RENU MULTIPLUS MULTI-PURPOSE SOLUTION

K974723 · Bausch & Lomb, Inc. · LPN · Mar 10, 1998 · Ophthalmic

Device Facts

• Record ID: K974723
• Device Name: RENU MULTIPLUS MULTI-PURPOSE SOLUTION
• Applicant: Bausch & Lomb, Inc.
• Product Code: LPN · Ophthalmic
• Decision Date: Mar 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended 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.

Device Story

Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution is a sterile, isotonic chemical solution for soft (hydrophilic) contact lens care. It contains HYDRANATE (hydroxyalkylphosphonate) for protein removal, poloxamine as a surfactant, and DYMED (polyaminopropyl biguanide) 0.0001% as a preservative. The solution functions by loosening proteins and deposits from the lens surface and suspending them in the solution, allowing for removal via manual rubbing and rinsing. It replaces the need for a separate enzymatic cleaner, consolidating cleaning, rinsing, disinfection, and protein removal into a single-bottle regimen. The device is intended for patient self-use at home. It provides the benefit of simplified lens maintenance while ensuring clean, disinfected lenses.

Clinical Evidence

Preclinical and clinical studies were completed and previously submitted under Premarket Approval Application P860023/S12. No concerns were raised at the time of approval.

Technological Characteristics

Sterile, isotonic solution. Ingredients: HYDRANATE (hydroxyalkylphosphonate) for protein removal, poloxamine (surfactant), salts (tonicity/buffering), and DYMED (polyaminopropyl biguanide) 0.0001% (preservative). Packaged in plastic bottles with lot number and expiration date. Chemical disinfection (non-heat).

Indications for Use

Indicated for daily cleaning, protein deposit removal, rinsing, chemical disinfection, and storage of soft (hydrophilic) contact lenses for patients as recommended by an eye care practitioner.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”

Predicate Devices

• Bausch & Lomb ReNus Multi-Purpose Solution
• Bausch & Lomb ReNus 1 Step Enzymatic Cleaner

Submission Summary (Full Text)

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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.

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### 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.

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone].

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

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# 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