Bausch + Lomb PeroxiClear™ 3% Hydrogen Peroxide Cleaning and Disinfecting Solution is indicated for the daily cleaning, removal of protein deposits, disinfection, and storage of soft (hydrophilic) contact lenses (including silicone hydrogel) and rigid gas permeable contact lenses, as recommended by your eye care practitioner.

Device Description

Bausch + Lomb PeroxiClear™ 3% Hydrogen Peroxide Cleaning & Disinfecting Solution (referred to as PeroxiClear) is a sterile, buffered solution containing 3% hydrogen peroxide (which contains a phosphonic acid stabilizer), potassium chloride, propylene glycol, carbamide (urea), a citrate/phosphate buffer system, and a poloxamer (P-181) surfactant. The sterile solution is aseptically filled and packaged in ethylene oxide (EtO) sterilized plastic bottles with a tamper-evident seal and labeled with a lot number and expiration date. A special lens case, containing a platinum-coated neutralizing disc, is provided with each bottle of PeroxiClear. This is the same lens case as provided with the previously cleared device.

The solution and lens case combined are considered a lens care system. As with the previously cleared device, the solution requires the use of the provided lens case specifically designed for neutralization of the peroxide and cannot be used in combination with any other lens case. The system is designed to clean and disinfect contact lenses by filling solution into the provided lens case and allowing the lenses to soak for a minimum of four hours. During the soaking period, the hydrogen peroxide is neutralized by a platinum-coated disc, thereby allowing the lenses to be safely inserted in the eye.

AI/ML Overview

The provided submission describes a contact lens cleaning and disinfecting solution, not an AI/ML-driven device. Therefore, many of the requested criteria, such as number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not applicable.

The submission focuses on demonstrating substantial equivalence to a predicate device for safety and effectiveness through non-clinical testing.

Here's an analysis of the provided information, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

The relevant acceptance criteria are based on microbiological requirements for contact lens care products. The "device performance" refers to the solution meeting these standards.

Acceptance Criteria (Standard)	Reported Device Performance
EN ISO 14729:2001/AMD.1:2010(E) Microbiological requirements (Disinfection)	Met (demonstrated through non-clinical testing)
EN ISO 147302000(E) Antimicrobial preservative efficacy	Met (demonstrated through non-clinical testing)
Stability studies	Met (demonstrated through non-clinical testing)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample sizes used for the microbiological and stability testing. Standardized tests (like ISO 14729 and 14730) typically involve specific numbers of microbial samples and product batches.
Data Provenance: The studies were non-clinical (laboratory-based) tests, not involving human subjects or real-world patient data. Therefore, "country of origin" and "retrospective/prospective" are not applicable in the human data sense.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This is not applicable as the studies are non-clinical (microbiological and stability testing) against established scientific standards. The "ground truth" is defined by the performance criteria outlined in the ISO standards, not by expert consensus on clinical images or data.

4. Adjudication Method for the Test Set

Not applicable, as the tests are objective laboratory measurements against predefined microbial reduction and preservative efficacy standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or data, often assisted by AI. This submission is for a contact lens cleaning solution.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a chemical solution, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for these non-clinical studies is defined by established scientific standards and accepted microbiological performance criteria as set forth in the EN ISO standards (14729 and 14730). For stability studies, the ground truth would be the maintenance of the product's chemical and physical properties over time within specified limits.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML system and does not involve training data.

9. How the Ground Truth for the Training Set was Established

Not applicable.

Summary of Study Demonstrating Acceptance Criteria:

The study demonstrating the device meets acceptance criteria was a series of non-clinical laboratory studies, specifically:

Microbiological testing performed according to EN ISO 14729:2001/AMD.1:2010(E), which outlines ophthalmic optics standards for contact lens care product microbiological requirements and test methods for hygienic management of contact lenses. This would assess its disinfection efficacy against specified microorganisms.
Antimicrobial preservative efficacy testing performed according to EN ISO 147302000(E), which provides guidance on determining discard dates and ensures the solution remains effective over its shelf-life.
Stability studies to confirm the product's physical and chemical integrity and efficacy over its intended shelf life.

The submission states that "The results of the non-clinical and stability testing demonstrate that the safety and effectiveness of Bausch + Lomb PeroxiClear™ 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is substantially equivalent to the previously cleared device." This implies that the device successfully met the performance thresholds set by these international standards, thus confirming its safety and effectiveness for its intended use.

Summary

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K132216

510(k) Summary

· � ା

SEP 0 9 2013

Submitter Information:

Date Prepared:	July 16, 2013
Name:	Bausch & Lomb Incorporated
Address:	1400 North Goodman StreetRochester, NY 14609
Contact Person:	Heather MichaelsSenior Specialist, Global Regulatory Affairs
Phone Number:	(585) 338-8493(585) 338-0702 (fax)
Email:	Heather.michaels@bausch.com

Device Information:

Trade Name:	Bausch + Lomb PeroxiClear™ 3% Hydrogen PeroxideCleaning & Disinfecting Solution
Common Name:	Contact Lens Disinfection Solution
DeviceClassification:	Class II
ClassificationName:	Soft (hydrophilic) Contact Lens Care Products(21 CFR 886.5928)Rigid Gas Permeable Contact Lens Care Products(21 CFR 886.5918)
Product Codes:	LPN, MRC

Predicate Device:

The predicate device is Bausch + Lomb OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Solution (K112909).

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Device Description:

Intended Use:

Bausch + Lomb PeroxiClear™ 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is intended for the daily cleaning, removal of protein deposits, disinfection, and storage of soft (hydrophilic) contact lenses (including sillcone hydrogel) and rigid gas permeable contact lenses, as recommended by your eve care practitioner.

The intended use above is identical to what was cleared in the original 510(k) (K112909).

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Technological Characteristics:

The table below shows a side-by-side comparison of the technological characteristics of the modified device to the previously cleared device. Differences were evaluated during the design and development of the modified device and testing was completed to demonstrate the modified device and predicate device are substantially equivalent and the differences do not negatively impact the safety and efficacy of the device.

Feature	Bausch + Lomb OCD04 3%Hydrogen Peroxide Cleaning andDisinfecting Solution(predicate device)	Bausch + Lomb PeroxiClear™3% Hydrogen Peroxide Cleaning& Disinfecting Solution(modified device)
510(k) Number	K112909	K132216
Device Class	Class II	Identical
Regulation	Soft (hydrophilic) Contact LensCare Products (21 CFR 886.5928) Rigid Gas Permeable Contact LensCare Products (21 CFR 886.5918)	Identical
Product Codes	LPN, MRC	Identical
Indications for Use	Indicated for the daily cleaning,removal of protein deposits,disinfection, and storage of soft(hydrophilic) contact lenses (includingsilicone hydrogel) and rigid gaspermeable contact lenses, asrecommended by your eye carepractitioner.	Identical
Rub Regimen	Yes, only for Rigid Gas PermeableLenses	Identical
No-Rub Regimen	5 second rinse	Identical
Platinum-CoatedNeutralization Disc	Yes	Yes
Lens Case	Designed for System	Identical
Minimum DisinfectionTime	4 hours	Identical
Post Disinfection SalineRinse Prior to Wear	Optional	Identical
Hydrogen PeroxideContent	3%	Identical
Buffer System	Phosphate / Citrate Buffers	Identical
Stabilizer	Phosphonic Acid	Identical
Lens Storage Period	7 days	Identical
Discard After Opening	90 days or 35 uses	Identical
Primary Container(Material and Size)	HDPE Plastic(120 ml, 360 ml)	Identical

Table 1. Comparison of Technological Characteristics

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Summary of Non-Clinical Testing:

In addition to stability studies, a series of studies were conducted according to EN ISO 14729:2001/AMD.1:2010(E) Ophthalmic optics - Contact lens care products -Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses and EN ISO 147302000(E) Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date.

Substantial Equivalence Conclusion:

The results of the non-clinical and stability testing demonstrate that the safety and effectiveness of Bausch + Lomb PeroxiClear™ 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is substantially equivalent to the previously cleared device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/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 a stylized symbol of three overlapping shapes, resembling a person embracing another person.

Public Health Service

ood and Drug Administration 903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

September 9, 2013

Bausch & Lomb Incorporated Ms. Heather Michaels Senior Specialist, Global Regulatory Affairs 1400 North Goodman Street Rochester, NY 14609

K132216 Re:

RT52210
Trade/Device Name: Bausch + Lomb PeroxiClear™ 3% Hydrogen Peroxide Cleaning & Disinfecting Solution

Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) Contact lens Care Products Regulatory Class: Class II Product Code: LPN Dated: August 16, 2013 Received: August 19, 2013

Dear Ms. Michaels:

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 for use stated in the encreation to togally to the Medical Device Amendments, or to Commerce prior to May 20, 1970, and encordance 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 r ou may, mercesse, market 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), If your device is classified (000 above). Existing major regulations affecting your device can be It may of subject to additions, 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 ulat I DA has made a Geted regulations administered by other Federal agencies. You must of any I collars and regending, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Crk Fall 607), ademig (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Heather Michaels

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Kesia Y. Alexander -S

for Malvina 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: K132216

Device Name:

Bausch + Lomb PeroxiClear™ 3% Hydrogen Peroxide Cleaning & Disinfecting Solution

Indications for Use:

Prescription Use (part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Leonid Livshitz ... - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - . 2013.09.06 '00'04- 10:25:37

(Division Sign-Off) Division of Ophthalmic and Ear, Nose, and Throat Devices 510(k) Number:

page 1 of _____l

Regulation Number and Section

§ 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.”