(178 days)
Not Found
No
The 510(k) summary describes a standard contact lens with a labeling modification. There is no mention of AI, ML, image processing, or any data-driven algorithms. The performance studies rely on previous submissions and general observations, not AI/ML model training or testing.
No.
The device is indicated for the correction of visual acuity, which is a refractive purpose, not a therapeutic one. It does not treat or cure a disease.
No
The device is indicated for the correction of visual acuity, which is a treatment or corrective measure, not a diagnostic one.
No
The device description clearly outlines a physical contact lens made of specific materials and manufactured through a spin-casting method. It is a tangible hardware 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 visual acuity in the eye. This is a therapeutic or corrective function, not a diagnostic one.
- Device Description: The description details the physical properties and materials of a contact lens, which is a medical device used for vision correction.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) or to provide information about a patient's health status or disease.
- Anatomical Site: The device is applied to the eye, which is consistent with a vision correction device, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This contact lens does not perform any of these functions.
N/A
Intended Use / Indications for Use
Discon Daily (Etafilcon A) One-Day Soft (hydrophilic) Contact Lens is indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopia or hyperopia and may exhibited refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. The eye care practitioner may prescribe the contact lens for single-use daily disposable wear. The Discon Daily Lenses are not intended to be disinfected and should be discarded after a single use.
Product codes
MVN, LPL
Device Description
Discon daily Contact Lens are available as non-spherical fenses manufactured by spin-casting method. The model illuminated with high water content (58 The hydrogel lens' material is a random copolymer composed of %). 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo- polymerization. The Discon Daily Contact lens with visible tint is light 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. 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.
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 practitioner
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)
The 510(k) describes a labeling modification to the "Wearing Schedual" section of the Package Insert and to the "introduction" section of the Patient Instruction and professional fitting Guide for Daily disposable Wear. There is no change in lens material, the manufacturing process, nor the parameter and properties therefore, the clinical data previously submitted in K051129 supports the clinical safety of the subject device. There is a slightly exchange of blue-tint concentration in the polymer composition. Discon Daily lenses have been wide-used around the world, including Taiwan, China, etc. Among the users being daily worn the Discon Daily lenses, all the procedures were in generally stable condition without severe complication. There are no significant side effects and complaints to be observed.
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
510 (K) Summary
K053/91
SUMMARY OF SAFETY AND EFFECTIVENESS FOR
Discon Daily (Etafilcon A) One-Day Soft (hydrophilic) Contact Lens Submitter Information:
Company: INNOVA VISION INC. No. 231-1, Wen-Te Road, Chiung-lin Village, Hsin-Chu County, Taiwan. Contact Person: Mr. Michael w. Hsu Executive Vice President Phone: 886-3-592-7299 FAX: 886-3-592-6213 E-Mail: mikehsu@innovavision.com.tw Date Prepared Oct. 20, 2005
Identification of Device:
| Classification Name: | Soft hydrophilic contact lens, per 21 CFR. 886.5925 |
|---|---|
| Trade Name: | Discon Daily (Etafilcon A) One-Day Soft (hydrophilic) |
| Contact Lens | |
| Common or usual | |
| Name: | Soft (hydrophilic) Contact lens (daily wear) |
| FDA Classification: | Class II |
| Registration Number | 3003746024 |
Predict Device:
ﻨﮯ
Discon (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear cleared via K051129 from Innova Vision Corp., Taiwan. Acuvue Brand (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear cleared via K013973 from Johnson & Johnson Vision Care, Inc. USA.
Indications for Use:
Discon Daily (Etafilcon A) One-Day Soft (hydrophilic) Contact Lens is indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopia or hyperopia and may exhibited refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. The eye care practitioner may prescribe the contact lens for single-use daily disposable wear.
Description of Device:
1
Discon daily Contact Lens are available as non-spherical fenses manufactured by spin-casting method. The model illuminated with high water content (58 The hydrogel lens' material is a random copolymer composed of %). 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo- polymerization. The Discon Daily Contact lens with visible tint is light 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. 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.
Clinical Studies:
The 510(k) describes a labeling modification to the "Wearing Schedual" section of the Package Insert and to the "introduction" section of the Patient Instruction and professional fitting Guide for Daily disposable Wear. There is no change in lens material, the manufacturing process, nor the parameter and properties therefore, the clinical data previously submitted in K051129 supports the clinical safety of the subject device. There is a slightly exchange of blue-tint concentration in the polymer composition.
Discon Daily lenses have been wide-used around the world, including Taiwan, China, etc. Among the users being daily worn the Discon Daily lenses, all the procedures were in generally stable condition without severe complication. There are no significant side effects and complaints to be observed.
Nonclinical Studies:
Non-clinical studies (chemistry, toxicology, microbiology, shelf-life and leachability) on the lens material were not conducted since the lens material (Etafilcon A) and manufacturing process do not change as compared with our own product- Discon (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear cleared via K051129.
a) Technological characteristics studies
Discon Daily contact lens designs in the following parameter ranges:
Diameter range; 13.8 to 14.2 mm
Power range: +6.00D to -12.00D
Center thickness: varies with power (0.08 to 0.12 mm for -3.00D)
Lenses have the following properties:
Refractive index: 1.407 (hydrated)
2
Light transmittance: >93% Water content: 56 to 60 % Oxygen permeability (edged corrected) : 24 x 10-11 [(cm2/sec)(ml 02/ml-mmHg)] @ 35℃
These technological characteristics of Discon Daily Contact lenses do not change to that of predicate lenses previously submitted in K051129.
Substantial equivalence Statement:
Testing performed on the Discon Daily (Etafilcon A) One-Day Soft (hydrophilic) Contact Lens indicated that it can support the efficiency and security use as well as the predicate devices- Discon (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear (K051129) & ACUVUE (Etafilcon A) Contact Lens visibility tint- K013973), 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 Innova'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 Discon Daily (Etafilcon A) One-Day Soft (hydrophilic) Contact Lens, with the same established safety profile and effectiveness as the predicate device-- Discon (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear (K051129) & ACUVUE (Etafilcon A) Contact Lens visibility tint (K013973).
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 12 2006
Innova Vision Inc. c/o Ms. Jennifer Reich Harvest Consulting Corp 2904 N. Boldt Drive Flaggstaff, Az 86001
Re: K053191
Trade/Device Name: Discon Daily (Etafilcon A) One-Day Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact lens (daily wear) Regulatory Class: II Product Code: MVN; LPL Dated: April 17, 2006 Received: April 20, 2006
Dear Ms. Reich:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 aft 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); 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.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 827-8910. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Egelston - M.D.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
| 510(k) Number: | K053191 |
|---|---|
| ---------------- | --------- |
Device Name: Discon Daily (Etafilcon A) One-Day Soft (hydrophilic) Contact Lens
Indications for Use:
Discon Daily (Etafilcon A) One-Day Soft (hydrophilic) Contact Lens is indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopia or hyperopia and may exhibited refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.
The eye care practitioner may prescribe the contact lens for single-use daily disposable wear. The Discon Daily Lenses are not intended to be disinfected and should be discarded after a single use.
Prescription Use
(Part 21 CFR 801 Subpart D)
X
OR : Over-The-Counter (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
ce of Device Evaluation (ODE) Concurrence of CDF
Ming-chuen Shui
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K053191
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