(63 days)
Not Found
No
The summary describes a standard contact lens with different designs (spherical, toric, multifocal) and color pigments. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI or ML. The testing described is standard for contact lenses (stability, toxicology, physical/chemical).
No.
The device is indicated for the correction of ametropia, which is a refractive error, not a disease. While it corrects vision, it does not treat a disease or restore health to diseased tissue, which are characteristics of a therapeutic device.
No
Explanation: The device description clearly states its intended use is for "correction of refractive ametropia" and to "enhance or alter the apparent color of the eye," which are therapeutic/cosmetic purposes, not diagnostic ones. There is no mention of it being used to detect or identify a disease or condition.
No
The device description clearly describes a physical contact lens made of a hydrophilic polymer, containing water, pigments, and a UV absorbing compound. 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:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Saview-Colors Aqua 42 UV contact lenses are medical devices intended for the correction of refractive errors (myopia, hyperopia, astigmatism, presbyopia) and to alter the appearance of the eye color. They are placed directly on the surface of the eye.
- Lack of Biological Sample Testing: The description and intended use do not involve the analysis of any biological samples taken from the patient.
Therefore, the Saview-Colors Aqua 42 UV contact lens falls under the category of a medical device, specifically an ophthalmic device, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for the correction of refractive ametropia (myperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. The Saview-Colors Aqua 42 UV also acts to enhance or alter the apparent color of the eye.
The Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic persons with nondiseased eyes that may exhibit refractive astigmatism up to 2.50 diopters that does not interfere with visual acuity. The Saview-Colors Aqua 42 UV Toric lens also acts to enhance or alter the apparent color of the eye.
The Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with nondiseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity and require add power of up to +3.25 diopters. The Saview-Colors Aqua 42 UV lens also acts to enhance or alter the apparent color of the eye.
Saview-Colors Aqua 42 UV, Saview-Colors Aqua 42 UV Toric, and Saview-Colors Aqua 42 UV Multifocal lenses are to be prescribed for single-use daily disposable wear and not intended to be cleaned or disinfected and should be discarded after a single use.
Product codes (comma separated list FDA assigned to the subject device)
LPL, MVN
Device Description
The lens material (hefilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and n-vinyl-2-pyrrolidone (NVP) crosslinked with ethylene glycol dimethacrylate (EGDMA). A UV absorbing compound 2-[3-(2H-Benzotriazol-2y1)-4-hydroxyphenyl] ethyl methacrylate is incorporated into the lens polymer. The lens contains 42% water by weight and each lens is supplied sterile in a blister container containing hyaluronic acid polymer in saline solution. The lenses are printed with an intermittent coating containing a combination of the following approved pigments: iron oxides, titanium dioxide, phthalocyanine green and carbazole violet listed in 21 CFR Part 73 and [phthalocyaninato (2-)] copper list in 21 CFR Part 74. The lens designs include spherical, toric and multifocal lenses.
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
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:
The following tests were conducted as recommended by the Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, revised May 1994.
- Stability Testing
- Toxicology Testing
- Cytotoxicity
- Ocular Irritation
- Acute Systemic Injection
- Physical/Chemical Testing
Clinical Testing:
Clinical data is not required for this submission.
Description of Safety and Substantial Equivalence:
Information submitted in the 510(k) establishes that the Saview-Colors Aqua 42 UV lenses have comparable physicochemical properties to the predicate devices and do not raise questions of safety and effectiveness. Shelf life testing has shown the lenses remain sterile and that lens properties do not change before the expiration date. Results of acute systemic injection, ocular irritation and in vitro cytotoxicity tests showed the Saview-Colors Aqua 42 UV lenses are substantially equivalent to the predicate device in safety and biocompatibility. Therefore, the Saview-Colors Aqua 42 UV, Saview-Colors Aqua 42 UV Toric, and Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens are substantially equivalent to the predicate devices.
Conclusion:
A series of pre-clinical tests were performed to demonstrate the safety and effectiveness of the Saview-Colors Aqua 42 UV, Saview-Colors Aqua 42 UV Toric, and Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens and to establish substantial equivalence to the predicate devices. Information submitted in the 510(k) also establishes that the Saview-Colors Aqua 42 UV lenses do not raise questions of safety and effectiveness. Therefore, the Saview-Colors Aqua 42 UV, Saview-Colors Aqua 42 UV Toric, and Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens are substantially equivalent to the predicate devices.
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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 21, 2016
St. Shine Optical Co., Ltd. Ms. Ella Lee Project Manager, R&D Div. 4,5F No. 276-2, Sec. 1, Ta Tung Rd., Hsi Chih Dist. New Taipei City, TW 22146
Re: K162317
Trade/Device Name: Saview-Colors Aqua 42 UV (hefilcon A) Soft (hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL. MVN Dated: August 15, 2016 Received: September 2, 2016
Dear Ms. Lee:
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.
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
1
(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,
Kesia Alexander
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) K162317
Device Name
Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens
Indications for Use (Describe)
The Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for the correction of refractive ametropia (myperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. The Saview-Colors Aqua 42 UV also acts to enhance or alter the apparent color of the eye.
The Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic persons with nondiseased eyes that may exhibit refractive astigmatism up to 2.50 diopters that does not interfere with visual acuity. The Saview-Colors Aqua 42 UV Toric lens also acts to enhance or alter the apparent color of the eye.
The Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with nondiseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity and require add power of up to +3.25 diopters. The Saview-Colors Aqua 42 UV lens also acts to enhance or alter the apparent color of the eye.
Saview-Colors Aqua 42 UV, Saview-Colors Aqua 42 UV Toric, and Saview-Colors Aqua 42 UV Multifocal lenses are to be prescribed for single-use daily disposable wear and not intended to be cleaned or disinfected and should be discarded after a single use.
| 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) |
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Submitter Information:
| Address: | St. Shine Optical Co., Ltd. | ||
|---|---|---|---|
| 4,5F No. 276-2, Sec. 1, Ta Tung Rd. | |||
| Hsi Chih Dist., 22146, New Taipei City | |||
| Taiwan R.O.C. | |||
| Registration No.: | 9617499 | ||
| Contact Person: | Ella Lee | ||
| Project Manager, R&D Div. | |||
| Telephone: | 886-2-2647-9356 | ||
| Fax: | 886-2-8691-6776 | ||
| Date Prepared: | Aug.10, 2016 |
Device:
| Common Name: | Soft (Hydrophilic) Contact Lens |
|---|---|
| Trade/Proprietary Name: | Saview-Colors Aqua 42 UV (hefilcon A) Soft |
| (Hydrophilic) Contact Lens | |
| Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft | |
| (Hydrophilic) Contact Lens | |
| Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft | |
| (Hydrophilic) Contact Lens | |
| Classification Name: | Soft (Hydrophilic) Contact Lens (daily wear) |
| Device Classification: | Class II (21 CFR 886.5925) |
| Product Code: | LPL, MVN |
| Panel: | Ophthalmic |
Predicate Devices:
The predicate devices are Saview-Colors 42 UV, Saview-Colors 42 UV Toric, and Saview-Colors 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens covered under 510(k) K123484 and Saview-Aqua 55 UV, Saview-Aqua 55 UV Toric, and Saview-Aqua 55 UV Multifocal(methafilcon A) Soft (Hydrophilic) Contact Lens covered under 510(k) K121201.
4
Description of Devices:
The lens material (hefilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and n-vinyl-2-pyrrolidone (NVP) crosslinked with ethylene glycol dimethacrylate (EGDMA). A UV absorbing compound 2-[3-(2H-Benzotriazol-2y1)-4-hydroxyphenyl] ethyl methacrylate is incorporated into the lens polymer. The lens contains 42% water by weight and each lens is supplied sterile in a blister container containing hyaluronic acid polymer in saline solution. The lenses are printed with an intermittent coating containing a combination of the following approved pigments: iron oxides, titanium dioxide, phthalocyanine green and carbazole violet listed in 21 CFR Part 73 and [phthalocyaninato (2-)] copper list in 21 CFR Part 74. The lens designs include spherical, toric and multifocal lenses.
Indication for Use:
The Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. The Saview-Colors Aqua 42 UV also acts to enhance or alter the apparent color of the eye.
The Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.50 diopters that does not interfere with visual acuity. The Saview-Colors Aqua 42 UV Toric lens also acts to enhance or alter the apparent color of the eye.
The Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity and require add power of up to +3.25 diopters. The Saview-Colors Aqua 42 UV Multifocal lens also acts to enhance or alter the apparent color of the eye.
The Saview-Colors Aqua 42 UV, Saview-Colors Aqua 42 UV Toric and Saview-Colors Aqua 42 UV Multifocal lenses are to be prescribed for single-use daily disposable wear and not intended to be cleaned or disinfected and should be discarded after a single use.
5
Non-Clinical Testing:
The following tests were conducted as recommended by the Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, revised May 1994.
- Stability Testing
- Toxicology Testing
- Cytotoxicity ■
- Ocular Irritation ■
- Acute Systemic Injection ■
- Physical/Chemical Testing
Clinical Testing:
Clinical data is not required for this submission.
Description of Safety and Substantial Equivalence:
Information submitted in the 510(k) establishes that the Saview-Colors Aqua 42 UV lenses have comparable physicochemical properties to the predicate devices and do not raise questions of safety and effectiveness. Shelf life testing has shown the lenses remain sterile and that lens properties do not change before the expiration date. Results of acute systemic injection, ocular irritation and in vitro cytotoxicity tests showed the Saview-Colors Aqua 42 UV lenses are substantially equivalent to the predicate device in safety and biocompatibility. Therefore, the Saview-Colors Aqua 42 UV, Saview-Colors Aqua 42 UV Toric, and Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens are substantially equivalent to the predicate devices.
6
| | Saview-Colors Aqua 42
UV, Saview-Colors Aqua
42 UV Toric, and
Saview-Colors Aqua 42
UV Multifocal (hefilcon
A) Soft (Hydrophilic)
Contact Lens | Saview-Colors 42 UV,
Saview-Colors 42 UV
Toric, and
Saview-Colors 42 UV
Multifocal (hefilcon A)
Soft (Hydrophilic)
Contact Lens (K123484) | Saview-Aqua 55 UV,
Saview-Aqua 55 UV
Toric, and
Saview-Aqua 55 UV
Multifocal Soft
(Hydrophilic) Contact
Lens (K121201) | |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Material
(Classification) | hefilcon A
(Group 1) | hefilcon A
(Group 1) | methafilcon A
(Group 4) | |
| Indication for
use | myopia, hyperopia,
presbyopia and
astigmatism | myopia, hyperopia,
presbyopia and
astigmatism | myopia, hyperopia,
presbyopia and
astigmatism | |
| Water content | 42 % | 42 % | 55 % | |
| Visible light
transmittance | 97.06 % | 97.06 % | 96.78 % | |
| UV
Transmittance | UVA : 9.22 %
UVB : 0.49 % | UVA : 9.22 %
UVB : 0.49 % | UVA : 12.370 %
UVB : 1.025 % | |
| Dk (35° C) | $10.89×10^{-11}$ | $10.89×10^{-11}$ | $21.4x10^{-11}$ | |
| Powers | +12.00D to -20.00D; | +12.00D to -20.00D; | +12.00D to -20.00D | |
| Refractive index | 1.4347 (wet) | 1.4347 (wet) | 1.404 (wet) | |
| Method of
manufacture | Moulded | Moulded | Moulded | |
| Packaging | PP Blister Pack | PP Blister Pack | PP Blister Pack | |
| Colorants | Iron oxides
Titanium dioxide
[Phthalocyaninato (2-)]
copper
Phthalocyanine green
Carbazole violet | Iron oxides
Titanium dioxide
[Phthalocyaninato (2-)]
copper
Phthalocyanine green
Carbazole violet | Copper phthalocyanine
(visibility tinted) | |
| | Package Storage
saline solution | Saline solution containing
hyaluronic acid polymer | Saline solution | Saline solution
containing hyaluronic
acid polymer |
Table 1 Comparison Chart
7
Conclusion:
A series of pre-clinical tests were performed to demonstrate the safety and effectiveness of the Saview-Colors Aqua 42 UV, Saview-Colors Aqua 42 UV Toric, and Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens and to establish substantial equivalence to the predicate devices. Information submitted in the 510(k) also establishes that the Saview-Colors Aqua 42 UV lenses do not raise questions of safety and effectiveness. Therefore, the Saview-Colors Aqua 42 UV, Saview-Colors Aqua 42 UV Toric, and Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens are substantially equivalent to the predicate devices.