(78 days)
No
The document describes standard contact lenses and does not mention any AI or ML components in the device description, intended use, or performance studies.
No
The device is indicated for the correction of visual acuity (e.g., in myopic or hyperopic persons), which addresses a refractive error rather than treating a disease or disorder.
No
Explanation: The device is a contact lens indicated for the correction of visual acuity, which is a treatment or correction, not a diagnostic function.
No
The device description clearly states it is a contact lens, which is a physical medical device, 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 worn on the human cornea to correct visual acuity. They do not analyze or test any biological samples.
- The purpose is vision correction. The primary function of these contact lenses is to physically alter the light entering the eye to improve vision for individuals with myopia, hyperopia, and/or presbyopia. This is a therapeutic/corrective function, not a diagnostic one.
- The device description focuses on the physical properties and intended use on the eye. There is no mention of analyzing biological markers, detecting diseases, or providing diagnostic information.
The information provided describes a medical device used for vision correction, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
86LPL
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human cornea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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.
42
1
SUBSTANTIAL EQUIVALENCE S-38™
| Material | S-38™ Clear Untinted | S-38™ Blue Tinted |
|---|---|---|
| Description | hydrophilic polymer | |
| of 2-hydroxyethyl | ||
| methacrylate cross- | ||
| linked with | ||
| ethyleneglycol | ||
| dimethacrylate | hydrophilic polymer | |
| of 2-hydroxyethyl | ||
| methacrylate cross- | ||
| linked with | ||
| ethyleneglycol | ||
| dimethacrylate | ||
| containing the dye | ||
| Procion blue MX-R. | ||
| Water Content | 38% | same |
| Refractive | ||
| Index | 1.43, hydrated | same |
| Light | ||
| Transmittance | ||
| (visible) | >97% | >95% |
| Oxygen | ||
| permeability | Dk = 8.5(cm/sec)(ml | |
| O2/mlxmm Hg) | ||
| Measured at 35°C | ||
| (Fatt method). | same | |
| Actions | When placed on the | |
| human cornea, the | ||
| hydrated lens | ||
| acts as a corrective | ||
| refracting medium to | ||
| focus light | ||
| rays on the retina. | same | |
| Chord Diameter | 12.5 to 15.0 mm | same |
| Center | ||
| thickness | 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 Clear | |
| Untinted | ESSTECH® PS Blue | |
| Tinted | ||
| Description | hydrophilic polymer | |
| of 2-hydroxyethyl | ||
| methacrylate cross- | ||
| linked with | ||
| ethyleneglycol | ||
| dimethacrylate | hydrophilic polymer | |
| of 2-hydroxyethyl | ||
| methacrylate cross- | ||
| linked with | ||
| ethyleneglycol | ||
| dimethacrylate | ||
| containing the dye | ||
| Procion blue MX-R. | ||
| Water Content | 38% | same |
| Refractive | ||
| Index | 1.43, hydrated | same |
| Light | ||
| Transmittance | ||
| (visible) | > 97% | > 95% |
| Oxygen | ||
| permeability | $D_k = 8.5 (cm/sec) (ml O_2/ ml x mm Hg)$ | |
| Measured at 35°C | ||
| (Fatt method). | same | |
| Actions | When placed on the | |
| human cornea, the | ||
| hydrated lens acts | ||
| as a corrective | ||
| refracting medium to | ||
| focus light rays on | ||
| the retina. | same | |
| Chord Diameter | $14.00 \pm 0.20$ mm | same |
| Center | ||
| thickness | 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 in | |
| 0.25 dioptric steps | same | |
| Material | ESSTECH® SV Clear | |
| Untinted | ESSTECH® SV Blue | |
| Tinted | ||
| Description | hydrophilic polymer | |
| of 2-hydroxyethyl | ||
| methacrylate cross- | ||
| linked with | ||
| ethyleneglycol | ||
| dimethacrylate | hydrophilic polymer | |
| of 2-hydroxyethyl | ||
| methacrylate cross- | ||
| linked with | ||
| ethyleneglycol | ||
| dimethacrylate | ||
| containing the dye | ||
| Procion blue MX-R. | ||
| Water Content | 38% | same |
| Refractive | ||
| Index | 1.43, hydrated | same |
| Light | ||
| Transmittance | >97% | >95% |
| Oxygen | ||
| permeability | Dk = 8.5(cm/sec)(ml | |
| O2/ml x mm Hg) | ||
| Measured at 35°C | ||
| (Fatt method). | same | |
| Actions | When placed on the | |
| human cornea, the | ||
| hydrated lens | ||
| acts as a corrective | ||
| refracting medium to | ||
| focus light | ||
| rays on the retina. | same | |
| Chord Diameter | 14.00 ± 0.20 mm | same |
| Center | ||
| thickness | ||
| Minus powers: | 0.07 to | |
| 0.14 ± 0.02 mm | same | |
| same | ||
| Variable from | ||
| Plus powers: | ||
| Variable from | 0.15 to | |
| 0.30 ± 0.02 mm | same | |
| Base Curve | 8.30, 8.70, and 9.10 | |
| ±0.10 mm | same | |
| Powers | +10.00 to -10.00D in | |
| 0.25 diopter steps | same |
2
SUBSTANTIAL EQUIVALENCE ESSTECH® PS
3
45
SUBSTANTIAL EQUIVALENCE ESSTECH® SV
4
SUMMARY
PRODUCT DESCRIPTION AND CHEMISTRY
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).
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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5
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 .
6
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
7
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
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.
(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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