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.

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.

AI/ML Overview

This document is a 510(k) Pre-Market Notification for a contact lens, and it primarily focuses on establishing substantial equivalence to existing predicate devices rather than providing detailed acceptance criteria and a study proving device performance in the way one might expect for a novel AI/software medical device.

Based on the provided text, here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (Discon Daily)	Predicate Device (Discon K051129) Performance
Material/Composition	No change from predicate lens material (Etafilcon A, HEMA, MAA, TMPTMA, EGDMA)	Same (Etafilcon A, HEMA, MAA, TMPTMA, EGDMA)
Manufacturing Process	No change from predicate lens manufacturing process (spin-casting)	Same (spin-casting)
Diameter Range	13.8 to 14.2 mm	No explicit range given, but implied same as predicate due to no change statement
Power Range	+6.00D to -12.00D	No explicit range given, but implied same as predicate due to no change statement
Center Thickness (-3.00D)	0.08 to 0.12 mm	No explicit range given, but implied same as predicate due to no change statement
Refractive Index (hydrated)	1.407	No explicit value given, but implied same as predicate due to no change statement
Light Transmittance	>93%	No explicit value given, but implied same as predicate due to no change statement
Water Content	56 to 60 %	No explicit value given, but implied same as predicate due to no change statement
Oxygen Permeability	24 x 10^-11 [(cm² /sec)(ml 02/ml-mmHg)] @ 35℃	No explicit value given, but implied same as predicate due to no change statement
Clinical Safety	"generally stable condition without severe complication," "no significant side effects and complaints" observed in wide usage.	Supported by prior submission K051129; deemed clinically safe.
Efficiency and Security of Use	Indicated to support efficiency and security as well as predicate devices.	Established by predicate device.

Explanation of the Table:
The document repeatedly states "There is no change in lens material, the manufacturing process, nor the parameter and properties" and "These technological characteristics of Discon Daily Contact lenses do not change to that of predicate lenses previously submitted in K051129." Therefore, the acceptance criteria for these characteristics are implicitly that they are identical to the predicate device, K051129. The reported performance of the Discon Daily is the same as these predicate device characteristics. The only explicit change mentioned is a "slightly exchange of blue-tint concentration," which is not given a specific acceptance criterion.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated as a defined "test set" with a numerical sample size. The document refers to "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." This implies a post-market surveillance type of observation rather than a structured clinical trial test set.
Data Provenance: "wide-used around the world, including Taiwan, China, etc." The nature is observational/retrospective, based on existing usage data rather than a new prospective study for this 510(k).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. No formal "ground truth" establishment by experts for a specific test set is described. The assessment of "generally stable condition without severe complication" and "no significant side effects and complaints" appears to be an aggregation of real-world usage and reporting, rather than an expert panel review of individual cases.

4. Adjudication Method for the Test Set

Not applicable. No formal adjudication method is mentioned as there isn't a structured test set requiring such.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a contact lens, not an AI/software device, so MRMC studies involving AI assistance are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a contact lens, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for showing clinical safety and effectiveness is primarily clinical outcomes/usage data (i.e., observation of "generally stable condition without severe complication" and "no significant side effects and complaints" from wide usage) and equivalence to predicate devices which had previously established safety and effectiveness. There is no mention of pathology or other objective diagnostic criteria as ground truth for a clinical study.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/learning algorithm, so there is no concept of a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. See point 8.

Summary of the Study:

The "study" in this 510(k) submission is not a new clinical trial but rather a demonstration of substantial equivalence to previously cleared predicate devices (K051129 and K013973). The key "study" elements are:

Assertion of No Change: The core of the argument is that the device (Discon Daily) uses the same material and manufacturing process as a previously cleared device (Discon K051129). This implies that all non-clinical and most clinical performance data for the predicate device directly apply to the new device.
Technological Characteristics Comparison: The document lists several key technological characteristics (diameter, power, thickness, refractive index, light transmittance, water content, oxygen permeability) and states they "do not change to that of predicate lenses."
Clinical Data Leverage: The clinical data submitted in the predicate K051129 is leveraged to support the clinical safety of the subject device.
Real-World Usage Observation: Complementing the equivalence, the document mentions that Discon Daily lenses have been "wide-used around the world" and "all the procedures were in generally stable condition without severe complication" with "no significant side effects and complaints." This serves as real-world observational evidence reinforcing safety.

In essence, for this 510(k), the "study" is a comparative analysis, relying heavily on the established safety and effectiveness of its predicate devices, combined with observational real-world data indicating no new safety concerns.

Summary

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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 usualName:	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:

Description of Device:

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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)

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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).

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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.

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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

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INDICATIONS FOR USE

510(k) Number:	K053191
----------------	---------

Device Name: Discon Daily (Etafilcon A) One-Day Soft (hydrophilic) Contact Lens

Indications for Use:

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)

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

Page 1 of 1

Regulation Number and Section

§ 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.