(170 days)
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No
The document describes a contact lens solution and its performance studies. While it mentions "Image Analysis" for evaluating protein deposition and lens cleanliness, there is no indication that this analysis utilizes AI or ML algorithms. The focus is on the chemical and physical properties of the solution and its effects on lenses.
No.
This device is a multi-purpose solution for cleaning, disinfecting, and storing soft contact lenses, not for treating a disease or condition.
No
Explanation: This device is a multi-purpose contact lens solution used for cleaning, disinfecting, and storing contact lenses. Its intended use does not involve diagnosing any medical condition or disease.
No
The device is a multi-purpose contact lens solution, which is a chemical product, not a software-only medical device. While image analysis is mentioned in performance studies, it appears to be a method used for evaluating the chemical solution's efficacy, not the primary function of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the cleaning, disinfection, and storage of contact lenses. This is a direct interaction with a medical device (contact lenses) and not a test performed in vitro (outside the body) on biological specimens to diagnose a condition.
- Device Description: The description details a sterile solution for contact lens care, not a reagent or instrument used for diagnostic testing.
- Lack of Diagnostic Purpose: The entire document focuses on the efficacy of the solution in maintaining contact lenses, not on detecting or measuring substances in the body for diagnostic purposes.
- No Mention of Biological Specimens: There is no mention of the solution being used with blood, urine, tissue, or other biological samples.
- Performance Studies: The performance studies focus on lens compatibility, microbiology (disinfection efficacy), cleaning efficacy, and clinical safety and efficacy related to contact lens wear. These are not studies typically associated with IVDs, which would involve evaluating diagnostic accuracy (sensitivity, specificity, etc.).
While the document mentions "Image Analysis" for evaluating protein deposition and lens cleanliness, this is a method used to assess the performance of the contact lens solution on the lens itself, not a diagnostic test on a patient.
Therefore, Bausch & Lomb Multi-Purpose Solution NRC03 is a medical device intended for the care of contact lenses, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Bausch & Lomb Multi-Purpose Solution NRC03 is indicated for use in the daily cleaning, removal of protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
Product codes
LPN
Device Description
Bausch & Lomb Multi-Purpose Solution NRC03 is a sterile isotonic solution containing boric acid, sodium chloride, sodium phosphate, Hydranate® (hydroxyalkylphosphonate), poloxamer 407, polyquaternium-10, poloxamine 1107, purified water and preserved with polyaminopropyl biguanide (0.0001%). The product is indicated for use in the daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner. The sterile solution is contained in a plastic bottle with a tamper evident seal and is labeled with a lot number and expiration date.
Mentions image processing
The ability of the solution to prevent the deposition of protein has been established by the evaluation of protein present on the lens following solution usage in a no rub with a rinse regimen with a four (4) hour disinfection time. Protein deposition was significantly prevented as measured by Image Analysis.
The analysis of lens cleanliness from both Test and Control regimens indicates that these regimens are substantially equivalent when evaluated by Image Analysis.
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of preclinical and clinical studies were completed on this product. The following studies have been completed:
Toxicology: A series of cytotoxicity and eye irritation studies of the Bausch & Lomb Multi-Purpose Solution NRC03 and lenses cycled in the solution were undertaken. In these studies, there was no evidence of toxicity.
Lens Compatibility: Lens compatibility studies were undertaken after cycling lenses in the solution. The results indicated that lenses were compatible with the solution.
Microbiology: Disinfection efficacy was evaluated according to the FDA Guidance document as well as modifications to established procedures. The results indicate satisfactory levels of disinfection efficacy.
Cleaning Efficacy: The cleaning efficacy of the solution has been evaluated through the determination of the Critical Micelle Concentration. The surfactant concentrations are well above the CMC for the individual surfactants.
The ability of the solution to prevent the deposition of protein has been established by the evaluation of protein present on the lens following solution usage in a no rub with a rinse regimen with a four (4) hour disinfection time. Protein deposition was significantly prevented as measured by Image Analysis.
The efficacy of the product to remove protein deposits measured by chemical analysis was evaluated with protein deposited lenses. The results indicated statistical equivalence between Test and Control.
Cleanliness Analysis of Clinical Lens Returns: The analysis of lens cleanliness from both Test and Control regimens indicates that these regimens are substantially equivalent when evaluated by Image Analysis.
Lens Wettability: Lens wettability over time has been assessed by measurement of contact angle and continued presence of wetting agents over time. The results indicated statistical significance for longer wetting ability over the controls.
Clinical Studies: A 3-month controlled, randomized study designed to evaluate the safety and efficacy of the Multi-Purpose Solution NRC03 was completed to demonstrate the safety and efficacy of the solution and substantial equivalence to the Control.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Bausch & Lomb ReNu Multi-Purpose Solution, Alcon Opti-Free Express Multi-Purpose Disinfecting Solution, AMO Complete brand Multi-Purpose Solution
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.”
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510(k) Premarket Notification Bausch & Lomb® Multi-Purpose Solution NRC03
K031646 510 (k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS
NOV 1 4 2003
FOR
BAUSCH & LOMB® MULTI-PURPOSE SOLUTION NRC03
(TRADENAME TO BE DETERMINED)
1. Submitter Information
Bausch & Lomb Incorporated 1 400 North Goodman Street Rochester, New York 14609
Contact Person: Paul G. Stapleton Director, Regulatory Affairs
585-338-8172 Telephone Number:
2. Device Name
Classification Name: Soft (hydrophilic) Contact Lens Care Solution
Proprietary Name: Bausch & Lomb Multi-Purpose Solution NRC03
Predicate Devices 3.
Bausch & Lomb ReNu Multi-Purpose Solution, Alcon Opti-Free Express Multi-Purpose Disinfecting Solution and AMO Complete brand Multi-Purpose Solution have been selected as the predicate devices for Bausch & Lomb Multi-Purpose Solution NRC03.
Description of the Device 4.
Bausch & Lomb Multi-Purpose Solution NRC03 is a sterile isotonic solution containing boric acid, sodium chloride, sodium phosphate, Hydranate® (hydroxyalkylphosphonate), poloxamer 407, polyquaternium-10, poloxamine 1107, purified water and preserved with polyaminopropyl biguanide (0.0001%). The product is indicated for use in the daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner. The sterile solution is
1
contained in a plastic bottle with a tamper evident seal and is labeled with a lot number and expiration date.
Indications for Use ડ.
Bausch & Lomb Multi-Purpose Solution NRC03 is indicated for use in the daily cleaning, removal of protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) lenses as recommended by your eye care practitioner.
Description of Safety and Substantial Equivalence Q.
A series of preclinical and clinical studies were completed on this product. The following studies have been completed:
Toxicology
A series of cytotoxicity and eye irritation studies of the Bausch & Lomb Multi-Purpose Solution NRC03 and lenses cycled in the solution were undertaken. In these studies, there was no evidence of toxicity.
Lens Compatibility
Lens compatibility studies were undertaken after cycling lenses in the solution. The results indicated that lenses were compatible with the solution.
Microbiology
Disinfection efficacy was evaluated according to the FDA Guidance document as well as modifications to established procedures. The results indicate satisfactory levels of disinfection efficacy.
Cleaning Efficacy
The cleaning efficacy of the solution has been evaluated through the determination of the Critical Micelle Concentration. The surfactant concentrations are well above the CMC for the individual surfactants.
The ability of the solution to prevent the deposition of protein has been established by the evaluation of protein present on the lens following solution usage in a no rub with a rinse regimen with a four (4) hour disinfection time. Protein deposition was significantly prevented as measured by Image Analysis.
The efficacy of the product to remove protein deposits measured by chemical analysis was evaluated with protein deposited lenses. The results indicated statistical equivalence between Test and Control.
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Cleanliness Analysis of Clinical Lens Returns
The analysis of lens cleanliness from both Test and Control regimens indicates that these regimens are substantially equivalent when evaluated by Image Analysis.
Lens Wettability
Lens wettability over time has been assessed by measurement of contact angle and continued presence of wetting agents over time. The results indicated statistical significance for longer wetting ability over the controls.
Clinical Studies
A 3-month controlled, randomized study designed to evaluate the safety and efficacy of the Multi-Purpose Solution NRC03 was completed to demonstrate the safety and efficacy of the solution and substantial equivalence to the Control.
Substantial Equivalence
Bausch & Lomb Multi-Purpose Solution NRC03 is substantially equivalent to Bausch & Lomb ReNu Multi-Purpose Solution, Opti-Free Express Multi-Purpose Disinfecting Solution and Complete brand Multi-Purpose Solution.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wing-like shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
NOV 1 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bausch & Lomb C/O Paul G. Stapleton Director. Global Regulatory Affairs 1400 N. Goodman St. Rochester, NY 14609
Re: K031646 Trade/Device Name: Bausch & Lomb Multi-Purpose Solution NRC03 Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LPN Dated: October 14, 2003 Received: October 15, 2003
Dear Mr. Stapleton:
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 commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance 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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 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); good manufacturing practice requirements as set 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.
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Page 2 - Mr. Paul G. Stapleton
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, 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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Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14692-0450
Indications for Use Statement
0311646 510(k) Number (if known):
Device Name: Bausch & Lomb Multi-Purpose Solution NRC03 (Tradename to be determined)
Indications for Use:
Bausch & Lomb Multi-Purpose Solution NRC03 is indicated for use in the daily cleaning, removal of protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care provider.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter-Use
-Use
^
Kane Wahabik
510(k) Number K031646