COMPLETE® 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.

Device Description

COMPLETE® brand Multi-Purpose Solution is a sterile, isotonic, buffered, preserved solution. This aqueous formulation includes purified water, sodium chloride, hydroxypropyl methylcellulose as a lubricant, preserved with polyhexamethylene biguanide 0.0001%, Poloxamer 237 as a surfactant, a phosphate buffer, and edetate disodium as a chelating agent. This preparation contains no chlorhexidine, no thimerosal and no other mercury containing ingredients. Both current and reformulated products are clear, colorless solutions packaged in plastic bottles with controlled dropper tips.

AI/ML Overview

The provided document is a 510(k) summary for a contact lens solution, not an AI device. Therefore, many of the requested criteria, such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only) performance," "sample size for the training set," and "number of experts used to establish the ground truth," are not applicable.

However, I can extract the relevant acceptance criteria and study information for the COMPLETE® brand Multi-Purpose Solution (Revised) as presented in the document.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Solution Compatibility & Cleaning Effectiveness	Product is compatible with and an effective cleaner for all soft (hydrophilic) contact lenses.
Critical Micelle Concentration of Poloxamer 237	Aggregation concentration range reached at a concentration >0.01% (well below product amount). Surface tension ~45 dynes/cm (in range of current and competitor products).
Passive Protein Cleaning	Both current and proposed COMPLETE® formulation have significantly (2.8 times) better passive protein cleaning ability than the competitive product (compared to a competitive product).
Microbiological Efficacy (Disinfection)	Meets current FDA requirements for disinfection against bacteria, yeast, and mold.
Microbiological Efficacy (Preservative Effectiveness)	Meets USP Modified criteria for Preservative Effectiveness Testing.
Microbiological Efficacy (Sterility)	Meets USP Sterility test requirements.
Cytotoxicity	New formulation compares favorably with the old formulation.
Sensitization	No dermal reactions observed in either test or control groups; comparable to marketed formulation.
Acute Oral Toxicity	Caused no adverse effects when administered to rats at a single oral dose.
28-Day Ocular Safety Study	All animals remained healthy with no clinically significant ocular discomfort or conjunctival irritation.
Stability	Accelerated testing predicts stability for at least 24 months.
Clinical Safety (Adverse Device Effects)	No adverse device effects reported during the study.
Clinical Safety (Slit Lamp Findings)	No statistically significant differences in the number of examinations with clinically significant slit lamp findings.
Clinical Safety (Maximum Severity Grades)	Statistically significant differences in maximum severity grades for injection and tarsal anomaly, with more severe findings in the COMPLETE® MPS group than in the Investigational MPS group (Note: This refers to the predicate, not the new investigational product).
Clinical Safety (Refraction, VA, Keratometry, Mire Distortion)	Incidence of clinically significant changes was similar for both groups, no findings directly attributed to study regimens.
Clinical Acceptability (Discomfort Symptoms)	Statistically significant difference with higher maximum severity score for discomfort in the Investigational MPS group (Note: this is the new product). However, overall incidence was low, and severe symptoms not regimen related (not clinically relevant). No statistically significant difference in examinations with clinically significant ocular symptoms of discomfort.
Clinical Acceptability (Average Lens Comfort Scores)	No statistically significant difference between Investigational MPS and COMPLETE® MPS.
Clinical Acceptability (Lens Wearing Time)	No statistically significant difference between Investigational MPS and COMPLETE® MPS.
Clinical Acceptability (Lens Cleanliness - Investigator Analysis)	No statistically significant difference between the groups.
Clinical Acceptability (Lens Discoloration)	Low incidence of discoloration for untinted lenses in both groups; no discoloration of tinted lenses.
Clinical Acceptability (Lens Fit & Replacement)	Lens fit well-maintained; unscheduled replacement similar between groups.

Study Details (Non-Clinical and Clinical)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Non-Clinical Studies: No specific sample sizes for each non-clinical test (e.g., solution compatibility, protein cleaning, microbiological, toxicology) are provided, only the results. The data provenance is not explicitly stated beyond "The product was tested with the same protocol used to test the prior (substantially equivalent) formulation."
Clinical Study:
- Total Subjects Enrolled: 124 subjects
- Investigational MPS Group: 62 subjects (60 evaluable after disqualifications)
- COMPLETE® MPS Group (Predicate): 62 subjects (all evaluable)
- Data Provenance: Not specified (e.g., country of origin). A clinical study implies prospective data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Non-Clinical: Not applicable in the context of expert consensus for ground truth as these are lab-based tests.
Clinical: The clinical study involved "Six clinical investigators," but their specific qualifications or their role in establishing "ground truth" (beyond conducting the study and evaluating subjects) are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable as this is a clinical trial for a contact lens solution, not an imaging device requiring expert adjudication for ground truth. The "adjudication" in this context would be the assessment of individual investigators.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm. The device itself (contact lens solution) is "standalone" in its function, but this term typically refers to AI performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Non-Clinical:
- Solution Compatibility & Cleaning, Protein Cleaning: Lab-based quantitative measurements of cleaning efficacy.
- Microbiological Studies: Adherence to established FDA guidelines (FDA's Premarket Notification [510(k)] Guidance Document for Contact Lens Care Products, USP Modified criteria).
- Toxicology: Observation of biological responses in animal models and in vitro tests (cytotoxicity, sensitization, oral toxicity, ocular safety).
- Stability: Accelerated aging tests to predict shelf-life.
Clinical:
- Safety Data: Clinical observations and measurements by investigators (slit lamp findings, visual acuity, refraction, keratometry, mire distortion) and reported adverse events.
- Acceptability Data: Clinical observations and measurements by investigators (lens cleanliness, fit, discoloration, wearing time) and subjective symptom reporting by subjects (comfort, discomfort).

8. The sample size for the training set

Not applicable as this is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable as this is not an AI algorithm.

Summary

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K9811 510(k) SUMMARY

COMPLETE® brand Multi-Purpose Solution

This summary formatted as directed by 21 CFR 807 92:

Submitter: (a)(1)

Paul J. Nowacki Manager Regulatory Affairs Allergan 2525 Dupont Drive Irvine CA 92612

Phone: (714) 246-6761 (714) 246-5457 Fax:

Summary Prepared:

COMPLETE® brand Multi-Purpose Solution ( Revise ) Device Trade Name: (a)(2) Soft (Hydrophilic) Contact Lens Solution Device Common Name:
June 30, 1998

Device Classification Names:

Contact Lens Solution (86LPM)

Identification of Predicate Device: COMPLETE® brand Multi-Purpose (a)(3) Solution is substantially equivalent to the formulations of this product marketed now and to other contact lens multi-purpose solutions.
Device Description: COMPLETE® brand Multi-Purpose Solution is a sterile, (a)(4) isotonic, buffered, preserved solution. This aqueous formulation includes purified water, sodium chloride, hydroxypropyl methylcellulose as a lubricant, preserved with polyhexamethylene biguanide 0.0001%, Poloxamer 237 as a surfactant, a phosphate buffer, and edetate disodium as a chelating agent. This preparation contains no chlorhexidine, no thimerosal and no other mercury containing ingredients.

Both current and reformulated products are clear, colorless solutions packaged in plastic bottles with controlled dropper tips.

Intended Use: COMPLETE® brand Multi-Purpose Solution is indicated for (a)(5) 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.
Except for protein removal, these uses are identical to the predicate, currently marketed products.
Comparison of Technological Characteristics: The technological (a)(6) characteristics of the new formulation remain essentially the same as the current product.

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Discussion of Nonclinical: (b)(1)

Solution Compatibility and Cleaning Effectiveness: The product was tested with the same protocol used to test the prior (substantially equivalent) formulation. Results show that the product is compatible with, and an effective cleaner for, all soft (hydrophilic) contact lenses.

Critical Micelle Concentration of Poloxamer 237: Using data provided by the manufacturer of this surfactant, we show that the aggregation concentration range (pseudo critical micelle concentration) of this surfactant is reached at a concentration >0.01% which is well below the amount found in our product. Surface tension of our product is approximately 45 dynes/cm, which is in the same range as the current and competitor multi-purpose solutions.

Passive Protein Cleaning: We compared the ability of four formulations/products to passively remove lysozyme protein adsorbed to contact lens surfaces and within the lens matrix. The results of the study show that both current and proposed COMPLETE® formulation have significantly (2.8 times) better passive protein cleaning ability than the competitive product.

Microbiological Studies The product was evaluated for microbiological efficacy using studies outlined in FDA's Premarket Notification [510(k)] Guidance Document for Contact Lens Care Products, issued May 1, 1997.

The product meets current FDA requirements for disinfection of contact . lenses against bacteria, yeast and mold.
The product meets the USP Modified criteria for Preservative . Effectiveness Testing.
The product meets USP Sterility test requirements. .

Toxicology Product safety was evaluated using the following tests:

Cytotoxicity: The new formulation compares favorably with the old . formulation.
Sensitization: No dermal reactions were observed in either test or control groups. The new formulation is comparable to the marketed formulation.
. Acute Oral Toxicity: The product caused no adverse effects when administered to rats at a single oral dose.
. 28-Day Ocular Safety Study: All animals remained healthy throughout the test with no clinically significant ocular discomfort or conjunctival irritation.

Stability: Accelerated testing predicts that the product will remain stable for at least 24 months.

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510(k) SUMMARY COMPLETE® brand Multi-Pupose Solution June 30, 1998 Page 3 of 4

(b)(2) Discussion of Clinical Data:

Six clinical investigators enrolled a total of 124 subjects, of whom 62 were assigned to the Investgational MPS group and 62 to the COMPLETE® MPS group. Two subjects in the Investigational MPS group were disqualified, leaving 60 evaluable subjects in the Investigational MPS group and 62 evaluable subjects inthe COMPLETE® MPS group. Of these:

90.3% (56/62) in the Investigational MPS group and 90.3% (56/62) in the COMPLETE® MPS group completed the study.
No subjects in the investigational MPS group and 4.8% (3/62) in the COMPLETE® MPS group were discontinued for non-regimen related reasons.
1.6% (1/62) in the Investigational MPS group and 1.6% (1/62) in the COMPLETE® MPS group were discontinued for findings of uncertain etiology.
4.8% (3/62) in the investigational MPS group and 3.2% (2/62) in the COMPLETE® MPS group were discontinued for regimen related reasons.

Safety:

No adverse device effects were reported during this study. .
. There were no staistically significant differences in the number of examinations with clinically significant slit lamp findings.
There were statisfically significant differences between the Investigational MPS and COMPLETE® MPS groups in the maximum severity grades for injection and tarsa anomaly, with more severe findings in the COMPLETE® MPS group than in the Investigational MPS group.
. The incidence of chically significant changes in subjective spherical refraction, best-comected visual acuity, keratometry, and mire distortion was similar for both the Investigational MPS and COMPLETE® MPS groups, with no findings drectly attributed to the study regimens.

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510(k) SUMMARY COMPLETE® brand Multi-Purpose Solution June 30, 1998 Page 4 of 4

Discussion of Clinical Data (continued): (b)(2)

Acceptability:

There was a statistically significant difference between the Investigational . MPS and COMPLETE® MPS groups with higher maximum severity score for symptoms of discomfort in the Investigational MPS group. The overall incidence of these selected symptoms were low. The severe symptoms reported were not regimen related and therefore not clinically relevant to the performance of the investigational regimen. There was no statistically significant difference between the Investigational MPS and COMPLETE® MPS groups in the number of examinations with clinically significant ocular symptoms of discomfort.
There was no statistically significant difference between the Investigational . MPS and COMPLETE® MPS for average lens comfort scores
There was no statistically significant difference between the Investigational . MPS and COMPLETE® MPS for lens wearing time
There was no statistically significant difference between the groups in . investigators' analysis of lens cleanliness.
The incidence of lens discoloration of untinted lenses was low in both . groups, and no lens discoloration or atypical tint of tinted lenses was reported in either group.
Lens fit was well-maintained in both groups throughout the study, and . unscheduled replacement of lenses was similar between the groups.
Conclusions Drawn from Data Supporting Equivalence Determination: (b)(3) It is concluded that the safety, efficacy and performance of the investigational COMPLETE® brand Multi-Purpose Solution formulation is substantially equivalent to formulations of these products currently on the market.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized image of an eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 1998

Mr. Paul J. Nowacki Manager, Regulatory Affairs Allergan 2525 Dupont Drive, P.O. Box 19534 Irvine, CA 92623-9534

Re: K981168 Trade Name: COMPLETE ® brand Multi-Purpose Solution (Revised) Regulatory Class: II Product Code: 86 LPN Dated: July 1, 1998 Received: July 2, 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 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 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

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510(k) NUMBER: (IF KNOWN):

K981168

DEVICE NAME:

COMPLETE® brand Multi-Purpose Solution

INDICATIONS FOR USE:

(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 ﮈ (Optional Format 1-2-96)

E
Division Sign Off

Division Sign-Off) Division of Ophthalmic Devices 510(k) Number

Regulation Number and Section

§ 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.”