(143 days)
No
The summary describes a contact lens made of a specific material and its intended use for vision correction and comfort. There is no mention of AI or ML technology in the device description, intended use, or performance studies.
No
The device is a contact lens intended for correcting visual acuity in myopic or hyperopic individuals. While it may provide improved comfort for those experiencing mild discomfort or dryness, its primary function is visual correction, not the treatment or prevention of a disease beyond symptomatic relief of dryness.
No
The device is a contact lens used for vision correction and to improve comfort, not to diagnose a medical condition.
No
The device description clearly states it is a physical contact lens made of a specific material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that these are contact lenses designed to be worn on the eye for vision correction and comfort. They do not involve the analysis of biological samples like blood, urine, or tissue.
- The purpose of an IVD is to provide information about a physiological state, health, or disease. While these contact lenses address symptoms related to dryness, their primary function is vision correction and improving comfort during wear. They are not used to diagnose, monitor, or screen for diseases in the way an IVD would be.
The provided information describes a medical device intended for direct application to the body (the eye) for a therapeutic or diagnostic purpose (vision correction and comfort). This falls under the category of a medical device, but specifically not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
86 LPL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eyecare practitioners
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)
Clinical Tests:
This was a prospective, randomized, controlled, crossover study 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.
Conclusions:
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 in Phase 2, any beneficial effect in Phase 1 was projected to be sustained or further enhanced.
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.
Signs and Symptoms Analysis: Visual Analogue Scale Method Results:
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
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.
- 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 and the various Symptoms, Problems and Complaints (SPCs).
- 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, particularly Comfort, Moistness of the Frequency of Dry Eye Symptoms.
Statistical Analysis:
- Repeated Measures Analysis indicates significant differences in favor of Proclear at all intervals for the parameters of Lens Comfort.
- 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 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: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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).
Not Found
§ 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.
0
SAFETY AND EFFECTIVENESS SUMMARY
| 1. | Name and address of submitter | Biocompatibles Eyecare Inc.
1215 Boissevain Avenue
Norfolk VA USA 23507
Contact Person: Lisa Hahn
Telephone number: 800-225-3069 or 757-664-2421
Date summary prepared: 4/1/98 |
|----|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Identification of Device | Trade Name: Proclear and Proclear Compatibles (omafilcon A) Soft Contact Lens
Common or Usual Name: Soft (hydrophilic) Contact Lens (daily wear)
Classification: Group II |
| 3. | Predicate Device | Proclear (omafilcon A) Contact Lens |
4. Description of Device
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.
5. Intended Use (indications)
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.
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
1
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
2
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.
3
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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.
4
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.
5
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.
6
| 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 difference | |||||||
| of Water Content | |||||||
| at | |||||||
| 6 Weeks (%) | Mean | ||||||
| SD | 1.36 | ||||||
| 1.54 | 1.80 | ||||||
| 1.61 | 1.63 | ||||||
| 1.22 | 2.92 | ||||||
| 1.69 | 1.49** | ||||||
| 1.58 | 3.99 | ||||||
| 3.81 | |||||||
| Relative | |||||||
| Dehydration at 6 | |||||||
| Weeks (%) | Mean | ||||||
| SD | 2.21** | ||||||
| 2.46 | 4.65 | ||||||
| 4.15 | 2.65 | ||||||
| 1.98 | 4.09 | ||||||
| 1.69 | 2.41** | ||||||
| 2.54 | 6.78 | ||||||
| 6.34 |
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.
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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 (