Bausch + Lomb Sensitive Eyes Plus Saline Solution

K170483 · Bausch & Lomb, Incorporated · LPN · Apr 11, 2017 · Ophthalmic

Device Facts

• Record ID: K170483
• Device Name: Bausch + Lomb Sensitive Eyes Plus Saline Solution
• Applicant: Bausch & Lomb, Incorporated
• Product Code: LPN · Ophthalmic
• Decision Date: Apr 11, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

Bausch + Lomb Sensitive Eyes Plus Saline Solution is a sterile, preserved solution for rinsing soft (hydrophilic) and gas permeable contact lenses after cleaning and before lens insertion with chemical (not heat) and hydrogen peroxide systems.

Device Story

Bausch + Lomb Sensitive Eyes Plus Saline Solution is a sterile, isotonic, buffered aqueous solution used for rinsing contact lenses. It contains boric acid, sodium borate, potassium chloride, sodium chloride, polyaminopropyl biguanide (0.00003%), and edetate disodium (0.025%). The device is packaged in a multi-use plastic bottle with a tamper-evident seal. It is intended for over-the-counter use by contact lens wearers to rinse soft (hydrophilic) and rigid gas permeable lenses after cleaning and prior to insertion. The solution functions via mechanical rinsing to remove debris. It is compatible with chemical and hydrogen peroxide disinfection systems. The product supports a 90-day discard date after opening.

Clinical Evidence

No clinical data. Safety and effectiveness were established through bench testing, including antimicrobial preservative efficacy testing (ISO 14730), regimen evaluation (FDA 1997 Guidance), and lens compatibility testing (ISO 11981).

Technological Characteristics

Isotonic, buffered aqueous solution. Ingredients: boric acid, sodium borate, potassium chloride, sodium chloride, polyaminopropyl biguanide (0.00003%), edetate disodium (0.025%). Form factor: multi-use plastic bottle. Standards: ISO 14730 (antimicrobial efficacy), ISO 14729 (regimen testing), ISO 11981 (lens compatibility).

Indications for Use

Indicated for rinsing soft (hydrophilic) and gas permeable contact lenses after cleaning and before insertion with chemical or hydrogen peroxide systems. For use by contact lens wearers.

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 Sensitive Eyes Plus Saline Solution (P800024/S16)
• Menicon Saline Rinse Solution (K151768)

Submission Summary (Full Text)

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

April 11, 2017

Bausch & Lomb Incorporated Ms. Melissa Thomas Senior Manager, Regulatory Affairs 1400 North Goodman Street Rochester, New York 14609

Re: K170483

Trade/Device Name: Bausch + Lomb Sensitive Eyes Plus Saline Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LPN, MRC Dated: February 14, 2017 Received: February 16, 2017

Dear Ms. 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

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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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# Denise L. Hampton -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 (if known)

#### K170483

Device Name Bausch + Lomb Sensitive Eyes Plus Saline

#### Indications for Use (Describe)

Bausch + Lomb Sensitive Eyes Plus Salinon is a sterile, preserved solution for rinsing soft (hydrophilic) and gas permeable contact lenses after cleaning and before lens insertion with chemical (not heat) and hydrogen peroxide systems.

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

| | 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 K170483

### Bausch + Lomb Sensitive Eyes Plus Saline 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: April 2017

#### 2. Device Name

| Trade Name: | Bausch + Lomb Sensitive Eyes Plus Saline Solution |
|------------------------|-----------------------------------------------------------------------------------------------------|
| Classification: | Accessories, Contact Lens Care Products |
| Device classification: | Class II |
| Regulation Number: | 886.5928 Soft Contact Lens Care Products<br>886.5918 Rigid Gas Permeable Contact Lens Care Products |
| Product Code: | LPN, MRC |

#### 3. Predicate Device

Bausch + Lomb Sensitive Eyes Plus Saline Solution (P800024/S16) Menicon Saline Rinse Solution (K151768)

#### 4. Description of the Device

Bausch + Lomb Sensitive Eyes Plus Saline Solution is a sterile, isotonic, buffered solution that contains boric acid, sodium borate, potassium chloride, sodium chloride, preserved with polyaminopropyl biguanide (0.00003%) and edetate disodium (0.025%). 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

Bausch + Lomb Sensitive Eyes Plus Saline Solution is a sterile, preserved solution for rinsing soft (hydrophilic) and gas permeable contact lenses after cleaning and before lens insertion with chemical (not heat) and hydrogen peroxide systems.

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

A series of preclinical testing was performed to demonstrate the safety and effectiveness of 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 performed to establish discard dating of 90 days for Sensitive Eves Plus Saline Solution. The test articles were evaluated initially and again following simulated use for the proposed discard date of 90 days.

The results of these evaluations demonstrate that Sensitive Eyes Plus Saline Solution meets the requirements of ISO 14730, Annex C Procedure II. Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard for the designation of a 90 day discard date.

Additionally a modified regimen procedure allowing for a rinse with Sensitive Eves Plus Saline Solution In Place of Tap Water was conducted for both Boston Conditioning Solution and Boston Advance Conditioning Solution. The results of both evaluations demonstrate that modified regimen with Sensitive Eyes Plus Saline Solution meets the FDA performance criteria for reqimen 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. The Sensitive Eyes Plus Saline Solution was previously cleared for use and expansion of the indication did not prompt the need for new testing.

#### Lens Compatibility

The results of lens compatibility studies per ISO 11981 demonstrate Bausch + Lomb Sensitive Eyes Plus Saline Solution is compatible with rigid gas permeable contact lenses.

#### Clinical Data

Clinical studies involving Sensitive Eyes Plus Saline Solution were unnecessary for this application. The Sensitive Eyes Plus Saline Solution has been commercially available in the market for over 25 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 Bausch + Lomb Sensitive Eyes Plus Saline Solution when used with gas permeable contact lenses are substantially equivalent to the current product which is indicated for use with soft contact lenses.

| Feature | Menicon Saline Rinse<br>Solution (K151768) | Sensitive Eyes Plus<br>Saline Solution<br>(P800024/S16) | Sensitive Eyes Plus<br>Saline Solution<br>(K170483) |
|------------------------------------------------|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Product Code | LPN, MRC | LPN | LPN, MRC |
| Regulation Number | 21 CFR 886.5918<br>21 CFR 886.5928 | 21 CFR 886.5928 | 21 CFR 886.5918<br>21 CFR 886.5928 |
| Indicated for Soft<br>Lenses | Yes | Yes | Yes |
| Indicated for Rigid<br>Gas Permeable<br>Lenses | Yes | No | Yes |
| Rinse Required for<br>Cleaning | Unknown | Thoroughly Rinse<br>5 Seconds Each Side | Thoroughly Rinse<br>5 Seconds Each Side |
| Discard After Opening | Unknown | NA | 90 day Discard Date |
| Primary Container | Plastic resin container<br>with twist off cap | Plastic Bottle<br>Multiple Sizes | Plastic Bottle<br>Multiple Sizes |
| Container Usage | Single Use | Multi Use | Multi Use |
| Preserved | No | Yes | Yes |
| Sterile | Yes | Yes | Yes |
| Technology<br>Features | Isotonic<br>Aqueous Solution | Isotonic<br>Aqueous Solution | Isotonic<br>Aqueous Solution |
| Materials | Plastic Resin Container<br>With Twist Off Cap | Plastic Resin Container<br>With Cap | Plastic Resin Container<br>With Cap |
| Principles of<br>Operation | Mechanical Rinsing | Mechanical Rinsing | Mechanical Rinsing |
| Directions for Use | Unknown | Rinse After Cleaning<br>(5 sec. per side)<br>Rinse After Disinfection<br>(20 seconds)<br>Carton Onsert<br>Bausch.com | Rinse After Cleaning<br>(5 sec. per side)<br>Rinse After Disinfection<br>(20 seconds)<br>Carton Onsert<br>Bausch.com |

### SUBSTANTIAL EQUIVALENCE SUMMARY TABLE