(78 days)
P830034/S26
Not Found
No
The device description and performance studies focus on the chemical composition and cleaning/disinfection efficacy of a contact lens solution, with no mention of AI or ML technologies.
No.
The device is a multi-purpose solution for cleaning and disinfecting contact lenses, which are therapeutic devices, but the solution itself is not directly applied to a patient for therapeutic benefit. It is used to maintain the cleanliness of a medical device.
No
This device is a multi-purpose solution for cleaning, disinfecting, and storing contact lenses, not for diagnosing medical conditions.
No
The device description clearly states it is a sterile, buffered, isotonic, aqueous solution, which is a chemical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for cleaning, disinfecting, and storing contact lenses. This is a direct interaction with a medical device (contact lenses) and not a test performed in vitro (outside the body) on biological specimens to diagnose a condition.
- Device Description: The description details the chemical composition of a solution for contact lens care. It does not describe a test kit, reagent, or instrument used for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Measuring analytes or biomarkers
- Using techniques like immunoassays, PCR, or microscopy for diagnostic purposes.
The device is clearly intended for the maintenance and care of contact lenses, which are medical devices themselves, but the solution itself is not an IVD.
N/A
Intended Use / Indications for Use
For use in the daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
OPTI-ONE® Multi-Purpose Solution (modified directions for use) can also be as a d:luent for OPTI-ZYME® Enzymatic Cleaner.
Product codes
LPN
Device Description
OPTI-ONE® Multi-Purpose Solution is a sterile, buffered, isotonic, aqueous solution, containing borates, citrate, mannitol, and sodium chloride with Pationic® and Tetronic® surfactants and edetate disodium 0.05% and POLYQUAD® (polyquaternium-1) 0.0011% preservatives.
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: A laboratory study was conducted with OPTI-ONE® Multi-Purpose Solution. The purpose of the study was to evaluate passive cleaning using no rub regimen with soft contact lenses and its ability to clean laboratory deposited lenses.
Microbiology Studies: A study was conducted to evaluate the performance of OPTI-ONE® Multi-Purpose Disinfecting Solution in a regimen consisting of a 5 second rinse of lenses per side and soaking the lenses for 6 hours. No rubbing step or final rinse step was used. The results show that OPTI-ONE® Multi-Purpose Disinfecting Solution evaluated by the test regimen meets the FDA guidelines and the ISO 14729:2001 Regimen Test Requirements.
Clinical Study: A 90-day clinical study was conducted to demonstrate the safety and efficacy of OPTI-ONE* Multi-Purpose Solution using the modified directions for use. The control used in this study was Bausch & Lomb ReNu MultiPlus® Multi-Purpose Solution used according to its approved rub and rinse labeling. The efficacy of OPTI-ONE® Multi-Purpose Solution (modified directions for use) is clinically acceptable and similar to Bausch & Lomb ReNu MultiPlus * Multi-Purpose Solution used according to its approved label.
Biocompatibility Testing: OPTI-ONE Multi-Purpose Solution meets the guidelines set forth in FDA 's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products.
OPTI-ONE Multi-Purpose Solution remains unchanged from the previously approved product (P830034/S26) except for the labeling change revising the directions for use. The labeling changes require no new biocompatibility testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
P830034/S26
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
KO31193
510(K) SUMMARY
Submitted by:
JUL 0 3 2003
Kim B. Kracke Manager, Regulatory Affairs Alcon Research, Ltd. 6201 South Freeway Fort Worth, Texas 76134-2099 (817) 551-8338 (Phone) (817) 551-4630 (Fax)
Device Name:
Soft (Hydrophilic) Contact Lens Care Solution Common Name:
OPTI-ONE* Multi-Purpose Solution Proprietary Name:
Indications for Use:
For use in the daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
OPTI-ONE® Multi-Purpose Solution can also be used as the diluent for OPTI-ZYME® Enzymatic Cleaner.
1
Description:
OPTI-ONE® Multi-Purpose Solution is a sterile, buffered, isotonic, aqueous solution, containing borates, citrate, mannitol, and sodium chloride with Pationic® and Tetronic® surfactants and edetate disodium 0.05% and POLYQUAD® (polyquaternium-1) 0.0011% preservatives.
Substantial Equivalence:
OPTI-ONE * Multi-Purpose Solution is substantially equivalent in terms of its actions and indications for use to MULTI-PURPOSE SOLUTION ID NO. 81573, approved under P830034/S26 (OPTI-ONE) Multi-Purpose Solution).
OPTI-ONE* Multi-Purpose Solution meets the guidelines set forth in FDA's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products.
Safety and Effectiveness:
Cleaning Studies
A laboratory study was conducted with OPTI-ONE® Multi-Purpose Solution. The purpose of the study was to evaluate passive cleaning using no rub regimen with soft contact lenses and its ability to clean laboratory deposited lenses.
Microbiology Studies
A study was conducted to evaluate the performance of OPTI-ONE® Multi-Purpose Disinfecting Solution in a regimen consisting of a 5 second rinse of lenses per side and soaking the lenses for 6 hours. No rubbing step or final rinse step was used. The results show that OPTI-ONE® Multi-Purpose Disinfecting Solution evaluated by the test regimen meets the FDA guidelines and the ISO 14729:2001 Regimen Test Requirements.
2
Clinical Study
A 90-day clinical study was conducted to demonstrate the safety and efficacy of OPTI-ONE* Multi-Purpose Solution using the modified directions for use. The control used in this study was Bausch & Lomb ReNu MultiPlus® Multi-Purpose Solution used according to its approved rub and rinse labeling. The efficacy of OPTI-ONE® Multi-Purpose Solution (modified directions for use) is clinically acceptable and similar to Bausch & Lomb ReNu MultiPlus * Multi-Purpose Solution used according to its approved label
Biocompatibility Testing
OPTI-ONE Multi-Purpose Solution meets the guidelines set forth in FDA 's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products.
OPTI-ONE Multi-Purpose Solution remains unchanged from the previously approved product (P830034/S26) except for the labeling change revising the directions for use. The labeling changes require no new biocompatibility testing.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure. The symbol is composed of three curved lines that converge at the bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 03 2003
Alcon Research. Ltd. c/o Ms. Kim Kracke 6201 South Freeway Fort Worth, TX 76134-0450
Re: K031193
Trade/Device Name: OPTI-ONE® Multi-Purpose Solution (Modified Directions for Use) Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LPN Dated: April 14, 2003 Received: April 16, 2003
Dear Ms. Kracke:
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
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 (301) 594-4613. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Patipi forenthal
A. Ralph Rosenthal, M.D Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: OPTI-ONE Multi-Purpose Solution (modified directions for use)
Indications for Use:
For use in the daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
OPTI-ONE® Multi-Purpose Solution (modified directions for use) can also be as a d:luent for OPTI-ZYME® Enzymatic Cleaner.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sorrola
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K031193
Prescription Use______________________________________________________________________________________________________________________________________________________________
i
OR Over-The Counter Use X
(Per 21 CFR 801.109)