The S-38™ (polymacon) Soft (hydrophilic) Contact Lens with blue tint is indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who may exhibit astigmatism of 1.50 diopters or less that does not interfere with visual acuity.

The Esstech® PS (polymacon) Soft (hydrophilic) Contact Lens, with blue tint is indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic The lens may be worn by persons who may presbyopes. exhibit astigmatism of not more than 2.00 diopters that does not interfere with visual acuity.

The Esstech® SV (polymacon) Soft (hydrophilic) Contact Lens, with blue tint is indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic and/or marqinally presbyopic requiring up to +1.00 D of The lens may be worn by persons who exhibit add. astiqmatism of 1.50 diopters or less but may not be suitable for higher degrees of astigmatism.

Device Description

The lenses are identical to the already approved and cleared products S-38™ (polymacon) Soft (hydrophilic) Contact Lens, the Esstech® PS (polymacon) Soft (hydrophilic) Contact Lens and the Esstech® SV (polymacon) Soft (hydrophilic) Contact Lens, except for the addition of the listed color additive Procion Blue MX-R (Reactive Dye Blue #4).

AI/ML Overview

The provided text describes a 510(k) submission for tinted contact lenses and focuses on establishing substantial equivalence to previously cleared devices. It does not contain information about the acceptance criteria or a study proving that the device meets those acceptance criteria in the way typically associated with a medical device performance study (e.g., measuring sensitivity, specificity, or reader agreement for an AI/algorithm-based device). Instead, the submission relies on demonstrating that the new tinted lenses have the "same" performance characteristics as the predicate untinted lenses, which were previously approved.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable to this particular document. I will fill in what is available and indicate where information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly defined by demonstrating that the blue-tinted lenses maintain the same characteristics or remain within acceptable ranges compared to their untinted predicate devices. The "reported device performance" are the physical and chemical properties of the tinted lenses.

Characteristic	Acceptance Criteria (based on predicate untinted lenses)	Reported Device Performance (Blue Tinted Lenses)
S-38™ (polymacon)
Water Content	38%	Same (38%)
Refractive Index (hydrated)	1.43	Same (1.43)
Light Transmittance (visible)	>97%	>95%
Oxygen Permeability (Dk)	8.5 (cm/sec)(ml O2/ml x mm Hg) @ 35°C	Same (8.5 Dk)
Chord Diameter	12.5 to 15.0 mm	Same (12.5 to 15.0 mm)
Center Thickness	0.07 to 0.97 mm	Same (0.07 to 0.97 mm)
Base Curve	7.40 to 9.60 mm	Same (7.40 to 9.60 mm)
Powers	-20.00 to +20.00 D	Same (-20.00 to +20.00 D)
ESSTECH® PS (polymacon)
Water Content	38%	Same (38%)
Refractive Index (hydrated)	1.43	Same (1.43)
Light Transmittance (visible)	>97%	>95%
Oxygen Permeability (Dk)	8.5 (cm/sec)(ml O2/ml x mm Hg) @ 35°C	Same (8.5 Dk)
Chord Diameter	14.00 ± 0.20 mm	Same (14.00 ± 0.20 mm)
Center Thickness	0.17 ± 0.02 mm	Same (0.17 ± 0.02 mm)
Base Curve	8.30, 8.70, and 9.10 ± 0.10 mm	Same (8.30, 8.70, and 9.10 ± 0.10 mm)
Powers	+10.00 to -10.00 D in 0.25 steps	Same (+10.00 to -10.00 D in 0.25 steps)
ESSTECH® SV (polymacon)
Water Content	38%	Same (38%)
Refractive Index (hydrated)	1.43	Same (1.43)
Light Transmittance (visible)	>97%	>95%
Oxygen Permeability (Dk)	8.5 (cm/sec)(ml O2/ml x mm Hg) @ 35°C	Same (8.5 Dk)
Chord Diameter	14.00 ± 0.20 mm	Same (14.00 ± 0.20 mm)
Center Thickness (Minus)	0.07 to 0.14 ± 0.02 mm	Same (0.07 to 0.14 ± 0.02 mm)
Center Thickness (Plus)	0.15 to 0.30 ± 0.02 mm	Same (0.15 to 0.30 ± 0.02 mm)
Base Curve	8.30, 8.70, and 9.10 ± 0.10 mm	Same (8.30, 8.70, and 9.10 ± 0.10 mm)
Powers	+10.00 to -10.00 D in 0.25 steps	Same (+10.00 to -10.00 D in 0.25 steps)

Additionally, the lenses passed toxicology (cytotoxicity, systemic toxicity, ocular irritation testing) for the blue tint. Microbiology and manufacturing were stated to be identical to the predicate devices or with standard tinting processes.

2. Sample size used for the test set and the data provenance:

Sample size: Not explicitly stated as a "test set" in the context of clinical performance comparison for an AI device. The new tinted devices themselves are the "test" in comparison to the predicate devices. The data provenance related to the properties listed above would be from manufacturing and laboratory testing of the tinted lenses.
Data provenance: Laboratory measurements and toxicology testing. No country of origin is specified. The data is likely prospective (generated for this submission).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. The data is based on physical and chemical measurements and toxicology tests, not expert interpretation of diagnostic images or clinical scenarios for which ground truth would be established by experts.

4. Adjudication method for the test set:

Not applicable.

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

Not applicable. This is not an AI/algorithm device; it is a contact lens.

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

Not applicable. This is not an AI/algorithm device.

7. The type of ground truth used:

The "ground truth" for the assessment of these contact lenses is based on established physical and chemical measurement standards (e.g., for water content, refractive index, oxygen permeability, dimensions) and recognized toxicology testing protocols. For the tinted lenses, the ground truth is that they perform "the same" as the untinted predicate lenses for these parameters, with a slight adjustment noted for light transmittance.

8. The sample size for the training set:

Not applicable. This is not an AI/algorithm device that requires a training set.

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

Not applicable.

Summary

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APR 16 100

K990281, FOI Summary

510(k) SUMMARY FOR FOI

S-38™ (polymacon) Soft (hydrophilic) Contact Lens, blue tint

Contact Lens Classification Name:
Contact Lens Common/Usual Name:
5-38m (polymacon) Soft (hydrophilic) Proprietary Name: Contact Lens, the Esstech® PS Concact Bens) Soft (hydrophilic) Contact (polymacon) SEsstech® SV (polymacon) Soft (hydrophilic) Contact Lens
Establishment Registration Number: 9610790 Owner/Operator No: 8010037
Contact lenses were reclassified as Class II Classification: devices in November, 1993. 21 CFR 886.5925, 86LPL
Performance Standards: None

Copies of labeling, revised to include the Labeling: Copies of rabeling, " the blue tint, were included in this submission.

Substantial Equivalence: The sponsor considers these to be substantially equivalent to the S-38™ Soft (polymacon) Contact Lens covered in Sort (porymacon) 920036 and the Esstech® PS (polymacon) Soft (hydrophilic) Contact Lens and the Esstech® SV Contact on) Soft (hydrophilic) Contact (porymateen) bon the 510(k)'s K942186 and K942187, respectively.

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SUBSTANTIAL EQUIVALENCE S-38™

Material	S-38™ Clear Untinted	S-38™ Blue Tinted
Description	hydrophilic polymerof 2-hydroxyethylmethacrylate cross-linked withethyleneglycoldimethacrylate	hydrophilic polymerof 2-hydroxyethylmethacrylate cross-linked withethyleneglycoldimethacrylatecontaining the dyeProcion blue MX-R.
Water Content	38%	same
RefractiveIndex	1.43, hydrated	same
LightTransmittance(visible)	>97%	>95%
Oxygenpermeability	Dk = 8.5(cm/sec)(mlO2/mlxmm Hg)Measured at 35°C(Fatt method).	same
Actions	When placed on thehuman cornea, thehydrated lensacts as a correctiverefracting medium tofocus lightrays on the retina.	same
Chord Diameter	12.5 to 15.0 mm	same
Centerthickness	0.07 to 0.97 mm	same
Base Curve	7.40 to 9.60 mm	same
Powers	-20.00 to +20.00 D	same
Material	ESSTECH® PS ClearUntinted	ESSTECH® PS BlueTinted
Description	hydrophilic polymerof 2-hydroxyethylmethacrylate cross-linked withethyleneglycoldimethacrylate	hydrophilic polymerof 2-hydroxyethylmethacrylate cross-linked withethyleneglycoldimethacrylatecontaining the dyeProcion blue MX-R.
Water Content	38%	same
RefractiveIndex	1.43, hydrated	same
LightTransmittance(visible)	> 97%	> 95%
Oxygenpermeability	$D_k = 8.5 (cm/sec) (ml O_2/ ml x mm Hg)$Measured at 35°C(Fatt method).	same
Actions	When placed on thehuman cornea, thehydrated lens actsas a correctiverefracting medium tofocus light rays onthe retina.	same
Chord Diameter	$14.00 \pm 0.20$ mm	same
Centerthickness	0.17 $\pm 0.02$ mm	same
Base Curve	8.30, 8.70, and 9.10$\pm 0.10$ mm	same
Powers	+10.00 to -10.00D in0.25 dioptric steps	same

Material	ESSTECH® SV ClearUntinted	ESSTECH® SV BlueTinted
Description	hydrophilic polymerof 2-hydroxyethylmethacrylate cross-linked withethyleneglycoldimethacrylate	hydrophilic polymerof 2-hydroxyethylmethacrylate cross-linked withethyleneglycoldimethacrylatecontaining the dyeProcion blue MX-R.
Water Content	38%	same
RefractiveIndex	1.43, hydrated	same
LightTransmittance	>97%	>95%
Oxygenpermeability	Dk = 8.5(cm/sec)(mlO2/ml x mm Hg)Measured at 35°C(Fatt method).	same
Actions	When placed on thehuman cornea, thehydrated lensacts as a correctiverefracting medium tofocus lightrays on the retina.	same
Chord Diameter	14.00 ± 0.20 mm	same
CenterthicknessMinus powers:	0.07 to0.14 ± 0.02 mm	samesame
Variable fromPlus powers:Variable from	0.15 to0.30 ± 0.02 mm	same
Base Curve	8.30, 8.70, and 9.10±0.10 mm	same
Powers	+10.00 to -10.00D in0.25 diopter steps	same

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SUBSTANTIAL EQUIVALENCE ESSTECH® PS

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SUBSTANTIAL EQUIVALENCE ESSTECH® SV

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SUMMARY

PRODUCT DESCRIPTION AND CHEMISTRY

TOXICOLOGY:

The lenses passed cytotoxicity, systemic toxicity and ocular irritation testing.

MICROBIOLOGY

All microbiological testing is contained in P920036.

CLINICAL DATA

Since there is no change other than the addition of a listed color additive, no new clinical data was generated. All prior clinical data is contained in P920036.

MANUFACTURING

The blue tinted lenses are manufactured in a manner identical to that described in P920036, K942186 and K942187, with the addition of the tinting process.

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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird-like figure with three heads, suggesting a sense of unity or collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.

APR 16 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NISSEL LIMITED c/o John M. Szabocsik, Ph.D. 203 North Wabash Avenue Suite 1200 Chicago, IL 60601

Re: K990281

Trade Name: S-38™ (polymacon) Soft (hydrophilic) Contact Lens, the Esstech® PS Lens and the Esstech ® SV (polymacon) Soft (hydrophilic) Contact Lens, With blue tint Regulatory Class: II Product Code: 86 LPL

Dated: January 26, 1999 Received: January 28, 1999

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 - 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 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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January 26, 1999

Page 1 of 1

510(k) NUMBER (IF KNOWN) K990281

S-38™ (polymacon) Soft (hydrophilic) DEVICE NAME Contact Lens, the Esstech® PS (polymacon) Soft (hydrophilic) Contact Lens and the Esstech® SV (polymacon) Soft (hydrophilic) Contact Lens, with blue tint

INDICATIONS FOR USE

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter-Use OR (Optional Format 1-2-96)

Marcel W. Brown, Ph.D.

(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number_K990281

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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.