Bausch + Lomb OCD04 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 OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Solution 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 poloxamer 181. A special lens case containing a platinum coated neutralizing disc is provided with the OCD04 Cleaning and Disinfecting Solution. The sterile solution is packaged in a plastic bottle with a tamper evident seal and labeled with a lot number and expiration date.

AI/ML Overview

The provided text describes the acceptance criteria and the studies conducted for the Bausch + Lomb OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Solution. This device is a contact lens care product, and the studies performed are primarily in vitro and pre-clinical, along with a clinical evaluation, rather than focusing on AI/human-in-the-loop performance.

Here's the breakdown of the information requested:

Acceptance Criteria and Device Performance

The acceptance criteria are not explicitly stated in a quantified manner with pass/fail thresholds for each test. Instead, the document states that the device "meets the criteria for disinfection and preservative efficacy" and "was substantially equivalent to the predicate device."

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Noncytotoxic, not an ocular irritant, and not a sensitizing agent (demonstrated through cytotoxicity, ocular irritation, and sensitization studies in accordance with FDA Guidance for Contact Lens Solutions and Accessory Products and recognized testing Standards under GLP).
Microbiology (Disinfection Efficacy)	Meets the criteria for disinfection according to EN ISO 14729:2001/AMD.1:2010(E) and the requirements of the ISO-FDA Regimen Procedure for Disinfecting Regimens for all nine lens materials tested.
Microbiology (Preservative Efficacy)	Meets the criteria for preservative efficacy according to EN ISO 14730:2000(E).
Lens Compatibility	Compatible with soft contact lenses (including silicone hydrogel) and rigid gas permeable lenses.
Residual Peroxide & Area Under Curve	Residual peroxide specification was met for cases cycled for the entire recommended use period (35 cycles) and a safety margin (50 cycles). Area Under Curve (total peroxide exposure) was greater than the control solution.
In-Vitro Protein Removal	Substantially equivalent to the predicate device (Ciba Clear Care) across seven contact lens materials (FDA groups I and IV, and silicone hydrogel materials), when evaluated against lenses deposited in vitro with lysozyme and subjected to a single cleaning/disinfection regimen.
Cleaning Efficacy (Surfactant)	The surfactant concentration in the formulation was determined to exceed the Critical Micelle Concentration (CMC) value.
Clinical Performance (Comfort)	Statistically significant differences over all follow-up visits in favor of Bausch + Lomb OCD04 for Comfort upon insertion (p = 0.017), Overall Comfort (p = 0.020), and Comfort at end of day (p = 0.009) compared to Clear Care. There were no significant differences in lens wetting or fitting characteristics.
Clinical Safety	Clinically acceptable and similar to Clear Care when used with both rub, rinse and no-rub regimens.

Study Details

Given that this is a submission for a contact lens cleaning and disinfecting solution, the "test set" and "training set" concepts as typically applied to AI/ML models are not directly applicable in the same way. The studies are pre-clinical (in vitro) and clinical, focusing on the chemical and biological efficacy and safety of the product.

2. Sample Size and Data Provenance for Test Sets:

Biocompatibility Studies: Not explicitly stated, but performed "in accordance with FDA Guidance for Contact Lens Solutions and Accessory Products, May 1997, as well as referencing several recognized testing Standards" under Good Laboratory Practice (GLP) regulations. These are typically controlled laboratory experiments.
Microbiology Studies: Not explicitly stated, but followed EN ISO 14729:2001/AMD.1:2010(E) and EN ISO 14730:2000(E), and the ISO-FDA Regimen Procedure. Nine lens materials were tested for disinfection. These are in vitro laboratory studies.
Lens Compatibility Studies: Not explicitly stated, but confirm compatibility with "soft contact lenses including, silicone hydrogel contact lenses and rigid gas permeable lenses." These are likely in vitro laboratory studies.
Residual Peroxide and Area Under Curve: Cases cycled for 35 cycles (recommended use period) and a safety margin out to 50 cycles. This is an in vitro laboratory study.
In-Vitro Protein Removal and Cleaning Efficacy: Evaluated using seven contact lens materials (FDA groups I and IV and silicone hydrogel materials). This is an in vitro laboratory study.
Clinical Evaluation: Not explicitly stated, but described as a "three-month multicenter, randomized, masked, parallel, bilateral clinical trial." Subject recruitment included "currently adapted wearers of both soft and RGP lenses." The number of subjects is not given in this summary. Data provenance would be multi-center clinical data (presumably within the US or compliant with international clinical trial standards). This is a prospective study.

3. Number of Experts and Qualifications for Ground Truth:

For the in vitro and pre-clinical studies (Biocompatibility, Microbiology, Lens Compatibility, Residual Peroxide, In-Vitro Protein Removal, Cleaning Efficacy), the "ground truth" is established by the standardized methods themselves (e.g., ISO standards, FDA guidance). The "experts" are the laboratory personnel conducting these GLP-compliant tests, who are qualified to perform such scientific evaluations.
For the clinical evaluation, the "ground truth" for patient comfort and safety endpoints is based on patient self-reported outcomes and investigator observations. The "experts" are the investigators (likely ophthalmologists or optometrists) involved in the multicenter clinical trial. Their qualifications are not specified but would include medical licensure and experience in eye care.

4. Adjudication Method for Test Set:

For in vitro and pre-clinical studies, adjudication methods (like 2+1 or 3+1) are not typically relevant as the results are based on objective measurements and adherence to standardized protocols. Replicate testing and statistical analysis ensure data reliability.
For the clinical evaluation, the study was "multicenter, randomized, masked, parallel, bilateral." This design inherently builds in robustness against bias. Adjudication refers more to agreement on specific endpoints or readings, which is not described as a separate process here beyond the study design (e.g., masking helps prevent bias, and "investigators evaluated the lenses").

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not applicable as the device is a contact lens solution, not an AI-assisted diagnostic or imaging device. There is no "human reader" in the context of interpreting images or medical cases with or without AI assistance. The clinical study does compare the new solution to a predicate solution in terms of human experience (comfort) and safety.

6. Standalone (Algorithm Only) Performance:

This information is not applicable as the device is a contact lens solution, not an algorithm.

7. Type of Ground Truth Used:

For in vitro and pre-clinical studies: The ground truth is established by objective measurements against defined standards and protocols (e.g., microbial counts, chemical concentrations, physical compatibility, protein removal quantification).
For the clinical evaluation: The ground truth is based on patient-reported outcomes (e.g., comfort levels) and investigator observations (e.g., lens wetting, fitting characteristics, safety assessments).

8. Sample Size for Training Set:

This information is not applicable as there is no "training set" in the context of an AI/ML model for this type of device. The formulation development and optimization would involve internal testing, but not in the sense of a machine learning training set described here.

9. How Ground Truth for Training Set Was Established:

This information is not applicable for the reasons stated above.

Summary

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510(k) SUMMARY

1.0 Submitter Information:

Bausch + Lomb
1400 N. Goodman Street
Rochester, NY 14609

Contact: Tricia Garrett
Senior Specialist, Global Regulatory Affairs
1400 North Goodman Street
Rochester, NY 14609
(585) 338-6706 (office)
(585) 338-0702 (fax)
Tricia.m.garrett@bausch.com

2.0 Device Name:

Trade Name:	TBD
Common Name:	Soft (hydrophilic) contact lens care productsRigid Gas Permeable contact lens care products
Device Classification:	Class II (21 CFR 886.5918 & 21 CFR 886.5928)
Product Code	LPN, MRC

3.0 Predicate Device:

The predicate device is Ciba, Clear Care Cleaning and Disinfecting Solution cleared in K022687 on November 19, 2002 and K023455 on February 28, 2003.

4.0 Device Description:

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5.0 Intended Use:

6.0 Description of Safety and Substantial Equivalence:

A series of preclinical testing was performed to demonstrate the safety and effectiveness of Bausch + Lomb OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Solution. A summary of the test results is provided below:

6.6 Biocompatibility

Bausch + Lomb OCD04 3% Hydrogen Peroxide Cleaning and 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 regulations. Cytotoxicity, ocular irritation, and sensitization studies were completed for Bausch + Lomb OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Solution. The test results demonstrated that Bausch + Lomb OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Solution is noncytotoxic, and not an ocular irritant or sensitizing agent.

6.7 Microbiology

of studies were conducted according to EN ISO র্ব series 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 14730:2000(E) Ophthalmic optics - Contact lens care products -Antimicrobial preservative efficacy testing and guidance on determining discard date. The testing demonstrated Bausch + Lomb OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Solution meets the criteria for disinfection and preservative efficacy. Additionally, OCDO4 met the requirements of the ISO-FDA Regimen Procedure for Disinfecting Regimens for all nine lens materials tested.

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6.8 Lens Compatibility

The results of lens compatibility studies demonstrate Bausch + Lomb OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Solution is compatible with soft contact lenses including, silicone hydrogel contact lenses and rigid gas permeable lenses.

6.9 Residual Peroxide and Area Under Curve

The results of the study demonstrate that the residual peroxide specification was met on cases cycled for the entire recommended use period, (35 cycles), as well as a safety margin out to 50 cycles. In addition, the area under curve for OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Solution, a measurement of the total peroxide exposure available to kill microorganisms, was greater than that for the control solution.

6.10 In-Vitro Protein Removal and Cleaning Efficacy

The protein removal ability of Bausch + Lomb OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Solution and predicate device Ciba Clear Care was evaluated using seven contact lens materials representing FDA groups I and IV and silicone hydrogel materials. The study evaluated the efficacy of the tested products against lenses deposited in vitro with lysozyme and subjected to a single cleaning / disinfection regimen. The results demonstrated that Bausch + Lomb OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Solution was substantially equivalent to the predicate device, Ciba Clear Care Cleaning and Disinfecting Solution.

In addition, the overall 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.

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7.0 Clinical Evaluation Summary:

A three-month multicenter, randomized, masked, parallel, bilateral clinical trial was conducted to support the substantial equivalence of Bausch + Lomb OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Solution when compared to Clear Care solution when used by habitual contact lens wearers to bilaterally clean and disinfect their contact lenses. Subject recruitment was open to currently adapted wearers of both soft and RGP lenses who met all of the inclusion criteria and none of the exclusion criteria.

There were significant differences over all follow-up visits between Bausch + Lomb OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Solution aroup and the Clear Care group in favor of the Bausch + Lomb OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Solution group for the following: Comfort upon insertion (p = 0.017), Overall Comfort (p = 0.020), and Comfort at end of day (p = 0.009).

Investigators evaluated the lenses for lens wetting while on the eye and found no significant differences between the B+L Peroxide Solution group and the Clear Care group. Other Investigator measures while lenses were on the eye included lens fitting characteristics (centration and movement). There were no significant differences between the B+L Peroxide Solution group and the Clear Care group for either fitting characteristic.

The safety of Bausch + Lomb OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Solution used with both a rub, rinse regimen and no-rub reqimen is clinically acceptable and similar to Clear Care.

8.0 Substantial Equivalence Conclusion:

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 OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Solution are substantially equivalent to Ciba Clear Care Cleaning and Disinfecting Solution for soft contact lenses (including silicone hydrogels) as well as rigid gas permeable lenses.

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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" arranged around the perimeter. Inside the circle is a stylized eagle or bird-like symbol, with three curved lines representing the body and wings.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

APR 3 0 2012

Bausch and Lomb c/o Ms. Tricia Garrett Senior Specialist, Global Regulatory Affairs 1400 North Goodman Street Rochester, NY 14609

Re: K112909

K112707
Trade/Device Name: Bausch and Lomb OCD04 3% Hydrogen Peroxide 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, MRC Dated: April 25, 2012 Received: April 26, 2012

Dear Ms. Garrett:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed 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 encreatinent date of the Medical Device Amendments, or 10 Conninerely province May 20, 1978, the occordance with the provisions of the Federal Food, Drug, de vices mat have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (11ct) that do not required to the general controls provisions of the Act. The I ou may, merciole, maixet the act include requirements for annual registration, listing of general controls proficions of ractice, labeling, and prohibitions against misbranding and de vices, good mananating praction, and evaluate information related to contract liability adulticlation. Thease note: OD10 as , 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 If your device is classified (600 acove) institute major regulations affecting your device can be finay be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may round in the Code of I caeral resgueerning your device in the Federal Register.

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/ Page 2- Ms. Tricia Garrett

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 device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Kesia Alexandir

Malvina B. Eydelman, 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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K1129.09

Indications for Use Statement

510(k) Number (if known):

K112909

Device Name:

Bausch + Lomb OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Solution

Indications for Use:

Over-The-Counter Use > Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duise Hayh

(Division Sign-Off)

Page 1 of 1

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

K112909 510(k) Number.

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.”