Proclear and Proclear Compatibles (omafilcon A) Soft Hydrophilic Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic and exhibit astigmatism of 2.00D or less that does not interfere with visual acuity. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).

Eyecare practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement.

Device Description

The Proclear and Proclear Compatibles contact lenses are available as a lathe cut spherical lens, and a molded spherical lens. The lens material (omafilcon A) is a copolymer of 2-hydroxyethy)methacrylate and 2methactyloyloxyethyl phosphorylcholine crosslinked with ethylenestycol dimethacrylate. The Proclear lens with visibility tint is timed blue using Reactive Blue Dye #4 to make the lens more visible for handling.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Device Performance Study (K974408)

The study aimed to demonstrate the safety and effectiveness of the Proclear (omafilcon A) Soft Contact Lenses in Defined Dry Eye patients, specifically those with Evaporative Tear Deficiency or Aqueous Tear Deficiency (non-Sjogren's only). The acceptance criteria were formulated around comparing the Proclear lens with control lenses.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Definition of Success for Proclear lens in dry eye subjects)	Reported Device Performance
A. Statistically significantly difference in the On-eye hydration relative to the Control lenses in Matched Pair Analysis.	Achieved: The data indicated that the Relative Dehydration for the Proclear lenses in Dry Eyes was consistently low as compared to that reported for the population of Control lenses in Dry Eyes (p=0.0001). The Matched Pair analysis confirms that the hydration retention characteristic of the Omafilcon A material in the Proclear lens is significantly more resistant to on-eye dehydration than the control lenses. See "Relative Dehydration at 6 Weeks (%)" in Table 1 for Proclear (Mean: 2.21-2.65%) vs. Control (Mean: 4.09-6.78%).
B. Achievement of a statistically significant increase in wearing time over baseline and/or the Control lens.	Achieved: The omafilcon A lenses had statistically significantly longer wearing times at each interval, determined using the Wilcoxon's Test for Matched Pairs.
C. Improvement or no significant difference in visual acuity; slit lamp findings; symptoms, problems, and complaints; or Adverse Reactions as compared to the performance of the Control lens in the same population.	Achieved (partially and with nuance): On the FDA defined comparative parameters, the omafilcon A lenses performed in an equivalent manner to the Control lenses except for the parameters of Wearing Time (which was an improvement for Proclear) and various Symptoms, Problems and Complaints (SPCs). Adverse reactions were minimal (one severe injection with a control lens, attributed to tight lens syndrome).
D. A significant difference in Signs and Symptoms relative to the Control lenses.	Achieved: A review of the data confirms this premise. Of greatest interest were the differences seen on the parameters of Comfort, Moistness of the Eye, and Frequency of Dry Eye Symptoms. The results for Comfort were further supported by differences in irritation, itchiness, burning, grittiness, watering, variation in eye sensations, and noticeability. Repeated Measures Analysis, Matched Pair Analysis, and Chi Squares Test all indicated significant differences in favor of Proclear for various comfort and dryness-related symptoms.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: 76 Dry Eye subjects.
Data Provenance: The study was a "prospective, randomized, controlled, crossover study" conducted to assess the performance of the Proclear lens. While the specific country of origin is not explicitly stated, the submitter's address is in Norfolk, VA, USA, suggesting the study was likely conducted in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts used to establish ground truth or their qualifications. The "ground truth" for this study appears to be derived from objective measurements (visual acuity, slit lamp findings, on-eye dehydration) and subjective patient self-evaluations (Visual Analogue Scale for symptoms, comfort, etc.) rather than expert consensus on imaging or diagnostic criteria.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method in the typical sense for diagnostic studies (e.g., 2+1 reader adjudication). The study design involved a crossover trial where subjects wore both Proclear and control lenses, and their responses (objective findings and subjective self-evaluations via Visual Analogue Scale) were compared. Statistical tests (paired Student's t-test, Wilcoxon's signed ranks test, Repeated Measures analysis, Chi Squares Test) were used to analyze the differences.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is testing the performance of a contact lens in human subjects directly, not the performance of AI in assisting human readers.

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

Yes, in a conceptual sense, the "device" (Proclear lens) was evaluated in a standalone manner relative to a control lens. There is no AI algorithm being tested here; it's a medical device (contact lens) performance study. The data analyzed reflected the direct impact and performance of wearing the Proclear lens compared to control lenses on various physiological and subjective parameters.

7. The Type of Ground Truth Used

The "ground truth" in this study is a combination of:

Objective Clinical Measurements: Visual acuity, slit lamp findings, and on-eye dehydration measurements.
Subjective Patient-Reported Outcomes: Self-evaluation of symptoms, problems, and complaints using a Visual Analogue Scale (VAS) for parameters like comfort, moistness, frequency of dryness, irritation, itchiness, etc.
Behavioral Data: Lens wearing time.

8. The Sample Size for the Training Set

This study evaluates a medical device (contact lens) directly in a clinical trial and does not involve a "training set" in the context of machine learning or AI. Therefore, this question is not applicable.

9. How the Ground Truth for the Training Set Was Established

As stated in point 8, this study does not involve a training set for machine learning or AI. This question is not applicable.

Summary

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K974408

SAFETY AND EFFECTIVENESS SUMMARY

1.	Name and address of submitter	Biocompatibles Eyecare Inc.1215 Boissevain AvenueNorfolk VA USA 23507Contact Person: Lisa HahnTelephone number: 800-225-3069 or 757-664-2421Date summary prepared: 4/1/98
2.	Identification of Device	Trade Name: Proclear and Proclear Compatibles (omafilcon A) Soft Contact LensCommon or Usual Name: Soft (hydrophilic) Contact Lens (daily wear)Classification: Group II
3.	Predicate Device	Proclear (omafilcon A) Contact Lens

4. Description of Device

5. Intended Use (indications)

Eyecare practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement.

62 Characteristics comparison of predicate to this device

Design, material, and chemical composition remain unchanged from those approved in Premarket 510(k) Notification's K952152, and K970095

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6b 1. Non Clinical tests and results

Not performed; lenses remain unchanged from approved Premarket 510(k) Notification's listed above.

6b 2. Clinical Tests

The Safety and Effectiveness of the Proclear (omafilcon A) Soft Contact Lenses in Defined Dry Eye patients is demonstrated by the clinical result summarized here.

Dry Eye patients have been categorized in the National Eye Institute/Industry Workshop on Clinical Trials in Dry Eyes, published in the CLAO Journal, October 1995, Vol. 21, No. 4.

This study was undertaken to assess the Proclear lens in Defined Dry Eye subjects, who have a dry eye condition arising from Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).

This prospective, randomized, controlled, crossover study was designed to assess the relative performance of the Proclear lens in 76 Dry Eye subjects as compared to their experience with which they entered the study. It also addresses differences in signs and symptoms, lens preference, comfort and duration of continuous daily lens wearing time.

In Phase 1, the baseline against which the performance of the lens (Control or Test) is measured is the pre-study entry data. In Phase II, the baseline against which the lens is measured is the crossover point in the study.

6b 3. Conclusions drawn from the studies

(Conclusions demonstrate device is safe, effective and performs as well as or hetter in the Defined population as in the population currently covered in the predicate approval)

、・・・・・・・・・・

Summary statistics are presented for selected variables. In the case of visual acuity and slit lamp findings, differences from baseline for each variable were calculated. These differences were compared pairwise between the Iens types worn in each phase of the crossover trial at the given visits. With other variables, the actual values were compared in a similar pairwise fashion. The paired Student's t-test or Wilcoxon's signed ranks test for matched pairs were applied to normally distributed data and non-normal data respectively. In addition in the statistical analysis of the data from the Visual Analogue Scale, the Repeated Measures analysis method was used.

Adverse Reactions

There was only one adverse reaction involving severe injection in one eye at two weeks, of a subject who was wearing a Control lens. The problem was attributed to tight lens syndrome. The subject was discontinued.

7. Conclusion

The differences noted between the experience of Proclear and Control lens wear, by study Phase, supports the premise that on entry to the clinical trial, an improvement over baseline measures is gained as a function of a change to fresh lenses. It also supports the magnitude of beneficial change is greater for the Proclear lens wearing subjects in Phase 1. On crossover, the premise was that the beneficial effect achieved through Proclear lens wear in Phase 1 might be diminished or lost by use of Control lenses in Phase 2. Conversely, the beneficial effect, gained from use of fresh Control lenses in Phase 1, were expected to be manifest in the early interval(s), but possibly erode thereafter. On crossover to Proclear use

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in Phase 2, any beneficial effect in Phase 1 was projected to be sustained or further enhanced. As discussed above, validity of this premise has been demonstrated.

Comparison of Proclear and Proclear Compatibles Performance in defined 8. Dry Eyes Vs. Normal, Eyes : 510(k) Reference K970095 FDA Tables 1-11

The Definition of success for the comparison to the performance of Proclear in a Normal Vs. Defined Dry Eye population is provided below:

Improvement or no significant difference in visual acuity; slit lamp findings; symptoms, problems, or Adverse Reactions as compared to the performance of the lens in the Normal eye population.

The Proclear and Proclear Compatibles lens performs in an equivalent manner in Normal and Dry Eyes except for the parameter of Average Wearing Time. However, the Proclear lens had a statistically significant greater Average Wearing Time in Dry Eyes (clinical relevance of this difference has not been established) than was reported for the Control lenses in the Dry Eye Population, as assessed in the Matched Pairs analysis.

9. Further basis for modification in indication for use to permit inclusion of Defined Dry Eye subjects

Resistance to On-eye Dehydration

The data indicated that the Relative Dehydration for the Proclear lenses in Dry Eyes was consistently low as compared to that reported for the population of Control lenses in Dry Eves p=0.0001. The Matched Pair analysis confirms that the hydration retention characteristic of the Omafilcon A material in the Proclear lens is significantly more resistant to on-eve dehydration than the control lenses in the study ranged in power from -9.00 to + 6.00 D, encompassing center thicknesses of 0.07 mm to 0.31 mm. Not every quarter diopter power was represented in the study, therefore individual patient on-eve dehydration response may vary. ...

Signs and Symptoms Analysis: Visual Analogue Scale Method Results

The Subjects were required to provide their Self-evaluation of Symptoms Problems and Complaints on a Visual Analogue Scale (VAS) at each post-fit interval. These data have been analyzed in three ways:

a. Graph of Mean Scores for the Proclear and Control Populations, as a function of study Phase

b. Frequency Distribution of Change from Baseline for the Proclear and Control populations, as a function of study Phase and the control of the control of the control of the control of the control of the contribution of the contribution of the contribution of the contribution of the contributio

c. Performance Comparison in Phase 1 and Effect of Phase 1 Lens Used on performance in Phase 2

PERFORMANCE OF THE OMAFILCON A LENS DEFINED DRY EYE SUBJECTS RELATIVE TO THE DEFINITION OF SUCCESS

Success for the Proclear lens in dry eye subjects was defined as the following:

A. A statistically significantly difference in the On-eye hydration relative to the Control lenses in Matched Pair Analysis.
This has been demonstrated in the analysis found above.

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B. Achievement of a statistically significant increase in wearing time over baseline and/or the Control lens.
The omafilcon A lenses had statistically significantly longer wearing times at each intervals, determined using the Wilcoxon's Test for Matched Pairs.
C. Improvement or no significant difference in visual acuity; slit lamp findings; symptoms, problems, and complaints; or Adverse Reactions as compared to the performance of the Control lens in the same population.
On the FDA defined comparative parameters, the omafilcon A lenses performed in an equivalent manner to the Control lenses except for the parameters of Wearing Time, as discussed above, and the various Symptoms, Problems and Complaints (SPCs). This difference is explored more fully in the Signs and ysis using the VAS method, as discussed in the Statistical Analysis section below.

D. A significant difference in Signs and Symptoms relative to the Control lenses.

A review of the data confirms that this premise is valid on each of the parameters. Of greatest interest are the differences seen on the parameters of Comfort, Moistness of the Frequency of Dry Eye Symptoms. The results for Comfort are further supported by the differences on the various parameters, which detail Comfort: irritation, itchiness, burning, grittiness, watering, variation in eye sensations throughout the day, and noticeability.

Statistical Analysis

Repeated Measures Analysis indicates significant differences in favor of Proclear at all intervals for the parameters of Lens Comfort. The elements of comfort were significantly better for the omafilcon A lenses in each study Phase as determined with the Repeated Measures Analysis for the Dry Eye population.

Matched Pair Analysis indicates significant differences in favor of omafilcon A lenses at all intervals for the parameter of Comfort, Moistness of Eye, Frequency of Dryness symptoms, Frequency of Itchiness symptoms, Frequency of Screness. Frequency of Scratchiness symptoms. Frequency of Grittiness symptoms, and Frequency of Light Sensitivity.

Chi Squares Test (Analysis of the Frequency Distribution of change from baseline) identified significant differences in favor of omafilcon A lens at each interval on the parameters of: Lens Comfort, Moistness of Eye, Frequency of Dryness Symptoms Noticeability (just noticeable/unbearable), Frequency of scratchiness, and Frequency of Itchiness.

Overall, the subjects wearing omafilcon A lenses reported improved lens performance to that reported for the Control lenses, with the differences in performance becoming more marked as the period of post-fit time increased. Graphs showing the performance of these subjective parameters were plotted for both the Proclear and the Control lenses. The graphs clearly depict the greater degree of improvement in performance of the Proclear Vs Control lenses in Dry Eyes. The frequency distribution of the change from baseline for each of these parameters further details the specific differences between the two populations.

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Image /page/4/Figure/1 description: The image is a graph comparing comfort scores between Phase 1 and Phase 2. The y-axis represents comfort scores from 0 to 10, labeled as 'Bad - Good'. The x-axis represents time points labeled as BL, 1w, 4w, and 6w/BL for Phase 1, and 1w, 4w, and 6w for Phase 2. There are four lines on the graph representing Phase 1 (Proclear), Phase 2 (Control), Phase 1 (Control), and Phase 2 (Proclear).

Image /page/4/Figure/2 description: The image is a graph titled "Frequency of Irritation Scores" and "Freq. of Irritation (Phase 1 vs Phase 2)". The y-axis is labeled "0-10 Never Constantly", and the x-axis is divided into two phases, Phase 1 and Phase 2, with labels BL, 1w, 4w, 6w/BL, 1w, 4w, and 6w. There are four lines on the graph, representing Phase 1 (Proclear), Phase 2 (Control), Phase 1 (Control), and Phase 2 (Proclear), showing the frequency of irritation scores for each phase.

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Image /page/5/Figure/1 description: This image is a line graph titled "Dryness/Moistness (Phase 1 vs Phase 2)". The y-axis is labeled "Dryness - Moistness" with a scale from 0-10. The x-axis represents two phases, with Phase 1 showing BL, 1w, 4w, and 6w/BL, and Phase 2 showing 1w, 4w, and 6w. There are four lines on the graph, representing Phase 1 - (Proclear), Phase 2 - (Control), Phase 1 - (Control), and Phase 2 - (Proclear).

Image /page/5/Figure/2 description: The image shows the title of a graph. The title is "Graph 4 Frequency that Eyes Feel Dry Scores".

Image /page/5/Figure/3 description: The image is a line graph titled "Freq. Eyes Feel Dry (Phase 1 vs Phase 2)". The y-axis is labeled "Never - Constantly 0-10", and the x-axis is labeled with time points such as BL, 1w, 4w, and 6w/BL for Phase 1 and 1w, 4w, and 6w for Phase 2. There are four lines on the graph, representing Phase 1 (Proclear), Phase 2 (Control), Phase 1 (Control), and Phase 2 (Proclear), showing the frequency of dry eyes over time for each condition.

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		Group 1		Group 2		Group 4
Material		Proclear	Control	Proclear	Control	Proclear	Control
Number of Eyes		28	23	8	6	42	44
Baseline Water	Mean	61.0	40.9	60.0	68.4	61.2	57.1
Content (%)	SD	1.07	6.45	1.07	7.36	0.94	6.73
Water Content	Mean	60.0	40.1	60.1	65.5	60.2	53.1
6 Weeks (%)	SD	1.56	7.15	1.48	5.86	1.63	6.65
Absolute differenceof Water Contentat6 Weeks (%)	MeanSD	1.361.54	1.801.61	1.631.22	2.921.69	1.49**1.58	3.993.81
RelativeDehydration at 6Weeks (%)	MeanSD	2.21**2.46	4.654.15	2.651.98	4.091.69	2.41**2.54	6.786.34

Water Content Results by Lens Material Type Table 1

The lenses in the study ranged in power from -9.00 to + 6.00 D, encompassing center thicknesses of 0.07 mm to 0.31 mm. Not every quarter diopter power was represented in the study, therefore individual patient on-eye dehydration response may vary.

. . . . . . . .

· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·

N.B. No measurements were completed for lenses from Group 3 due to insufficient lenses for statistical analysis ..

Asterisks indicate significant differences : * p ≤ 0.05, ** p ≤ 0.05, ** p ≤ 0.001

Control Lenses used in above Groups are:

Group 1 -Low water content (<50%), Nonionic

Group 2 -High water content (≥50%), Nonionic

Group 4 -High water content (≥50%), Ionic

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Image /page/7/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 6 1998

Ms. Lisa Hahn Director of Regulatory Affairs Biocompatibles Eyecare, Inc. 1215 Boissevain Avenue Norfolk, VA 23507

Re: K974408

Trade Name: Proclear and Proclear Compatibles (Omafilcon A ) Soft Contact Lenses for Daily Wear Regulatory Class: Class II Product Code: 86 LPL Dated: March 9, 1998 Received: March 10, 1998

Dear Ms. Hahn:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 devices 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- Ms. Lisa Hahn

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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 tollfree number (800) 638-2041 or at (301) 443-6597.

Sincerely yours,

Alvez L. 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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K974408 510(K) Number :

Device Name: Proclear and Proclear Compatibles(omafilcon A) Daily Wear Contact Lens

Indication for use:

Proclear or Proclear Compatibles :

(omafilcon A) Soft Hydrophilic Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic and exhibit astigmatism of 2.00D or less that does not interfere with visual acuity. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of the CDRH, Office of Device Evaluation (ODE)

SAetto

(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number_上974408

V Prescription Use _

Over the counter use _________________________________________________________________________________________________________________________________________________________

(Optional format 1-2-96)

Regulation Number and Section

§ 886.5925 Soft (hydrophilic) contact lens.

(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.