(78 days)
The SatureEyes II (acofilcon A), (acofilcon B) & (tetrafilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.
The SatureEyes II (acofilcon B) & (tetrafilcon A) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eves with myopia or hyperopia and may have astigmatism of 10.00 diopters or less where the astigmatism does not interfere with visual acuity.
The SatureEyes II (acofilcon A), (acofilcon B) & (tetrafilcon A) Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic persons with non-diseased eves with myopia or hyperopia and are presbyopic.
The SatureEyes II (acofilcon A), (acofilcon B) & (tetrafilcon A) Toric Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not-aphakic persons with nondiseased eyes with myopia or hyperopia, have astigmatism of 10.00 diopters or less and are presbyopic.
Eyecare practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
The SatureEyes II Soft Contact Lens for Daily Wear is fabricated from (acofileon A), (acofilcon B) or (tetrafilcon A), which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (acofilcon A), (acofilcon B) & (tetrafilcon A) soft hydrophilic contact lens a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out. it will become hard and appear somewhat warped however, it will return to its proper configuration when completely re-hydrated in the proper storage solution.
The non-ionic lens material, (acofilcon A), is a terpolymer based on high purity Glycerol Methacrylate2, 3-Dihydroxypropyl Methacrylate (GMA), with N-vinyl-2 pyrrolidone (NVP), methyl methacrylate (MMA), and 2-hydroxyethyl methacrylate (2-HEMA) and crossed-linked with Diallyl Maleate (DAM). It consists of 42% acofilcon A and 58% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The lenses are available in clear and with a blue visibility-handling tint, Color additive 'Reactive Blue 4'.
The non-ionic lens material, (acofilcon B), is a terpolymer based on high purity Glycerol Methacrylate2,3-Dihydroxypropyl Methacrylate (GMA), with N-vinyl-2 pyrrolidone (NVP), methy) methacrylate (MMA), and 2-hydroxyethyl methacrylate (2-HEMA) and crossed-linked with Diallyl Maleate (DAM). It consists of 51% acofilcon B and 49% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The lenses are available in clear and with a blue visibility-handling tint, Color additive 'Reactive Blue 4'.
The non-ionic lens material, (tetrafilcon A), is a random terpolymer of 2-hydroxyethy) methacrylate, N-vinylpyrrolidone (NVP), methylmethacrylate (MMA), in a three dimensional network of terpolymer chains by divinylbenzene cross links. It consists of 58% (tetrafilcon A) and 42% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The lenses are available in clear and with a blue visibility-handling tint, Color additive 'Reactive Blue 163'.
This document describes the safety and effectiveness of the SatureEyes II contact lenses by demonstrating substantial equivalence to previously cleared predicate devices. The submission focuses on adding new materials (acofilcon A, acofilcon B, and tetrafilcon A) to an existing cleared device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating substantial equivalence to predicate devices across various characteristics. The "reported device performance" refers to the physical properties of the new materials, which are compared to the predicate devices.
| Characteristic | Acceptance Criteria (Predicate Device Examples) | Reported Device Performance (SatureEyes II - New Materials) |
|---|---|---|
| Intended Use | Daily wear, Soft Contact Lens | Daily wear, Soft Contact Lens |
| Indication | Correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia, and/or astigmatism (up to 10.00 diopters for some predicate models), and may be presbyopic. | Correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10 diopters and may be presbyopic. (Specific versions for Spherical, Toric, Multifocal, Toric Multifocal listed.) |
| Production Method | Lathe-Cut | Lathe-Cut |
| Design | Spherical, Toric, Multifocal, Toric Multifocal | Spherical, Toric, Multifocal, Toric Multifocal |
| Hydrophilic Material | (hioxifilcon A), (hioxifilcon B) | (acofilcon A), (acofilcon B), (tetrafilcon A) |
| Water Content | (hioxifilcon A) - 58%, (hioxifilcon B) - 48% | (acofilcon A) - 58%, (acofilcon B) - 49%, (tetrafilcon A) - 43% |
| Specific Gravity | (hioxifilcon A) - 1.18 hydrated, (hioxifilcon B) - 1.142 hydrated | (acofilcon A) - 1.103 (hydrated), (acofilcon B) - 1.142 (hydrated), (tetrafilcon A) - 1.12 (hydrated) |
| Oxygen Permeability | (hioxifilcon A) - 25.50 X 10^-11, (hioxifilcon B) - 15.0 X 10^-11 (cm^2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method) | (acofilcon A) - 25.50 X 10^-11, (acofilcon B) - 15.8 X 10^-11, (tetrafilcon A) - 9.3 X 10^-11 (cm^2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method) |
| Light Transmittance | >95% (hioxifilcon A and B) | (acofilcon A) - >93%, (acofilcon B) - >94.8%, (tetrafilcon A) - >93% |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" and its sample size in the context of device performance data collected for the SatureEyes II lenses themselves within this submission. Instead, the approach taken is demonstrating substantial equivalence to predicate devices, which implies that the predicate devices have already undergone sufficient testing.
The provenance of the data presented for the new materials (e.g., refractive index, water content, oxygen permeability) is not specified as "country of origin" or "retrospective/prospective." This data appears to be inherent physical properties of the materials themselves, likely determined through laboratory testing during material development.
Pre-clinical performance data for cytotoxicity, systemic injection, and ocular eye irritation are referenced in other 510(k) submissions (K023349 & K024045 for Contamac Ltd. and K954139 for CooperVisions), implying that these tests were conducted on the specific materials or similar materials by those companies. The details of those studies (sample size, provenance) are not provided here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for the device's performance is based on its physical properties and comparison to existing, legally marketed predicate devices, not on expert labeling of a dataset.
4. Adjudication Method for the Test Set
This is not applicable as there is no specific test set undergoing human review or adjudication mentioned in this document.
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
This is not applicable. The device is a contact lens, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a contact lens.
7. The Type of Ground Truth Used
The ground truth used for demonstrating substantial equivalence is:
- Physical and Chemical Properties: Laboratory measurements of material properties (water content, oxygen permeability, light transmission, refractive index, specific gravity) for the new materials.
- Established Performance of Predicate Devices: The known design, intended use, indications, and material properties of several already cleared contact lenses (MetroFocal Toric, Metro-G 55 (5X), Metro-G (3X)).
- Pre-clinical data: Referenced cytotoxicity, systemic injection, and ocular eye irritation tests from other 510(k) submissions. This suggests that the biological safety of the materials has been previously established or validated through these referenced tests.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of a machine learning algorithm for this medical device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable.
{0}------------------------------------------------
AUG - 1 2003
SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| The assigned 510(k) number is: | K031532 |
|---|---|
| -------------------------------- | ---------------- |
Applicant information:
| Date Prepared: | May 12, 2003 |
|---|---|
| Name: | Metro Optics of Austin, Ltd. |
| Address | 15802 Vision DrivePflugerville, TX 78660 |
| Contact Person: | Mr. Steve WebbVice President |
| Phone Number: | (512) 251-2382 |
| Fax: | (512) 251-6554 |
| Official Correspondent:Regulatory Consultant: | Med-Vice Consulting, Inc.Ms. Deanna Werber or Mr. Martin Dalsing623 Glacier DriveGrand Junction, CO 81503 |
| Phone Number: | (970) 243-5490 |
| Fax Number: | (970) 243 -5501 |
Device Information:
| Regulatory Classification: | Class II |
|---|---|
| Product Code: | LPL |
| Trade Name: | SatureEyes II (acofilcon A), (acofilcon B) & (tetrafilcon A) Lens forDaily Wear (clear and blue visibility-handling tint, lathe-cut) |
| Purpose for 510(k) | Addition of Material to an already cleared device |
| Classification Name: | Lenses, Contact (other material), Daily Wear |
{1}------------------------------------------------
Purpose of 510(k) submission:
ADDITION OF MATERIALS TO AN ALREADY CLEARED DEVICE ~
Metro Optics of Austin, Inc. proposes to manufacture the SatureEyes II (acofilcon A), (acofilcon B) & (tetrafilcon A) Soft Contact Lens for Daily Wear. Data supporting substantial equivalency to the predicate devices, performance, and safety and efficacy of the (acofilcon B) & (tetrafilcon A) polymer is contained in this submission.
Equivalent Devices:
The SatureEyes II (acofilcon B) & (tetrafilcon A) Soft Contact Lens for Daily Wear is substantially equivalent to the predicate device identified below in terms of intended use and design.
| Predicate device manufacturer: | Device name: |
|---|---|
| Metro Optics of Austin, Ltd.15802 Vision DrivePflugerville, TX 78660 | Metro-G 55 (5X) (hioxifilcon A) Spherical & Toric510(k) #: K953199 |
| Metro-G 3X (hioxifilcon B) Spherical & Toric Soft ContactLenses for Daily Wear510(k) #: K964902 | |
| MetroFocal Toric Multifocal (hioxifilcon A) Soft Daily WearContact Lens510(k) #: K001584 |
Device Description:
The SatureEyes II Soft Contact Lens for Daily Wear is fabricated from (acofileon A), (acofilcon B) or (tetrafilcon A), which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (acofilcon A), (acofilcon B) & (tetrafilcon A) soft hydrophilic contact lens a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out. it will become hard and appear somewhat warped however, it will return to its proper configuration when completely re-hydrated in the proper storage solution.
The non-ionic lens material, (acofilcon A), is a terpolymer based on high purity Glycerol Methacrylate2, 3-Dihydroxypropyl Methacrylate (GMA), with N-vinyl-2 pyrrolidone (NVP), methyl methacrylate (MMA), and 2-hydroxyethyl methacrylate (2-HEMA) and crossed-linked with Diallyl Maleate (DAM). It consists of 42% acofilcon A and 58% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The lenses are available in clear and with a blue visibility-handling tint, Color additive 'Reactive Blue 4'.
The physical properties of the (acofilcon A) lens are:
{2}------------------------------------------------
| Refractive Index | 1.40 (hydrated) |
|---|---|
| Light Transmission (clear) | greater than 95% T |
| Light Transmission (tinted) | greater than 95% T |
| Water Content | 58 % |
| Specific Gravity | 1.103 (hydrated) |
| Oxygen Permeability | $25.50 X 10^{-11}$ (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fattmethod) |
The non-ionic lens material, (acofilcon B), is a terpolymer based on high purity Glycerol Methacrylate2,3-Dihydroxypropyl Methacrylate (GMA), with N-vinyl-2 pyrrolidone (NVP), methy) methacrylate (MMA), and 2-hydroxyethyl methacrylate (2-HEMA) and crossed-linked with Diallyl Maleate (DAM). It consists of 51% acofilcon B and 49% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The lenses are available in clear and with a blue visibility-handling tint, Color additive 'Reactive Blue 4'.
| Refractive Index | 1.42 (hydrated) |
|---|---|
| Light Transmission (clear) | greater than 95% T |
| Light Transmission (tinted) | greater than 95% T |
| Water Content | 49 % |
| Specific Gravity | 1.142 (hydrated) |
| Oxygen Permeability | $15.8 X 10^{-11} (cm^2/sec) (ml O_2/ml x mm Hg @ 35^\circ C)$ , (revised Fatt method) |
The non-ionic lens material, (tetrafilcon A), is a random terpolymer of 2-hydroxyethy) methacrylate, N-vinylpyrrolidone (NVP), methylmethacrylate (MMA), in a three dimensional network of terpolymer chains by divinylbenzene cross links. It consists of 58% (tetrafilcon A) and 42% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The lenses are available in clear and with a blue visibility-handling tint, Color additive 'Reactive Blue 163'.
The physical properties of the (tetrafilcon A) lens are:
| Refractive Index | 1.43 (hydrated) |
|---|---|
| Light Transmission (clear) | greater than 93% T |
| Light Transmission (tinted) | greater than 95% T |
| Water Content | 42 % |
| Specific Gravity | 1.12 (hydrated) |
| Oxygen Permeability | 9.3 X 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method) |
Pre-Clinical Performance Data:
Pre-clinical performance data addressing the cytotoxicity test, systemic injection test, and ocular eye irritation test can be referenced in Contamac Ltd.'s 510(k)s K023349 & K024045 and CooperVisions 510(k) K954139.
(Reference Permission to Reference letters appendix D of submission)
{3}------------------------------------------------
Intended Use:
The SatureEyes II (acofilcon A), (acofilcon B) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.
The SatureEyes II (acofilcon A), (acofilcon B) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia or hyperopia and may have astigmatism of 10.00 diopters or less where the astigmatism does not interfere with visual acuity.
The SatureEves II (acofilcon B) Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic.
The SatureEyes II (acofilcon B) Toric Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia or hyperopia, have astigmatism of .10.00 diopters or less and are presbyopic.
Eyecare practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
Substantial Equivalence:
The new device will be manufactured according to specified process controls and a Quality Management System certified to QSR guidelines. The new device will undergo manufacturing, packaging and sterilization procedures similar to devices currently marketed and distributed by Metro Optics of Austin, Inc. Being similar with respect to indications for use, materials, physical construction and safety & effectiveness to the predicate devices, this meets the requirements per section 510(k) of the act regarding substantial equivalence and dove not ruise different questions of safety and effectiveness than the predicate devices identified above.
{4}------------------------------------------------
The following table illustrates that the Intended Use, Indications, Production method, and design, of the SatureEyes II (acofilcon A), (acofilcon A) & (tetrafilcon A) Soft Contact Lens for Daily Wear is substantially equivalent to the predicate devices. In addition, the water content, material, polymer, dK value, and light transmission are as well substantially equivalent to the predicate devices.
• .
| New Device | Predicate Device | Predicate Device | ||
|---|---|---|---|---|
| CHARACTERISTICS | SatureEyes II | *MetroFocal Toric | *Metro-G 55 (5X) | |
| *Metro-G (3X) | ||||
| 1.) | INTENDED USE | Daily wear, Soft Contact Lens | Daily wear, Soft Contact Lens | Daily wear, Soft Contact Lens |
| 2.) | INDICATION | The SatureEyes II (acofilcon A),(acofilcon B) & (tetrafilcon A) SoftContact Lenses for Daily Wear(clear and blue visibility-handlingtint, lathe-cut)are indicated for thecorrection of visual acuity inaphakic and not-aphakic personswith non-diseased eyes with myopiaor hyperopia and/or possessesrefractive astigmatism notexceeding 10 diopters and may bepresbyopic. The lens is availableclear and with a blue visibility-handling tint. | *MetroFocal Toric (hioxifilcon A)Soft Multifocal) Daily WearContact Lensesare indicated for the correction ofvisual acuity in aphakic and not-aphakic persons with non-diseasedeyes with myopia or hyperopiaand/or possesses refractiveastigmatism not exceeding 10diopters and may be presbyopic.The lens is available clear and witha blue visibility-handling tint. | *Metro-G 55 (5X) (hioxifilcon A)*Metro-G (3X) (hioxifilcon B)Spherical and Toric Soft ContactLenses for Daily Wearare indicated for the correction ofvisual acuity in aphakic and not-aphakic persons with non-diseasedeyes with myopia or hyperopia and/orpossesses refractive astigmatism notexceeding 4.50 diopters. The lens isavailable clear and with a bluevisibility-handling tint. |
| 3.) | PRODUCTIONMETHOD | Lathe-Cut | Lathe-Cut | Lathe-Cut |
| 4.) | DESIGN | spherical, toric, multifocaltoric multifocal | multifocaltoric multifocal | spherical, toric. |
| 5.) | HYDROPHILLICMATERIAL/USAN | (acofilcon A)(acofilcon B)(tetrafilcon A) | (hioxifilcon A) | (hioxifilcon A)(hioxifilcon B) |
| a. | Water Content | (acofilcon A) - 58%(acofilcon B) - 49%(tetrafilcon A) - 43% | (hioxifilcon A) - 58% | (hioxifilcon A) - 58%(hioxifilcon B) - 48% |
| b. | Specific Gravity | (acofilcon A) - 1.103 (hydrated)(acofilcon B) - 1.142 (hydrated)(tetrafilcon A) - 1.12 (hydrated) | (hioxifilcon A) - 1.18 hydrated | (hioxifilcon A) - 1.18 hydrated(hioxifilcon B) - 1.142 hydrated |
| C. | Oxygen Permeability* Revised FATT method | (acofilcon A) - 25.50(acofilcon B) - 15.8(tetrafilcon A) - 9.3 | (hioxifilcon A) - 25.50 | (hioxifilcon A) - 25.50(hioxifilcon B) - 15.0 |
| d. | Light Transmittance | (acofilcon A) - >93%(acofilcon B) - >94.8%(tetrafilcon A) - > 93% | (hioxifilcon A) >95% | (hioxifilcon A) >95%(hioxifilcon B) >95% |
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The text is black and the background is white.
Image /page/5/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a human figure with three arms.
AUG - 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Metro Optics of Autin, Ltd. c/o Deanna Werber Medvice Consulting, Inc. 623 Glacier Drive Grand Junction, CO 81503
Re: K031532
Trade/Device Name: SatureEyes II (acofilcon A), (acofilcon B) & (tetrafilcon A) Soft Contact Lens for Daily Wear (clear and blue visibility-handling tint lathe-cut) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: May 12, 2003 Received: May 15, 2003
Dear Ms. Werber:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{6}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Kalpi Korenthol
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{7}------------------------------------------------
INDICATIONS FOR USE STATEMENT
Device Name: SatureEyes II (acofilcon A), (acofilcon B) & (tetrafilcon A) Soft Contact Lenses for daily wear (clear, blue visibility-handling tint)
INDICATIONS FOR USE:
The SatureEyes II (acofilcon A), (acofilcon B) & (tetrafilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.
The SatureEyes II (acofilcon B) & (tetrafilcon A) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eves with myopia or hyperopia and may have astigmatism of 10.00 diopters or less where the astigmatism does not interfere with visual acuity.
The SatureEyes II (acofilcon A), (acofilcon B) & (tetrafilcon A) Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic persons with non-diseased eves with myopia or hyperopia and are presbyopic.
The SatureEyes II (acofilcon A), (acofilcon B) & (tetrafilcon A) Toric Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not-aphakic persons with nondiseased eyes with myopia or hyperopia, have astigmatism of 10.00 diopters or less and are presbyopic.
Eyecare practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | X |
| or | |
| (Optional Format 1-2-96) | |
| (Division Sign-Off) | |
| Division of Ophthalmic Ear, Nose and Throat Devises | |
| Over-The-Counter Use | ______ |
| 510(k) Number | K031532 |
| 77 |
§ 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.