(50 days)
Not Found
No
The summary describes standard contact lenses with different designs (single vision, toric, multifocal) and UV protection. There is no mention of any computational analysis, image processing, or adaptive features that would suggest the use of AI or ML. The testing described is standard for contact lenses and does not involve AI/ML performance metrics.
No
The device corrects refractive ametropia and presbyopia, and protects against UV radiation, which are functions of a corrective and protective device rather than a therapeutic one designed to treat a disease or condition.
No
This device is a contact lens used for the correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia). It is a corrective device, not a diagnostic one.
No
The device is a contact lens, which is a physical medical device made of a hydrophilic polymer. The description details the material composition and physical properties of the lens, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use clearly state that this device is a contact lens designed to be worn on the eye for the correction of refractive errors (myopia, hyperopia, astigmatism, presbyopia) and to provide UV protection. It is a physical device applied to the body, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing procedures, which are hallmarks of IVD devices.
Therefore, the Saview-Aqua 58 UV contact lens and its variations are medical devices, but they fall under a different classification than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Saview-Aqua 58 UV (etafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hypcropia) in aphakic or not-aphakic persons with non-diseased cycs that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.
The Saview-Aqua 58 UV Toric (etafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lcns is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic or not-aphakic persons with non-discased cycs that may exhibit refractive astigmatism up to 2.50 diopters that docs not interfere with visual acuity.
The Saview-Aqua 58 UV Multifocal (etafilcon A) Visibility Tinted 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 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-Aqua 58 UV, Saview-Aqua 58 UV Toric and Saview-Aqua 58 UV Multifocal lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The 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 matcrial (ctafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate and methacrylic acid crosslinked with 1, 1, 1-irimethylol propane trimethacrylate. A UV absorbing monomer, 2-13-(2H-Benzotriazol-2y1)-4hydroxypheny]] ethyl methacrylate, is incorporated into the lens polymer and used to block UV radiation. The UV blocker for Saview-Aqua 58 UV (etafilcon A) Visibility tinted Soft (Hydrophilic) Contact Lens averages 85.063 % in the UVA range of 316 nm to 380 nm and 97.984 % in the UVB range of 315 nm to 280 nm. The lens contains 58% water by wcight and each lens is supplied sterile in a blister container containing SYS TO.2 % "hyaluronic acid polymer in saline solution. The lens is visibility innelli Pigment Blue 15(Copper phthalocyanine) to make the lens more visible for handling.
The Saview-Aqua 58 UV (ctafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is available as a single vision lens.
The Saview-Aqua 58 UV Toric (etafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is available in a double slab-off back surface design. The lens design incorporates a cylinder and base curve. From the bi-curve reduced optic front surface, there exists a slab-off of the upper and lower half of the lens. This makes both sides thicker at the horizontal level on the front surface to keep the axis stable.
The Saview-Aqua 58 UV Multifocal (etafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is available as an aspherical multifocal lens.
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 I
- Ocular Irritation ■
- 트 Acute Systemic Injection
- . Physical/Chemical Testing
Clinical Testing:
Clinical data is not required for this submission.
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
St, Shine Optical Co., Ltd
.
r
05 Summary of 510(k) Submission
Submitter Information:
| Address: | St. Shine Optical Co., Ltd.
4,5F No. 276-2, Sec. 1, Ta Tung Rd.
Hsi Chih Dist., 221, New Taipei City
Taiwan R.O.C. |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Registration No.: | 9617499 |
| Contact Person: | Ella Lee,
Product Manager, R&D Div. |
| Telephone: | 886-2-2647-9356 |
| Fax: | 886-2-8691-6776 |
| Date Prepared: | June 28, 2013 |
AUG 30 2013
Device:
| Common Name: | Soft (Hydrophilic) Contact Lens |
|---|---|
| Trade/Proprietary Name: | Saview-Aqua 58 UV (etafilcon A) Visibility Tinted Soft |
| (Hydrophilic) Contact Lens | |
| Saview-Aqua 58 UV Toric (etafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens | |
| Saview-Aqua 58 UV Multifocal (etafilcon A) Visibility Tinted 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 58 UV, Saview 58 UV Toric, and Saview 58 UV Multifocal (etafilcon A) Soft (hydrophilic) Lens for Daily Wear covered under 510(k) K092852 and Saview-Aqua 55, Saview-Aqua 55 UV Toric and Saview-Aqua 55 UV Multifocal UV (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens covered under 510(k) K121201.
Description of Devices:
1
ﺎ
The lens matcrial (ctafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate and methacrylic acid crosslinked with 1, 1, 1-irimethylol propane trimethacrylate. A UV absorbing monomer, 2-13-(2H-Benzotriazol-2y1)-4hydroxypheny]] ethyl methacrylate, is incorporated into the lens polymer and used to block UV radiation. The UV blocker for Saview-Aqua 58 UV (etafilcon A) Visibility tinted Soft (Hydrophilic) Contact Lens averages 85.063 % in the UVA range of 316 nm to 380 nm and 97.984 % in the UVB range of 315 nm to 280 nm. The lens contains 58% water by wcight and each lens is supplied sterile in a blister container containing SYS TO.2 % "hyaluronic acid polymer in saline solution. The lens is visibility innelli Pigment Blue 15(Copper phthalocyanine) to make the lens more visible for handling.
The Saview-Aqua 58 UV (ctafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is available as a single vision lens.
The Saview-Aqua 58 UV Toric (etafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is available in a double slab-off back surface design. The lens design incorporates a cylinder and base curve. From the bi-curve reduced optic front surface, there exists a slab-off of the upper and lower half of the lens. This makes both sides thicker at the horizontal level on the front surface to keep the axis stable.
The Saview-Aqua 58 UV Multifocal (etafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is available as an aspherical multifocal lens.
Indication for Use:
The Saview-Aqua 58 UV (ctafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hypcropia) in aphakic or not-aphakic persons with non-diseased cycs that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.
The Saview-Aqua 58 UV Toric (ctafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lcns is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic or not-aphakic persons with non-discased cycs that may exhibit refractive astigmatism up to 2.50 diopters that docs not interfere with visual acuity.
The Saview-Aqua 58 UV Multifocal (etafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia
2
(myopia and hyperopia) and presbyopia 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 and require add power of up to +3.25 diopters.
The Saview-Aqua 58 UV, Saview-Aqua 58 UV Toric and Saview-Aqua 58 UV Multifocal lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The 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.
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 I
- Ocular Irritation ■
- 트 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) cstablishes that the Saview-Aqua 58 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 biocompatibility tests showed the Saview-Aqua 58 UV lenses are substantially equivalent to the predicate device in safety and biocompatibility. Therefore, the Saview-Aqua 58 UV, Savicw-Aqua 58 UV Toric, and Saview-Aqua 58 UV Multifocal (ctafflcon A) Soft (Hydrophilic) Contact Lens are substantially equivalent to the predicate devices.
3
.
;
.
.
.
:
:
ﻳ
.
:
·
s,
| Table 1 Comparison Chart | |||
|---|---|---|---|
| Saview-Aqua 58 UV, | |||
| Saview-Aqua 58 UV | 58 UV, 58UV | ||
| Multifocal, and 58 | Saview-Aqua 55 UV, | ||
| Saview-Aqua 55 UV | |||
| Toric, and Saview-Aqua | UV Toric Soft | Toric, and Saview-Aqua | |
| 58 UV Multifocal Soft | (Hydrophilic) | 55 UV Multifocal Soft | |
| Device | (Hydrophilic) Contact | ||
| Lens | Contact Lens | ||
| ( K092852) | (Hydrophilic) Contact | ||
| Lens (K121201) | |||
| etafilcon A | etafilcon A | methafilcon A | |
| Material (Classification) | (Group 4) | (Group 4) | (Group 4) |
| myopia, hyperopia, | myopia, hyperopia, | myopia, hyperopia, | |
| Indication for use | presbyopia and | presbyopia and | presbyopia and |
| astigmatism | astigmatism | astigmatism | |
| Water content | 58 % | 58 % | 55 % |
| Visible light | |||
| transmittance | |||
| (381 nm ~ 780 nm) | 91.752% | 91.752% | 96.78 % |
| UV Transmittance | |||
| UVA(316 nm ~ 380 nm) | 14.937 % | 14.937 % | 12.370 % |
| UVB(280 nm ~ 315 nm) | 2.016 % | 2.016 % | 1.025 % |
| Dk (35° C) | $26.3 \times 10^{-11}$ | $26.3 \times 10^{-11}$ | $21.4 \times 10^{-11}$ |
| Powers | +12.00 to -20.00D | +12.00 to -12.00D | +12.00 to -20.00D |
| Color | Pigment blue 15 | Pigment blue 15 | Pigment blue 15 |
| Refractive index | 1.3992 (wet) | 1.3992 (wet) | 1.404 (wet) |
| Method of manufacture | Moulded | Moulded | Moulded |
| Package Storage saline | |||
| solution | Saline solution containing | ||
| hyaluronic acid polymer | Saline solution | Saline solution containing | |
| hyaluronic acid polymer |
·
:
:
.
Table 1 Comparison Chart
Saview-Aqua 58 UV (etafilcon A) Soft (Hydrophilic) Contact Lens 510(k)
・
:
4
Conclusion:
A series of pre-clinical tests were performed to demonstrate the safety and cffectivencss of the Saview-Aqua 58 UV, Saview-Aqua 58 UV Toric, and Saview-Aqua 58 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-Aqua 58 UV lenses do not raise questions of safety and effectiveness. Therefore, the Saview-Aqua 58 UV, Saview-Aqua 58 UV Toric, and Saview-Aqua 58 UV Multifocal (etafilcon A) Soft (Hydrophilic) Contact Lens are substantially equivalent to the predicate devices.
Saview-Aqua 58 UV (etafilcon A) Soft (Hydrophilic) Contact Lens 510(k)
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 30, 2013
St Shine Optical Co., Ltd. % Ms. Ella Lee Product Manager, R & D Div. . 4,5F No. 276-2, Sec. 1, Ta Tung Rd. His Chih Dist., 221 New Taipei City Taiwan R.O.C.
Re: K132146
Trade/Device Name: Saview-Aqua 58 UV (etallicon A) Visibility Tinted Soft (Hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (I-lydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: July 25, 2013 Received: July 26, 2013
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.
6
Page 2 - Ms. Ella Lee
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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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. Evdelman, M.D. Director Division of Ophthalmic and Ear. Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
7
Indications for Use
510(k) Number: K132146
Device Name:
Saview-Aqua 58 UV (etafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens, Saview-Aqua 58 UV Toric (etafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens, Saview-Aqua 58 UV Multifocal (etafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
Indications For Use:
The Saview-Aqua 58 UV (etafilcon A) Visibility Tinted 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-Aqua 58 UV Toric (etafilcon A) Visibility Tinted 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-Aqua 58 UV Multifocal (etafilcon A) Visibility Tinted 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 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-Aqua 58 UV, Saview-Aqua 58 UV Toric and Saview-Aqua 58 UV Multifocal lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The 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.
| Prescription Use (part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Jeffrev M. Brocious -S 2013.08.28 10:54:15 -04'00' (Division Sign-Off) Division of Ophthalmic and Ear, Nose, and Throat Devices
510(k) Number:________________________________________________________________________________________________________________________________________________________________