(82 days)
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No
The device description and intended use clearly define the product as a contact lens solution with chemical components for cleaning and disinfection, with no mention of AI or ML technologies.
No
The device is a multi-purpose solution for cleaning and disinfecting contact lenses, which are corrective devices, not therapeutic. Its function is maintenance of the contact lenses, not direct treatment of a disease or condition in the body.
No
The device is a multi-purpose contact lens solution, primarily for cleaning, disinfecting, and storing lenses, not for diagnosing medical conditions.
No
The device is a contact lens solution, which is a chemical 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 the cleaning, disinfection, and storage of contact lenses. This is a direct interaction with a medical device (contact lenses) and not for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description details the chemical composition and function of the solution for contact lens care. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Measuring biomarkers
- Using reagents for testing
The device is clearly intended for the maintenance and care of contact lenses, which falls under the category of medical device accessories or solutions, not in vitro diagnostics.
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) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
Product codes
86 LPN
Device Description
Bausch & Lomb ReNu Multi-Purpos. Solution is a sterile, isotonic solution that contains HYDRANATE™ (hydroxyalkylphosphonate) as a protein deposit remover, poloxamine as a surface active agent and salts as tonicity and buffering agents; preserved with DYMED (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 and is labeled with a lot number and expiration date.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
soft (hydrophilic) contact lenses
Indicated Patient Age Range
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Intended User / Care Setting
eye care practitioner
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
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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 and have previously been submitted under Premarket Approval Application P860023/ S12. No concerns were raised at the time of approval.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Bausch & Lomb ReNus Multi-Purpose Solution, Bausch & Lomb ReNus 1 Step Enzymatic Cleaner
Reference Device(s)
Not Found
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.”
0
K 974722
510 (k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS
FOR
BAUSCH & LOMB ReNu MultiPlusTM MULTI-PURPOSE SOLUTION
Submitter Information 1.
MAR 1 0 1998
Bausch & Lomb Incorporated Global Vision Care 1400 North Goodman Street Rochester, New York 14692-0450
Paul G. Stapleton Contact Person: Director, Regulatory Affairs
716-338-8172 Telephone Number:
2. Device Name
Classification Name: Soft (hydrophilic) Contact Lens Solution
BAUSCH & LOMB ReNu MultiPlus Multi-Purpose Solution Proprietary Name:
3. Predicate Devices
Bausch & Lomb ReNus Multi-Purpose Solution and Bausch & Lomb ReNus 1 Step Enzymatic Cleaner have been selected as the predicates devices for Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution.
4. Description of the Device
Bausch & Lomb ReNu Multi-Purpos. Solution is a sterile, isotonic solution that contains HYDRANATE™ (hydroxyalkylphosphonate) as a protein deposit remover, poloxamine as a surface active agent and salts as tonicity and buffering agents; preserved with DYMED (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 and is labeled with a lot number and expiration date.
1
510 (k) PREMARKET NOTIFICATION
BAUSCH & LOMB ReNu MultiPlus Multi-Purpose Solution
Indications for Use 5.
Bausch & Lomb ReNu Multi-Purpose Solution 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.
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/ S12. No concerns were raised at the time of approval.
Substantial Equivalence
Bausch & Lomb ReNu Multipurpose Solution is substantially equivalent to Bausch & Lomb ReNu Multi-Purpose Solution with Bausch & Lomb ReNu 1 Step Enzymatic Cleaner in that both ReNu MultiPlus Multipurpose Solution and ReNu Multi-Purpose Solution with ReNu 1 Step Enzymatic cleaner are indicated for the daily cleaning, rinsing, chemical (not heat) disinfection of soft (hydrophilic) contact lenses and the removal of protein deposits as recommended by the eye care practitioner.
The ReNu MultiPlus Multipurpose Solution will be sold in plastic bottles as a sterile solution; each bottle will be marked by a lot number and expiration date.
The active ingredient for ReNu Multipurpose Solution is Hydranate, which acts on protein removal and removal of other deposits. Hydranate acts on protein removal by two separate and distinct physical mechanisms that loosen proteins and deposits from the lens surface and suspend them in solution and provide a stable water soluble complex. Lenses are then freed from these deposits by rubbing and rinsing. When compared to the equivalent product ReNu Multi-Purpose Solution with ReNu 1 Step Enzymatic Cleaner, the activity of the new product reduces the protein cleaning portion to one less regimen activity required by the user. The end result is the same, clean, disinfected lenses without protein and other deposits. Each product provides equivalent indications for use which include cleaning, rinsing, chemical (not heat) disinfection and protein removal. The ReNu Multipurpose Solution which contains the Hydranate provides all these functions in one bottle. The ReNu Multi-Purpose Solution with ReNu 1 Step Enzymatic Cleaner provides these functions as a unit of two separate products.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 0 998
Mr. Paul Stapleton Director, Regulatory Affairs Bausch & Lomb Incorporated Global Vision Care 1400 North Goodman Street Rochester, NY 14692-0450
Re: K974723
Trade Name: Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Regulatory Class: II Product Code: 86 LPN Dated: December 16, 1997 Received: December 18, 1997
Dear Mr. Stapleton:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Paul Stapleton
This letter will allow you to begin marketing your device as described in your 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 and additionally 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 your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
AlrepL. Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): _ | 914723
Device Name: Bausch & Lomb ReNu MultiPlus™ Multi-Purpose Solution
Indications for Use:
Bausch & Lomb ReNu Multi-Purpose Solution 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.
(CLEASE 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 _
Moos
(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number_k 974723