(124 days)
Not Found
No
The summary describes a contact lens with specific material properties and surface treatment. There is no mention of any computational or analytical functions that would suggest the use of AI or ML.
No.
The device is indicated for the correction of refractive error (myopia, hyperopia, astigmatism, presbyopia) and is not intended to treat, cure, or prevent any disease or medical condition.
No
This device is a contact lens intended for the correction of refractive errors, not for diagnosing medical conditions.
No
The device description clearly states it is a physical contact lens made from safrofilcon A, a silicone hydrogel material, and treated with Hydra-PEG Technology. It is a tangible medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "correction of refractive error" in the eyes. This is a therapeutic or corrective function, not a diagnostic one.
- Device Description: The description details the material and physical properties of a contact lens, designed to be worn on the eye. This aligns with a medical device for vision correction.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information about a patient's health status or disease.
- Anatomical Site: The device is applied to the eye, which is consistent with a vision correction device, not an IVD which typically interacts with biological samples.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This contact lens does not perform any of these functions.
N/A
Intended Use / Indications for Use
The Intelliwave4 with HPT, sphere (safrofilcone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive error 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 Intelliwave4 with HPT, toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic persons with non diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters.
The Intelliwave4 with HPT, multifocal (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic persons with non diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The IntelliWave4 with HPT, multifocal toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
Product codes (comma separated list FDA assigned to the subject device)
LPL
Device Description
The Intelliwave4 with HPT, Silicone Hydrogel Soft Contact Lenses are fabricated from safrofilcon 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.
The non-ionic lens material, (safrofilcon A) is a daily wear silicone hydrogel contact lens that is characterized by high water content. The lens material is composed of silicone monomers cross linked with other monomers, and it optionally incorporates Reactive Blue 246 (21 CFR 73.3106) as an integrated handling tint. The lenses are made by lathe-cut for custom Ry. It consists of 35% safrofilcon A and 65% water by weight when immersed in a buffered saline solution. The (safrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).
The Intelliwave4 with HPT, Silicone Hydrogel Soft Contact Lenses are treated to incorporate Hydra-PEG Technology (HPT)-which is a thin polyethylene glycol (PEG)-based polymer that is covalently (permanently) bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with HPT, the underlying material (safrofilcon A) is completely encapsulated in a thin layer of polymer that results in measurable improvement of the surface characteristics, compared to untreated lenses, including: wettability (dynamic contact receding angle), lubricity (coefficient of friction), and water film stability (WBUT). The resulting layer is hydrophilic and approximately 30nm in thickness.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eyecare practitioners / 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing: A series of in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the IntelliWave4 with HPT (safrofilcon A) Silicone Hydrogel Soft Contact Lenses packaged in glass vials. All non-clinical toxicology tests were conducted in accordance with the GLP regulation. All other testing was conducted according to valid scientific protocols.
Test results of the non-clinical testing on the IntelliWave4 with HPT (safrofilcon A) Silicone Hydrogel Soft Contact Lenses demonstrate that:
- Lenses supplied in glass vials are sterile for the indicated shelf-life
- The packaging material and extracts are not toxic and not irritating
- Lens physical and material properties are consistent with currently marketed lenses.
Clinical Testing: A bilateral, open-label, parallel group, and randomized daily wear study was performed to evaluate the safety and efficacy of the IntelliWave4 with HPT (safrofilcon A) Silicone Hydrogel Soft Contact Lens. The study evaluated 30 patients over a one (1) month period. Clinical evaluation demonstrated similar overall performance to the concurrent predicate control in the clinically relevant areas of vision, health, and comfort and fit when worn for daily wear.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Wettability - captive bubble contact angle (degrees) (advancing contact angle): 46 (123% reduction)
- Inclined Plane Friction/Lubricity (degrees): 19 (46% reduction)
- Water Break Up Time – WBUT (seconds): 5.69 (262% increase)
- Friction/Lubricity at human eyelid – contact lens biointerface ($μ$ kinetic): 0.0434 (27% reduction)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol featuring a series of overlapping human profiles facing to the right, creating a sense of depth and continuity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 24, 2015
Art Optical Contact Lens, Inc. Mr. Bret Andre Principal Consultant Eyereg Consulting, Inc. 474 NE 61st Place Hillsboro. Oregon 97124
Re: K152046
Trade/Device Name: Intelliwave4 with HPT, sphere (safrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens Intelliwave4 with HPT, toric (safrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens Intelliwave4 with HPT, multifocal (safrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens Intelliwave4 with HPT, multifocal toric (safrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: October 12, 2015 Received: October 15, 2015
Dear Mr. Andre:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Y. Alexander -A
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152046
Device Name
Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)
Indications for Use (Describe)
The Intelliwave4 with HPT, sphere (safrofilcone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive error 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 Intelliwave4 with HPT, toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic persons with non diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters.
The Intelliwave4 with HPT, multifocal (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic persons with non diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The IntelliWave4 with HPT, multifocal toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
510 (k) 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: | K152046 |
|---|---|
| Applicant information: | |
| Date Prepared: | 07/18/2015 |
| Name: | |
| Address | Art Optical Contact Lens, Inc. |
| 3175 3 Mile Road NW | |
| Walker, Michigan 49534 | |
| Contact Person: | Mike Johnson, FCLSA |
| Director of Consultative Services | |
| Phone number: | (616) 559-5167 |
| Consultant: | Bret Andre |
| EyeReg Consulting, Inc. | |
| 474 NE 61st PL | |
| Hillsboro, OR 97124 | |
| Phone number | (503) 372-5226 |
| Device Information: | |
| Device Classification: | Class II |
| Product Code: | LPL |
| Classification Name: | Soft (hydrophilic) Contact Lens (21 CFR 886.5925) |
Trade Name:
Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)
4
Purpose of 510(k) Submission:
~ New Technology ~
Art Optical proposes to modify the surface of the Intelliwayed Silicone Hydrogel Contact Lens (safrofilcon A)—cleared under 510(k) K142641—to include Hydra-PEG Technology (HPT), which is a thin, polyethylene glycol (PEG)-based polymer designed to enhance the surface properties of the contact lens. Specifically, HPT treated contact lenses demonstrate a measureable improvement in the surface wettability, lubricity, and water break up time (WBUT) in comparison with the untreated lenses. The application of HPT to the surface of Intelliwave4 contact lenses does not change the indications for use in comparison with the untreated lenses, the predicate device (K142641).
Equivalent Devices:
The Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lenses (safrofilcon A) are substantially equivalent to the following predicate devices:
Predicate devices:
"IntelliWave4 (safrofilcon A) Silicone Hydrogel Contact Lens" by Art Optical Contact Lens, Inc. 510(k) number; K142641
Device Description:
The Intelliwave4 with HPT, Silicone Hydrogel Soft Contact Lenses are fabricated from safrofilcon 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.
The non-ionic lens material, (safrofilcon A) is a daily wear silicone hydrogel contact lens that is characterized by high water content. The lens material is composed of silicone monomers cross linked with other monomers, and it optionally incorporates Reactive Blue 246 (21 CFR 73.3106) as an integrated handling tint. The lenses are made by lathe-cut for custom Ry. It consists of 35% safrofilcon A and 65% water by weight when immersed in a buffered saline solution. The (safrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).
The Intelliwave4 with HPT, Silicone Hydrogel Soft Contact Lenses are treated to incorporate Hydra-PEG Technology (HPT)-which is a thin polyethylene glycol (PEG)-based polymer that is covalently (permanently) bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with HPT, the underlying material (safrofilcon A) is completely encapsulated in a thin layer of polymer that results in measurable improvement of the surface characteristics, compared to untreated lenses, including: wettability (dynamic contact receding angle), lubricity (coefficient of friction), and water film stability (WBUT). The resulting layer is hydrophilic and approximately 30nm in thickness. The following table depicts the enhanced surface properties of the Intelliwave4 with HPT versus the predicate device:
5
| Contact Lens Surface Property | ART Optical
IntelliWave4 with HPT
(New Device)
1,2,3,4 | ART Optical
IntelliWave4
(Predicate Device)
K142641 |
|-----------------------------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------|
| Wettability - captive bubble contact angle (degrees)
(advancing contact angle) | 461 | 103 |
| Inclined Plane Friction/Lubricity (degrees) | 192 | 35 |
| Water Break Up Time – WBUT (seconds) | 5.693 | 1.57 |
| Friction/Lubricity at human eyelid – contact lens biointerface
( $μ$ kinetic) | 0.0434 | 0.059 |
- 1 123% reduction in 'wettability' (n=6)*
- 2 46% reduction in 'inclined plane friction' (n=5)*
- 3 262% increase in 'WBUT' (n=10)*
- 4 27% reduction in 'friction at human eyelid-contact lens biointerface' (n=9)*
- Statistically significant based on a 95% confidence interval (p 99% in the UVB range of 280nm - 315nm and >77% in the UVA range of 316 - 380nm.
The Physical properties of the lens are:
| Refractive Index (wet) | 1.3841 |
|---|---|
| Visible Light Transmission | >98% |
| Surface Character | hydrophilic |
| Water Content | 65 % |
| Specific Gravity | 1.102 (hydrated) |
| Oxygen Permeability | 46.46 x 10-11 (cm2/sec) (ml O 2/ml x hPa @ 35°C), (revised Fatt |
| method). |
6
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 65% water by weight. The lenses will be manufactured in spherical, aspherical, toric, and multifocal configurations with the following features and properties.
- 12.0 mm to 16.00 mm Chord Diameter ●
- Center Thickness ●
- Base Curve
- Power Range ●
- Cylinder Power (Toric) ●
- Add Power (Multifocal) ●
- 0.01 mm to 0.50 mm 8.0 mm to 9.5 mm -20.00D to +20.00D in 0.25 steps -0.25D to -10.00D +0.50D to +3.00D
The lens is supplied sterile in vials containing a buffered saline solution. Vial labeling is printed with appropriate lot numbering, expiration dating and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterilization process.
Intended Use:
The Intelliwave4 with HPT, sphere (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with nondiseased 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 Intelliwave4 with HPT, toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters.
The Intelliwave4 with HPT, multifocal (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eves with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The IntelliWave4 with HPT, multifocal toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and nonaphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning. disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
7
Testing:
Non-clinical Testing A series of in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the IntelliWave4 with HPT (safrofilcon A) Silicone Hydrogel Soft Contact Lenses packaged in glass vials. All non-clinical toxicology tests were conducted in accordance with the GLP regulation. All other testing was conducted according to valid scientific protocols.
Test results of the non-clinical testing on the IntelliWave4 with HPT (safrofilcon A) Silicone Hydrogel Soft Contact Lenses demonstrate that:
- Lenses supplied in glass vials are sterile for the indicated shelf-life, ●
- The packaging material and extracts are not toxic and not irritating, and ●
- Lens physical and material properties are consistent with currently marketed ● lenses.
- Clinical Testing A bilateral, open-label, parallel group, and randomized daily wear study was performed to evaluate the safety and efficacy of the IntelliWave4 with HPT (safrofilcon A) Silicone Hydrogel Soft Contact Lens. The study evaluated 30 patients over a one (1) month period. Clinical evaluation demonstrated similar overall performance to the concurrent predicate control in the clinically relevant areas of vision, health, and comfort and fit when worn for daily wear.
Conclusions Drawn from Studies
Validity of Scientific Data
Several laboratories under Good Laboratory Practice regulations conducted toxicology studies, Microbiology, chemistry, shelf-life stability studies and followed scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7
Substantial Equivalence
Information presented in this Premarket Notification establishes that the IntelliWave4 with HPT, (safrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens is as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the requested indication.
Risks and Benefits
The risks of the subject device are the same as those normally attributed to the wearing of Silicone Hydrogel, Daily Wear Soft Contact Lens. The benefits to the patient are the same as those for other Silicone Hydrogel contact lenses.
8
Substantial Equivalence:
The following matrix illustrates the production method, lens function and material characteristics of the Intelliwave4 with HPT, (safrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens, as well as the predicate devices.
| | Art Optical
IntelliWave4 with HPT,
Silicone Hydrogel
(safrofilcon A)
New Device | Art Optical
IntelliWave4,
Silicone Hydrogel
(safrofilcon A)
Predicate Device
510(k) K142641 |
|---------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Same as predicate device | Indicated for daily wear for the
correction of visual acuity in aphakic
and not apjakic persons with non-
diseased eyes with myopia or
hyperopia. The lens may also be
prescribed for management of irregular
corneal conditions such as keratoconus
and post graft fitting. |
| Functionality | Same as predicate device | The contact lenses act as a
refractive medium that focus
light rays from near and distant
objects on the retina |
| Indications | Same as predicate device | Daily wear. Silicone Hydrogel
Soft (hydrophilic) Contact Lens |
| Production Method | Lathe-Cut, custom
manufactured
Processed to include Hydra-
PEG surfacing technology | Lathe-Cut, custom
manufactured |
| USAN name | Same as predicate device | safrofilcon A |
| Water Content (%) | Same as predicate device | 65% |
| Oxygen Permeability | Same as predicate device | 46.46 x 10-11 (cm2/sec) (ml O2/ml
x hPa @ 35oC), (revised Fatt
method) |
| Specific Gravity | Same as predicate device | 1.102 |