(273 days)
Not Found
No
The document describes a standard hydrogel contact lens and its physical properties. There is no mention of AI, ML, image processing, or any software-based analysis or functionality that would suggest the use of these technologies.
No
The device is indicated for the correction of refractive ametropia (myopia and hyperopia) and does not treat or cure any disease or condition.
No
Explanation: This device is a contact lens intended for correcting refractive errors (myopia and hyperopia) in the eye, which is a treatment, not a diagnostic, function.
No
The device description clearly states it is a hydrogel soft contact lens made of physical materials (hioxifilcon A and water) and supplied in blister packs with saline solution. This is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the correction of refractive ametropia (myopia and hyperopia) in phakic persons. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The description details a contact lens made of hydrogel material for vision correction. It does not describe any components or functions related to analyzing samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any biological markers or substances for diagnostic purposes.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This contact lens does not fit that description.
N/A
Intended Use / Indications for Use
HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens are daily disposable soft contact lens indicated 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.
Product codes (comma separated list FDA assigned to the subject device)
LPL, MVN
Device Description
The HydroSens A (hioxifilcon A) Hydrogel Soft Contact Lens is made of hydrogel material, hioxifilcon A, with UV blocker available as spherical lens. The composition of the lens is 43% hioxifilcon A and 57% water. A light blue color tinted with "reactive Blue19" listed in 21 CFR Part 73.3121 is for handling visibility purpose. 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 MPC polymer (2-(Methacryloyloxy) ethyl 2-(trimethylammonio) ethyl phosphate-n-butyl methacrylate copolymer) 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
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)
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 7, 2020
Visco Vision Inc Evan Huang Director of Global QA No. 1. Xingye St., Guishan Dist., Taoyuan City, 33341 Taiwan
Re: K200618
Trade/Device Name: HydroSens A (hioxifilcon A) Spherical 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: October 28, 2020 Received: November 2, 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.
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 (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-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.
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200618
Device Name
HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens
Indications for Use (Describe)
HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens are daily disposable soft contact lens indicated 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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/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 simple and clean, with a focus on the company name and its expertise in silicone hydrogels. The overall impression is professional and informative.
510(k) Summary
1. Establishment Information:
| 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 |
2. Contact Person:
| Name | Evan Huang |
|---|---|
| Phone No. | 886-3-3596868 |
| Fax No | 886-3-3490202 |
| E-mail: | evan.huang@viscovision.com.tw |
3. Preparation Date:
2020/03/04
4. Device Identification:
| Common or usual name | Hydrogel Soft Contact Lens |
|---|---|
| Classification Name | Soft (hydrophilic) contact lens |
| Regulation Number | 886.5925 |
| Product Code | LPL,MVN |
| Device Class | Class 2 |
| Panel | Ophthalmic |
| Device Name | HydroSens A (hioxifilcon A) Hydrogel Soft Contact Lens |
| Trade Name: | HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens |
5. Predicate Device:
- ◆ K040303, 59% Extreme H2O (hioxifilcon A) Soft Contact Lens for Daily Wear (cast-molded, with a visibility tint)
- ◆ K992692, 59% extreme H2O® soft contact lens
6. Device Description
The HydroSens A (hioxifilcon A) Hydrogel Soft Contact Lens is made of hydrogel material, hioxifilcon A, with UV blocker available as spherical lens. The composition of the lens is 43% hioxifilcon A and 57% water. A light blue color tinted with "reactive Blue19" listed in 21 CFR Part 73.3121 is for handling visibility purpose. The UV transmission (the thinnest lens measured
4
K200618
Image /page/4/Picture/1 description: The image shows the logo for VISCO. The word "VISCO" is written in large, bold, blue letters. Below the word "VISCO" is the phrase "The Silicone Hydrogel Expert" in a smaller, gray font.
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 MPC polymer (2-(Methacryloyloxy) ethyl 2-(trimethylammonio) ethyl phosphate-n-butyl methacrylate copolymer) 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.
7. Intended Use:
The HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens are daily disposable soft contact lens 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.
8. Technological characteristic
8.1 HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens characteristics:
- . Diameter Range : 13.0 to 15.0 mm, ±0.2mm
- . Base Curve : 8.0 to 9.2 mm, ±0.2mm
- Center Thickness : 0.08 mm for -3.00D (varies with power), ± [0.010 mm + 0.10 tc] .
- +8.00 to -12.00 D (JF L| ≤ 10,00 D: ±0.25D; 10,00 D 50%
Water, non-ionic
Polymer | Group #2 >50%
Water, non-ionic
Polymer | Group #2 >50%
Water, non-ionic
Polymer | Same |
| Manufacturing
Method | Cast Molded | Cast Molded | Cast Molded | Same |
| Lens Design | Spherical | Spherical | Spherical,Toric | Different |
| Water Content | 57% | 59% | 59% | Different |
| Light
Transmittance | 95% | 95% | 95% | Same |
| Refractive
Index | 1.402 (hydrated) | 1.404 (hydrated) | 1.404 (hydrated) | Different |
| Oxygen
Permeability
(DK, 35°C) | 22x10-11 (cm2/sec)(ml
O2/ml x mmHg @
35°C) | 18x10-11 (cm2/sec)(ml
O2/ml x mmHg @
35°C) | 18x10-11 (cm2/sec)(ml
O2/ml x mmHg @
35°C) | Different |
| Specific Gravity | 1.1300(hydrated) | 1.136 (hydrated) | 1.136 (hydrated) | Different |
| Sterilization | Steam Sterilization | Steam Sterilization | Steam Sterilization | Same |
| Modulus | 0.38 Mpa | - | 0.34 Mpa | Different |
| Tensile strength | 35.0 gf/mm² | - | 36 gf/mm² | Different |
| Elongation at
break | 108% | - | 128% | Different |
| | | | | |
| Toughness | 0.210 J/m3 | - | 0.215 J/m3 | Different |
6
Image /page/6/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 image is simple and clean, with a focus on the company name and its expertise in silicone hydrogel.
7
Image /page/7/Picture/1 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.
10. Non-clinical tests
10.1 Biocompatibility
The safety tests, such as biocompatibility have been performed in accordance with Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, May 1994 and GLP regulation (21 CFR part 58) and relevant ISO 10993 series biocompatibility standard. The biocompatibility report indicates that each test article (lens extracts from the final sterilized blister packaging , packaging buffer solution, extracts of packaging material (Al foil and PP blister)) does not negatively impact the safety of the devices and all of them are non-toxic and biocompatible.
These tests include: cytotoxicity, acute systemic toxicity, ocular irritation and skin sensitization testing. Biocompatibility testing performed includes the following referenced standards
- · ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- · ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
- · ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
- 10.2 Sterilization and Stability Testing
- � ISO17665-2 sterilization 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
- · ISO 11987 Ophthalmic optics-Contact lenses-Determination of shelf-life.
- 10.3 Performance Data
Physiochemical 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.
- . 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
8
Image /page/8/Picture/1 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, lighter font. The text is aligned to the left and the background is white.
11. Clinical study
This 510(k) submission does not utilize clinical study for establishing substantial equivalence therefore this section does not apply.
12. Conclusions:
HydroSens A (hioxifilcon A) Hydrogel Soft Contact Lens and 59% extreme H2O® soft contact lens, 59% Extreme H2O (hioxifilcon A) Soft Contact Lens for Daily Wear (cast-molded, with a visibility tint) have the same manufacturing process, operating principles, sterilization and materials as the above predicate devices. Being similar with respect to the physical, optical, mechanical property and performance characteristic to the predicated deice, this meets the Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses,May 1994, the information provided herein supports the claim of substantial equivalence. it shows that "HydroSens A (hioxifilcon A) Hydrogel Soft Contact Lens" is as safe, as effective and performs as well as the predicate device.