Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution

K180319 · Bausch and Lomb, Incorporated · MRC · Mar 27, 2018 · Ophthalmic

Device Facts

• Record ID: K180319
• Device Name: Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution
• Applicant: Bausch and Lomb, Incorporated
• Product Code: MRC · Ophthalmic
• Decision Date: Mar 27, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5918
• Device Class: Class 2

Intended Use

Boston ADVANCE Cleaner is indicated for use to clean fluoro silicone acrylate and silicone acrylate gas permeable contact lenses after each removal and before conditioning (wetting, soaking, disinfecting). Boston ADVANCE Conditioning Solution is indicated for wetting, disinfecting and soaking (after cleaning and rinsing) fluoro silicone acrylate and silicone acrylate gas permeable contact lenses.

Device Story

Boston ADVANCE Cleaner and Conditioning Solution are contact lens care products for rigid gas permeable lenses. Cleaner uses surfactant solution (alkyl ether sulfate, ethoxylated alkyl phenol, tri-quaternary cocoa-based phospholipid, silica gel, titanium dioxide) to remove deposits. Conditioning solution uses cationic cellulose derivative, cellulosic viscosifier, polyvinyl alcohol, and derivatized polyethylene glycol for wetting/cushioning; preserved with chlorhexidine gluconate, polyaminopropyl biguanide, and edetate disodium. Used by patients at home; involves manual cleaning (rubbing) and rinsing with saline solution before soaking/disinfecting. System maintains lens hygiene, comfort, and safety for lens wearers.

Clinical Evidence

No clinical data provided. Safety and effectiveness established via bench testing. Microbiology studies confirmed preservative efficacy per ISO 14730 and regimen performance per ISO 14729:2001/Amd. 1:2010. Lens compatibility verified per ISO 11981. Regimen evaluation followed FDA 1997 Guidance for Industry for Contact Lens Care Products.

Technological Characteristics

Chemical solution system. Cleaner: surfactant-based with silica gel and titanium dioxide. Conditioning solution: aqueous, buffered, hypertonic solution with cellulose derivatives, polyvinyl alcohol, and PEG; preserved with chlorhexidine gluconate, polyaminopropyl biguanide, and edetate disodium. Standards: ISO 14730, ISO 14729, ISO 11981.

Indications for Use

Indicated for cleaning, wetting, disinfecting, and soaking fluoro silicone acrylate and silicone acrylate gas permeable contact lenses.

Regulatory Classification

Identification

A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.

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 Boston ADVANCE Cleaner (K974466)
• Bausch + Lomb Boston ADVANCE Conditioning Solution (P920055)
• Bausch + Lomb Sensitive Eyes Plus Saline Solution (K170483)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

March 27, 2018

Bausch and Lomb Incorporated Melissa Thomas Senior Manager Regulatory Affairs 1400 North Goodman Street Rochester, NY 14609

Re: K180319

Trade/Device Name: Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution Regulation Number: 21 CFR 886.5918 Regulation Name: Rigid Gas Permeable Contact Lens Care Products Regulatory Class: Class II Product Code: MRC Dated: February 1, 2018 Received: February 5, 2018

Dear Melissa Thomas:

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. 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), 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.

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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 of medical devicerelated adverse events) (21 CFR 803); 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.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Denise L. Hampton -S

for Malvina B. 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 (if known) K180319

Device Name

Bausch + Lomb Boston ADVANCE Cleaner Bausch + Lomb Boston ADVANCE Conditioning Solution

#### Indications for Use (Describe)

Boston ADVANCE Cleaner is indicated for use to clean fluoro silicone acrylate and silicone acrylate gas permeable contact lenses after each removal and before conditioning (wetting, soaking, disinfecting).

Boston ADVANCE Conditioning Solution is indicated for wetting, disinfecting and soaking (after cleaning and rinsing) fluoro silicone acrylate and silicone acrylate gas permeable contact lenses.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <input type="checkbox"/> Research Use (Part 21 CFR 201. Subject to Change) | <input checked="" type="checkbox"/> <i> In-Vitro </i> Diagnostic Use (21 CFR 801. Subject to Change) |
|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|

| | Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### 510(k) SUMMARY

### Bausch + Lomb Boston ADVANCE Cleaner & Conditioning Solution

#### 1. Submitter Information

| Primary | Alternate |
|------------------------------------|----------------------------------|
| Melissa Thomas | Glenn Davies, O.D. |
| Senior Manager, Regulatory Affairs | Sr. Director Regulatory Affairs, |
| 1400 North Goodman Street | 1400 North Goodman Street |
| Rochester, NY 14609 | Rochester, NY 14609 |
| Tel. [phone] | Tel. [phone] |
| Fax [phone] | Email: [e-mail] |
| Email: [e-mail] | |

Summary Prepared: February 1, 2018

### 2. Device Name

| Trade Name: | Boston ADVANCE Cleaner & Conditioning Solution |
|------------------------|---------------------------------------------------------|
| Classification: | Accessories, Contact Lens Care Products |
| Device classification: | Class II |
| Regulation Number: | 886.5918 Rigid Gas Permeable Contact Lens Care Products |
| Product Code: | MRC |

#### 3. Predicate Device

Bausch + Lomb Boston ADVANCE Cleaner (K974466) Bausch + Lomb Boston ADVANCE Conditioning Solution (P920055) Bausch + Lomb Sensitive Eyes Plus Saline Solution (K170483)

#### 4. Description of the Device

Boston ADVANCE Cleaner is a sterile, concentrated, homogeneous surfactant solution containing alkyl ether sulfate, ethoxylated alkyl phenol, tri-quaternary cocoa-based phospholipid and silica gel as cleaning agents; with titanium dioxide.

Boston ADVANCE Conditioning Solution is a sterile, aqueous, buffered, slightly hypertonic solution containing a cationic cellulose derivative polymer, a cellulosic viscosifier, polyvinyl alcohol and a derivatized polyethylene glycol as wetting and cushioning agents; preserved with chlorhexidine gluconate (0.003%), polyaminopropyl biguanide (0.0005%) and edetate disodium (0.05%).

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## 5. Intended Use

Boston ADVANCE Cleaner is indicated for use to clean fluoro silicone acrylate and silicone acrylate gas permeable contact lenses after each removal and before conditioning (wetting, soaking, disinfecting).

Boston ADVANCE Conditioning Solution is indicated for wetting, disinfecting and soaking (after cleaning and rinsing) fluoro silicone acrylate and silicone acrylate gas permeable contact lenses.

#### 6. Description of Safety and Substantial Equivalence

A series of preclinical testing was performed to demonstrate the safety and effectiveness of the modified regimen which replaces the water rinse with Bausch + Lomb Sensitive Eyes Plus Saline Solution as described in Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, May 1, 1997. A brief summary of the test results is provided below:

### Microbiology

Studies were previously performed to establish discard dating for both Boston ADVANCE Cleaner and Boston ADVANCE Conditioning Solution. The test articles were evaluated initially and again following simulated use for the proposed 90 discard dates.

The results of these evaluations demonstrate that both solutions meet the requirements of ISO 14730, Annex C, Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date.

Additionally a modified regimen procedure allowing for a rinse with Sensitive Eyes Plus Saline Solution in place of tap water was conducted. The results demonstrate that modified regimen with Sensitive Eyes Plus Saline Solution meets the FDA performance criteria for regimen evaluation as described in the May 1, 1997 Guidance for Industry, Pre-market Notification (510(k)) Guidance Document for Contact Lens Care Products when used in a 10 second rub, 5 second rinse (per lens side) regimen. The products used in this regimen also meet the performance criteria established in ISO Standard 14729: 2001/Amd. 1:2010: (E) for regimen testing.

#### Biocompatibility

Biocompatibility tests were unnecessary for this application. Previous data submitted is still applicable, please reference P920055 for Boston ADVANCE Conditioning Solution, and K974466 for Boston ADVANCE Cleaner.

#### Lens Compatibility

The results of lens compatibility studies per ISO 11981 demonstrate that replacing water with Bausch + Lomb Sensitive Eyes Plus Saline Solution as part of the regimen is compatible with gas permeable contact lenses.

#### Clinical Data

Clinical studies involving the modified regimen for Boston ADVANCE Cleaner and Conditioning Solution were unnecessary for this application. This Cleaner -Conditioning System has been commercially available in the market for almost 20 years with well demonstrated safety and efficacy.

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# 7. Substantial Equivalence

The cumulative results of laboratory testing sponsored by Bausch + Lomb demonstrate that the safety, effectiveness and performance of the modified regimen for Boston ADVANCE Cleaner and Conditioning Solution to include Bausch + Lomb Sensitive Eyes Plus Saline Solution when used with gas permeable contact lenses are substantially equivalent to the current regimen with a water rinse.