BPZ02 MULTIPURPOSE SOLUTION

K083757 · Bausch & Lomb, Inc. · LYL · Nov 18, 2009 · Ophthalmic

Device Facts

• Record ID: K083757
• Device Name: BPZ02 MULTIPURPOSE SOLUTION
• Applicant: Bausch & Lomb, Inc.
• Product Code: LYL · Ophthalmic
• Decision Date: Nov 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

Bausch & Lomb® BPZ02 MultiPurpose Solution is indicated for use in the daily conditioning, cleaning, removal of protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses, including silicone hydrogel contact lenses, as recommended by your eye care practitioner.

Device Story

BPZ02 MultiPurpose Solution is a sterile, isotonic chemical solution for soft contact lens care. It contains hyaluronan, sulfobetaine, poloxamine 1107, boric acid, sodium borate, edetate disodium, and sodium chloride, utilizing a dual disinfection system. The solution is packaged in a tamper-evident plastic bottle. It is intended for consumer self-use at home for daily lens maintenance, including cleaning, rinsing, and disinfection. The solution removes protein deposits and conditions lenses to improve comfort. It is compatible with both traditional soft and silicone hydrogel lenses.

Clinical Evidence

A controlled clinical study compared the safety and efficacy of the subject device to AQuify Multi-Purpose Disinfecting Solution using soft (hydrophilic) and silicone hydrogel contact lenses. Results supported substantial equivalence. Additional bench testing included biocompatibility (cytotoxicity, ocular irritation, oral toxicity, sensitization), microbiological testing per EN ISO 14729:2001 and EN ISO 14730:2000, lens compatibility, and cleaning efficacy (Critical Micelle Concentration).

Technological Characteristics

Sterile, isotonic solution containing hyaluronan, sulfobetaine, poloxamine 1107, boric acid, sodium borate, edetate disodium, and sodium chloride. Employs a dual disinfection system. Packaged in a plastic bottle with a tamper-evident seal. Non-cytotoxic, non-irritating, and non-sensitizing.

Indications for Use

Indicated for daily conditioning, cleaning, protein removal, rinsing, chemical disinfection, and storage of soft (hydrophilic) contact lenses, including silicone hydrogel lenses, as directed 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

• CIBA Vision AQuify Multi-Purpose Solution (K033608)
• Alcon OPTI-FREE® RepleniSH® Multi-Purpose Disinfecting Solution (K050729)

Submission Summary (Full Text)

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# 510(k) SUMMARY

K083757

## Bausch & Lomb BPZ02 MultiPurpose Solution

#### 1. Submitter Information

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Bausch & Lomb, Inc. 1400 North Goodman Street Rochester, NY 14609

Contact Person Glenn A. Davies, O.D. Director Global Regulatory Affairs NOV 1 8 2009

#### Telephone Number [phone]

# 2. Device Name

| Common Name: | Soft (hydrophilic) Contact Lens Care Solution |
|------------------------|-------------------------------------------------------|
| Trade Name: | BPZ02 MultiPurpose Solution |
| Classification: | Accessories, Solution, Ultrasonic Cleaners for Lenses |
| Device classification: | Class II (21 CFR §886.5928) |
| Product Code: | LYL |

#### 3. Predicate Devices

CIBA Vision AQuify Multi-Purpose Solution (K033608) Alcon OPTI-FREE® RepleniSH® Multi-Purpose Disinfecting Solution (K050729)

#### 4. Description of the Device

Bausch & Lomb BPZ02 MultiPurpose Solution is a sterile, isotonic solution that contains hyaluronan, sulfobetaine, poloxamine 1107, boric acid, sodium borate, edetate disodium and sodium chloride; and preserved with a dual disinfection system. The sterile solution is packaged in a plastic bottle with a tamper evident seal and labeled with a lot number and expiration date.

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# 5. Intended Use

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Bausch & Lomb® BPZ02 MultiPurpose Solution is indicated for use in the daily conditioning, cleaning, removal of protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses, including silicone hydrogel contact lenses, as recommended by your eye care practitioner.

# 6. Description of Safety and Substantial Equivalence

A series of preclinical and clinical testing was performed to demonstrate the safety and effectiveness of Bausch & Lomb BPZ02 MultiPurpose Solution. A summary of the test results is provided below:

#### Biocompatibility

Cytotoxicity, ocular irritation, oral toxicity, sensitization and in vivio ocular biocompatibility studies were completed for Bausch & Lomb BPZ02 MultiPurpose Solution. The test results demonstrated that BPZ02 MultiPurpose Solution is non-cytotoxic, and not an ocular irritant or sensitizing agent.

#### Microbiology

The sponsor conducted a series of studies according to EN ISO 14729:2001 Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses and EN ISO 14730:2000 Ophthalmic optics -Contact lens care products - Antimicrobial preservative efficacy testing and quidance on determining discard date and demonstrate Bausch & Lomb BPZ02 MultiPurpose Solution exceeds the criteria for disinfection and preservative efficacy.

#### Lens Compatibility

The results of lens compatibility studies demonstrate Bausch & Lomb BPZ02 MultiPurpose Solution is compatible with soft contact lenses including silicone hydrogel contact lenses.

#### Cleaning Efficacy

The cleaning efficacy of the solution was evaluated through the determination of the Critical Micelle Concentration. The surfactant concentrations are well above the CMC for the individual surfactants.

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# Clinical Study

ﺃ

Bausch & Lomb conducted a controlled clinical study with soft (hydrophilic) contact lenses, including silicone hydrogel lenses, comparing the safety and efficacy of Bausch & Lomb BPZ02 MultiPurpose Solution to AQuify Multi-Purpose Disinfecting Solution. The results of the study support a substantial equivalence determination.

# 7. Substantial Equivalence

The cumulative results of laboratory, in vivo, and clinical testing sponsored by Bausch & Lomb demonstrate that the safety, efficacy and performance of Bausch & Lomb BPZ02 MultiPurpose Solution are substantially equivalent to AQuify Multi-Purpose Solution and OPTI-FREE Express Multi-Purpose Disinfecting Solution for soft contact lenses, including silicone hydrogel contact lenses.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of three wavy lines, resembling a caduceus without the snake, or perhaps a stylized human figure. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Bausch & Lomb c/o Glenn A. Davies, O.D. Director, Regulatory Affairs 1400 North Goodman Street Rochester, NY 14609

NOV 1 & 2009

Re: K083757 Trade/Device Name: Bausch & Lomb® BPZ02 MultiPurpose Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: II Product Code: LYL Dated: November 10, 2009 Received: November 12, 2009

Dear Dr. Davies:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 - Glenn A. Davies, O.D.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Keona Alexander for

Malvina B. Eydelman, M.D Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K083757

Bausch & Lomb® BPZ02 MultiPurpose Solution Device Name:

Indications for Use:

Bausch & Lomb® BPZ02 MultiPurpose Solution is indicated for use in the daily conditioning, cleaning, removal of protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses, including silicone hydrogel contact lenses, as recommended by your eye care practitioner.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter-Use X (Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

CG

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

K083757
510(k) Number

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