The SuperView (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are myopia (nearsighted) and may exhibits 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 heat (not chemical), hydrogen peroxide, or chemical (not heat) disinfection system.

Device Description

SuperView (polymacon) soft (hydrophilic) contact lens for daily wear with water content (38.5%) when immersed in a sterile saline solution. It consists of a polymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with Ethylene Glycol Dimethacrylate (EGDMA) served as crosslinker. The lenses are produced by spin-casting method to form non-spherical flexible surface, which covers the cornea. The SuperView Contact lens with visible tint is tinted blue using C.) Reactive blue 19 to make the lens more visible for handling. Lenses are supplied sterile in sealed blister PP cup containing isotonic phosphate buffered saline solution. The compatibility and package integrity of the blister cup 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 SuperView (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Metric	Reported Device Performance (SuperView Lens)	Predicate Device Performance (Optima FW / SeeQuence)
Material / Design Characteristics
Diameter Range	13.7 to 14.1 mm	Equivalent/Comparable
Power Range	Plano to -12.00 D	Equivalent/Comparable
Center Thickness (for -3.00D)	0.08 to 0.12 mm	Equivalent/Comparable
Refractive Index (hydrated)	1.437	Equivalent/Comparable
Light Transmittance	>93%	Equivalent/Comparable
Water Content	38.5%	Equivalent/Comparable
Oxygen Permeability (edged corrected) @ 35°C	8.6 x 10^-11 [(cm²/sec)(ml O3/ml-mmHg)]	Equivalent/Comparable
Biocompatibility (Irritation Test in Rabbit Eye)	Non-toxic, non-irritated	Not explicitly detailed, assumed predicate equivalence
Biocompatibility (Systemic Toxicity in Mouse)	Non-toxic	Not explicitly detailed, assumed predicate equivalence
Biocompatibility (Cytotoxicity)	Not cytotoxic	Not explicitly detailed, assumed predicate equivalence
Sterilization (SAL)	Minimum SAL of 10^-6 (via steam sterilization)	Not explicitly detailed, assumed predicate equivalence
Shelf-Life Sterility	Remains sterile through 3 years expiration date	Not explicitly detailed, assumed predicate equivalence
Leachability (monomers & addictive residues)	No leachable monomers and addictive residues at detectable levels	Not explicitly detailed, assumed predicate equivalence
Clinical Performance
Visual Acuity Correction	Nearly a hundred percent of participants' vision was corrected	Not explicitly detailed, assumed predicate equivalence
Patient Satisfaction (lens wearing and care)	Nearly all were satisfied	Not explicitly detailed, assumed predicate equivalence
Safety (No severe complications observed in daily wear users worldwide)	Generally stable condition without severe complication	Not explicitly detailed, assumed predicate equivalence
Appropriateness of Fit	Good fit for human eyes	Not explicitly detailed, assumed predicate equivalence
Intended Use	Correction of visual acuity in not-aphakic persons with non-diseased eyes, myopia (nearsighted) and up to 2.00 diopters refractive astigmatism that does not interfere with visual acuity.	Same as predicate devices
FDA Material Classification Group	Group 1	Same as predicate devices (Group 1)
USAN Name	Polymacon	Same as predicate devices (Polymacon)

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

Sample Size: 60 human eyes (for the clinical study).
Data Provenance: The document does not explicitly state the country of origin for the clinical study participants. It mentions the lenses have been "wide-used around the world, including Taiwan, China, Europe, Japan, etc.," but the specific clinical study's origin isn't detailed. The study appears to be a prospective clinical trial, as it describes testing the lenses "within 6 months" and ophthalmologists making conclusions.

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

The document states that "The ophthalmologists concludes, based on the specified clinical protocol..." This implies that the ground truth for safety and effectiveness, including visual acuity correction, patient satisfaction, and fit, was established by multiple ophthalmologists.
Qualifications of Experts: They are referred to as "ophthalmologists," implying they are medical doctors specializing in eye and vision care. No further specific qualifications (e.g., years of experience) are provided.

4. Adjudication Method for the Test Set

The document does not specify a formal adjudication method (e.g., 2+1, 3+1). It states "The ophthalmologists concludes," suggesting a consensus among the involved ophthalmologists or a lead investigator's final determination.

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

No MRMC comparative effectiveness study was done. This device is a contact lens, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

No standalone (algorithm only) performance study was done. Again, this is a physical medical device (contact lens), not a standalone algorithm.

7. The Type of Ground Truth Used

The ground truth for the clinical study appears to be a combination of:
- Expert Consensus/Clinical Judgment: Based on the assessments and conclusions of the ophthalmologists regarding safety, effectiveness, visual acuity, and fit.
- Patient-Reported Outcomes: Patient satisfaction with wearing and care.
- Observed Outcomes: Lack of severe complications.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" as it would for a machine learning model. For this type of device, the "training set" would implicitly refer to all the research and development, materials testing, and previous predicate device data that informed the design and manufacturing of the SuperView lens.
However, if we strictly consider explicit "set" sizes, the large-scale "wide-used around the world" population (Taiwan, China, Europe, Japan, etc.) with "all the procedure was in generally stable condition without severe complication to be observed" could be seen as an informal "real-world training/validation set" demonstrating long-term safety, though not a formally controlled study.

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

As there isn't a formal "training set" described in the context of an algorithm, the ground truth for the general development and underlying knowledge base for this contact lens was established through:
- Established scientific principles in polymer chemistry and ophthalmology.
- Non-clinical performance tests (material characteristics, biocompatibility, microbiology, leachability) which have their own established performance standards and methods.
- Historical data and experience from predicate devices and similar contact lenses, whose safety and effectiveness profiles are well-understood and supported by previous regulatory approvals. This forms a foundational "ground truth" that guides the design and testing of new, substantially equivalent devices.

Summary

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Ko33136

510 (K) Summary

SUMMARY OF SAFETY AND EFFECTIVENESS

FOR

SuperView (polymacon) 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. James Chang
	General manager
Phone:	886-3-592-7299
FAX:	886-3-592-6213
E-Mail:	jameschang@innovavision.com.tw
Date Prepared	10 Sep, 2003
Identification of Device:

Classification Name: Soft hydrophilic contact lens, per 21 CFR. 886,5925 Trade Name: SuperView (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear Common or usual Soft Contact lens Name: FDA Classification: Class II

Predicated Device:

Optima FW™ (polymacon) Visibility Tinted Contact Lenses (NDA number N16895/S087) & SeeQuence (polymacon) Contact Lens for Daily Wear made from Bausch & Lomb Inc.

Indications for Use:

SuperView (polymacon) soft (hydrophilic) contact lens for daily wear is indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are myopia (nearsighted) and may exhibits | 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 heat (not chemical), hydrogen peroxide, or chemical (not heat) disinfection system.

Description of Device:

SuperView (polymacon) soft (hydrophilic) contact lens for daily wear with water content (38.5%) when immersed in a sterile saline solution. lt

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consists of a polymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with Ethylene Glycol Dimethacrylate (EGDMA) served as crosslinker. The lenses are produced by spin-casting method to form non-spherical flexible surface, which covers the cornea. The SuperView Contact lens with visible tint is tinted blue using C.) Reactive blue 19 to make the lens more visible for handling. Lenses are supplied sterile in sealed blister PP cup containing isotonic phosphate buffered saline solution. The compatibility and package integrity of the blister cup packaging system has been demonstrated and successfully used for other marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave.

Summary of Clinical Study:

The SuperView lenses were test in 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. The ophthalmologists concludes, based on the specified clinical protocol, that the achieved report demonstrates the SuperView Lenses are safe and effective means of daily wear vision correction and make sure they are a good fit for the human eyes.

Furthermore, SuperView lenses have been wide-used around the world, including Taiwan, China, Europe, Japan, etc. Among the users being daily worn the Super/iew lenses, all the procedure was in generally stable condition without severe complication to be observed.

Nonclinical Studies:

A series of non-clinical performance tests were performed to demonstrate the safety and effectiveness of the SuperView Soft Contact lens, and establish substantial equivalence to currently marketed predicate lenses-Optima FW™ (polymacon) Visibility Tinted Contact Lenses (NDA number N16895/S087) & SeeQuence (polymacon) Contact Lens for Daily Wear made from Bausch & Lomb Inc. The evidence of substantial equivalent to the predicate lens described as follow:

a) Technological characteristics studies
SuperView lenses designs in the following parameter ranges:

Diameter range; 13.7 to 14.1 mm

Power range: Plano to -12.00D

Center thickness: varies with power (0.08 to 0.12 mm for -3.00D) Lenses have the following properties:

REV (B)

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Refractive index: 1.437 (hydrated) Light transmittance: >93% Water content: 38.5 % Oxygen permeability (edged corrected) : 8.6x 10-11 [(cm²/sec)(ml O3/ml-mmHg)] @ 35°C

These characteristics of SuperView Contact lenses are equivalent and comparable to that 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: SuperView Contact lens. The Irritation test in the rabbit eye and Systemic toxicity studies in the mouse indicate the extracts would be considered as non-toxic, nor irritated. The Cytotoxicity inspect demonstrates the lens is not cytotoxic under the conditions of the study.
c) Microbiology
The lens sterilization process, steam sterilization, has been validated to deliver a minimum SAL of 10*, thereby meeting the requirement of FDA Group I. There is shelf-life stability data supporting that the lens remains sterile through the three years of 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 SuperView (polymacon) soft (hydrophilic) contact lens for daily wear indicated that it can support the efficiency and safety use as well as the predicate devices- Optima FW™ (polymacon) Visibility Tinted Contact Lenses (NDA number N16895/S087) & SeeQuence (polymacon) Contact Lens for Daily Wear made from Bausch & Lomb Inc., when used in accordance with the instructions for use. It is due to the facts that both fall into the same FDA material classification grouping (Group 1), USAN name (Polymacon), intended use, and efficiency & safety. In conclusion, it is Innova's conviction that data submitted in this 510(k) to validate the claim of substantial equivalency, the SuperView soft contact lens with the same established safety profile and effectiveness as the predicate device.

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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 circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with flowing lines, representing the department's mission related to health and human welfare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 5 2004

INNOVA VISION, Inc. c/o Ms. Jennifer Reich 3892 South America West Trail Flagstaff, AZ 86001

Re: K033136

K033150
Trade/Device Name: SuperView (polymacon) 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: December 11, 2003 Received: January 29, 2004

Dear Ms. Reich:

Wc have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your Bection 910(x) production is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the encrosure) thanksett promoted in Medical Device Amendments, or to devices that probl to May 26, i 770, the onections and the provisions of the Federal Food, Drug, and Cosmetic have been reclassified in accordance with and proval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, market the device, subject to an as for annual registration, listing of devices, good controls provibitions of allabeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (600 a00 70) . Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation Fran may be subject to sam additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of I cannouncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I that FDA has made a determination that your device complies with other requirements of the Act that I D7X has made a decembalized administered by other Federal agencies. You must comply or any I coclar statutes and regalaries and regulation and listing and listing - (21 CFR with an the Act 3 requirements) meets); good manufacturing practice requirements as set forth in I all 807), labeling (21 CFR Part 821), grFR Part 820); and if applicable, the elcctronic product the quality by home (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Jennifer Reich

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) 594-4613. 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/dsma/dsmamain.html

Sincerely yours,

A Kalph Rosenthal

A. Ralph Rosenthal, 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 STATEMENT

K033136 510(k) Number:

Device Name: SuperView (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear Innova Vision, Inc.

Indications for Use:

The SuperView (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is The Ouper visw (polyments)
indicated for the correction of visual acuity in not-aphakic persons with nonindouted for the corre myopia (nearsighted) and may exhibit . refractive discussu byou that are mypters that does not interfere with visual acuity.

The eye care practitioner may prescribe the contact lens for frequent replacement The Cyc ours practitions way |
wear, with cleaning, rinsing and disinfection and scheduled replacement. The weat, with cleaning, mising and and themical), hydrogen peroxide, or chemical (not heat) disinfection system.

Concurrence of CDRH, Office of Device Evaluation (ODE)

T. is G
(Division Sign Off)

(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devices

Ko33136 510(k) Number _

AND/OR Prescription Use (Per 21 CFR 801.109)

Over-The-Counter

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.