(84 days)
Not Found
No
The summary describes a standard contact lens made of a specific material with UV blocking properties. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No.
The 'Intended Use / Indications for Use' section states the device is used for correction of refractive ametropia (myopia and hyperopia) and astigmatism, not for treating a disease or condition.
No
Explanation: The device description states it is a soft contact lens for the correction of refractive ametropia. Its purpose is to correct vision, not to diagnose a condition.
No
The device description clearly states it is a physical contact lens made of hydrogel material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a contact lens for the correction of refractive errors (myopia, hyperopia, astigmatism, presbyopia). This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The description details the material, composition, and physical properties of the contact lens. It does not mention any components or mechanisms for analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on biocompatibility, sterilization, stability, and physical/optical properties of the lens itself. There are no studies related to analyzing patient samples or providing diagnostic results.
- Lack of Diagnostic Function: An IVD is a device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility with potential recipients, or concerning a therapeutic measure or to monitor therapeutic measures. This contact lens does not perform any of these functions.
Therefore, the Daily Breeze B (olifilcon B) Silicone Hydrogel Soft Contact Lens is a medical device, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens is indicated as daily wear and single use soft contact lens for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00 D or less here the astigmatism does not interfere with visual acuity.
The Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear and single use for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with nondiseased eyes and whose powers are from -12.00 to +8.00 D and astigmatism corrections are from -0.75 to -2.25 D.
The Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lenses are indicated as daily wear and single use for the correction of ametropia (myperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -12.00 to +8.00 D with add powers from +0.25 to +2.75 D. The lenses may be worn by persons who exhibit astigmatism of 1.00 D or less where the astigmatism does not interfere with visual acuity.
Evecare practitioners prescribe the lens for single-use disposable wear.
Product codes (comma separated list FDA assigned to the subject device)
LPL, MVN
Device Description
The Daily Breeze B (olifilcon B) Silicone Hydrogel Soft Contact Lens is made of hydrogel material, olifilcon B, with UV blocker available as spherical lens, toric lens and multifocal lens. The composition of the lens is 53% olifilcon B, which is a copolymer of 1-vinyl-2-pyrrolidinone (NVP) and Siloxane macromer, and 47% water. A light blue color tinted with "reactive Blue19" listed in 21 CFR Part 73.3121is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The UV transmission (the thinnest lens measured by spectrophotometry as stated in ISO 18369) is less than 50% in the UVA range of 315 - 380 nm and less than 5% in the range of UVB range of 280-315 nm.
Lenses are supplied sterile in sealed blister packs containing isotonic buffered saline solution. The compatibility and package integrity of the blister pack packaging system has been demonstrated and successfully used for other marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Blister pack containers are labeled with the lens parameters, lot number and product expiration date. The expiration date has been established through stability studies that have assessed the chemical stability of the lens and package integrity (ability to maintain sterility). Shelf-life studies are ongoing to establish and extend the labeled expiration date.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eyecare practitioners prescribe the lens for single-use disposable wear.
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 tests:
Biocompatibility: The safety tests, such as biocompatibility have been performed in accordance with ISO10993. Toxicology studies report shows that the lenses are non-toxic and biocompatibility result is acceptable in ocular environment.
Sterilization and Stability Testing: Performed according to ISO17665-2, ISO17665-1, and ISO 11987.
Performance Data: Physicochemical studies were conducted according to ISO 18369 Ophthalmic optics - Contact lenses (Ophthalmic). The physical, optical and chemical properties of the lens are within established specifications for the lenses, following ISO18369-3, ISO18369-4, and ISO18369-2.
Clinical study:
This 510(k) submission does not utilize clinical study for establishing substantial equivalence therefore this section does not apply.
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.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 15, 2020
Visco Vision Inc. Evan Huang Director of Global QA No. 1. Xingye St., Guishan Dist., Taoyuan City, TW 33341 Taiwan
Re: K201080
Trade/Device Name: Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL. MVN Dated: April 17, 2020 Received: April 22, 2020
Dear Evan Huang:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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) K201080
Device Name
Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens
Indications for Use (Describe)
The Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens is indicated as daily wear and single use soft contact lens for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00 D or less here the astigmatism does not interfere with visual acuity.
The Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear and single use for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with nondiseased eyes and whose powers are from -12.00 to +8.00 D and astigmatism corrections are from -0.75 to -2.25 D.
The Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lenses are indicated as daily wear and single use for the correction of ametropia (myperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -12.00 to +8.00 D with add powers from +0.25 to +2.75 D. The lenses may be worn by persons who exhibit astigmatism of 1.00 D or less where the astigmatism does not interfere with visual acuity.
Evecare practitioners prescribe the lens for single-use disposable wear.
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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Image /page/3/Picture/0 description: The image contains the word "VISCO" in large, bold, blue letters. Below the word "VISCO" is the phrase "The Silicone Hydrogel Expert" in a smaller, gray font. The text is simple and clear, with a focus on the brand name and its expertise in silicone hydrogel.
510(k) Summary
K201080
Establishment Information: 1.
| Company Name: | Visco Vision Inc |
|---|---|
| Company Address: | No. 1, Xingye St., Guishan Dist., Taoyuan City, 33341, TAIWAN |
| Telephone: | +886-3-359-6868 |
| Fax: | +886-3-359-6868 |
Contact Person: 2.
| Name: | Evan Huang |
|---|---|
| Phone No. | 886-3-3596868 |
| Fax No. | 886-3-3490202 |
| E-mail: | evan.huang@viscovision.com.tw |
Preparation Date: 3.
2020/04/08
Device Identification: 4.
| Classification Name: | Soft (hydrophilic) contact lens. |
|---|---|
| Regulation Number: | 886.5925 |
| Product Code: | LPL, MVN |
| Device Class: | Class 2 |
| Panel: | Ophthalmic |
| Device Name: | Daily Breeze B (olifilcon B) Silicone Hydrogel Soft Contact Lens |
| Trade Name: | Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens |
| Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens | |
| Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens |
Predicate Device: 5.
- ◆ K160344, Si-Hy (olifilcon B) Silicone Hydrogel soft contact lens
Device Description 6.
The Daily Breeze B (olifilcon B) Silicone Hydrogel Soft Contact Lens is made of hydrogel material, olifilcon B, with UV blocker available as spherical lens, toric lens and multifocal lens. The composition of the lens is 53% olifilcon B, which is a copolymer of 1-vinyl-2-pyrrolidinone (NVP) and Siloxane macromer, and 47% water. A light blue color tinted with "reactive Blue19" listed in 21 CFR Part 73.3121is for handling visibility purpose. A benzotriazole UV absorbing monomer is used
4
Image /page/4/Picture/0 description: The image contains the word "VISCO" in large, bold, blue letters. Below the word "VISCO" is the phrase "The Silicone Hydrogel Expert" in a smaller, gray font. The text is horizontally aligned and centered.
to block UV radiation. The UV transmission (the thinnest lens measured by spectrophotometry as stated in ISO 18369) is less than 50% in the UVA range of 315 - 380 nm and less than 5% in the range of UVB range of 280-315 nm.
Lenses are supplied sterile in sealed blister packs containing isotonic buffered saline solution. The compatibility and package integrity of the blister pack packaging system has been demonstrated and successfully used for other marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Blister pack containers are labeled with the lens parameters, lot number and product expiration date. The expiration date has been established through stability studies that have assessed the chemical stability of the lens and package integrity (ability to maintain sterility). Shelf-life studies are ongoing to establish and extend the labeled expiration date.
Indications for Use: 7.
The Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens is indicated as daily wear and single-use soft contact lens for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
The Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear and single-use for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -12.00 to +8.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.
The Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear and single-use for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -12.00 to +8.00 diopters with add powers from +0.25 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.
Eyecare practitioners prescribe the lens for single-use disposable wear.
Technological characteristic 8.
8.1 Daily Breeze B (olifilcon B) Silicone Hydrogel Soft Contact Lenses characteristics:
| • Diameter Range : | 13.0 to 15.0 mm, ±0.2mm |
|---|---|
| • Base Curve : | 8.0 to 9.2 mm, ±0.2mm |
| • Center Thickness : | 0.00 mm for 3.00D (varies with power) + [0.010 mm, -0.10 to |
- 0.09 mm for -3.00D (varies with power), ± [0.010 mm + 0.10 tc | Center Thickness : .
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Image /page/5/Picture/0 description: The image shows the logo for VISCO, a company that specializes in silicone hydrogel. The word "VISCO" is written in large, bold, blue letters. Below the company name is the tagline "The Silicone Hydrogel Expert" in a smaller, gray font. The logo is simple and professional, and it clearly communicates the company's area of expertise.
+8.00 to -12.00 D (JF ´ L| ≤ 10,00 D: ±0.25D; 10,00 D