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.

Device Description

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%

AI/ML Overview

The provided text describes the 510(k) Premarket Notification for Altaire MPS#1 Multipurpose Contact Lens Solution. The submission focuses on demonstrating substantial equivalence to a predicate device (SOLO-Care Plus Multipurpose Solution, K012731) rather than a de novo study proving efficacy against specific acceptance criteria with detailed performance metrics.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

The device's performance is not reported in terms of specific numerical values against quantitative acceptance criteria for each study type. Instead, the document states that the device "satisfies the requirements" or "met acceptance criteria" according to FDA guidance.

Study Type	Acceptance Criteria	Reported Device Performance
Cleaning Studies (Critical Micelle Concentration)	"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)"	"Results of the study showed that Altaire MPS#1 Multipurpose Contact Lens Solution satisfies the requirements for daily cleaner."
Cytotoxicity	No specific numerical criteria are given, but implies "non-toxic and a non-irritant" is the acceptance criteria.	"Results of the testing demonstrated that Altaire MPS#1 Multipurpose Contact Lens Solution is non-toxic and a non-irritant."
Microbiological (Disinfection Properties - Standalone with and without soil)	Acceptance criteria are implied to be those for disinfection properties described in "FDA's Guidance for Industry Premarket Notification 510(k) Guidance Document for Contact Lens Care Products (May 1, 1997)". Specific numerical log reductions for various microorganisms are typically required but not stated in this summary.	"All three studies showed that the Altaire MPS#1 Multipurpose Contact Lens Solution met acceptance criteria."
Microbiological (Disinfection Properties - No rub regime)	Acceptance criteria are implied to be those for disinfection properties described in "FDA's Guidance for Industry Premarket Notification 510(k) Guidance Document for Contact Lens Care Products (May 1, 1997)". Specific numerical log reductions for various microorganisms are typically required but not stated in this summary.	"All three studies showed that the Altaire MPS#1 Multipurpose Contact Lens Solution met acceptance criteria."
Microbiological (Preservative Efficacy with 14-day re-challenge)	No specific numerical criteria are given, but implied to be "met acceptance criteria" based on relevant FDA guidance.	"the Altaire MPS#1 Multipurpose Contact Lens Solution met acceptance criteria."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for the various tests (Critical Micelle Concentration, Cytotoxicity, Microbiological studies).
The data provenance is also not specified (e.g., country of origin, retrospective or prospective). These details are typically found in the full study reports, not in the 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to this type of device and study. The testing for a contact lens solution involves laboratory-based chemical and microbiological evaluations, not assessments requiring expert interpretation of clinical data or images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the type of laboratory testing conducted for a contact lens solution. Adjudication methods are typically used in clinical studies or image-based diagnostic studies where multiple readers' opinions need to be reconciled.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices often involving AI assistance and human interpretation, which is not the case for a contact lens solution. The submission explicitly states: "clinical performance data was not performed, nor is it a requirement for the purpose of this premarket notification" because the device is substantially equivalent to a predicate.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not applicable to the device. A contact lens solution is not an algorithm, nor does it involve human-in-the-loop performance. The microbiological studies for disinfection were "standalone" in the sense that they evaluated the solution's efficacy against microbes without human intervention during the disinfection process.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the tests performed can be inferred as:

Cleaning Studies: Established scientific and regulatory standards (FDA Guidance document) for micelle concentration and cleaning effectiveness.
Cytotoxicity: Established cell viability assays and irritation assessment protocols which determine what constitutes "non-toxic" and "non-irritant."
Microbiological Studies: Established microbiological testing standards (e.g., ISO, USP, or FDA guidelines) that define specific log reduction requirements for various microorganisms or preservative efficacy.

8. The sample size for the training set

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable as the device is not an AI/ML algorithm.

Summary

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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: (631) 722-5988 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

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.

...

. .

SubstantialEquivalency	Altaire MPS#1 MultipurposeContact Lens Solution	SOLO-Care PlusMultipurpose Solution
Manufacture	Altaire Pharmaceuticals	CIBA Vision Corp
INTENDED USE	The Altaire MPS#1 MultipurposeContact Lens Solutionis indicated for use in the daily cleaning,removing protein deposits, rinsing,chemical(not heat) disinfecting, and storage ofsoft (hydrophilic) contact lenses, rigidgas permeable (fluorosilicone acrylateand silicone acrylate) contact lenses asrecommended by your eye carepractitioner.	The SOLO-Care Plus MultipurposeSolutionis indicated for use in the daily cleaning,removing protein deposits, rinsing,chemical(not heat) disinfecting, and storage ofsoft (hydrophilic) contact lenses, rigidgas permeable (fluorosilicone acrylateand silicone acrylate) contact lenses asrecommended by your eye carepractitioner.
Ingredient ActionBenefits	Ingredient	Ingredient
Surfactant, dailyprotein depositremover	Pluronic F127	Pluronic F127
Preservative, killsbacteria that cancause eye infections	PHMB, Polyhexanide 0.0001%,	PHMB, Polyhexanide 0.0001%,
Chelating Agent,breaks downcalcium bridges	Disodium edetate	Disodium edetate
Biological Buffer,maintain pH close tothat of natural tears	Bis-tris Propane	Bis-tris Propane
Lubricate, dualcomfort action;a.cushioning affectb. reduce proteindeposition	Cremophor RH40	Cremophor RH40
Tears SimulationAdditive, 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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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:

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

Regulation Number and Section

§ 886.5928 Soft (hydrophilic) contact lens care products.

(a)
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.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”