EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION

K111877 · Bausch & Lomb, Inc. · LPN · Jan 24, 2012 · Ophthalmic

Device Facts

• Record ID: K111877
• Device Name: EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION
• Applicant: Bausch & Lomb, Inc.
• Product Code: LPN · Ophthalmic
• Decision Date: Jan 24, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

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.

Device Story

BAUSCH + LOMB EZS05 Disinfecting Solution is a sterile, buffered 3% hydrogen peroxide solution used for cleaning, disinfecting, and storing soft (hydrophilic) contact lenses. The system includes a specialized lens case equipped with a platinum-coated neutralizing disc. The platinum disc catalyzes the decomposition of the 3% hydrogen peroxide into water and oxygen, neutralizing the solution during the disinfection process. The device is intended for consumer use at home. Users place lenses in the provided case with the solution for a minimum of 6 hours. The process removes proteins and microorganisms from the lens surface. The solution is compatible with various soft contact lens materials, including silicone hydrogels. By ensuring proper disinfection and protein removal, the device helps maintain lens hygiene and comfort, reducing the risk of ocular irritation or infection associated with contaminated lenses.

Clinical Evidence

No clinical data. Safety and efficacy were established through non-clinical bench testing, including biocompatibility (cytotoxicity, ocular irritation, sensitization), microbiological testing per EN ISO 14729 and EN ISO 14730, and in vitro protein removal studies using HPLC assay. Lens compatibility was confirmed for various soft contact lens materials.

Technological Characteristics

Chemical solution containing 3% hydrogen peroxide, phosphonic acid stabilizer, sodium chloride, and phosphate buffers. Includes a specialized lens case with a platinum-coated neutralizing disc. Disinfection requires a 6-hour minimum contact time. Compatible with soft (hydrophilic) and silicone hydrogel contact lenses.

Indications for Use

Indicated for disinfecting, protein removal, and storage of soft (hydrophilic) contact lenses for users as recommended by an eye care practitioner.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”

Predicate Devices

• Ciba AOSEPT Disinfecting Solution (K003345, K013512)
• Ciba Clear Care Cleaning and Disinfecting Solution (K022687)

Submission Summary (Full Text)

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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 [phone]

## 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 + LOMB<br>EZS05 Disinfecting Solution | Ciba Clear Care<br>Cleaning and<br>Disinfecting Solution K022687 | Ciba AOSEPT<br>Disinfecting Solution K003345,<br>K013512 |
|----------------------------------------------------|----------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------|
| Indicated for soft<br>lenses | Yes | Yes | Yes |
| Indicated for the<br>removal of<br>Protein | Yes | Yes | No |
| Rub Regimen | No | Yes, only for Rigid<br>Gas Permeable<br>Lenses | No |
| Lens Case | Designed for<br>system | Designed for<br>system | Designed for<br>system |
| Minimum<br>Disinfection Time | 6 hours | 6 hours | 6 hours |
| Post disinfection<br>saline rinse prior to<br>wear | Optional | Optional | Yes |
| Hydrogen Peroxide<br>Content | 3% | 3% | 3% |
| Buffer System | Phosphate Buffer | Phosphate Buffer | Phosphate Buffer |
| Stabilizer | Phosphonic Acid | Phosphonic Acid | Phosphonic Acid |
| Lens Storage<br>Period | 7 days | 7 days | 24 hours |

## SUBSTANTIAL EQUIVALENCE SUMMARY TABLE

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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 [phone] or [phone] 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