(132 days)
No
The device description and performance studies focus on the material properties, manufacturing process, and clinical performance of a contact lens, with no mention of AI or ML.
No.
The device is indicated for the correction of refractive error (myopia, hyperopia, and early presbyopia) and astigmatism, which are conditions addressed by corrective rather than therapeutic means.
No
Explanation: This device, a contact lens, is intended for the correction of refractive errors and the enhancement of eye color. It does not perform any diagnostic function.
No
The device is a physical contact lens made of polymacon, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the correction of refractive error in the eye (myopia, hyperopia, astigmatism, and early presbyopia) and for cosmetic purposes (altering eye color). This is a direct interaction with the body for therapeutic and cosmetic purposes.
- Device Description: The device is a contact lens, which is a medical device placed on the surface of the eye.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of bodily specimens.
The device described is a medical device, specifically a contact lens, intended for vision correction and cosmetic enhancement.
N/A
Intended Use / Indications for Use
The POLYVUE and POLYVUE COLOR (polymacon) ASPHERIC Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of refractive error in not-aphakic persons with otherwise non-diseased eyes with myopia or hyperopia and early presbyopia up to 1.25 diopters. The lenses may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The lenses are available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The POLYVUE and POLYVUE COLOR (polymacon) ASPHERIC TORIC Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of refractive error in not-aphakic persons with otherwise non-diseased eyes with myopia or hyperopia and early presbyopia up to 1.25 diopters. The lenses may be worn by persons who exhibit refractive astigmatism of 5.00 diopters or less. The lenses are available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Eye care practitioners may prescribe the lenses in a frequent/planned replacement program with cleaning, disinfection, and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
Product codes (comma separated list FDA assigned to the subject device)
LPL
Device Description
The POLYVUE and POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lenses are manufactured using the cast molding method. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from polymacon, which is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). The co-polymer consists of 62% polymacon and 38% water by weight when immersed in saline solution. The polymacon name has been adopted by the United States Adopted Names Council (USAN).
The POLYVUE (polymacon) Soft (hydrophilic) Contact Lens is available clear or tinted for visibility using phthalocyanine blue. The POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens contains a unique tinted pattern to enhance or alter the apparent color of the eye. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives:
| Color Additive | Listing |
|---|---|
| Phthalocyanine blue | 21 CFR 74.3045 |
| Phthalocyanine green | 21 CFR 73.3124 |
| Titanium dioxide | 21 CFR 73.3126 |
| Iron Oxide | 21 CFR 73.3125 |
| Reactive black 5 | 21 CFR 73.3121 |
| Carbazole violet | 21 CFR 73.3107 |
When producing the color lenses, the manufacturing process changes the specifications of the clear lens by pad-printing the color pigment(s)-entrapping the colorants in the interpenetrating network of the contact lens material-in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the clear, pre-tinted lens. The tinting pattern has a clear pupil diameter of 6.0 mm.
The POLYVUE and POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lenses are manufactured in an aspheric design configuration. The material properties and available parameters of the finished lenses are as follows:
| Parameter | Range | Tolerance* |
|---|---|---|
| Chord Diameter | 11.00 mm to 15.00 mm | ±0.20 mm |
| Center Thickness | 0.05 mm to 0.15 mm | When ≤ 0.10 mm → ±0.010 mm + 10% |
| When > 0.10 mm → ±0.015 mm + 5% | ||
| Base Curve | 7.00 mm to 10.0 mm | ±0.20 mm |
| Back Vertex Power (F'v) | +10.00 D to -20.00D | |
| (in 0.25D steps) | When 0.00 1.50 D → ± 5° | |
| Surface Appearance | - | Lenses should be clear with no surface defect |
| Oxygen Permeability | ||
| (x 10-11(cm²/sec)(mlO2)/(ml x mmHg)) | 8.9 | ±20% |
| Light Transmission - Clear | ||
| (@ 380-780nm) | 95% | ±5% |
| Light Transmission - Tinted | ||
| (@ 380-780nm) | 95% | ±5% |
| Water Content | 38% | ±2% |
| Refractive Index | 1.440 (hydrated) | +0.005 |
- ISO 18369-2:2017 Ophthalmic optics - Contact lenses - Part 2: Tolerances
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
Eye care practitioners
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 non-clinical testing was performed to demonstrate the safety and effectiveness of the POLYVUE and POLYVUE COLOR (polymacon) finished contact lenses. The results support the claim that the POLYVUE and POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lenses are substantially equivalent to the currently marketed predicate device.
Toxicology:
- In-Vitro Cytotoxicity: Cytotoxicity testing was performed in accordance with ISO 10993-5 with results indicating that the finished lenses extracts are non-toxic.
- Sensitization: Skin sensitization testing was performed in accordance with ISO 10993-10 with the results confirming the lens extracts do not cause sensitization.
- Acute Ocular Irritation: Acute ocular irritation testing was performed in accordance with ISO 10993-10 and finished lens extracts were non-irritating.
- Systemic Toxicity: The finished lenses meet the requirements of the systemic injection test in accordance with ISO 10993-11 and are considered non-toxic.
Shelf Life:
Testing was performed to evaluate the stability, sterility, and package integrity of the POLYVUE and POLYVUE COLOR (polymacon) finished contact lenses over the duration of the labeled expiration date. The data presented supports substantial equivalence of the contact lenses to the already marketed predicate device.
Physicochemical & Mechanical Properties:
The following tests were completed to verify substantial equivalence to predicate devices: refractive index, water content, oxygen permeability, light transmission, tensile strength, modulus, elongation to break, specific gravity and polymerization residuals. Results of physicochemical and mechanical property testing demonstrate consistency of the material properties between the POLYVUE and POLYVUE COLOR (polymacon) contact lenses and the predicate device.
Clinical Testing:
Clinical testing is not required. The clinical performance of soft (hydrophilic) contact lenses manufactured from polymacon materials has been demonstrated previously.
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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' in blue, with 'ADMINISTRATION' written below in a smaller font.
October 04, 2022
Interojo Inc. % Mr. Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Lane West Linn, OR 97068
Re: K221517
Trade/Device Name: POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: August 30, 2022 Received: August 30, 2022
Dear Mr. Bret 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221517
Device Name
POLYVUE (polymacon) Soft (hydrophilic) Contact Lens; POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens
Indications for Use (Describe)
The POLYVUE and POLYVUE COLOR (polymacon) ASPHERIC Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of refractive error in not-aphakic persons with otherwise non-diseased eyes with myopia or hyperopia and early presbyopia up to 1.25 diopters. The lenses may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The lenses are available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The POLYVUE and POLYVUE COLOR (polymacon) ASPHERIC TORIC Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of refractive error in not-aphakic persons with otherwise non-diseased eyes with myopia or hyperopia and early presbyopia up to 1.25 diopters. The lenses may be worn by persons who exhibit refractive astigmatism of 5.00 diopters or less. The lenses are available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Eye care practitioners may prescribe the lenses in a frequent/planned replacement program with cleaning, disinfection, and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
Type of Use (Select one or both, as applicable)
| ü Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510 (k) SUMMARY
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: K221517
I. SUBMITTER
- August 22nd, 2022 Date Prepared: Name: INTEROJO INC. Address: 28& 25 Sandan-Ro 15 Beon-Gil PYONGTAEK-CITY Gyeonggi, SOUTH KOREA Contact Person: Si-Chul, Rho CEO +82-031-612-8500 Phone number: Consultant: Bret Andre EyeReg Consulting, Inc. 6119 Canter Ln. West Linn, OR 97068 Phone number: (503) 372-5226
II. DEVICE
| Trade Name: | POLYVUE (polymacon) Soft (hydrophilic) Contact Lens;
POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens |
|-------------------------|-------------------------------------------------------------------------------------------------------------------|
| Common
Name: | Contact Lens, Daily Wear |
| Classification
Name: | Soft (hydrophilic) Contact Lens (21 CFR 886.5925) |
| Regulatory
Class: | Class II |
| Product Code: | LPL |
4
III. PREDICATE DEVICE
The POLYVUE and POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lenses are substantially equivalent to the following predicate device:
- I "HD/HDT, (polymacon) Soft Contact Lens for Daily Wear (clear and tinted, fully castmolded lens)" By PolyVue Technologies, Inc. 510(k) number; K020608 Primary Predicate
- I "Clalen 54 (hioxifilcon D) & Clalen 58 (hioxifilcon A) Soft Contact Lenses" By Interojo, Inc. 510(k) number; K153766 Reference Predicate
IV. DEVICE DESCRIPTION
The POLYVUE and POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lenses are manufactured using the cast molding method. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from polymacon, which is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). The co-polymer consists of 62% polymacon and 38% water by weight when immersed in saline solution. The polymacon name has been adopted by the United States Adopted Names Council (USAN).
The POLYVUE (polymacon) Soft (hydrophilic) Contact Lens is available clear or tinted for visibility using phthalocyanine blue. The POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens contains a unique tinted pattern to enhance or alter the apparent color of the eye. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives:
| Color Additive | Listing |
|---|---|
| Phthalocyanine blue | 21 CFR 74.3045 |
| Phthalocyanine green | 21 CFR 73.3124 |
| Titanium dioxide | 21 CFR 73.3126 |
| Iron Oxide | 21 CFR 73.3125 |
| Reactive black 5 | 21 CFR 73.3121 |
| Carbazole violet | 21 CFR 73.3107 |
When producing the color lenses, the manufacturing process changes the specifications of the clear lens by pad-printing the color pigment(s)-entrapping the colorants in the interpenetrating network of the contact lens material-in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the clear, pre-tinted lens. The tinting pattern has a clear pupil diameter of 6.0 mm.
5
The POLYVUE and POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lenses are manufactured in an aspheric design configuration. The material properties and available parameters of the finished lenses are as follows:
| Parameter | Range | Tolerance* |
|---|---|---|
| Chord Diameter | 11.00 mm to 15.00 mm | ±0.20 mm |
| Center Thickness | 0.05 mm to 0.15 mm | When ≤ 0.10 mm → ±0.010 mm + 10% |
| When > 0.10 mm → ±0.015 mm + 5% | ||
| Base Curve | 7.00 mm to 10.0 mm | ±0.20 mm |
| Back Vertex Power (F'v) | +10.00 D to -20.00D | |
| (in 0.25D steps) | When 0.00 1.50 D → ± 5° | |
| Surface Appearance | - | Lenses should be clear with no surface defect |
| Oxygen Permeability | ||
| (x 10-11(cm²/sec)(mlO2)/(ml x mmHg)) | 8.9 | ±20% |
| Light Transmission - Clear | ||
| (@ 380-780nm) | 95% | ±5% |
| Light Transmission - Tinted | ||
| (@ 380-780nm) | 95% | ±5% |
| Water Content | 38% | ±2% |
| Refractive Index | 1.440 (hydrated) | +0.005 |
- ISO 18369-2:2017 Ophthalmic optics - Contact lenses - Part 2: Tolerances
V. INDICATIONS FOR USE
The POLYVUE and POLYVUE COLOR (polymacon) ASPHERIC Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of refractive error in not-aphakic persons with otherwise non-diseased eyes with myopia or hyperopia and early presbyopia up to 1.25 diopters. The lenses may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The lenses are available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The POLYVUE and POLYVUE COLOR (polymacon) ASPHERIC TORIC Soft (hydrophilic)
Contact Lenses for daily wear are indicated for the correction of refractive error in not-aphakic persons with otherwise non-diseased eves with mvopia or hyperopia and early presbyopia up to 1,25 diopters. The lenses may be worn by persons who exhibit refractive astigmatism of 5.00 diopters or less. The lenses are available clear or tinted and may be used to enhance or alter the apparent color of the eye.
6
Eye care practitioners may prescribe the lenses in a frequent/planned replacement program with cleaning, disinfection, and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE
The POLYVUE and POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lenses are substantially equivalent to the predicate device (K020608) in terms of the following:
- 트 USAN contact lens material (polymacon)
- FDA Group 1 (50% H2O, non-ionic polymer) |
| Production
Method | Fully molded | Fully molded | Fully molded |
| USAN name | polymacon | polymacon | hioxifilcon D
hioxifilcon A |
| Water Content
(%) | 38±2% | 38±2% | 54±2%
59±2% |
| Oxygen
Permeability
x 10-11
(cm²/sec)(mlO2)/(ml x
mmHg @ 35°C))
(revised Fatt method) | 10.26± 20% | 8.9± 20% | 18.42± 20%
20.76± 20% |
| Refractive Index
(hydrated) | 1.438 ± 0.005 | 1.440 ± 0.005 | 1.404 ± 0.005
1.403 ± 0.005 |
| UV Blocker | No | No | Yes |
| Pad-Printed
Tinting | Yes | Yes | Yes |
| Primary
Packaging | blister base, foil seal | blister base, foil seal | blister base, foil seal |
| Sterilization
Method | Steam sterilization | Steam sterilization | Steam sterilization |
| Indications for Use | |
|---|---|
| Interojo Inc. | |
| POLYVUE and | |
| POLYVUE | |
| COLOR | |
| (Subject Device) | The POLYVUE and POLYVUE COLOR (polymacon) ASPHERIC Soft (hydrophilic) Contact Lenses for |
| daily wear are indicated for the correction of refractive error in not-aphakic persons with otherwise non-diseased | |
| eyes with myopia or hyperopia and early presbyopia up to 1.25 diopters. The lenses may be worn by persons who | |
| exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. | |
| The lenses are available clear or tinted and may be used to enhance or alter the apparent color of the eye. | |
| The POLYVUE and POLYVUE COLOR (polymacon) ASPHERIC TORIC Soft (hydrophilic) Contact Lenses | |
| for daily wear are indicated for the correction of refractive error in not-aphakic persons with otherwise non-diseased | |
| eyes with myopia or hyperopia and early presbyopia up to 1.25 diopters. The lenses may be worn by persons who | |
| exhibit refractive astigmatism of 5.00 diopters or less. The lenses are available clear or tinted and may be used to | |
| enhance or alter the apparent color of the eye. | |
| Eye care practitioners may prescribe the lenses in a frequent/planned replacement program with cleaning, | |
| disinfection, and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be | |
| disinfected using a chemical disinfecting system. | |
| PolyVue | |
| Technologies, | |
| Inc. | |
| HD/HDT | |
| (K020608) | The HD (polymacon) ASPHERIC Soft Contact Lenses for daily wear are indicated for the correction of visual |
| acuity in not aphakic persons with non-diseased eyes with myopia or hyperopia and early presbyopia up to 1.25 | |
| diopters. The lenses may be worn by persons who exhibit refractive astigmatism of 1.50 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 HDT (polymacon) ASPHERIC TORIC Soft Contact Lenses for daily wear are indicated for the correction of | |
| visual acuity in not aphakic persons with otherwise non-diseased eyes with myopia or hyperopia, possesses | |
| refractive astigmatism not exceeding 5.00 diopters and early presbyopia up to 1.25 diopters. The lens is available | |
| clear or tinted and may be used to enhance or alter the apparent color of the eye. | |
| 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. | |
| The Clalen 54 (hioxifilcon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of | |
| refractive error 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 0.75 diopters or less where the astigmatism does not | |
| interfere with visual acuity. The lens is available clear or tinted for visibility and handling. | |
| Interojo, Inc. | |
| Clalen 54 & | |
| Clalen 58 | |
| (K153766) | The Clalen 54 (hioxifilcon D) Toric Soft Contact Lenses for daily wear are indicated for the correction of refractive |
| error 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 for visibility and handling. | |
| The Clalen 54 (hioxifilcon D) Multifocal Soft Contact Lenses for daily wear are indicated for the correction of | |
| refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may | |
| be worn by presbyopic persons requiring an add power ranging from +1.25D to +2.50D, and who exhibit refractive | |
| astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available | |
| clear or tinted for visibility and handling. | |
| The Clalen 54 (hioxifilcon D) Toric-Multifocal Soft Contact Lenses for daily wear are indicated for the correction | |
| of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia, possesses | |
| refractive astigmatism not exceeding 5.00 diopters. The lens may be worn by presbyopic persons requiring an add | |
| power ranging from +1.25D to +2.50D. The lens is available clear or tinted for visibility and handling. | |
| The Clalen 58 (hioxifilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of | |
| refractive error 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 0.75 diopters or less where the astigmatism does not | |
| interfere with visual acuity. The lens is available clear or tinted for visibility and handling. | |
| The Clalen 58 (hioxifilcon A) Toric Soft Contact Lenses for daily wear are indicated for the correction of refractive | |
| error 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 for visibility and handling. | |
| The Clalen 58 (hioxifilcon A) Multifocal Soft Contact Lenses for daily wear are indicated for the correction of | |
| refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may | |
| be worn by presbyopic persons requiring an add power ranging from +1.25D to +2.50D, and who exhibit refractive | |
| astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available | |
| clear or tinted for visibility and handling. | |
| The Clalen 58 (hioxifilcon A) Toric-Multifocal Soft Contact Lenses for daily wear are indicated for the correction | |
| of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia, possesses | |
| refractive astigmatism not exceeding 5.00 diopters. The lens may be worn by presbyopic persons requiring an add | |
| power ranging from +1.25D to +2.50D. The lens is available clear or tinted for visibility and handling. | |
| Daily wear replacement schedules may vary from patient to 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. |
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VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Non-clinical Testing
A series of non-clinical testing was performed to demonstrate the safety and effectiveness of the POLYVUE and POLYVUE COLOR (polymacon) finished contact lenses. The results support the claim that the POLYVUE and POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lenses are substantially equivalent to the currently marketed predicate device. A summary of the results from the non-clinical studies is presented below.
Toxicology:
All non-clinical toxicology tests were conducted in accordance with the GLP regulation.
- · In-Vitro Cytotoxicity: Cytotoxicity testing was performed in accordance with ISO 10993-5 with results indicating that the finished lenses extracts are non-toxic.
- · Sensitization: Skin sensitization testing was performed in accordance with ISO 10993-10 with the results confirming the lens extracts do not cause sensitization.
- · Acute Ocular Irritation: Acute ocular irritation testing was performed in accordance with ISO 10993-10 and finished lens extracts were non-irritating.
- · Systemic Toxicity: The finished lenses meet the requirements of the systemic injection test in accordance with ISO 10993-11 and are considered non-toxic.
Shelf Life:
Testing was performed to evaluate the stability, sterility, and package integrity of the POLYVUE and POLYVUE COLOR (polymacon) finished contact lenses over the duration of the labeled expiration date. The data presented supports substantial equivalence of the contact lenses to the already marketed predicate device.
Physicochemical & Mechanical Properties:
The following tests were completed to verify substantial equivalence to predicate devices: refractive index, water content, oxygen permeability, light transmission, tensile strength, modulus, elongation to break, specific gravity and polymerization residuals. Results of physicochemical and mechanical property testing demonstrate consistency of the material properties between the POLYVUE and POLYVUE COLOR (polymacon) contact lenses and the predicate device.
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Clinical Testing
Clinical testing is not required. The clinical performance of soft (hydrophilic) contact lenses manufactured from polymacon materials has been demonstrated previously.
VIII. CONCLUSIONS
Validity of Scientific Data
Laboratories conducted non-clinical studies following 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 POLYVUE and POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lenses are as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the proposed indication.
Risks and Benefits
The risks of the subject device are the same as those normally attributed to the wearing of soft (hydrophilic) daily wear contact lenses. The benefits to the patient are the same as those for other soft (hydrophilic) daily wear contact lenses.