The Igel®56 (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.

Device Description

The Igel® 56 (hefilcon C) soft (hydrophilic) contact lens is a hemispherical, flexible transparent shell of the following dimensions: 14 - 2mm Chord diameter: Center thickness: Sphere: 0.09mm (at-3.00 D) variable optic zone Optic Zone: with power Base Curve: 8.60mm -0.50D to -8.00D (in Power : 0.25D steps): -8.50D -12.00D (in to 0.50D steps); +0.50D to +6.00D (in 0.25D steps) Chord diameter: 14 - 6mm Toric: 0.15mm Center thickness: 8.45mm Optic Zone: 8.70mm Base Curve: Sphere: Plano to -8.00 D (in 0.25 D steps) Plano to +6.00 D (in 0.25 D steps) up to 7.00 D Cvlinder: 80, 90, 100, 160, 170, 180, 10 Axis: & 20° The lens material (hefilcon C) is a copolymer of 2 hydroxethylmethacrylate and N-vinyl pyrrolidinone. The blue tinted lens also contains D&C Green #6. The apparent color of the visibility tint may decrease slowly following repeated disinfection, but this will not affect the safety or performance of the lenses. When fully hydrated, the lens is 56% water by weight.

AI/ML Overview

The provided document describes the Igel® 56 (hefilcon C) Soft (hydrophilic) Contact Lens and its clinical evaluation for market clearance. The study aimed to demonstrate substantial equivalence to existing devices rather than meeting specific quantifiable performance benchmarks.

Here's an analysis of the acceptance criteria and study in the requested format:

Acceptance Criteria and Device Performance

The acceptance criteria for this device, as presented in the document, are primarily qualitative and focused on demonstrating clinical safety and efficacy comparable to already marketed predicate devices. Since this is a 510(k) submission, the primary goal is "substantial equivalence."

Acceptance Criteria Category	Specific Criteria / Goal	Reported Device Performance
Safety - Adverse Events	No unanticipated serious adverse events.	"There were no adverse events during this study."
Safety - Slit Lamp Findings	Incidence comparable to baseline and/or predicate devices; findings manageable.	"No Findings" at final visit: 58.6% (Initial: 51.4%)Reduction in Neovascularization, Staining, and Tarsal findings. Edema and Injection remained 0%.
Safety - Symptoms/Complaints	Incidence comparable to baseline and/or predicate devices; manageable.	"None" reported for 62.6% of visits. Lens awareness (14.5%), handling problems (8.4%), reading problems (7.9%). 2 subjects reported dryness, 1 reported torn lenses.
Safety - Discontinuations	Low rate of discontinuation due to device-related issues.	2 out of 37 subjects (5.4%) discontinued the study. (Reason for discontinuation not specified as device-related).
Efficacy - Visual Acuity	Maintain or achieve appropriate visual acuity.	"All but 2 eyes had a final visual acuity within 1 line of the initial best corrected acuity." "Appropriate acuity was achieved by all eyes, since those two eyes were in subjects fit for monovision."
Efficacy - Wear Time	Sustained comfortable wear time.	"Wear time remained essentially unchanged over the one month of the study, indicating continuing comfort and cleanliness."
Efficacy - Lens Cleanliness	Maintain acceptable clinical cleanliness.	91% of test lenses were clinically clean (Rudko grades I and II) during the study.
Overall Conclusion	Substantially equivalent to currently marketed lenses in safety and efficacy.	"The data of the clinical trial confirm that the Igel® 56 (hefilcon C) Soft (hydrophilic) Contact Lenses are substantially equivalent to currently marketed lenses in safety and efficacy."

Study Information:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: 37 subjects.
- Data Provenance: Prospective clinical trial conducted in the US (implied by FDA submission and approval process). The study was initiated July 11, 1997, and completed August 19, 1997.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document states "Two (2) investigators enrolled a total of 37 test subjects." It does not explicitly state their qualifications beyond being "investigators." In the context of a contact lens study, these would typically be optometrists or ophthalmologists. They would have performed the slit lamp examinations, assessed visual acuity, and recorded symptoms/complaints.
Adjudication method for the test set:
- The document does not describe a formal adjudication method (like 2+1 or 3+1). The "investigators" collected and reported the data. It's implied that they themselves made the clinical judgments for slit lamp findings and efficacy measures.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is for a medical device (contact lens), not an AI diagnostic tool, so this type of study is not applicable here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This study evaluates a physical medical device (contact lens) with human wearers, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the safety and efficacy outcomes was based on clinical observation and assessment by the investigators. This includes:
  - Slit lamp findings: Direct observation and grading by the investigators.
  - Symptoms, problems, and complaints: Subject self-report collected and categorized by investigators.
  - Visual Acuity: Measured by standard clinical methods (e.g., Snellen chart) by the investigators.
  - Lens Cleanliness: Evaluated by investigators using a "modified Rudko classification."
  - Adverse events: Reported by investigators based on monitoring subjects.
The sample size for the training set:
- This being a medical device (contact lens) study, there wasn't a "training set" in the machine learning sense. The "training" for the device's design and manufacturing would have been part of its development process, which is not detailed as a separate data set for a clinical trial.
How the ground truth for the training set was established:
- Not applicable as there was no "training set" for a machine learning model. The development of the contact lens material and design would have relied on material science, engineering principles, and pre-clinical testing, which are distinct from establishing ground truth for clinical outcomes in a learning algorithm.

Summary

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K974837, Amendment

510(k) SUMMARY FOR FREEDOM OF INFORMATION IGEL® 56 (hefilcon C) SOFT (hydrophilic) CONTACT LENS FOR DAILY WEAR Igel Vision Care PTE, Ltd 1. 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 June 5, 1998 2. Date prepared: 3. Device: Igel® 56 (hefilcon C) Soft (hydrophilic) Common Name Contact Lens Igel® 56 (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 The Igel® 56 (hefilcon C) soft 6. Device (hydrophilic) contact lens is a description hemispherical, flexible transparent shell of the following dimensions: 14 - 2mm Chord diameter:
Center thickness: Sphere: 0.09mm (at-3.00 D) variable optic zone Optic Zone: with power Base Curve: 8.60mm -0.50D to -8.00D (in Power : 0.25D steps): -8.50D -12.00D (in to 0.50D steps); +0.50D to +6.00D (in 0.25D

steps)

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Chord diameter: 14 - 6mm Toric: 0.15mm Center thickness: 8.45mm Optic Zone: 8.70mm Base Curve: Sphere: Plano to -8.00 D (in 0.25 D steps) Plano to +6.00 D (in 0.25 D steps) up to 7.00 D Cvlinder: 80, 90, 100, 160, 170, 180, 10 Axis: & 20°

The lens material (hefilcon C) is a copolymer of 2 hydroxethylmethacrylate and N-vinyl pyrrolidinone. The blue tinted lens also contains D&C Green #6. The apparent color of the visibility tint may decrease slowly following repeated disinfection, but this will not affect the safety or performance of the lenses. When fully hydrated, the lens is 56% water by weight.

The Igel®56 (hefilcon C) Soft 7. Intended use: (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.

Comparison to predicate devices: see following table

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SUBSTANTIAL EQUIVALENCE

Material	Igel® 56hefilcon 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%
Oxygenpermeability	$21x10^{-11}$ (cm/sec)(mlO₂/mlxmm Hg)Measured at 35°C(Fatt method).	$17x10^{-11}$ (cm/sec) (mlO₂/mlxmm Hg) Measuredat 35°C (Fattmethod).
Actions	When placed on thehuman cornea, thehydrated Igel® 56(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
Chord diameter:	14.2mm
Center thickness:	0.09mm (at-3.00 D)
Optic Zone:	variable optic zone withpower
Base Curve:	8.60mm
Power:	-0.50D to -8.00D (in 0.25Dsteps) -8.50D to -12.00D (in0.50D steps) +0.50D to +6.00D(in 0.25D steps)

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Introduction

The Igel® 56 (hefilcon C) Soft (hydrophilic) Contact Lens is a spherical lens for the correction of nearsightedness (myopía) 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. The blue tinted lens also contains D&C Green #6. The apparent color of the visibility tint may decrease slowly following repeated disinfection, but this will not affect the safety or performance of the lenses. When fully hydrated, the lens is 56% water by weight.

The Igel® 56 (hefilcon C) Soft (hydrophilic) Spherical Contact Lens is a hemispherical, flexible transparent shell of the following dimensions:

The Igel® 56 (hefilcon C) Soft (hydrophilic) Toric Contact Lens has the following characteristics: Chord diameter: 14.6mm 0.15mm Center thickness: 8.45mm 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

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	The physical properties of the lens (sphere or toric)
are as follows:
Specific Gravity:	1.16
Refractive index:	1.41 (hydrated)
Light transmission:	94.5% (clear)90.3% (blue handlingtint)
Surface character:	hydrophilic
Water content:	56% weight in normalbuffered saline
Tensile strength:	2.85 kg/cm2
Elongation:	72%
Modulus of Elasticity:	5.20 kg/cm2
Oxygen permeability:	Dk: 21x10-11(cm/sec)(mlO2/mlxmm Hg) Measured at35°C (Fatt 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.

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 .

Agar Overlay Cytotoxicity: A.

Igel® 56 (hefilcon C) Soft (hydrophilic) Contact Lenses were tested in a direct contact cytotoxicity The lenses were noncytotoxic. assay.

Systemic toxicity: B.

Saline and cottonseed oil extracts of Igel® 56 (hefilcon C) Soft (hydrophilic) Contact Lenses were evaluated for systemic toxicity by intraperitoneal (ip) injection in healthy mice, 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.

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Acute Ocular irritation: C.

Saline and cottonseed oil extracts of Igel® 56 (hefilcon C) Soft (hydrophilic) Contact Lenses were evaluated for ocular irritation by instillation into the inferior ocular cul-de-sac of rabbits. The eyes were examined over a 72 hour period and showed no irritation.

III. Microbiology

A -Sterility

The Igel® 56 (hefilcon C) Soft (hydrophilic) Contact Lenses passed the requirements of sterility testing.

B. Stability

Accelerated shelf-life testing has demonstrated a shelf-life in excess of 16 months. Sterility stability testing, accelerated and real-time, continue.

IV. Clinical Studies

A clinical trial of 4 weeks usage of the Igel® 56 (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

অ SAFETY :

(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

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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.

TABLE B

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

» Percent of eyes examined with no findings,

regularly scheduled visits only

Percent of eyes with finding, regularly scheduled visits only

(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 .

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The "other" symptoms were dryness (reported by 2 subjects); torn lenses reported by 1 subject.

TABLE C

SELECTED SYMPTOMS, PROBLEMS AND COMPLAINTS

SYMPTOM	Incidence
NONE*	62.6%
LENS AWARENESSb	14.5%
HANDLING PROBLEMS	8.4%
READING PROBLEMS	7.9%

다 Percent of eyes examined with no findings, regularly scheduled visits only
D Percent of eyes with finding, regularly scheduled visits only

Discontinuations: ( 4 )

Throughout the study, 2 subjects (5.4%) were discontinued.

b. EFFICACY :

(1) Visual Acuity:

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.

(2) Wear Time:

Wear time remained essentially unchanged over the one month of the study, indicating continuing comfort and cleanliness with the investigational solution.

(3) Lens Cleanliness:

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. }

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These results confirm that the Igel® 56 (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 63%, among males at 47% of the visits. There were no 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 (hefilcon C) Soft (hydrophilic) Contact Lenses are substantially equivalent to currently marketed lenses in safety and efficacy.

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Image /page/9/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 symbol of three human profiles facing right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 1998 JUL

Igel Vision Care PTE, Ltd. c/o John M. Szabocsik, Ph.D. Szabocsik and Associates 203 N. Wabash, St. 1200 Chicago, IL 60601

Re: K974837

Trade Name: IGEL ® 56 (hefilcon C) soft (hydrophilic) Contact Lens for Daily Wear (clear or visitint.cast molded)

Regulatory Class: II Product Code: 86 LPL Dated: June 8, 1998 Received: June 9, 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 (OS) 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 Szabocsik

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 a legally marketed predicate device 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 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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June 29, 1998

Page 1 of 1

510(k) NUMBER (IF KNOWN) K974837

IGEL® 56 (hefilcon C) SOFT DEVICE NAME (HYDROPHILIC) CONTACT LENS

INDICATIONS FOR USE

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

Mig-chen Star

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR

Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________

21 CFR 801.109)

(Per

(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.