(260 days)
Hydron Biomedics 55 (Ocufilcon D) Visibility Tint Molded daily wear soft contact lens (K972303)
No
The document describes a standard contact lens and its manufacturing process, with no mention of AI or ML technology.
No
The device is indicated for the correction of refractive ametropia (myopia and hyperopia), which addresses a refractive error rather than treating a disease or condition.
No
Explanation: The device is a contact lens intended for correcting refractive ametropia (myopia and hyperopia), not for diagnosing a condition.
No
The device description clearly states it is a physical contact lens made from a hydrogel material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The EZvue contact lens is a medical device that is placed directly on the eye to correct vision. It does not analyze any biological samples.
- Intended Use: The intended use is for the correction of refractive errors (myopia and hyperopia) and astigmatism, which is a physical correction of vision, not a diagnostic test.
The provided information clearly describes a contact lens for vision correction, which falls under the category of ophthalmic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
EZvue(Ocufilcon D)1-day Soft (hydrophilic) Contact Lens for daily wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes who may exhibited refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.
Eyecare practitioners may prescribe the contact lens for single-use disposable daily wear. The EZvue(Ocufilcon D)1-day Soft (hydrophilic) Contact Lenses are not intended to be disinfected and should be discarded after a single use.
Product codes
LPL, MVN
Device Description
EZvue (Ocufilcon D) 1-Day Soft (hydrophilic) Contact Lens for Daily Wear is available as spherical lenses manufactured by cast molded method. The lens is made from a lens material that is approximately 55% water. The hydrogel lens' material is a copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with Ethylene Glycol Dimethacrylate (EGDMA) via UV photopolymerization. The EZvue (Ocufilcon D) 1-Day Soft (hydrophilic) Contact Lens with visible tint is tinted blue using Reactive Blue Dye #19 to make the lens more visible for handling. Lenses are supplied sterile in sealed blister packers containing sterile isotonic phosphate buffered saline.
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
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Intended User / Care Setting
Eyecare practitioners may prescribe the contact lens for single-use disposable daily 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The EZvue (Ocufilcon D) 1-Day Soft (hydrophilic) Contact Lenses for Daily Wear were tested over 60 human eyes separately within 6 months. Nearly a hundred percent of the participants' vision was corrected and nearly all were satisfied with the lens wearing and care of lenses. In general, these products are good and safe for customers.
Nonclinical Studies:
A series of nonclinical performance tests were performed to demonstrate the safety and effectiveness of the EZvue (Ocufilcon D) 1-Day Soft (hydrophilic) Contact Lens for Daily Wear, and establish substantial equivalence to predicate lenses - Hydron Biomedics 55 (Ocufilcon D) Visibility Tint Molded daily wear soft contact lens (K972303). All testing was conducted in accordance with the May 1994 FDA guideline titled Premarket Notification 510(K) Guidance Document for Class IV Contact lenses, and in conformance to applicable device regulations. The evidence of substantial equivalent to the predicate lens described as follow:
- a) Technological characteristics studies
EZvue (Ocufilcon D) 1-Day Soft (hydrophilic) Contact Lens for Daily Wear designs in the following parameter ranges:
Diameter range; 13.9014.30mm-12.00D
Power range: +8.00D
Center thickness: varies with power (0.080~0.150mm)
Lenses have the following properties:
Refractive index: 1.410 (hydrated)
Light transmittance: >93%
Water content: 53 to 57 %
Oxygen permeability (edged corrected): 16×10-14(cm²/sec)(mlQz/ml-mmHg)]@ 35℃
These characterizations of EZvue (Ocufilcon D) 1-Day Soft (hydrophilic) Contact Lenses are equivalent and comparable to those of predicate lenses.
b) Biocompatibility
In accordance with the May 1994 Guidance Document for daily wear contact lenses, toxicity studies have been conducted on the model: EZvue (Ocufilcon D) 1-Day Soft (hydrophilic) Contact Lens for Daily Wear. The Irritation test in the rabbit eye and Systemic toxicity studies indicate the extracts would be considered as non-toxic and nor irritated. The Cytotoxicity testing demonstrates the lens is not cytotoxic under the conditions of the study.
c) Microbiology
Steam sterilization process has been validated to deliver a minimum SAL of 10°, thereby complying with the requirement of FDA Group IV. There is shelf-life stability data supporting that the lens remains sterile through the expiration date claimed for the product.
d) Leachability
Studies were conducted to determine the leachable materials from the finished lens. The results show that, at the levels of the detection reported, there are no leachable monomers and addictive residues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
Nu'"
K082880
510 (K) Summary
SUMMARY OF SAFETY AND EFFECTIVENESS FOR EZvue (Ocufilcon D) Soft (hydrophilic) Contact Lens for Daily Wear JUN 1 6 2009
Submitter Information:
| Company: | I-SEE VISION TECHNOLOGY INC. |
|---|---|
| 1F, No. 45, Lane 2, Section 2, Kuang-Fu Rd., Hisnchu, Taiwan, | |
| 30071 | |
| Contact Person: | Mr. Tom Lin, |
| Special Assistant of President Office | |
| Phone: | 886-3-5752822 |
| FAX: | 886-3-5752823 |
| E-Mail: | tomlin@iseevision.com |
Identification of Device:
| Classification Name: | Lens, Contact, (Disposable) |
|---|---|
| Trade Name: | EZvue (Ocufilcon D) 1-Day Soft (hydrophilic) Contact Lens |
| ( or EZvue (Ocufilcon D) 1-Day Soft (hydrophilic) Contact | |
| Lens for daily wear) | |
| Common or usual Name: | Soft (hydrophilic) Contact lens (daily wear) |
| FDA Classification: | Class II |
Predicate Device:
Hydron Biomedics 55 (Ocufilcon D) Visibility Tint Molded daily wear soft contact lens cleared via K972303 Ocular Sciences / American Hydron Inc.
Indications for Use
EZvue(Ocufilcon D)1-day Soft (hydrophilic) Contact Lens for daily wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes who may exhibited refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.
Eyecare practitioners may prescribe the contact lens for single-use disposable daily wear. The EZvue(Ocufilcon D)1-day Soft (hydrophilic) Contact Lenses are not intended to be disinfected and should be discarded after a single use.
Description of Device
EZvue (Ocufilcon D) 1-Day Soft (hydrophilic) Contact Lens for Daily Wear is available as spherical lenses manufactured by cast molded method. The lens is made from a lens material that is approximately 55% water. The hydrogel lens' material is a copolymer
1
composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with Ethylene Glycol Dimethacrylate (EGDMA) via UV photopolymerization. The EZvue (Ocufilcon D) 1-Day Soft (hydrophilic) Contact Lens with visible tint is tinted blue using Reactive Blue Dye #19 to make the lens more visible for handling. Lenses are supplied sterile in sealed blister packers containing sterile isotonic phosphate buffered saline.
Summary of Clinical Study:
The EZvue (Ocufilcon D) 1-Day Soft (hydrophilic) Contact Lenses for Daily Wear were tested over 60 human eyes separately within 6 months. Nearly a hundred percent of the participants' vision was corrected and nearly all were satisfied with the lens wearing and care of lenses. In general, these products are good and safe for customers.
Nonclinical Studies:
A series of nonclinical performance tests were performed to demonstrate the safety and effectiveness of the EZvue (Ocufilcon D) 1-Day Soft (hydrophilic) Contact Lens for Daily Wear, and establish substantial equivalence to predicate lenses - Hydron Biomedics 55 (Ocufilcon D) Visibility Tint Molded daily wear soft contact lens (K972303). All testing was conducted in accordance with the May 1994 FDA guideline titled Premarket Notification 510(K) Guidance Document for Class IV Contact lenses, and in conformance to applicable device regulations. The evidence of substantial equivalent to the predicate lens described as follow:
- a) Technological characteristics studies
EZvue (Ocufilcon D) 1-Day Soft (hydrophilic) Contact Lens for Daily Wear designs in the following parameter ranges:
Diameter range; 13.90~14.30mm
Power range: +8.00D~-12.00D
. Center thickness: varies with power (0.080~0.150mm)
Lenses have the following properties:
Refractive index: 1.410 (hydrated)
Light transmittance: >93%
Water content: 53 to 57 %
Oxygen permeability (edged corrected): 16×10-14(cm²/sec)(mlQz/ml-mmHg)]@ 35℃
There characterizations of EZvue (Ocufilcon D) 1-Day Soft (hydrophilic) Contact Lenses are equivalent and comparable to those of predicate lenses.
b) Biocompatibility
In accordance with the May 1994 Guidance Document for daily wear contact lenses,
2
toxicity studies have been conducted on the model: EZvue (Ocufilcon D) 1-Day Soft (hydrophilic) Contact Lens for Daily Wear. The Irritation test in the rabbit eye and Systemic toxicity studies indicate the extracts would be considered as non-toxic and nor irritated. The Cytotoxicity testing demonstrates the lens is not cytotoxic under the conditions of the study.
c) Microbiology
Steam sterilization process has been validated to deliver a minimum SAL of 10°, thereby complying with the requirement of FDA Group IV. There is shelf-life stability data supporting that the lens remains sterile through the expiration date claimed for the product.
d) Leachability
Studies were conducted to determine the leachable materials from the finished lens. The results show that, at the levels of the detection reported, there are no leachable monomers and addictive residues.
Substantial equivalence Statement:
Testing performed on the EZvue (Ocufilcon D) 1-Day Soft (hydrophilic) Contact Lens for Daily Wear indicated that it can support the efficiency and security use as well as the predicate devices- Hydron Biomedics 55 (Ocufilcon D) Visibility Tint Molded daily wear soft contact lens (K972303), when used in accordance with the instructions for use. It is due to the facts that The risks and benefits of the subject device are the same as soft contact lenses for to the daily wear.
In conclusion, it is I-SEE's conviction that data submitted in this 510(k) to validate the claim of substantial equivalency, substantiates our ability to manufacture a soft contact lens, the EZvue (Ocufilcon D) 1-Day Soft (hydrophilic) Contact Lens for Daily Wear, with the same established safety profile and effectiveness as the predicate device-- Hydron Biomedics 55 (Ocufilcon D) Visibility Tint Molded daily wear soft contact lens (K972303).
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.
2009 SEP 9
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
I-See Vision Technology Inc. c/o Ms. Jennifer Reich Senior Consultant Harvest Consulting Corp. 2904 N. Boldt Drive Flagstaff, AZ 86001
Re: K082880
Trade/Device Name: EZvue (Ocufilcon D) 1-Day Soft (hydrophilic) Contact Lens for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lenses Regulatory Class: Class II Product Code: LPL, MVN Dated: June 9, 2009 Received: June 11, 2009
Dear Ms. Reich:
This letter corrects our substantially equivalent letter of June 16, 2009.
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 (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.
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
4
Page 2 - Ms. Jennifer Reich
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); 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 vours.
Kesia Alexander for
Malvina B. Eydelman. N Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K082880
Device Name: EZvue (Ocufilcon D) 1-Day Soft (hydrophilic) Contact Lens for Daily Wear I-SEE Vision Technology, Inc.
Indications For Use:
EZvue (Ocufilcon D) 1-Day Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes who may exhibited refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.
Eyecare practitioners may prescribe the contact lens for single-use disposable daily wear. The EZvue (Ocufilcon D) 1-Day Soft (hydrophilic) Contact Lenses are not intended to be disinfected and should be discarded after a single use.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Afhoang
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K082880
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