use × (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K111877
§ 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.”