(57 days)
The Igel®56 UV (hefilcon C) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism, for the spherical lens up to 1.50 diopters that does not interfere with visual acuity, and for the toric lens up to 7.00 diopters) in not-aphakic persons with non-diseased eyes. The lens may be disinfected using chemical disinfecting systems only.
The Igel® 56 UV (hefilcon C) soft (hydrophilic) contact lens is a hemispherical, flexible transparent shell of the following dimensions: Chord diameter: 14.2mm Center thickness: 0.09mm (at-3.00 D) Optic Zone: variable optic zone with power Base Curve: 8.60mm Power : -0.50D to -8.00D (in 0.25D steps); -8.50D to -12.00D (in 0.50D steps); +0.50D to +6.00D (in 0.25D steps). The lens material (hefilcon C) is a copolymer of 2 hydroxethylmethacrylate and N-Vinyl pyrrolidone, and contains a UV absorbing compound. The blue tinted lens also contains D&C Green #6. When fully hydrated, the lens is 56% water by weight.
The provided text describes the Igel® 56 UV (hefilcon C) Soft (hydrophilic) Contact Lens and its clinical study for substantial equivalence to other marketed lenses. However, it does not explicitly state "acceptance criteria" in a tabulated format with corresponding "reported device performance" as requested in point 1. The document primarily focuses on establishing substantial equivalence based on safety and efficacy, assessed through the absence of adverse reactions, improvement/maintenance of slit lamp findings, resolution of symptoms, and maintenance of visual acuity and lens cleanliness.
Here's an attempt to extract and infer the closest information to
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from clinical findings) | Reported Device Performance |
|---|---|
| Safety: | |
| - Absence of unanticipated adverse device effects | - "There were no adverse events during this study." |
| - Slit lamp findings not worsening significantly (e.g., no findings greater than Grade 2) | - "The Trend Analysis Profile showed no reports of positive slit lamp findings greater than Grade 2."- Initial "No Findings" (51.4%) increased to "No Findings" (58.6%).- Neovascular decreased from 18.9% to 11.4%.- Tarsal decreased from 48.6% to 40.0%. |
| - Resolution or non-worsening of symptoms, problems, and complaints (e.g., lens awareness, handling, reading problems) | - "Symptoms, problems and complaints were reported by the investigators at each visit."- "NONE" (62.6%). Other reported: "Lens Awareness" (14.5%), "Handling Problems" (8.4%), "Reading Problems" (7.9%). The document implies these were not considered disqualifying for substantial equivalence. "The 'other' symptoms were dryness (reported by 2 subjects); torn lenses reported by 1 subject." |
| - Low discontinuation rate | - "Throughout the study, 2 subjects (5.4%) were discontinued." (Implied acceptable for substantial equivalence). |
| Efficacy: | |
| - Maintenance of visual acuity (within 1 line of initial best corrected acuity, where appropriate) | - "All but 2 eyes had a final visual acuity within 1 line of the initial best corrected acuity. The appropriate acuity was achieved by all eyes, since those two eyes were in subjects fit for monovision." |
| - Acceptable wear time | - "Wear time remained essentially unchanged over the one month of the study, indicating continuing comfort and cleanliness with the investigational solution." |
| - Good lens cleanliness (e.g. clinically clean) | - "91% of test lenses were clinically clean during the study. (Rudko grades I and II are considered clinically clean.)" |
2. Sample size used for the test set and the data provenance:
- Sample Size: 37 subjects. 35 (94.6%) completed 1 month of wear.
- Data Provenance: The study was conducted from July 11, 1997, to August 19, 1997. The location is not explicitly stated, but the submission is from "Igel Vision Care PTE, Ltd, Singapore" with an agent in Chicago, IL, USA. This suggests a prospective clinical trial, although the specific country of origin of the subjects is not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: The study involved two (2) investigators.
- Qualifications of experts: The document does not specify their exact qualifications (e.g., "radiologist with 10 years of experience"). However, being "investigators" in a clinical trial for contact lenses implies they are qualified eye care professionals (e.g., optometrists, ophthalmologists) capable of conducting such assessments, measuring visual acuity, and interpreting slit lamp findings.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not specify an adjudication method for the test set. Findings and symptoms were "reported by the investigators at each visit." It appears the assessments were made by the two investigators, but there's no mention of a consensus or arbitration process if their findings differed.
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:
- No, an MRMC comparative effectiveness study was not done. This study is a clinical trial assessing the safety and efficacy of a contact lens for daily wear, not an AI-assisted diagnostic device. The document does not mention any AI component or human reader assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone (algorithm only) performance study was not done. The device in question is a contact lens, which is physically worn by humans, and its performance is assessed through clinical observations by human investigators. There is no algorithm involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the safety and efficacy assessments was based on clinical observations and measurements by investigators, including:
- Slit lamp findings (presence/absence and grade of conditions like edema, neovascularization, staining, injection, tarsal, etc.)
- Patient-reported symptoms, problems, and complaints (lens awareness, handling, reading issues, dryness, torn lenses)
- Visual acuity measurements
- Wear time
- Lens cleanliness scores (modified Rudko classification)
- Adverse reaction reports.
- This can be categorized as expert clinical assessment and patient-reported outcomes data.
8. The sample size for the training set:
- The document describes a clinical trial for the new device, not a machine learning model. Therefore, there is no "training set" in the context of an algorithm. The clinical trial data (37 subjects) serves as the basis for demonstrating substantial equivalence.
9. How the ground truth for the training set was established:
- As there is no training set for a machine learning model, this question is not applicable. The clinical study's "ground truth" (as described in point 7) was established through the professional assessments and observations of the two clinical investigators during the 4-week trial.
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984523 510(k) SUMMARY FOR FREEDOM OF INFORMATION, K984523 IGEL® 56 UV (hefilcon C) SOPT (hydrophilic) CONTACT LENS FOR DAILY WEAR NOTE: This summary is identical to that provided for K974837, except for the name change, the inclusion of the UV absorbing compound in the material description, and the inclusion of the UV transmittance in the physical properties. Labeling changes include the name change and the inclusion of the appropriate UV transmittance graphs and warnings. Igel Vision Care PTE, Ltd l. Submitted by: 139 Joo Seng Road, #06-01 ATD Centre Singapore 368362 John M. Szabocsik, Ph.D. Contact : Official agent Szabocsik and Associates 203 N. Wabash, Ste 1200 Chicago, IL 60601 (312) 553-0828 February 9, 1999 2. Date prepared: 3. Device: Igel® 56 UV (hefilcon C) Soft (hydrophilic) Common Name Contact Lens Igel® 56 UV (hefilcon C) Soft (hydrophilic) Trade Name Contact Lens Class II (Performance Standards) 4. Classification 21 CFR 886.5925 Soft (hydrophilic) contact lens This product is substantially 5. Substantial equivalent to other currently marketed equivalence hefilcon lenses, such as Gold Medalist Toric lenses 6. Device The Igel® 56 UV (hefilcon C) soft (hydrophilic) contact lens is a description hemispherical, flexible transparent shell of the following dimensions: Chord diameter: 14.2mm Center thickness: 0.09mm (at-3.00 D) Optic Zone: variable optic zone with power Base Curve: 8.60mm Power : -0.50D to -8.00D (in 0.25D steps); -8.50D to
-12.00D (in 0.50D steps); +0.50D to +6.00D (in 0.25D steps)
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The lens material (hefilcon C) is a copolymer of 2 hydroxethylmethacrylate and N-Vinyl pyrrolidone, and contains a UV absorbing compound. The blue tinted lens also contains D&C Green #6. When fully hydrated, the lens is 56% water by weight.
- The Igel® 56 UV (hefilcon C) Soft 7. Intended use (hydrophilic) Contact Lens for Daily Wear is available as a spherical lens for the correction of near-sightedness (myopia) and farsightedness (hyperopia). A toric version of the same lens is able to correct for astiqmatism from 0.50D to 7.00D.
-
- Comparison to predicate devices: see following table
SUBSTANTIAL EQUIVALENCE
| Material | Igel® 56 UVhefilcon C | Gold Medalist™ Torichefilcon C |
|---|---|---|
| Description | random copolymer of2-hydroxyethylmethacrylate and N-vinyl-2-pyrrolidone | random copolymer of2-hydroxyethylmethacrylate and N-vinyl-pyrrolidone |
| Water Content | 56% in bufferedsaline | 57% in normal saline |
| SpecificGravity | 1.16 | 1.1 |
| RefractiveIndex | 1.41 (hydrated) | 1.41 |
| LightTransmittance(visible) | 94.5% (clear)90.3% (blue handlingtint) | at least 90% |
| UVTransmittance | <10% (-7.00D,thinnest lens) | not applicable |
| Oxygenpermeability | 21x10-11(cm/sec)(mlO2/mlxmm Hg)Measured at 35°C(revised Fattmethod). | 17x10-11(cm/sec)(mlO2/mlxmm Hg) Measuredat 35°C (revised Fattmethod). |
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SUBSTANTIAL EQUIVALENCE (continued)
| Material | Igel® 56 UVhefilcon C | Gold Medalist™ Torichefilcon C |
|---|---|---|
| Actions | When placed on thehuman cornea, thehydrated Igel® 56 UV(hefilcon C) Soft(hydrophilic)Contact Lens acts asa correctiverefracting medium tofocus light rays onthe retina. | In its hydratedstate, the Bausch &Lomb Gold Medalist™Toric (hefilcon C)Visibility TintedContact Lens whenplaced on the corneaacts as a correctiverefracting medium tofocus light rays onthe retina. |
| Chord Diameter* | 14.2mm | 12.0 to 18.0mm |
| Centerthickness* | 0.09mm (at -3.00D) | 0.02mm to 1.0mm |
| Base Curve* | 8.6mm | 8.3mm to 9.2mm |
| Powers(Spherical)(Cylinder) | -12.00 to +6.00Dup to 7.00D | +20.00 to -20.00Dup to 5.00D |
| Optical Zone | vary with power |
- Igel® 56 UV parameters for spheres only provided in this table
Introduction
The Igel® 56 UV (hefilcon C) Soft (hydrophilic) Contact Lens is a spherical lens for the correction of nearsightedness (myopia) and farsightedness (hyperopia). A toric version of the same lens is able to correct for astigmatism from 0.50D to 7.00D.
Contained in the submission are comparisons of the product to the predicate device, information on the chemistry and manufacturing, results of toxicological and microbiological tests, and the report of a clinical trial of 37 subjects, who have used the product over a period of four weeks .
I. Chemistry and Manufacturing
The lens material (hefilcon C) is a copolymer of 2 hydroxethylmethacrylate and N-Vinyl pyrrolidinone and contains a UV absorbing compound. The blue tinted lens also contains D&C Green #6. When fully hydrated, the lens is 56% water by weight.
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P.05/15
The Igel® 56 UV (hefilcon C) Soft (hydrophilic) Spherical Contact Lens is a hemispherical, flexible transparent shell of the following dimensions: Chord diameter: 14.2mm 0.09mm (at-3.00 D) Center thickness: variable optic zone with Optic Zone: power 8.60mm Base Curve: -0.50D to -8.00D (in 0.25D Power: steps) -8.50D to -12.00D (in 0.50D steps) +0.50D to +6.00D (in 0.25D steps) The Igel® 56 UV (hefilcon C) Soft (hydrophilic) Toric Contact Lens has the following characteristics: 14.6mm Chord diameter: 0.15mm Center thickness: 8 - 4 5mm Optic Zone: 8.70mm Base Curve: Plano to -8.00 D (in 0.25 D steps) Sphere: Plano to +6.00 D (in 0.25 D steps) up to 7.00 D Cylinder: 80, 90, 100, 160, 170, 180, 10 & 20 Axis : Dynamic Stabilizing Stabilizing Mechanism: Sectors The physical properties of the lens (sphere or toric) are as follows: Specific Gravity: 1.16 1.41 (hydrated)
94.5% (clear) Refractive index: Light transmission: 90.3% (blue handling tint) <10%(-7.00D, thinnest UV transmittance lens hydrophilic Surface character: 56% weight in normal Water content: buffered saline 2.85 kg/cm² Tensile strength: Elongation: 728 5.20 kg/cm² Modulus of Elasticity: Dx: 21x10-11 ( cm/sec ) { ml Oxygen permeability: O2/mlxmm Kg) Measured at 35°C (revised Patt method). A. Extractables
Samples of lenses were extracted in saline, and the extracts analyzed by high performance liquid chromatography to determine if any monomers were extracted from the material. There were no extractables detected.
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B. Process validation
The manufacturing process for this cast-moulded lens was shown to be valid both for lens quality and sterility.
II. Toxicology
The toxicological testing is summarized below. The lens material was shown to be non-toxic in all tests.
A -Agar Overlay Cytotoxicity:
Igel® 56 UV (hefilcon C) Soft (hydrophilic) Contact Lenses were tested in a direct contact cytotoxicity assay. The lenses were noncytotoxic.
Systemic toxicity: B.
Saline and cottonseed oil extracts of Igel® 56 UV (hefilcon C) Soft (hydrophilic) Contact Lenses were evaluated for systemic toxicity by intravenous (iv, saline) and intraperitoneal (ip, cottonseed oil) injection in healthy mice, both at 50ml/kg body weight. The animals were observed over a 72 hour period, and showed no difference from control animals. The lenses passed the test requirements, that there be no difference between the response of test and control animals.
C. Acute Ocular irritation:
Saline and cottonseed oil extracts of Igel® 56 UV (hefilcon C) Soft (hydrophilic) Contact Lenses were evaluated for ocular irritation by instillation into The eyes the inferior ocular cul-de-sac of rabbits. were examined over a 72 hour period and showed no irritation.
III. Microbiology
A. Sterility
The Igel® 56 UV (hefilcon C) Soft (hydrophilic) Contact Lenses passed the requirements of sterility testing.
B. Stability
Stability data, including package integrity, lens parameters (diameter, base curve, power, optics, appearance), stability of tint and UV transmittance, and sterility will be collected according to protocol. Product will not be marketed until data supporting the expiration dating are available.
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IV. Clinical Studies
A clinical trial of 4 weeks usage of the Igel® 56 UV (hefilcon C) Soft (hydrophilic) Contact Lenses by 37 subjects, wearing lenses on a daily wear schedule, showed that the product is substantially equivalent to other lenses available on the market. The clinical summary follows.
The study was conducted over 1 month of wear, subjects being seen initially, and after 1, 2 and 4 The study was initiated July 11, 1997 and weeks. completed August 19, 1997.
Two (2) investigators enrolled a total of 37 test subjects. The age range of the test population was from 17 to 61, with 26 (70.3%) females and 11 (29.7%) males.
Of the 37 subjects, 35 (94.6%) completed 1 month of wear, and 2 (5.4%) discontinued.
FINDINGS
SAFETY : a.
(1) Adverse Reactions
The FDA regulations for medical devices (21 CFR 812.3) define an unanticipated adverse device effect as :
"any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem or death was not previously identified in nature, severity or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that related to the rights, safety or welfare of the subject"
There were no adverse events during this study.
Slit Lamp Findings: (2)
A positive slit lamp finding is a routinely occurring complication that can be expected with or without the presence of contact lenses. The degree of severity may range from very slight, representing no medical concern, to serious, requiring medical treatment.
Table B shows the incidence of slit lamp findings in the investigational group at the initial and final visits.
The slit lamp finding listed as "Other" at the initial visit was an old healed neovascularization.
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6.08/15
TABLE B
| FINDINGS | INCIDENCE OF SLIT LAMP FINDINGS | |
|---|---|---|
| FINDING | INITIAL | FINAL |
| NO FINDINGSa | 51.4 | 58.6 |
| EDEMAb | 0.0 | 0.0 |
| NEOVASCULAR | 18.9 | 11.4 |
| STAINING | 5.4 | 1.4 |
| INJECTION | 0.0 | 0.0 |
| TARSAL | 48.6 | 40.0 |
| OTHER | 1.4 | 0.0 |
a Percent of eyes examined with no findings, regularly scheduled visits only
D Percent of eyes with finding, regularly scheduled visits only
The Trend Analysis Profile showed no reports of positive slit lamp findings greater than Grade 2.
(3) Symptoms, Problems and Complaints:
Symptoms, problems and complaints were reported by the investigators at each visit. Lens awareness, handling problems and reading problems were the most frequently reported symptoms among all subjects. Table C shows the overall incidence of these selected symptoms .
The "other" symptoms were dryness (reported by 2 subjects); torn lenses reported by 1 subject.
TABLE C
SELECTED SYMPTOMS, PROBLEMS AND COMPLAINTS
| SYMPTOM | Incidence |
|---|---|
| NONEa | 62.6% |
| LENS AWARENESSb | 14.5% |
| HANDLING PROBLEMS | 8.4% |
| READING PROBLEMS | 7.9% |
scheduled visits only
A Percent of eyes examined with no findings, regularly scheduled visits only D Percent of eyes with finding, reqularly
Discontinuations: ( 4 )
READING PROBLEMS
Throughout the study, 2 subjects (5.4%) were discontinued.
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EFFICACY : b.
Visual Acuity: (1)
All but 2 eyes had a final visual acuity within 1 line of the initial best corrected acuity. The appropriate acuity was achieved by all eyes, since those two eyes were in subjects fit for monovision.
Wear Time: (2)
Wear time remained essentially unchanged over the one month of the study, indicating continuing comfort and cleanliness with the investigational solution.
Lens Cleanliness: (3)
Lenses were evaluated at each visit, according to a modified Rudko classification. Overall, the reports of the Rudko evaluation showed that 91% of test lenses were clinically clean during the study. (Rudko grades I and II are considered clinically clean.)
These results confirm that the Igel® 56 UV (hefilcon C) Soft (hydrophilic) Contact Lenses are effective in the correction of myopia and hyperopia.
Gender Comparisons:
The overall test population was 70.3% female, 29.7% male, and the visit distribution over the study was 69% female, 31% male. Overall, there were no slit lamp findings at 58% of the visits; among females, at There were no 63%, among males at 47% of the visits. symptoms reported at 61% of the visits; among females, no symptoms were reported at 64%, among males, at 56%. There is no significant difference in the findings, and no further analysis was warranted. Because of the small sample size, the gender analysis may be statistically irrelevant.
OVERALL CONCLUSION OF THE CLINICAL STUDY:
The data of the clinical trial confirm that the Igel® 56 UV (hefilcon C) Soft (hydrophilic) Contact Lenses are substantially equivalent to currently marketed lenses in safety and efficacy.
LABELING
The name of the lens has been changed from the Igel® 56 (hefilcon C) Soft (hydrophilic) Contact Lens to the Igel® 56 UV (hefilcon C) Soft (hydrophilic) The appropriate UV transmittance graphs, Contact Lens. warnings, and note have been included in the labeling.
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Image /page/8/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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 6 1999
Igel Vision Care PTE, Ltd. c/o John M. Szabocsik, Ph.D. Szabocsik and Associates 203 N. Wabash Avenue, Suite 1200 Chicago, IL 60601
Re: K984523
Trade Name: IGEL ® 56 UV (hefilcon C) soft (hydrophilic) Contact Lens for Daily Wear (clear or visitint. Spherical and Toric, cast molded) Regulatory Class: II
Product Code: 86 LPL Dated: December 14, 1998 Received: December 21, 1998
Dear Dr. Szabocsik:
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 - Dr. John M. Szabocsik, Ph.D.
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. Roerl forentthal
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)
DEVICE NAME Igel®56 UV (hefilcon C) Soft (hydrophilic) Contact Lens
INDICATIONS FOR USE
The Igel®56 UV (hefilcon C) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism, for the spherical lens up to 1.50 diopters that does not interfere with visual acuity, and for the toric lens up to 7.00 diopters) in not-aphakic persons with non-diseased The lens may be disinfected using chemical eyes. disinfecting systems only.
ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Over-The-Counter-Use Prescription Use _ V (Per
21 CFR 801.109)
(Optional Format 1-2-96)
Division Sign-Off
Division of Ophthalmic Devices
S10(k) Number K984523
§ 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.