(80 days)
ReNu MultiPlus Multi-Purpose Solution is indicated for use in daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
Bausch & Lomb ReNu Multi-Purpose Solution is a sterile, isotonic solution that contains HYDRANATE® (hydroxyalkyl phosphonate) as a protein deposit remover, poloxamine as a surface active agent and salts as tonicity and buffering agents; preserved with DYMED® (polvaminopropyl 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 and is labeled with a lot number and expiration date.
The provided text describes a 510(k) Premarket Notification for the Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution. It details the device, its indications for use, and a clinical study conducted to demonstrate its safety and efficacy. However, the document does not contain a table of acceptance criteria or specific performance metrics (like sensitivity, specificity, accuracy, etc.) typically found when evaluating the performance of a device against numerical acceptance criteria.
The study described is a clinical study for a contact lens care solution, which focuses on safety and efficacy in terms of lens cleanliness and eye health, rather than a diagnostic or AI-driven device with quantifiable performance criteria like those for image analysis or disease detection.
Here's an attempt to answer the questions based on the available information, noting the limitations of the provided text:
Acceptance Criteria and Device Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format, nor does it provide specific quantifiable performance metrics in terms of sensitivity, specificity, or similar measures typically associated with diagnostic or AI devices. The study's conclusion is qualitative: "Both regimens demonstrated clinically acceptable lens cleanliness. Safety and efficacy were demonstrated."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the provided text for the new clinical study. The text only mentions "A multi-site randomized, controlled clinical study."
- Data Provenance: The study was a "multi-site randomized, controlled clinical study," implying prospective data collection across various clinical sites. The country of origin is not specified, but the submission is to the U.S. FDA by a Rochester, New York-based company, suggesting the study likely involved U.S. sites.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. For a contact lens solution, ground truth would likely involve clinical assessments by ophthalmologists or optometrists, but the number and qualifications are not specified.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study, as typically understood for diagnostic imaging or decision support AI, was not performed. The study mentioned compares ReNu MultiPlus solution with Alcon OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution (Control solution) in terms of "clinically acceptable lens cleanliness, safety and efficacy." This is a comparative study of two products, but not in the context of human readers improving with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable. The device is a contact lens care solution, not an algorithm or AI system. Its performance is evaluated through clinical use by human subjects, not as a standalone algorithm.
7. The Type of Ground Truth Used
The ground truth was established through clinical assessment of lens cleanliness, safety (e.g., adverse events), and efficacy in human subjects. This would involve observations and evaluations by eye care practitioners.
8. The Sample Size for the Training Set
This question is not applicable. The device is a chemical solution, not an AI model that requires a training set. The clinical study described evaluates the product's performance directly.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there is no "training set" for this type of device.
Summary of Limitations:
The provided document is a 510(k) summary for a medical device (contact lens solution) and describes a clinical study to demonstrate its safety and efficacy for its intended use. The questions posed, however, are typically asked when evaluating diagnostic devices, particularly those involving Artificial Intelligence (AI) algorithms, which require specific metrics like sensitivity, specificity, sample sizes for training/test sets, expert adjudication, and ground truth methodologies (e.g., pathology, outcomes data). The information required to fully answer these questions in the context of an AI device is largely absent because the device being described is not an AI diagnostic tool.
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510(k) Premarket Notification Bausch & Lomb ReNu MultiPlus® Multi-Purpose Solution MAY 3 1 2002
Image /page/0/Picture/2 description: The image contains a sequence of handwritten characters and numbers. The sequence starts with the letter 'K', followed by the number '0', then '20', '80', and ends with the number '2'. The characters and numbers are written in a dark ink on a white background.
510 (k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS
FOR
BAUSCH & LOMB® ReNu MultiPlus® MULTI-PURPOSE SOLUTION
-
- Submitter Information Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, New York 14603-0450
Paul G. Stapleton Contact Person: Director, Regulatory Affairs
- Submitter Information Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, New York 14603-0450
Telephone Number: 585-338-8172
2. Device Name
Soft (hydrophilic) Contact Lens Care Solution Classification Name:
BAUSCH & LOMB ReNu MultiPlus Multi-Proprietary Name: Purpose Solution
3. Predicate Devices
Alcon OPTI-FREE EXPRESS has been selected as the predicate device for Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution
4. Description of the Device
Bausch & Lomb ReNu Multi-Purpose Solution is a sterile, isotonic solution that contains HYDRANATE® (hydroxyalkyl phosphonate) as a protein deposit remover, poloxamine as a surface active agent and salts as tonicity and buffering agents; preserved with DYMED® (polvaminopropyl 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 and is labeled with a lot number and expiration date.
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5. Indications for Use
Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution is indicated for use in the daily cleaning, removing protein deposits, rinsing, chemical (not heat) and storage of soft (hydrophilic) lenses as recommended by your eve care practitioner.
Description of Safety and Substantial Equivalence 6.
A series of preclinical and clinical studies were completed on this product and have previously been submitted under Premarket Approval Application P860023/S012, K974723, K002823 and K011796. No concerns were raised for these studies at the time of clearance.
In addition, the following studies have been completed:
Clinical Studies
A multi-site randomized, controlled clinical study was conducted to evaluate the safety and efficacy of ReNu MultiPlus solution when used with a 5 second cleaning rinse prior to the disinfection cycle; no postdisinfection rinse was required. The Control solution was Alcon OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution No Rub which employed a 5 second cleaning rinse per side both before and after disinfection. Both regimens demonstrated clinically acceptable lens cleanliness. Safety and efficacy were demonstrated.
ReNu MultiPlus Multi-Purpose Solution is substantially equivalent to Alcon OPTI-FREE EXPRESS No Rub.
Substantial Equivalence
Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution for use in a no rub regimen for lenses is substantially equivalent to Alcon OPTI-FREE EXPRESS No Rub.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 that resembles an abstract eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 1 2002
Mr. Paul G. Stapleton Director. Global Regulatory Affairs BAUSCH & LOMB 1400 N Goodman Street P.O. Box 30450 Rochester, NY 14603-0450
Re: K020802
Trade/Device Name: Bausch & Lomb* ReNu MultiPlus* Multi-Purpose Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LYL Dated: March 11, 2002 Received: March 12, 2002
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) I mis lotter with a son the FDA finding of substantial equivalence of your device to a legally proficed 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of Compliance at (201) of the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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
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510(k) Premarket Notification Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution
Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14603-0450
Indications for Use Statement
510(k) Number (if known): _
Device Name: Bausch & Lomb® ReNu MultiPlus* Multi-Purpose Solution
Indications for Use:
multialis for USC.
ReNu MultiPlus Multi-Purpose Solution is indicated for use in daily cleaning, removing ReNd Multin its Minit Furpose Default heat) disinfection and storage of soft (hydrophilic) protent lenses as recommended by your eye care practitioner.
KO20802
(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
$
$
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K020802
§ 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.”