(84 days)
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No
The device is a contact lens cleaning solution, and the description focuses on its chemical composition and performance in in-vitro and clinical studies related to lens cleaning and comfort. There is no mention of AI or ML.
No.
The device is a multi-purpose solution for cleaning, disinfecting, and storing contact lenses, which are care functions, not therapeutic ones.
No
This device is a multi-purpose solution for the care of soft contact lenses, performing functions like cleaning, disinfecting, rinsing, storing, removing protein, and conditioning. It does not diagnose any condition or disease.
No
The device description clearly states it is a sterile, isotonic, buffered solution containing various chemical components, indicating it is a liquid chemical product, 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 the care of soft contact lenses (cleaning, disinfecting, rinsing, storing, etc.). This is a direct interaction with a medical device (contact lens) and not a diagnostic test performed on a biological sample to determine a medical condition.
- Device Description: The description details the chemical composition of a solution for contact lens care. It does not describe a device or reagent used to analyze biological samples.
- Performance Studies: The performance studies focus on the physical and chemical properties of the solution and its effect on contact lenses and user comfort. They do not involve the analysis of biological samples for diagnostic purposes.
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 product does not fit that description.
N/A
Intended Use / Indications for Use
COMPLETE® brand Multi-Purpose Solution is indicated for the care of soft (hydrophilic) contact lenses. Use this product, as recommended by your eye care practitioner, to: Chemically (NOT HEAT) Disinfect . Clean ● Rinse . Store ● Remove Protein ● Condition .
Product codes (comma separated list FDA assigned to the subject device)
LPN
Device Description
COMPLETE® brand MULTI-PURPOSE Solution is a sterile, isotonic, buffered, solution containing hydroxypropyl methylcellulose as a lubricant, preserved with polyhexamethylene biguanide 0.0001%, a phosphate buffer, Poloxamer 237 as a surfactant, edetate disodium as a chelating agent, sodium chloride, potassium chloride, and purified water. COMPLETE® brand MULTI-PURPOSE Solution contains no chlorhexidine or thimerosal.
The product is a clear, colorless solution packaged in plastic bottles with controlled dropper tips.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical: In Vitro Studies were conducted to compare the physical and chemical properties of COMPLETE® Solution with other multi-purpose solutions in order to evaluate the effects of adding hydroxypropyl methylcellulose (HPMC). They were as follows:
- Compare viscosity of COMPLETE® Solution with HPMC to COMPLETE® . without HPMC, and to other multipurpose solutions.
- Investigate the uptake of HPMC onto the lens surface during the soak . period, and its subsequent release, over time, in a saline solution.
- . Compare the effect of three COMPLETE® Solution formulations to B&L's ReNu® MultiPlus® and Alcon's OPTI-FREE® Express on surface fluid retention.
- Examine the effect of various multipurpose solutions on receding contact . angle as a measure of wetting.
The studies show uptake of HPMC onto the lens surface during the soak period, and its subsequent release, over time, in saline. This laver of adsorbed HPMC appears to enhance the lens' ability to retain moisture and remain more wettable.
Clinical: Study subjects in three clinical studies received questionnaires asking them to rate the comfort and acceptability of two COMPLETE® formulations with hydroxypropyl methylcellulose (HPMC) demulcent/lubricant, vs. original COMPLETE® without HPMC and other Advanced Medical Optics and competitor regimens. This subjective data shows that COMPLETE® Solution, used with a rub regimen, has comfort substantially equivalent to other marketed contact lens care multipurpose solutions. Objective data from an additional clinical study demonstrate the substantial equivalence of COMPLETE® Solution used in a "no-rub" regimen, with COMPLETE® Solution used in a "rub" regimen.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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.”
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Image /page/0/Picture/1 description: The image shows the logo for AMO, which stands for Advanced Medical Optics. The logo features a stylized letter "A" with a curved line above the letters "AMO". Below the letters is the text "ADVANCED MEDICAL OPTICS" in a smaller font. The logo is simple and professional, and it is likely used to represent the company's brand.
APR 0 4 2003
510(k) SUMMARY COMPLETE® brand Multi-Purpose Solution
This summary uses the format provided in 21 CFR 807.92:
- Paul J. Nowacki Submitter: (a)(1) Manager Regulatory Affairs Advanced Medical Optics, Inc. 1700 E. St. Andrew Place P.O. Box 25162 Santa Ana, CA 92799-5162 Phone: (714) 247-8601 Fax: (714) 247-8677 Summary Prepared: December 16, 2002 (a)(2) Device Trade Name: COMPLETE® brand Multi-Purpose Solution
- Soft (Hydrophilic) Contact Lens Solution Device Common Name:
Device Classification Names: Accessories to Contact Lens Solution (86LPN)
- (a)(3) Identification of Predicate Device: COMPLETE® brand Multi-Purpose Solution is substantially equivalent to other contact lens care multi-purpose solutions.
- (a)(4) Device Description: COMPLETE® brand MULTI-PURPOSE Solution is a sterile, isotonic, buffered, solution containing hydroxypropyl methylcellulose as a lubricant, preserved with polyhexamethylene biguanide 0.0001%, a phosphate buffer, Poloxamer 237 as a surfactant, edetate disodium as a chelating agent, sodium chloride, potassium chloride, and purified water. COMPLETE® brand MULTI-PURPOSE Solution contains no chlorhexidine or thimerosal.
The product is a clear, colorless solution packaged in plastic bottles with controlled dropper tips.
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.. ..
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- Intended Use (Indications for Use): COMPLETE® brand Multi-Purpose (a)(5) Solution is indicated for the care of soft (hydrophilic) contact lenses. Use this product, as recommended by your eye care practitioner, to:
- Chemically (NOT HEAT) Disinfect .
- Clean ●
- Rinse .
- Store
- Remove Protein .
- Condition .
- Comparison of Technological Characteristics: No changes have been (a)(6) made to the product formulation subject to this application.
Discussion of Nonclinical: (b)(1)
In Vitro Studies were conducted to compare the physical and chemical properties of COMPLETE® Solution with other multi-purpose solutions in order to evaluate the effects of adding hydroxypropyl methylcellulose (HPMC). They were as follows:
- Compare viscosity of COMPLETE® Solution with HPMC to COMPLETE® . without HPMC, and to other multipurpose solutions.
- Investigate the uptake of HPMC onto the lens surface during the soak . period, and its subsequent release, over time, in a saline solution.
- . Compare the effect of three COMPLETE® Solution formulations to B&L's ReNu® MultiPlus® and Alcon's OPTI-FREE® Express on surface fluid retention.
- Examine the effect of various multipurpose solutions on receding contact . angle as a measure of wetting.
The studies show uptake of HPMC onto the lens surface during the soak period, and its subsequent release, over time, in saline. This laver of adsorbed HPMC appears to enhance the lens' ability to retain moisture and remain more wettable.
2
Discussion of Clinical Data: (b)(2)
Study subjects in three clinical studies received questionnaires asking them to rate the comfort and acceptability of two COMPLETE® formulations with hydroxypropyl methylcellulose (HPMC) demulcent/lubricant, vs. original COMPLETE® without HPMC and other Advanced Medical Optics and competitor regimens. This subjective data shows that COMPLETE® Solution, used with a rub regimen, has comfort substantially equivalent to other marketed contact lens care multipurpose solutions.
Objective data from an additional clinical study demonstrate the substantial equivalence of COMPLETE® Solution used in a "no-rub" regimen, with COMPLETE® Solution used in a "rub" regimen.
- Conclusions Drawn from Data Supporting Equivalence Determination: (b)(3) In view of the in vitro and clinical studies supporting this application, we believe the safety, efficacy and comfort of COMPLETE® brand Multi-Purpose Solution is substantially equivalent to other marketed contact lens care multipurpose solutions.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Advanced Medical Optics c/o Paul J. Nowacki Manager, Regulatory Affairs 1700 E. St. Andrew Place P.O. Box 25162 Santa Ana, CA 97299-5162
Re: K030092 Trade/Device Name: COMPLETE® brand Multi-Purpose Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LPN Dated: January 10, 2003 Received: January 10, 2003
Dear Mr. Nowacki:
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.
APR 0 4 2003
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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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 vours,
A. Palgi Rosenthal
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
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510(k) NUMBER: (IF KNOWN):
K030092
DEVICE NAME:
COMPLETE® brand Multi-Purpose Solution
INDICATIONS FOR USE:
COMPLETE® brand Multi-Purpose Solution is indicated for the care of soft (hydrophilic) contact lenses. Use this product, as recommended by your eye care practitioner, to:
- Chemically (NOT HEAT) Disinfect .
- Clean ●
- Rinse .
- Store ●
- Remove Protein ●
- Condition .
Mirafratt
on Sign-C lean of Ophthalmic Ear, ୍ୟ and Throat Devises
Number K030092
(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 | X |
|---|---|
| (Optional Format 1-2-96) |
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