(258 days)
Not Found
No
The device is a contact lens solution, and the description and performance studies focus on its chemical and microbiological properties, not on any computational or analytical capabilities. There is no mention of AI, ML, image processing, or data analysis.
No
The device is a contact lens solution intended for cleaning, rinsing, disinfecting, protein removal, and storing contact lenses, not for treating a disease or condition.
No
The device is a contact lens solution indicated for cleaning, rinsing, disinfecting, protein removal, and storing contact lenses. It does not perform any diagnostic function.
No
The device description clearly states it is a sterile aqueous solution with chemical components, indicating it is a physical product (contact lens solution) and not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the product is for cleaning, rinsing, disinfecting, and storing contact lenses. These are actions performed on the contact lenses themselves, which are medical devices worn on the eye.
- Device Description: The description lists the chemical components of the solution.
- Performance Studies: The performance studies focus on the efficacy of the solution in cleaning, disinfecting, and its safety (cytotoxicity, non-irritant). These studies evaluate the product's ability to perform its intended function on contact lenses and its safety for use with the eye.
- Lack of Diagnostic Purpose: There is no mention of the product being used to diagnose a disease, condition, or state of health. It does not analyze a biological sample from the patient to provide diagnostic information.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This contact lens solution does not fit that description.
N/A
Intended Use / 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, and rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses as recommended by your eye care practitioner.
Product codes (comma separated list FDA assigned to the subject device)
LPN, MRC
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%
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
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
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.
1
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.
2
510(k) Premarket Notification
Altaire Pharmaceuticals, Inc.
...
. .
| Substantial
Equivalency | Altaire MPS#1 Multipurpose
Contact Lens Solution | SOLO-Care Plus
Multipurpose Solution |
|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacture | Altaire Pharmaceuticals | CIBA Vision Corp |
| INTENDED USE | The Altaire MPS#1 Multipurpose
Contact Lens Solution
is indicated for use in the daily cleaning,
removing protein deposits, rinsing,
chemical
(not heat) disinfecting, and storage of
soft (hydrophilic) contact lenses, rigid
gas permeable (fluorosilicone acrylate
and silicone acrylate) contact lenses as
recommended by your eye care
practitioner. | The SOLO-Care Plus Multipurpose
Solution
is indicated for use in the daily cleaning,
removing protein deposits, rinsing,
chemical
(not heat) disinfecting, and storage of
soft (hydrophilic) contact lenses, rigid
gas permeable (fluorosilicone acrylate
and silicone acrylate) contact lenses as
recommended by your eye care
practitioner. |
| Ingredient Action
Benefits | Ingredient | Ingredient |
| Surfactant, daily
protein deposit
remover | Pluronic F127 | Pluronic F127 |
| Preservative, kills
bacteria that can
cause eye infections | PHMB, Polyhexanide 0.0001%, | PHMB, Polyhexanide 0.0001%, |
| Chelating Agent,
breaks down
calcium bridges | Disodium edetate | Disodium edetate |
| Biological Buffer,
maintain pH close to
that of natural tears | Bis-tris Propane | Bis-tris Propane |
| Lubricate, dual
comfort action;
a.cushioning affect
b. reduce protein
deposition | Cremophor RH40 | Cremophor RH40 |
| Tears Simulation
Additive, comfort | Sodium chloride | Sodium chloride |
SUBSTANTIAL EQUIVALENCY CHART
3
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.
4
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
5
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