(334 days)
Not mentioned
Not Found
No
The device is a chemical solution for contact lens care and the summary does not mention any AI or ML components.
No.
This device is a contact lens care product used for cleaning, disinfecting, and storing contact lenses, not for treating a medical condition or disease.
No
This device is a multi-purpose disinfecting solution for contact lenses, indicated for cleaning, rinsing, disinfecting, storing, removing protein, and conditioning. These functions are for the care and maintenance of contact lenses, not for diagnosing a medical condition.
No
The device is a chemical solution for contact lens care, not a software program. The description details its chemical composition and packaging, and the performance studies focus on its chemical and biological effects.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the care of soft contact lenses (disinfecting, cleaning, rinsing, storing, removing protein, conditioning). This is a direct interaction with a medical device (contact lenses) and not a diagnostic test performed on a biological sample from the human body.
- Device Description: The description details a sterile aqueous solution with various chemical components for contact lens care. It does not describe a device designed to analyze biological samples.
- Performance Studies: The performance studies focus on the solution's compatibility with contact lenses, protein removal from lenses, wettability of lenses, microbiological efficacy against microbes on lenses, stability of the solution, and biocompatibility in relation to ocular tissue and contact lenses. These studies are relevant to the safety and efficacy of a contact lens care product, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
Therefore, the AMO brand Multi-Purpose Disinfecting Solution is a contact lens care product, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
AMO Brand Multi-Purpose Disinfecting Solution is indicated for the care of soft (hydrophilic) contact lenses, including silicone hydrogel lenses. Use this product as recommended by your eye care practitioner to:
- Chemically (NOT HEAT) Disinfect ●
- Clean ●
- Rinse ●
- Store
- Remove Protein ●
- Condition
Product codes
LPN
Device Description
AMO Brand Multi-Purpose Disinfecting Solution is a sterile and buffered aqueous solution containing disinfectants / preservatives, buffers, a surfactant, a chelating agent, other ancillary agents, and purified water. The solution is packaged in tamper-resistant multi-dose plastic bottles with controlled dropper tips.
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)
- Solution Compatibility: Tested for compatibility with conventional Group 1 and Group 4 soft (hydrophilic) contact lenses, and with four (4) representative marketed silicone hydrogel lenses. Results demonstrate compatibility.
- Protein Removal: Tested for ability to remove lysozyme protein on contact lens surfaces. Demonstrated ability to passively and effectively remove protein comparable to predicate device.
- Wettability of Contact Lenses: Measured contact angles of water drops on contact lenses using sessile drop method. Contact lenses presoaked in MPDS 9608X or predicate device. Results demonstrate equivalence in wettability, conditioning, and moisturizing.
- Microbiological Studies: Evaluated for microbiological efficacy. Meets current FDA requirements for disinfection against bacteria, yeast, and mold. Formulated with dual-disinfection technology.
- Stability: Accelerated testing indicates stability for labeled shelf-life.
- Biocompatibility: Safety evaluated using worst-case formulation.
- Cytotoxicity: Neither test formulation nor predicate device were cytotoxic to mouse fibroblasts after 24 hours. MPDS 9608X was less cytotoxic than the predicate device with pre-soaked contact lenses.
- Sensitization: No dermal reactions.
- Ocular irritation: 1-day acute ocular irritation study in rabbits demonstrated no ocular irritation.
- 22-day Ocular Safety Studies with Contact Lenses: Treatment with test formulation or control was well tolerated in rabbits.
- Acute Oral Toxicity: No adverse effect when administered to rats in a single oral dose.
- Clinical Data:
- Multi-center clinical trial: Evaluated safety and performance in soft contact lenses, including silicone hydrogel lens wearers. Demonstrated safe and effective.
- Single-center clinical trial: Evaluated safety and performance in PureVision™ lenses. Comparable to predicate device in patient acceptability, lens wearing comfort, and corneal staining.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ALCON® Opti-free® RepleniSH® Multi-purpose disinfecting solution.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(K) SUMMARY
AMO Brand Multi-Purpose Disinfecting Solution
This summary used the format provided in 21 CFR 807.92:
| (a)(1) Submitter: | Kesley E. Gallagher
Sr. RA Specialist
Global Regulatory Affairs
Abbott Medical Optics
1700 E. St. Andrew Place
Santa Ana, CA 92705 |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: 714-247-8930
Fax: 714-247-8784
E-mail: kesley.gallagher@amo.abbott.com |
| (a)(2) Device Trade Name: | AMO Brand Multi-Purpose Disinfecting
Solution |
| Device Common Name: | Soft (Hydrophilic) Contact Lens Solution |
| Device Classification/Panel: | Class II (Special Controls)/Ophthalmic
Device |
| Device Classification Names: | Accessories to Contact Lens Solution
(86LPN) |
(a)(3) Identification of Predicate Device:
AMO Brand Multi-Purpose Disinfecting Solution (MPDS 9608X) is substantially equivalent to ALCON® Opti-free® RepleniSH® Multi-purpose disinfecting solution.
(a)(4) Device Description:
AMO Brand Multi-Purpose Disinfecting Solution is a sterile and buffered aqueous solution containing disinfectants / preservatives, buffers, a surfactant, a chelating agent, other ancillary agents, and purified water. The solution is packaged in tamper-resistant multi-dose plastic bottles with controlled dropper tips.
Intended Use (Indications for Use) (a)(5)
AMO Brand Multi-Purpose Disinfecting Solution is indicated for the care of soft (hydrophilic) contact lenses, including silicone hydrogel lenses. Use this product as recommended by your eye care practitioner to:
- Chemically (NOT HEAT) Disinfect ●
- Clean ●
1
- Rinse ●
- Store
- Remove Protein ●
- Condition
(a)(6) Comparison of Technological Characteristics
The technological characteristics of the new formulation remain the same as the predicate device.
(b)(1) Discussion of Non-Clinical Testing
Solution Compatibility: AMO Brand Multi-Purpose Disinfecting Solution was tested for compatibility with conventional Group 1 and Group 4 soft (hydrophilic) contact lenses, and with four (4) representative marketed silicone hydrogel lenses. The results demonstrate the product is compatible with soft contact lenses, including silicone hydrogel lenses. The tests were primarily carried out in accordance with the FDA Guidelines, Premarket Notification (510(k)) Guidance Documents for Contact Lens Care Products, May 1, 1997.
Protein Removal: AMO Brand Multi-Purpose Disinfecting Solution and the predicate device were tested for their abilities to remove lysozvme protein on contact lens surfaces. AMO® Brand Multi-Purpose Disinfecting Solution demonstrated its ability to passively and effectively remove protein from soft (hydrophilic) contact lenses, including silicone hydrogels, which is comparable to the predicate device.
Wettability of Contact Lenses: The contact angles of water drops on contact lenses were measured using the sessile drop method. Contact lenses, including four (4) representative silicone hydrogel contact lenses and FDA Group IV contact lenses, were presoaked in MPDS 9608X, or the predicate device, Opti-Free® RepleniSH®. The results demonstrate AMO® Brand Multi-Purpose Disinfecting Solution and Opti-Free® RepleniSH® are equivalent in soft (hydrophilic) contact lens, including silicone hydrogels, wettability, conditioning, and moisturizing.
Microbiological Studies: The product was evaluated for microbiological efficacy using studies outlined in FDA's Premarket Notification (510(k)) Guidance Documents for Contact Lens Care Products, May 1, 1997, modified to include organic soil in the stand alone test and test solution formulated to the low specification of the disinfectants / preservatives.
- The product meets current FDA requirements for disinfection of contact ● lenses against bacteria, yeast, and mold at low shelf specifications for the disinfectant / preservative system.
- AMO brand Multi-Purpose Disinfecting Solution is formulated with dualdisinfection technology designed specifically for soft contact lenses, including silicone hydrogel lenses. Dual disinfectants work to destroy microbes on the surface of the lens and provide safe contact lens storage up to 30-days. All
2
tests used AMO® Brand Multi-Purpose Disinfecting Solution at the low shelf specifications for the disinfectant / preservative system.
- . The product meets USP sterility test requirements.
Stability: Accelerated testing indicates AMO Brand Multi-Purpose Disinfecting Solution will remain stable for the labeled shelf-life.
Biocompatibility: The safety of the product was evaluated with a worst case formulation at the upper specification for the disinfectants / preservatives using studies outlined in the FDA's Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, May 1, 1997 and Pre-IDE 1080487 Investigational Multi-Purpose Solution for Contact Lens Care, July 31, 2008.
- . Cytotoxicity: Neither the test formulation, nor the predicate device, were cytotoxic to mouse fibroblasts cells after 24 hours.
- Sensitization: There were no dermal reactions from either test or control.
- Ocular irritation: 1-day acute ocular irritation study in rabbits demonstrated ● no ocular irritation.
- 22-day Ocular Safety Studies with Contact Lenses: Treatment with either the . test formulation or control with either PureVision™ or Acuvue® 2 contact lenses was well tolerated in rabbits over the indicated period of time.
- . Acute Oral Toxicity: Neither the test formulation or the control caused an adverse effect when administered to rats in a single oral dose.
- . Cytotoxicity with pre-soaked contact lenses - Direct Contact. Overall results showed MPDS 9608X was less cytotoxic than the predicate device.
(b)(2) Discussion of Clinical Data:
A multi-center clinical trial was conducted using AMO Brand Multi-Purpose Disinfecting Solution. The safety and performance of the product were evaluated in soft contact lenses, including silicone hydrogel lens wearers. lt was demonstrated the product is safe and effective when using soft (hydrophilic) contact lenses, including currently marketed silicone hydrogel lenses.
An additional single-center clinical trial was conducted using AMO Brand Multi-Purpose Disinfecting Solution. The safety and performance of the product were evaluated in PureVision™ lenses at specified time points over a period of four days. It was demonstrated that the product is comparable to the predicate device in terms of patient acceptability, lens wearing comfort, and corneal staining.
(b)(3) Conclusions Drawn from Data Supporting Equivalence Determination
It is concluded that the safety, efficacy, and performance of AMO Brand Multi-Purpose Disinfecting Solution is substantially equivalent to the predicate device, ALCON® Opti-Free® RepleniSH®.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract emblem resembling an eagle or bird in flight, composed of three curved lines. The logo is rendered in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Abbott Medical Optics, Inc. c/o Ms. Kesley E. Gallagher Sr. RA Specialist Global Regulatory Affairs 1700 E. St. Andrews Place Santa Ana, CA 92705
Re: K093254
SEP 1 5 2010
Trade/Device Name: AMO brand Multi-Purpose Disinfecting Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LPN Dated: July 29, 2010 Received: July 30, 2010
Dear Ms. Gallagher:
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. 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 (reporting of medical
4
Page 2 - Ms. Kesley Gallagher
device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
17
Sincerely yours,
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological, and Ear. Nose and Throat Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
5
Page 1 of 1
510(k) NUMBER: (IF KNOWN)
DEVICE NAME:
AMO brand Multipurpose Disinfecting
Solution
INDICATIONS FOR USE:
AMO brand Multi-Purpose Disinfecting Solution is indicated for the care of soft (hydrophilic) contact lenses, including silicone hydrogel lenses. Use this product as recommended by your eye care practitioner to:
- Chemically (NOT HEAT) Disinfect ●
- Clean ●
- Rinse .
- Store
- Remove Protein
- Condition
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR K. Warbnb Over-the-Counter-Use ✓
(Optional Format 1-2-96)
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K093254
SEP 1 5 2010