(260 days)
Not Found
No
The description focuses on the material composition, physical properties, and intended use of contact lenses, with no mention of AI or ML.
Yes
The devices are indicated for the correction of refractive ametropia (myopia and hyperopia) and to help protect against transmission of harmful UV radiation to the cornea and into the eye, which addresses a medical condition or performs a medical function.
No
The device is a contact lens used for the correction of refractive ametropia (myopia and hyperopia), not for diagnosing medical conditions.
No
The device description clearly states it is a physical contact lens made of silicone hydrogel material, 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 described devices are contact lenses. Their intended use is for the correction of refractive errors (myopia and hyperopia) in the eye. They are worn on the surface of the eye and do not involve testing samples taken from the body.
- Lack of Diagnostic Claims: The intended use and device description focus on vision correction and UV protection, not on diagnosing any disease or condition.
- Performance Studies: The performance studies mentioned are non-clinical tests and a comparison to a predicate device for substantial equivalence, which is typical for medical devices, but not specifically for establishing diagnostic performance metrics like sensitivity, specificity, etc., which are key for IVDs.
Therefore, the Vexillum Zephyr and OxyPure A contact lenses are classified as medical devices, but not as In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
Eye care practitioners may prescribe the lens for either single-use daily disposable wear, or for frequent/ planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. The Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The OxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
Eye care practitioners may prescribe the single-use daily disposable wear, or for frequent/ planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. The OxyPure A (olifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
Product codes
LPL, MVN
Device Description
Device Description for Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft Contact Lenses
The Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material, olifilcon A, with UV blocker available as spherical lens. The composition of the lens is 53% olifilcon A 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 316 - 380 mm and less than 5% in the range of UVB range of 280-315 nm.
Lenses are supplied sterile in sealed blister packs containing Tangible Polymers (coating on the lens surface during sterilization process) with 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.
Device Description for OxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lenses
The OxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material, olifilcon A, with UV blocker available as spherical lens. The composition of the lens is 53% olifilcon A 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 316 - 380 nm and less than 5% in the range of UVB range of 280-315 nm.
OxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lenses are supplied sterile in sealed blister packs containing Sodium Hyaluronate and Sodium Alginate with 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
Eye care practitioners / 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
Non-clinical tests: The safety tests, such as biocompatibility have been performed and meet the requirement of following FDA Recognized Consensus Standards. Regarding the performance, the bench tests were performed in accordance with following FDA Recognized Consensus Standards. All tests passed the requirement to demonstration that new device is as substantial equivalent as the predicate device.
- ISO18369-3 Ophthalmic optics - Contact lenses - Part 3: Measurement Methods
- ISO18369-4 Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials
- ISO18369-2 Ophthalmic optics - Contact lenses - Part 2: Tolerances
- ISO11987 Ophthalmic optics -- Contact lenses and contact lens care products --Determination of physical compatibility of contact lens care products with contact lenses
- ISO17665-2 terilization Of Health Care Products - Moist Heat - Part 2: Guidance on the Application of ISO 17665-1. (Sterility)
- ISO17665-1 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- ASTM D792-13 Standard Test Methods For Density And Specific Gravity (Relative ● Density) Of Plastics By Displacement. (Materials)
Clinical study: This 510(k) submission does not utilize clinical study for establishing substantial equivalence therefore this section does not apply.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized depiction of human figures. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder font, and "ADMINISTRATION" in a smaller font below.
September 13, 2019
Visco Vision, Inc. Mr. Evan Huang Director of Global QA No. 1, Xingye St., Guishan Dist., Taoyuan City 33341, TW
Re: K183670
Trade/Device Name: Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft Contact Lenses OxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL, MVN Dated: August 8, 2019 Received: August 8, 2019
Dear Mr. 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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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-safetyreporting-combination-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-devices/medical-device-safety/medical-devicereporting-mdr-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.
for 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) K183670
Device Name
Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft Contact Lenses OxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lenses
Indications for Use (Describe)
The Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
Eye care practitioners may prescribe the lens for either single-use daily disposable wear, or for frequent/ planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. The Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The OxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
Eye care practitioners may prescribe the single-use daily disposable wear, or for frequent/ planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. The OxyPure A (olifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
| 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 shows the logo for VISCO. The logo is in blue and gray. The text below the logo says "The Silicone Hydrogel Expert".
510(k) Summary
| Company Name: | Visco Vision Inc |
|---|---|
| Company Address: | No. 1, Xingye St., Guishan Dist., |
| Taoyuan City, 33341, TAIWAN | |
| Telephone: | +886-3-359-6868 |
| Fax: | +886-3-349-0202 |
| Contact Person: | Evan Huang |
| Summary Preparation Date: | 2018.10.05 |
| Device Name: | |
| Trade Name: | Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone |
| Hydrogel Soft Contact Lenses | |
| OxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lenses | |
| Classification Name: | Soft (hydrophilic) contact lens. |
| Regulation Number: | 886.5925 |
| Product Code: | LPL, MVN |
| Device Class: | Class 2 |
| Panel: | Ophthalmic |
PREDICATE DEVICE:
K171447, OxyPure Color Silicone Hydrogel Soft Contact Lenses
Device Description for Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft Contact Lenses
The Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material, olifilcon A, with UV blocker available as spherical lens. The composition of the lens is 53% olifilcon A 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 316 - 380 mm and less than 5% in the range of UVB range of 280-315 nm.
Lenses are supplied sterile in sealed blister packs containing Tangible Polymers (coating on the lens surface during sterilization process) with 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
4
Image /page/4/Picture/0 description: The image shows 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.
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.
Intended Use:
The Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft Contact Lenses are indicated as daily wear 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.
Eye care practitioners may prescribe the lens for either single-use daily disposable wear, or for frequent/ planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. The Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
All comparison table for applied devices are as following, and the substantial equivalence determination is based on the 510(k) Substantial Equivalence Decision-Making Process Flowchart which includes the comparison and discussion of indications for use, technology, and performance specifications.
Device Description for OxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lenses
The OxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material, olifilcon A, with UV blocker available as spherical lens. The composition of the lens is 53% olifilcon A 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 316 - 380 nm and less than 5% in the range of UVB range of 280-315 nm.
OxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lenses are supplied sterile in sealed blister packs containing Sodium Hyaluronate and Sodium Alginate with 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
5
Image /page/5/Picture/0 description: The image shows 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.
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.
Intended Use:
The OxyPure A (olifilcon A) Silicone Hydrogel soft contact lenses are daily wear indicated 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.
Eye care practitioners may prescribe the lens for either single-use daily disposable wear, or for frequent/ planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. The OxyPure A (olifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
All comparison table for applied devices are as following, and the substantial equivalence determination is based on the 510(k) Substantial Equivalence Decision-Making Process Flowchart which includes the comparison and discussion of indications for use, technology, and performance specifications.
| Category | Vexillum
Zephyr (olifilcon A) with Tangible
Polymers Silicone
Hydrogel Soft
Contact Lenses
New device | OxyPure A
(olifilcon A) Silicone
Hydrogel Soft
Contact Lenses
New device | OxyPure Color
Silicone Hydrogel
Soft Contact
Lenses
K171447 | Result of
Comparison |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-------------------------|
| Applicant | Visco Vision Inc | Visco Vision Inc | Visco Vision Inc | Same |
| Classification | class II | class II | class II | Same |
| Regulation
number | 886.5925 | 886.5925 | 886.5925 | Same |
| Product code | LPL, MVN | LPL, MVN | LPL, MVN | Same |
| Intended use | Myopia, Hyperopia,
astigmatism,
Presbyopia | Myopia, Hyperopia,
astigmatism,
Presbyopia | Myopia, Hyperopia,
astigmatism,
Presbyopia | Same |
| Replacement | Daily Wear | Daily Wear | Daily Wear | Same |
| Category | Vexillum
Zephyr (olifilcon
A) with Tangible
Polymers Silicone
Hydrogel Soft
Contact Lenses
New device | OxyPure A
(olifilcon A) Silicone
Hydrogel Soft
Contact Lenses
New device | OxyPure Color
Silicone Hydrogel
Soft Contact
Lenses
K171447 | Result of
Comparison |
| Schedule | | | | |
| USAN Name | olifilcon A | olifilcon A | olifilcon A | Same |
| FDA Category
(Group) | Group 5C (Nonionic,
Water