Discon (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear 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 frequent replacement wear, with cleaning, rinsing and disinfection and scheduled replacement. The contact lens may be disinfected using a chemical (not heat) disinfection system only.

Device Description

Discon (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear are available as non-spherical lenses 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 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. 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

Here's a breakdown of the acceptance criteria and study information for the Discon (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable sense that would typically be found for a new, independent safety/efficacy study. Instead, it focuses on demonstrating substantial equivalence to predicate devices through various tests and a clinical summary. The "acceptance criteria" are implicitly met if the device's performance is comparable to or meets the established safety and effectiveness profile of the predicate devices.

Acceptance Criteria (Implied by Substantial Equivalence to Predicates)	Reported Device Performance (Discon Lenses)
Clinical Performance (Safety & Efficacy)	- "Nearly a hundred percent of the participants' vision was corrected and nearly all were satisfied with the lens wearing and care of lenses." - "all the procedures were in generally stable condition without severe complication." - "No significant side effects and complaints to be observed." - Indicated for correction of visual acuity in non-aphakic persons with non-diseased eyes (myopia/hyperopia) and astigmatism up to 2.00 diopters.
Technological Characteristics	- Equivalent and comparable to predicate lenses in: - Diameter range: 13.8 to 14.2 mm - Power range: +6.00D to -12.00D - Center thickness: 0.08 to 0.12 mm for -3.00D - Refractive index: 1.407 (hydrated) - Light transmittance: >93% - Water content: 56 to 60 % - Oxygen permeability (edged corrected): 24x10-11 [(cm³/sec)(ml O2/ml-mmHg)] @ 35°C
Biocompatibility	- Non-toxic and non-irritated (rabbit eye irritation and systemic toxicity studies). - Not cytotoxic (cytotoxicity testing).
Microbiology	- Steam sterilization process validated to deliver minimum SAL of 10-6. - Shelf-life stability data supports sterility through expiration date.
Leachability	- No leachable monomers and addictive residues detected above reported levels.

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

Sample Size: 65 human eyes
Data Provenance: The study was conducted for 6 months. It also states that "Discon lenses have been wide-used around the world, including Taiwan, China, Europe, etc." and observations were made "Among the users being daily worn the Discon lenses". This suggests a combination of a prospective clinical study involving 65 eyes and potentially retrospective observations from wider market use, though the details of the latter are not specified as a formal study. The primary clinical study of 65 eyes provides prospective data. The submitter is based in Taiwan.

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

The document does not explicitly state the number of experts used or their qualifications for establishing ground truth in the clinical study. It mentions the "eye care practitioner may prescribe the contact lens" in the 'Indications for Use', implying practitioners would be involved in patient assessment and data collection.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method for the test set (e.g., 2+1, 3+1).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not conducted. This device is a contact lens, not an AI diagnostic tool.

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

This question is not applicable as the device is a contact lens, not a computational algorithm.

7. The Type of Ground Truth Used:

The ground truth for the clinical study seems to be based on clinical observation, patient feedback, and standard ophthalmological assessments of visual acuity and ocular health. Terms like "participants' vision was corrected," "satisfied with the lens wearing," "stable condition without severe complication," and "no significant side effects and complaints" indicate this. For the non-clinical studies (biocompatibility, microbiology, leachability), the ground truth is established through laboratory testing and established scientific methodologies/standards.

8. The Sample Size for the Training Set:

This document does not mention a training set in the context of device development or clinical validation, as it is not an AI/machine learning device. The 65 human eyes mentioned are for the clinical study/test set.

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

This question is not applicable as there is no mention of a training set for this type of device.

Summary

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AUG 1 2 2005 51129

510 (K) Summary

SUMMARY OF SAFETY AND EFFECTIVENESS FOR

Discon (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear 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	15 Apr. / 2005

ldentification of Device:

Classification Name:	Soft hydrophilic contact lens, per 21 CFR. 886.5925
Trade Name:	Discon (Etafilcon A) Soft (hydrophilic) Contact Lensfor Daily Wear
Common or usual Name:	Soft (hydrophilic) Contact lens (daily wear)
FDA Classification:	Class II
Registration Number	3003746024

Predict Device:

SuperView (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (K033136)-made from Innova Vision Inc., Taiwan. ACUVUE (etafilcon A) Contact Lens Visibility tint

(K962804) -made from Johnson & Johnson Co. USA.

Indications for Use:

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Summary of Clinical Study:

The Discon Lenses were tested in 65 human eves 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.

Discon lenses have been wide-used around the world, including Taiwan, China, Europe, etc. Among the users being daily worn the Discon 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:

A series of nonclinical performance tests were performed to demonstrate the safety and effectiveness of the Discon Soft Contact lens, and establish substantial equivalence to predicate lenses-SuperView Lens (K033136): ACUVUE Lens (K962804). 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

Discon 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) : 24x10'11 [(cm³/sec)(ml O2/ml-mmHg)] @ 35°C

There characterizations of Discon Contact lenses are equivalent and comparable to those of predicate lenses.

b) Biocompatibilitv
In accordance with the May 1994 Guidance Document for daily wear contact lenses, toxicity studies have been conducted on the model: Discon Contact lenses. 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 Discon (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear indicated that it can support the efficiency and security use as well as the predicate devices- SuperView (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (K033136) & ACUVUE (etafilcon A) Contact Lens visibility tint-K962804), 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 Soft (hydrophilic) Contact Lens for Daily Wear, with the same established safety profile and effectiveness as the predicate device-SuperView (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (K033136) & ACUVUE (etafilcon A) Contact Lens visibility tint (K962804).

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings or feathers.

AUG 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Innova Vision, Inc. c/o Ms. Jennifer Reich Harverst Consulting Corp. 3892 South America West Trail Flagstaff, AZ 86001

Re: K051129

Trade/Device Name: Discon (etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: July 11, 2005 Received: July 13, 2005

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 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); 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,

David M. Whipple

Acting 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

K051129 510(k) Number:

Device Name: Discon (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear

Indications for Use:

Discon (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear are 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 frequent replacement wear, with cleaning, rinsing and disinfection and scheduled replacement. TThe contact lens may be disinfected using a chemical (not heat) disinfection system only.

Prescription Use X OR
(Part 21 CFR 801 Subpart D)

Over-The-Counter (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number. Ko 51129

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.