(80 days)
Alcon OPTI-FREE EXPRESS
No
The document describes a contact lens solution and its chemical composition and clinical study results, with no mention of AI or ML.
No
The device is a multi-purpose solution for contact lens care (cleaning, disinfecting, storing), not a remedy for disease or a means of affecting the structure or function of the body.
No
The device is a multi-purpose solution for cleaning and disinfecting contact lenses. Its intended use and device description focus on maintenance of contact lenses, not on diagnosing medical conditions.
No
The device description clearly states it is a sterile, isotonic solution contained in a plastic bottle, indicating it is a physical product, not software.
Based on the provided information, 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 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 the chemical composition and function of a contact lens solution, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance study focuses on the efficacy of the solution in cleaning and disinfecting contact lenses, not on its ability to diagnose a condition.
Therefore, ReNu MultiPlus Multi-Purpose Solution is a medical device, but it falls under a different classification than an In Vitro Diagnostic.
N/A
Intended Use / 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.
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.
Product codes
LYL
Device Description
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.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Alcon OPTI-FREE EXPRESS
Reference Device(s)
P860023/S012, K974723, K002823, K011796
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
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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.
1
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.
2
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.
3
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
4
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