(210 days)
Not Found
No
The device is a chemical solution and a lens case, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are standard preclinical and clinical trials for a contact lens solution.
No.
The device is a cleaning and disinfecting solution for contact lenses, not a device used for diagnosis, cure, mitigation, treatment, or prevention of disease.
No
This device is a cleaning and disinfecting solution for contact lenses, not a diagnostic tool for identifying medical conditions. Its purpose is to maintain the hygiene of contact lenses.
No
The device description clearly states it is a sterile, buffered solution and includes a special lens case with a neutralizing disc, indicating it is a physical product, not software.
No, 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 process performed outside the body on a medical device (the contact lens).
- Device Description: The description details a solution and a lens case for treating the contact lens itself.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health. IVDs are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
This device is a contact lens care product, which is regulated as a medical device, but not as an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LPN, MRC
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.
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
Not Found
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)
A series of preclinical testing was performed to demonstrate the safety and effectiveness of Bausch + Lomb OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Solution.
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.
Microbiology: 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 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.
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.
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.
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.
Clinical Evaluation: 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 group 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 regimen is clinically acceptable and similar to Clear Care.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Comfort upon insertion (p = 0.017), Overall Comfort (p = 0.020), and Comfort at end of day (p = 0.009).
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.
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.”
0
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 products |
| Rigid 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:
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.
1
5.0 Intended Use:
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 vour eve care practitioner.
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.
2
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.
3
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.
4
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.
5
/ 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.
OL
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
6
K1129.09
Indications for Use Statement
510(k) Number (if known):
Device Name:
Bausch + Lomb OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Solution
Indications for Use:
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.
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.