(126 days)
P860023/S12
P910075
No
The document describes a contact lens multi-purpose solution and its chemical composition and performance studies. There is no mention of AI or ML technology.
No
The device is a multi-purpose solution for contact lenses used for disinfection, cleaning, rinsing, protein removal, and storing contact lenses, which are functions related to device maintenance rather than directly treating a disease or condition.
No
Explanation: The device is a multi-purpose solution for cleaning, disinfecting, rinsing, and storing contact lenses. It does not perform any diagnostic function.
No
The device description clearly states it is a sterile, isotonic solution containing various chemical components, indicating it is a liquid product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the care and maintenance of soft contact lenses (cleaning, rinsing, disinfection, storage). This is a direct interaction with a medical device (the contact lens) and the user's body (the eye), not for testing a sample taken from the body to diagnose a condition.
- Device Description: The description lists the chemical components of a contact lens solution. These are designed to interact with the contact lens and the eye, not to perform a diagnostic test on a biological sample.
- 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.)
- Detecting or measuring specific analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
This device falls under the category of a medical device used for the care and maintenance of another medical device (contact lenses).
N/A
Intended Use / Indications for Use
COMPLETE® (and Private Label) brand Multi-Purpose Solution is indicated for use in the chemical (NOT HEAT) disinfection, cleaning, rinsing, protein removal and storing of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
Product codes
86 LPN
Device Description
COMPLETE® brand Multi-Purpose Solution is a sterile, isolonic solution containing hydroxypropyl methylcellulose as a lubricant, preserved with TrisChem™ (polyhexamethylene biguanide) 0.0001%, buffered with tromethamine, tyloxapol as a surfactant, ederate disodium as a chelating agent, sodium chloride, and purified water. COMPLETE® brand Multi-Purpose Disinfecting Solution contains no chlorhexidine or thimerosal.
Private label brand Multi-Purpose Solution is a sterile, isotonic solution containing purified water, sodium chloride, preserved with TrisChem™ (polyhexamethylene biguanide) 0.0001%, buffered with tromethamine, tyloxapol as a surfactant, and edetate disodium as a chefating agent. Private label brand Multi-Purpose Disinfecting Solution contains no chlorhexidine or thimerosal.
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)
Microbiological Studies:
- Both products meet the current FDA criteria for disinfection of contact lenses against .bacteria, yeast, and molds
- Both products are effectively preserved by FDA standards.
- Both products conform to USP sterility requirements.
Preclinical:
- These products are safe for use in cleaning, rinsing, chemical disinfection and up to 30 day storage of all soft contact lenses.
- COMPLETE® brand Multi-Purpose Solution and private label brand should not present an ocular hazard to the contact lens wearer when used as directed in the labeling for soft contact lenses.
Compatibility/Cleaning Efficacy:
- COMPLETE® brand Multi-Purpose Solution and private label brand Multi-Purpose Solution were demonstrated previously under P910075 to be compatible with all soft contact lenses and able to remove non-protein deposits from the surface of the contact lens.
- An additional study was performed that demonstrated the ability of COMPLETE® brand Multi-Purpose Disinfecting Solution and private label brand Multi-Purpose Solution to remove protein deposits on the contract lens surface and in the lens matrix during disinfection compared to Bausch & Lomb's ReNu@ MultiPlus Multi-Purpose Solution.
Clinical:
- COMPLETE® brand Multi-Purpose Solution and private label brand Multi-purpose Solution were proven clinically safe and effective under P910075 and are substantially equivalent to Bausch & Lomb's ReNu@ Multi-Plus Multi-Purpose Solution (P860023/S12).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
P860023/S12
Reference Device(s)
P910075
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
K 980775
Image /page/0/Picture/1 description: The image shows the date "JUL 6 1998" in bold, black font. The month is abbreviated to "JUL". The day is the number "6". The year is "1998". The text is clear and easy to read.
510(k) SUMMARY
Submitted by:
Paul J. Nowacki Manager, Regulatory Affairs Allergan, Inc. 2525 Dupont Drive P.O. Box 19534 Irvine, CA 92623-9534 (714) 246-6761 (Voice) (714) 246-5457 (Fax)
Device Name:
| Common Name: | Contact Lens Care Multi-Purpose Solution |
|---|---|
| Proprietary Name: | COMPLETE® brand Multi-Purpose Solution (8772X) |
| Private label brand Multi-Purpose Solution (8474X) |
Indications for Use:
COMPLETE® (and Private Label) brand Multi-Purpose Solution is indicated for use in the chemical (NOT HEAT) disinfection, cleaning, rinsing, protein removal and storing of soft (hydrophilic) contact lenses as recommended by your eye care practitioner
Description:
COMPLETE® brand Multi-Purpose Solution is a sterile, isolonic solution containing hydroxypropyl methylcellulose as a lubricant, preserved with TrisChem™ (polyhexamethylene biguanide) 0.0001%, buffered with tromethamine, tyloxapol as a surfactant, ederate disodium as a chelating agent, sodium chloride, and purified water. COMPLETE® brand Multi-Purpose Disinfecting Solution contains no chlorhexidine or thimerosal.
Private label brand Multi-Purpose Solution is a sterile, isotonic solution containing purified water, sodium chloride, preserved with TrisChem™ (polyhexamethylene biguanide) 0.0001%, buffered with tromethamine, tyloxapol as a surfactant, and edetate disodium as a chefating agent. Private label brand Multi-Purpose Disinfecting Solution contains no chlorhexidine or thimerosal.
Substantial Equivalence:
COMPLETE® brand Multi-Purpose Solution and private label brand Multi-Purpose Solution are identical to the products that were approved under P910075 and are substantially equivalent to Bausch & Lomb's ReNu@ Multi-Plus Multi-Purpose Solution (P860023/S12).
1
Non-Clinical Data A.
Microbiological Studies
COMPLETE® brand Multi-Purpose Solution and private label brand Multi-Purpose Solution were previous evaluated and approved under P910075.
- Both products meet the current FDA criteria for disinfection of contact lenses against . bacteria, yeast, and molds
- Both products are effectively preserved by FDA standards. .
- Both products conform to USP sterility requirements. .
Preclinical
COMPLETE® brand Multi-Purpose Solution and private label brand Multi-Purpose Solution were previously evaluated under P910075. These products are safe for use in cleaning, rinsing, chemical disinfection and up to 30 day storage of all soft contact lenses.
COMPLETE® brand Multi-Purpose Solution and private label brand should not present an ocular hazard to the contact lens wearer when used as directed in the labeling for soft contact lenses.
Compatibility/Cleaning Efficacy
COMPLETE® brand Multi-Purpose Solution and private label brand Multi-Purpose Solution were demonstrated previously under P910075 to be compatible with all soft contact lenses and able to remove non-protein deposits from the surface of the contact lens. An additional study was performed that demonstrated the ability of COMPLETE® brand Multi-Purpose Disinfecting Solution and private label brand Multi-Purpose Solution to remove protein deposits on the contract lens surface and in the lens matrix during disinfection compared to Bausch & Lomb's ReNu@ MultiPlus Multi-Purpose Solution ..
B. Clinical
COMPLETE® brand Multi-Purpose Solution and private label brand Multi-purpose Solution were proven clinically safe and effective under P910075 and are substantially equivalent to Bausch & Lomb's ReNu@ Multi-Plus Multi-Purpose Solution (P860023/S12).
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of three stylized human profiles facing right, arranged in a stacked formation. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 1998 JUL
Mr. Paul J. Nowacki Manager, Regulatory Affairs Allergan 2525 Dupont Drive P.O. Box 19534 Irvine, CA 92623-9534
Re: K980775
Trade Name: Complete ® brand Multi-Purpose Solution and Private Label brand Multi-Purpose Solution Regulatory Class: II Product Code: 86 LPN Dated: May 20, 1998 Received: May 21, 1998
Dear Mr. Nowacki:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
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Page 2 - Mr. Paul J. Nowacki
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marked 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on.the.promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) NUMBER: (IF KNOWN):
DEVICE NAME:
COMPLETE® brand Multi-Purpose Solution and
Private Label brand Multi-Purpose Solution
INDICATIONS FOR USE:
COMPLETE® (and Private Label) brand Multi-Purpose Solution is indicated for use in a COMPLE I Fivate Label prand Mulier droose ontalier an and and storing of
the chemical (NOT HEAT) disinfection, cleaning, protein removal and storing of
the chemical in the co the chemical (NOT HEAT) ulsimection, cleaning, Misling Provinces.
soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
(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
Over-The-Counter-Use (Optional Format 1-2-96)
(Division Sign-Off)
Division of Ophthalmic Devices
$10(k) Number K 980775