(168 days)
Not Found
No
The document describes a standard soft contact lens with various configurations (spherical, toric, multifocal, toric-multifocal) and tints. There is no mention of any computational or analytical functions, let alone AI or ML. The description focuses on the material properties, physical dimensions, and intended use for vision correction.
No.
The contact lenses mentioned are designed to correct visual acuity for conditions like myopia, hyperopia, and astigmatism, and can also be used for cosmetic purposes (changing eye color). These functions are not considered therapeutic treatments for a disease, rather they address optical deficiencies or aesthetic preferences.
No
Explanation: The device is a soft contact lens intended for the correction of visual acuity; it is not used to diagnose a disease or condition.
No
The device is a physical contact lens made of a specific material (methafilcon A) and has defined physical properties. The description focuses on the material composition, manufacturing process, and physical characteristics of the lens itself, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the I-55 contact lenses is for the correction of visual acuity in individuals with myopia, hyperopia, and/or astigmatism. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The device is a physical contact lens designed to be worn on the eye to alter the way light enters the eye. It does not perform any tests on biological samples (like blood, urine, or tissue) to diagnose a condition.
- Performance Studies: The performance studies described focus on the safety, biocompatibility, and physical properties of the contact lens itself, not on its ability to diagnose a disease or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The I-55 contact lens does not fit this definition.
N/A
Intended Use / Indications for Use
The I-55 (methafilcon A) 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 2.00 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The I-55 (methafilcon 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/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The I-55 (methafilcon A) 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. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The I-55 (methafilcon A) 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 eves with myopia or hyperopia, possesses refractive astigmatism not exceeding 5.00 diopters and are presbyopic. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.
Frequent/Planned Replacement Wear:
Eyecare practitioners may prescribe any of the above lenses 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.
Disposable Wear:
Eyecare practitioners may prescribe any of the above lenses for single use Daily Disposable Wear. When Prescribed for Daily Disposable Wear the lens is to be discarded after each removal.
Product codes (comma separated list FDA assigned to the subject device)
LPL, MVN
Device Description
The I-55 soft contact lenses are hemispherical shells with molded spherical base curves and molded front surfaces.
The nonionic lens material (methafilcon A) is a hydrophilic co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid, cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% methafilcon A and 55% water by weight when immersed in saline solution. The (methafilcon A) name has been adopted by the United States Adopted Names Council (USAN).
I-55 lenses are available clear, visibility tinted (for handling), and tinted to enhance or alter the apparent color of the eye. Lenses are tinted with one or a combination of one or more of the following 'listed' color additives:
| Name of Colorant | Listing |
|---|---|
| [Phthalocyaninato(2-)] copper | 21 CFR § 74.3045 |
| D&C Green No.6 | 21 CFR § 74.3206 |
| D&C Red No.17 | 21 CFR § 74.3230 |
| D&C Violet No.2 | 21 CFR § 74.3602 |
| D&C Yellow No.10 | 21 CFR § 74.3710 |
| Titanium dioxide | 21 CFR § 73.3126 |
Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives, and contain only the amount of color additive needed to accomplish the intended coloring effect. When producing the tinted lenses, the manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive color additive(s) on the front surface of the contact lens in a location that corresponds to the iris. As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound color additives. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens in the location that corresponds to the iris, the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a standard Clear Pupil diameter of 6.5 mm.
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent or colored optical surface. The (methafilcon A) soft hydrophilic contact lens has 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 appear somewhat warped; however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The physical properties of the lens are:
| Refractive Index | 1.415 |
|---|---|
| Light Transmission (clear) | greater than 90% |
| Light Transmission (tinted) | greater than 90% |
| Surface Character | hydrophilic |
| Water Content | 55±2% |
| Specific Gravity | 1.039 (hydrated) |
| Oxygen Permeability | 19.01 x 10^-11 (cm²/sec)(mlO₂)/(ml x hPa @ 35°C)) (revised Fatt method) |
The hydrophilic characteristics allow aqueous solution to enter the lens, and in its fully hydrated state the lens is approximately 38% water by weight. The lenses will be manufactured in the sphere, toric, multifocal, and toric multifocal design configurations with the following features and properties:
| Chord Diameter: | 13.00 mm to 15.00 mm |
|---|---|
| Center Thickness: | 0.080 mm to 0.580 mm |
| Base Curve: | 8.0 mm to 9.8 mm |
| Power Range |
- Sphere Power: | -12.00D to +12.00D in 0.25D steps
- Cylinder Power (toric): | -0.25D to -2.25D in 0.25D steps
- Cylinder Axis (toric): | 10° to 180° in 10° steps
- Multifocal Power: | +1.25 to +2.50 in 0.25D steps
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.
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)
A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the I-55 soft contact lenses-including listed color additives. All non-clinical toxicology tests were conducted in accordance with the GLP regulation.
Test results of the non-clinical testing on the I-55 soft contact lenses demonstrate that:
- The parameters of finished contact lenses with listed color additives remain stable for proposed expiration date.
- The finished contact lenses with color additives, packaging material and extracts are not toxic and not irritating.
- The finished contact lenses with color additives remain within original specifications.
Pre-clinical performance data established by the I-55 predicate device (K080794) include:
- Data establishing the consistency of the physical and material properties between the I-55 sound contact lenses and other currently marketed lenses.
- Data establishing the sterility of finished lenses supplied in specified packaging for the indicated shelf-life.
- Biocompatibilty data to establish that the packaging material and extracts are not toxic and not irritating.
- All relevant manufacturing/chemistry data, including verification data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 seal of the Department of Health & Human Services - USA. The seal features a stylized image of three human profiles facing right, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 12, 2015
Interojo Inc. Mr. Bret Andre Official Correspondent EyeReg Consulting, Inc. 474 NE 61st PL Hillsboro, Oregon 97124
K142766 Re:
Trade/Device Name: I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear (clear and tinted, fully cast-molded) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: February 5, 2015 Received: February 12, 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 of medical device-related 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 -S
for Malvina B. Eydelman, MD 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) K142766
Device Name
I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear (clear and tinted, fully cast-molded)
Indications for Use (Describe)
The I-55 (methafilcon A) 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 2.00 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The I-55 (methafilcon 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 eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The I-55 (methafilcon A) 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. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The I-55 (methafilcon A) 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, possesses refractive astigmatism not exceeding 5.00 diopters and are presbyopic. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.
Frequent/Planned Replacement Wear:
Eyecare practitioners may prescribe any of the above lenses 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.
Disposable Wear:
Eyecare practitioners may prescribe any of the above lenses for single use Daily Disposable Wear. When Prescribed for Daily Disposable Wear the lens is to be discarded after each removal.
| Type of Use (Select one or both, as applicable) |
|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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.
and the same of the same of the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of
The assigned 510(k) number is:
Applicant information:
| Date Prepared: | September 23rd, 2014 | |
|---|---|---|
| Name: | Interojo, Inc. | |
| #803, Yulchon B/D, 24-1, | ||
| Youidong, Youngpodong, | ||
| Seoul, South Korea | ||
| Contact Person: | Si-Chul Rho | |
| President | ||
| Phone number: | +82-2-780-1225 | |
| Consultant: | Bret J Andre | |
| EyeReg Consulting, Inc. | ||
| 474 NE 61st Pl | ||
| Hillsboro, OR 97124 | ||
| United States | ||
| Phone number: | (503) 372-5226 | |
| Device Information: | ||
| Device Classification: | Class II | |
| Product Code: | LPL; MVN | |
| Classification Name: | Soft (hydrophilic) Contact Lens (21 CFR 886.5925) | |
| Trade Name: | I-55 (methafilcon A) Soft (hydrophilic) Contact | |
| Lenses for Daily Wear (clear and tinted, fully cast- | ||
| molded) |
5
Equivalent Devices:
The I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear (clear and tinted, fully cast-molded) are substantially equivalent to the following predicate devices:
Predicate devices:
- "I-55 (methafilcon A)" . By PolyVue Distribution, Inc. 510(k) number; K080794 -Primary Predicate
- "HD/HDT, PV/PVT (polymacon)" . By PolyVue Technologies, Inc. 510(k) number; K013220
Device Description:
The I-55 soft contact lenses are hemispherical shells with molded spherical base curves and molded front surfaces.
The nonionic lens material (methafilcon A) is a hydrophilic co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid, cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% methafilcon A and 55% water by weight when immersed in saline solution. The (methafilcon A) name has been adopted by the United States Adopted Names Council (USAN).
I-55 lenses are available clear, visibility tinted (for handling), and tinted to enhance or alter the apparent color of the eye. Lenses are tinted with one or a combination of one or more of the following 'listed' color additives:
| Name of Colorant | Listing |
|---|---|
| [Phthalocyaninato(2-)] copper | 21 CFR § 74.3045 |
| D&C Green No.6 | 21 CFR § 74.3206 |
| D&C Red No.17 | 21 CFR § 74.3230 |
| D&C Violet No.2 | 21 CFR § 74.3602 |
| D&C Yellow No.10 | 21 CFR § 74.3710 |
| Titanium dioxide | 21 CFR § 73.3126 |
Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives, and contain only the amount of color additive needed to accomplish the intended coloring effect. When producing the tinted lenses, the manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive color additive(s) on the front surface of the contact lens in a location that corresponds to the iris. As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound color additives. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens in the location that corresponds to the iris, the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a standard
6
Clear Pupil diameter of 6.5 mm.
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent or colored optical surface. The (methafilcon A) soft hydrophilic contact lens has 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 appear somewhat warped; however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The physical properties of the lens are:
| Refractive Index | 1.415 |
|---|---|
| Light Transmission (clear) | greater than 90% |
| Light Transmission (tinted) | greater than 90% |
| Surface Character | hydrophilic |
| Water Content | 55±2% |
| Specific Gravity | 1.039 (hydrated) |
| Oxygen Permeability | 19.01 x 10-11 (cm²/sec)(mlO₂)/(ml x hPa @ 35°C)) (revised |
| Fatt method) |
The hydrophilic characteristics allow aqueous solution to enter the lens, and in its fully hydrated state the lens is approximately 38% water by weight. The lenses will be manufactured in the sphere, toric, multifocal, and toric multifocal design configurations with the following features and properties:
| Chord Diameter: | 13.00 mm to 15.00 mm |
|---|---|
| Center Thickness: | 0.080 mm to 0.580 mm |
| Base Curve: | 8.0 mm to 9.8 mm |
| Power Range | |
| - Sphere Power: | -12.00D to +12.00D in 0.25D steps |
| - Cylinder Power (toric): | -0.25D to -2.25D in 0.25D steps |
| - Cylinder Axis (toric): | 10° to 180° in 10° steps |
| - Multifocal Power: | +1.25 to +2.50 in 0.25D steps |
Intended Use:
The I-55 (methafilcon A) 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 2.00 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The I-55 (methafilcon 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/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
7
The I-55 (methafilcon A) 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. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The I-55 (methafilcon A) 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 eves with myopia or hyperopia, possesses refractive astigmatism not exceeding 5.00 diopters and are presbyopic. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.
Frequent/Planned Replacement Wear:
Eyecare practitioners may prescribe any of the above lenses 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.
Disposable Wear:
Eyecare practitioners may prescribe any of the above lenses for single use Daily Disposable Wear. When Prescribed for Daily Disposable Wear the lens is to be discarded after each removal.
Pre-Clinical Performance Data:
A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the I-55 soft contact lenses-including listed color additives. All non-clinical toxicology tests were conducted in accordance with the GLP regulation.
Test results of the non-clinical testing on the I-55 soft contact lenses demonstrate that:
- The parameters of finished contact lenses with listed color additives remain stable for proposed expiration date.
- The finished contact lenses with color additives, packaging material and extracts are not toxic and not irritating.
- The finished contact lenses with color additives remain within original specifications.
Pre-clinical performance data established by the I-55 predicate device (K080794) include:
- Data establishing the consistency of the physical and material properties between the I-55 . soft contact lenses and other currently marketed lenses.
8
- . Data establishing the sterility of finished lenses supplied in specified packaging for the indicated shelf-life.
- Biocompatibilty data to establish that the packaging material and extracts are not toxic and not irritating.
- All relevant manufacturing/chemistry data, including verification data. ●
Substantial Equivalence:
The I-55 Soft Contact Lens will be manufactured according to specified process controls and a cGMP quality assurance program currently in place as established by the I-55 predicate device (K080794).
The final packaging and sterilization of the I-55 lenses will be carried out in accordance with procedures specified for the I-55 predicate device (K080794).
The I-55 Soft Contact Lenses are manufactured using the identical process to incorporate the listed color additives in the contact lenses as the HD/HDT, PV/PVT (polymacon) reference predicate device (K013220).
The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the I-55 contact lens material is equivalent to the predicate devices identified previously. 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 does not raise different questions of safety and effectiveness than the predicate device identified above.
The following matrix illustrates the equivalencies of the I-55 (methafilcon A) Soft Contact Lenses for Daily Wear, as well as the substantial equivalent predicate devices.
9
Substantial Equivalence Matrix
| | Interojo, Inc.
I-55
Subject Device | Poly Vue
Distribution, Inc.
I-55
Predicate Device | Poly Vue Technologies,
Inc.
HD/HDT, PV/PVT
Predicate Device |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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/or
possesses refractive
astigmatism not exceeding
5.00 Diopters, and/or are
presbyopic. The lens may be
used to enhance or alter the
apparent color of the eye. | 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/or
possesses refractive
astigmatism not exceeding
5.00 Diopters, and/or are
presbyopic. | 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/or
possesses refractive
astigmatism not exceeding
5.00 Diopters, and/or are
presbyopic. The lens may be
used to enhance or alter the
apparent color of the eye. |
| 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 | The contact lenses act
as a refractive medium
that focus light rays
from near and distant
objects on the retina |
| Indications | Daily Wear, Soft
(hydrophilic) Contact
Lens | Daily Wear, Soft
(hydrophilic) Contact
Lens | Daily Wear, Soft
(hydrophilic) Contact
Lens |
| Production Method | Fully-molded | Fully-molded | Fully-molded |
| USAN name | methafilcon A | methafilcon A | polymacon |
| Water Content (%) | 55±2% | 55±2% | 38±2% |
| Oxygen Permeability | $19.01 x 10-11(cm²/sec)(mlO₂)/(ml x hPa@ 35°C)) (revised Fattmethod)$ | $19.01 x 10-11(cm²/sec)(mlO₂)/(ml x hPa@ 35°C)) (revised Fattmethod)$ | $8.40 x 10-11(cm²/sec)(mlO₂)/(ml x hPa@ 35°C)) (revised Fattmethod)$ |
| Specific Gravity | 1.039 (hydrated) | 1.039 (hydrated) | - |