BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION

K132216 · Bausch & Lomb, Incorporated · LPN · Sep 9, 2013 · Ophthalmic

Device Facts

• Record ID: K132216
• Device Name: BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION
• Applicant: Bausch & Lomb, Incorporated
• Product Code: LPN · Ophthalmic
• Decision Date: Sep 9, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

Bausch + Lomb PeroxiClear™ 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is intended for the daily cleaning, removal of protein deposits, disinfection, and storage of soft (hydrophilic) contact lenses (including sillcone hydrogel) and rigid gas permeable contact lenses, as recommended by your eve care practitioner.

Device Story

PeroxiClear is a 3% hydrogen peroxide-based contact lens care system. Input: soft (hydrophilic) or rigid gas permeable contact lenses. Operation: lenses are placed in a provided lens case containing a platinum-coated neutralizing disc; hydrogen peroxide solution is added; minimum 4-hour soak required. Transformation: platinum disc catalyzes neutralization of hydrogen peroxide into water and oxygen, rendering lenses safe for insertion. Output: cleaned, disinfected, and stored contact lenses. Used in home setting by patients. Benefit: effective disinfection and protein removal for contact lens wearers.

Clinical Evidence

No clinical data. Bench testing performed per EN ISO 14729:2001/AMD.1:2010(E) for microbiological requirements and EN ISO 14730:2000(E) for antimicrobial preservative efficacy.

Technological Characteristics

Solution: 3% hydrogen peroxide, phosphonic acid stabilizer, potassium chloride, propylene glycol, carbamide, citrate/phosphate buffer, poloxamer (P-181) surfactant. System: HDPE plastic bottle, lens case with platinum-coated neutralizing disc. Disinfection: 4-hour soak. Sterilization: EtO for bottles. No software or electronic components.

Indications for Use

Indicated for daily cleaning, protein deposit removal, disinfection, and storage of soft (hydrophilic) contact lenses (including silicone hydrogel) and rigid gas permeable contact lenses, 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 OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Solution (K112909)

Submission Summary (Full Text)

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## K132216

#### 510(k) Summary

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# SEP 0 9 2013

#### Submitter Information:

| Date Prepared: | July 16, 2013 |
|-----------------|------------------------------------------------------------------|
| Name: | Bausch & Lomb Incorporated |
| Address: | 1400 North Goodman Street<br>Rochester, NY 14609 |
| Contact Person: | Heather Michaels<br>Senior Specialist, Global Regulatory Affairs |
| Phone Number: | [phone]<br>[phone] (fax) |
| Email: | [e-mail] |

#### Device Information:

| Trade Name: | Bausch + Lomb PeroxiClear™ 3% Hydrogen Peroxide<br>Cleaning & Disinfecting Solution |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Contact Lens Disinfection Solution |
| Device<br>Classification: | Class II |
| Classification<br>Name: | Soft (hydrophilic) Contact Lens Care Products<br>(21 CFR 886.5928)<br>Rigid Gas Permeable Contact Lens Care Products<br>(21 CFR 886.5918) |
| Product Codes: | LPN, MRC |

#### Predicate Device:

The predicate device is Bausch + Lomb OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Solution (K112909).

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#### Device Description:

Bausch + Lomb PeroxiClear™ 3% Hydrogen Peroxide Cleaning & Disinfecting Solution (referred to as PeroxiClear) is a sterile, buffered solution containing 3% hydrogen peroxide (which contains a phosphonic acid stabilizer), potassium chloride, propylene glycol, carbamide (urea), a citrate/phosphate buffer system, and a poloxamer (P-181) surfactant. The sterile solution is aseptically filled and packaged in ethylene oxide (EtO) sterilized plastic bottles with a tamper-evident seal and labeled with a lot number and expiration date. A special lens case, containing a platinum-coated neutralizing disc, is provided with each bottle of PeroxiClear. This is the same lens case as provided with the previously cleared device.

The solution and lens case combined are considered a lens care system. As with the previously cleared device, the solution requires the use of the provided lens case specifically designed for neutralization of the peroxide and cannot be used in combination with any other lens case. The system is designed to clean and disinfect contact lenses by filling solution into the provided lens case and allowing the lenses to soak for a minimum of four hours. During the soaking period, the hydrogen peroxide is neutralized by a platinum-coated disc, thereby allowing the lenses to be safely inserted in the eye.

#### Intended Use:

Bausch + Lomb PeroxiClear™ 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is intended for the daily cleaning, removal of protein deposits, disinfection, and storage of soft (hydrophilic) contact lenses (including sillcone hydrogel) and rigid gas permeable contact lenses, as recommended by your eve care practitioner.

The intended use above is identical to what was cleared in the original 510(k) (K112909).

2

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#### Technological Characteristics:

The table below shows a side-by-side comparison of the technological characteristics of the modified device to the previously cleared device. Differences were evaluated during the design and development of the modified device and testing was completed to demonstrate the modified device and predicate device are substantially equivalent and the differences do not negatively impact the safety and efficacy of the device.

| Feature | Bausch + Lomb OCD04 3%<br>Hydrogen Peroxide Cleaning and<br>Disinfecting Solution<br>(predicate device) | Bausch + Lomb PeroxiClear™<br>3% Hydrogen Peroxide Cleaning<br>& Disinfecting Solution<br>(modified device) |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K112909 | K132216 |
| Device Class | Class II | Identical |
| Regulation | Soft (hydrophilic) Contact Lens<br>Care Products (21 CFR 886.5928) Rigid Gas Permeable Contact Lens<br>Care Products (21 CFR 886.5918) | Identical |
| Product Codes | LPN, MRC | Identical |
| Indications for Use | Indicated for the daily cleaning,<br>removal of protein deposits,<br>disinfection, and storage of soft<br>(hydrophilic) contact lenses (including<br>silicone hydrogel) and rigid gas<br>permeable contact lenses, as<br>recommended by your eye care<br>practitioner. | Identical |
| Rub Regimen | Yes, only for Rigid Gas Permeable<br>Lenses | Identical |
| No-Rub Regimen | 5 second rinse | Identical |
| Platinum-Coated<br>Neutralization Disc | Yes | Yes |
| Lens Case | Designed for System | Identical |
| Minimum Disinfection<br>Time | 4 hours | Identical |
| Post Disinfection Saline<br>Rinse Prior to Wear | Optional | Identical |
| Hydrogen Peroxide<br>Content | 3% | Identical |
| Buffer System | Phosphate / Citrate Buffers | Identical |
| Stabilizer | Phosphonic Acid | Identical |
| Lens Storage Period | 7 days | Identical |
| Discard After Opening | 90 days or 35 uses | Identical |
| Primary Container<br>(Material and Size) | HDPE Plastic<br>(120 ml, 360 ml) | Identical |

Table 1. Comparison of Technological Characteristics

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#### Summary of Non-Clinical Testing:

In addition to stability studies, a series of studies were conducted according to EN ISO 14729:2001/AMD.1:2010(E) Ophthalmic optics - Contact lens care products -Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses and EN ISO 147302000(E) Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date.

#### Substantial Equivalence Conclusion:

The results of the non-clinical and stability testing demonstrate that the safety and effectiveness of Bausch + Lomb PeroxiClear™ 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is substantially equivalent to the previously cleared device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/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 of three overlapping shapes, resembling a person embracing another person.

Public Health Service

ood and Drug Administration 903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

September 9, 2013

Bausch & Lomb Incorporated Ms. Heather Michaels Senior Specialist, Global Regulatory Affairs 1400 North Goodman Street Rochester, NY 14609

K132216 Re:

RT52210
Trade/Device Name: Bausch + Lomb PeroxiClear™ 3% Hydrogen Peroxide Cleaning & Disinfecting Solution

Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) Contact lens Care Products Regulatory Class: Class II Product Code: LPN Dated: August 16, 2013 Received: August 19, 2013

Dear Ms. Michaels:

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 for use stated in the encreation to togally to the Medical Device Amendments, or to Commerce prior to May 20, 1970, and encordance 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 r ou may, mercesse, market of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (000 above). Existing major regulations affecting your device can be It may of subject to additions, 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 ulat I DA has made a Geted regulations administered by other Federal agencies. You must of any I collars and regending, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Crk Fall 607), ademig (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Heather Michaels

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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

### Kesia Y. Alexander -S

for Malvina Eydelman, M.D. Director Division of Ophthalmic 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: K132216

#### Device Name:

Bausch + Lomb PeroxiClear™ 3% Hydrogen Peroxide Cleaning & Disinfecting Solution

#### Indications for Use:

Bausch + Lomb PeroxiClear™ 3% Hydrogen Peroxide Cleaning and Disinfecting Solution is indicated for the daily cleaning, removal of protein deposits, disinfection, and storage of soft (hydrophilic) contact lenses (including silicone hydrogel) and rigid gas permeable contact lenses, as recommended by your eye care practitioner.

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

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Leonid Livshitz ... - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - . 2013.09.06 '00'04- 10:25:37

(Division Sign-Off) Division of Ophthalmic and Ear, Nose, and Throat Devices 510(k) Number:

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