ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION

K062332 · Altaire Pharmaceuticals, Inc. · LPN · Apr 25, 2007 · Ophthalmic

Device Facts

• Record ID: K062332
• Device Name: ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION
• Applicant: Altaire Pharmaceuticals, Inc.
• Product Code: LPN · Ophthalmic
• Decision Date: Apr 25, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

The Altaire MPS#1 Multipurpose Contact Lens Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting, daily protein removal, and storing of soft (hydrophilic) contact lenses, and rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses as recommended by your eye care practitioner.

Device Story

Altaire MPS#1 is a sterile aqueous multipurpose contact lens solution; contains sodium chloride, bis-tris propane, pluronic F127, cremophor RH40, edetate disodium dehydrate, and polyhexanide. Used for daily cleaning, rinsing, chemical disinfection, protein removal, and storage of soft and rigid gas permeable contact lenses. Solution acts as a surfactant, preservative, chelating agent, and biological buffer. Intended for use by contact lens wearers as directed by eye care practitioners. Benefits include lens maintenance, disinfection, and increased comfort through tear simulation and lubrication. No clinical performance data required due to identical formulation and manufacturing processes as predicate.

Clinical Evidence

No clinical data performed. Evidence consists of bench testing: Critical Micelle Concentration study for cleaning efficacy; cytotoxicity studies confirming non-toxic/non-irritant status; and microbiological studies (stand-alone disinfection with/without soil, no-rub regime, and 14-day preservative efficacy re-challenge) meeting all acceptance criteria.

Technological Characteristics

Sterile aqueous solution. Ingredients: sodium chloride, bis-tris propane, pluronic F127, cremophor RH40, edetate disodium dehydrate (0.025%), polyhexanide (0.0001%). Functions as surfactant, preservative, chelating agent, and biological buffer. No electronic or software components.

Indications for Use

Indicated for cleaning, rinsing, chemical disinfecting, daily protein removal, and storage of soft (hydrophilic) and rigid gas permeable (fluoro silicone acrylate and silicone acrylate) 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

• SOLO-care (K991403)
• SOLO-Care Plus Multipurpose Solution (K012731)

Submission Summary (Full Text)

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## Altaire Pharmaceuticals, Inc.

510(k) Premarket Notification

## 510(k) SUMMARY

## K062332

This summary follows the requirements of SMDA 1990 and 21 CFR 807.92, upon which the substantial equivalence determination is based.

> 510(k) Summary for Altaire Pharmaceuticals Multipurpose Solution

#### Submitter information 1. Altaire Pharmaceuticals Inc. P.O. Box 849 311 West Lane Aquebogue, NY 11931 Contact Person: Michael S. Sawaya Phone number: [phone] 2. Device Name Regulation name #1: Soft Lens Products, Contact Lens Solution Product Code #1: LPN

Requlation name #2: Rigid Gas Permeable, Contact lens care products Product Code #2: MRC

Propriety Name Altaire MPS#1 Multipurpose Contact Lens Solution

#### 3. Predicate Device

SOLO-care, and SOLO-Care Plus Multipurpose Solution: K991403 & K012731. This product was selected because the formulation and indications for use are identical to the device proposed in this submission.

#### 4. Description of Device

Altaire MPS#1 Multipurpose Contact Lens Solution is a sterile aqueous solution containing sodium chloride, bis-tris propane, pluronic F127, cremophor RH40and preserved with edetate disodium dehydrate 0.025% and polyhexanide 0.0001%

#### ર. Indications for Use

Altaire MPS#1 Multipurpose Contact Lens Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting, daily protein removal, and storing of soft (hydrophilic) contact lenses, and rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses as recommended by your eye care practitioner.

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## Altaire Pharmaceuticals, Inc.

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

Altaire MPS#1 Multipurpose Contact Lens Solution is substantially equivalent in terms of its actions and indications for use, to SOLO-Care Plus Multipurpose Solution cleared for marketing under 510(k) K012731. Altaire Pharmaceuticals Multipurpose Solution meets guidelines as set forth in FDA's May 1, 1997 Guidance for Industry, Premarket Notification 510(K) Guidance Document for Contact Lens Care Products.

### Cleaning Studies

The Critical Micelle Concentration was performed. Results of the study showed that Altaire MPS#1 Multipurpose Contact Lens Solution satisfies the requirements for daily cleaner of lens care products as per the FDA's Guidance for Industry Premarket Notification 510(k) Guidance Document for Contact Lens Care Products (May 1, 1997).

### Lens Compatibility Data

No lens compatibility data is required to be submitted herein this submission.

### Cytotoxicity

A series of Cytotoxicity studies were conducted to demonstrate the safety of Altaire MPS#1 Multipurpose Contact Lens Solution. Results of the testing demonstrated that Altaire MPS#1 Multipurpose Contact Lens Solution is non-toxic and a non-irritant.

### Microbiological

Microbiological studies were conducted to demonstrate the microbial efficacy of Altaire MPS#1 Multipurpose Contact Lens Solution. Two studies evaluated the disinfection properties of the product under stand alone with and without soil. Another study evaluated disinfection properties using a no rub regime. All three studies showed that the Altaire MPS#1 Multipurpose Contact Lens Solution met acceptance criteria. Preservative Efficacy testing with 14-day re-challenge was evaluated, and the Altaire MPS#1 Multipurpose Contact Lens Solution met acceptance criteria.

### Clinical testing

Altaire MPS#1 Multipurpose Contact Lens Solution possess the same active and inactive ingredients within marketed concentrations as that of the Solo-Care Plus Multipurpose Solution and utilizes the same manufacturing processes, and therefore clinical performance data was not performed, nor is it a requirement for the purpose of this premarket notification.

#### 7. Substantial Equivalence

The data provided in this 510(k) submission concludes that Altaire MPS#1 Multipurpose Contact Lens Solution is substantially equivalent to SOLO-Care Plus Multipurpose solution for cleaning, rinsing, chemical (not heat) disinfecting, protein removal, and storing soft (hydrophilic) contact lenses, and rigid gas permeable (flouro sillcon acrylate and silicon acrylate) contact lenses as recommended by your eye care practitioner.

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## 510(k) Premarket Notification

# Altaire Pharmaceuticals, Inc.

...

. .

| Substantial<br>Equivalency | Altaire MPS#1 Multipurpose<br>Contact Lens Solution | SOLO-Care Plus<br>Multipurpose Solution |
|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacture | Altaire Pharmaceuticals | CIBA Vision Corp |
| INTENDED USE | The Altaire MPS#1 Multipurpose<br>Contact Lens Solution<br>is indicated for use in the daily cleaning,<br>removing protein deposits, rinsing,<br>chemical<br>(not heat) disinfecting, and storage of<br>soft (hydrophilic) contact lenses, rigid<br>gas permeable (fluorosilicone acrylate<br>and silicone acrylate) contact lenses as<br>recommended by your eye care<br>practitioner. | The SOLO-Care Plus Multipurpose<br>Solution<br>is indicated for use in the daily cleaning,<br>removing protein deposits, rinsing,<br>chemical<br>(not heat) disinfecting, and storage of<br>soft (hydrophilic) contact lenses, rigid<br>gas permeable (fluorosilicone acrylate<br>and silicone acrylate) contact lenses as<br>recommended by your eye care<br>practitioner. |
| Ingredient Action<br>Benefits | Ingredient | Ingredient |
| Surfactant, daily<br>protein deposit<br>remover | Pluronic F127 | Pluronic F127 |
| Preservative, kills<br>bacteria that can<br>cause eye infections | PHMB, Polyhexanide 0.0001%, | PHMB, Polyhexanide 0.0001%, |
| Chelating Agent,<br>breaks down<br>calcium bridges | Disodium edetate | Disodium edetate |
| Biological Buffer,<br>maintain pH close to<br>that of natural tears | Bis-tris Propane | Bis-tris Propane |
| Lubricate, dual<br>comfort action;<br>a.cushioning affect<br>b. reduce protein<br>deposition | Cremophor RH40 | Cremophor RH40 |
| Tears Simulation<br>Additive, comfort | Sodium chloride | Sodium chloride |

## SUBSTANTIAL EQUIVALENCY CHART

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three bars representing the agency's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 5 2007

Grand Valley Business Plaza 2214 Sanford Drive, Suite #B7 Grand Junction, CO 81505

Altaire Pharmaceuticals, Inc.

c/o Mr. Martin Dalsing Medvice Consulting, Inc.

Re: K062332

Trade/Device Name: Altaire MPS#1 Multipurpose Contact Lens Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LPN, MRC Dated: March 23, 2007 Received: March 29, 2007

Dear Mr. Dalsing:

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 such 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); 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.

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## Page 2 - Mr. Martin Dalsing

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/industry/support/index.html.

Sincerely yours,

M.B. Egelman Simud

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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## Altaire Pharmaceuticals,

### INDICATIONS FOR USE

510(k) Number: K062332

Device Name: Altaire MPS#1 Multipurpose Contact Lens Solution

INDICATIONS FOR USE:

The Altaire MPS#1 Multipurpose Contact Lens Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting, daily protein removal, and storing of soft (hydrophilic) contact lenses, rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses as recommended by your eye care practitioner.

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

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

- 510(k) Premarket Notifica

(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mpe Smith

Ivision Sign Division of Onthalmic Ear. Nose and Theat Levises

510(k) Number K062332