The Flexlens Multifocal Soft Contact Lens (hioxifilcon A) and (hioxifilcon B) for Daily Wear is indicated for daily wear use for the correction of refractive ametropia (myopia, hyperopia and/or presbyopia) in non-aphakic persons.

Device Description

The Flexlens Multifocal Soft Contact Lens (hioxifilcon A) and (hioxifilcon B) for Daily Wear is a lathe-cut soft lens multifocal with an aspheric front surface and a spherical base curve. In the dry (unhydrated) state the lens is machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The progressive optics utilize the simultaneous vision concept which offers functional vision from distance to near throughout the viewing range. The pupil zone on the front surface varies with the size of the patient's pupil.

The non-ionic lens material, hioxifileon A, is a copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydrosypropyl Methacrylate (Glycerol Methacrylate, GMA). It consists of 41% hioxifilcon A and 59% water by weight. when immersed in normal saline solution buffered with sodium bicarbonate. Flexlens Multifocal Soft Contact Lenses for Daily Wear made out of hioxifilcon A are available in clear and with a blue visibility-handling tint, phthalocyanato (2) - (copper).

The non-ionic lens material, hioxifileon B, is a copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydrosypropyl Methacrylate (Glycerol Methacrylate, GMA). It consists of 52% hioxifilcon B and 48% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. FlexIens Multifocal Soft Contact Lenses for Daily Wear made out of hioxifilcon B are available in clear and with a blue visibility-handling tint, phthalocyanato (2) - (copper).

AI/ML Overview

The provided document, K070308, is a 510(k) summary for the Flexlens Multifocal Soft Contact Lens (hioxifilcon A) and (hioxifilcon B) for Daily Wear. It clarifies that this is a premarket notification for a Class II medical device, and the FDA has determined it to be substantially equivalent to legally marketed predicate devices.

Crucially, this document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting a de novo study with specific acceptance criteria and detailed performance data often seen in AI/algorithm-based device submissions.

Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not explicitly present in this 510(k) summary. The document primarily refers to "Pre-Clinical Performance Data" in previous 510(k) submissions for the materials themselves (hioxifilcon A and B).

Based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a traditional contact lens submission, specific "acceptance criteria" and "device performance" metrics in the context of an AI/ML algorithm (e.g., sensitivity, specificity, AUC) are not described. Instead, the document focuses on the physical and optical properties of the lens materials.

Property	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Flexlens Multifocal Soft Contact Lens)
For hioxifilcon A:	Should be comparable to predicate devices.
Refractive Index (hydrated)	N/A (implied by predicate)	1.404
Light Transmission (clear)	N/A (implied by predicate)	> 95% T
Light Transmission (tinted)	N/A (implied by predicate)	> 95% T
Water Content	N/A (implied by predicate)	59%
Specific Gravity (hydrated)	N/A (implied by predicate)	1.18
Oxygen Permeability (Dk)	N/A (implied by predicate)	$18 \times 10^{-11}$ (cm2/sec) (ml O₂/ml x mm Hg @ 35°C), (revised Fatt method)
For hioxifilcon B:	Should be comparable to predicate devices.
Refractive Index (hydrated)	N/A (implied by predicate)	1.404
Light Transmission (clear)	N/A (implied by predicate)	> 95% T
Light Transmission (tinted)	N/A (implied by predicate)	> 95% T
Water Content	N/A (implied by predicate)	48 %
Specific Gravity (hydrated)	N/A (implied by predicate)	1.136
Oxygen Permeability (Dk)	N/A (implied by predicate)	$15 \times 10^{-11}$ (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method)

2. Sample size used for the test set and the data provenance

This information is not provided in the 510(k) summary. The document references "Pre-Clinical Performance Data" in other 510(k) submissions (K983773 and K964528) for the hioxifilcon A and B materials, but it does not detail the specific studies, sample sizes, or data provenance conducted for this particular multifocal lens design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the 510(k) summary. It's not relevant for a traditional contact lens submission focused on physical/optical properties and chemical composition.

4. Adjudication method for the test set

This information is not provided and is not relevant for the type of device and submission described.

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, a MRMC comparative effectiveness study was not done. This is not an AI-assisted diagnostic device, but a contact lens.

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

No, a standalone algorithm performance study was not done. This is not an AI/ML algorithm.

7. The type of ground truth used

The concept of "ground truth" as it applies to AI/ML diagnostics (e.g., pathology, outcomes data) is not applicable here. The "truth" for this device relates to its physical, chemical, and optical properties meeting established standards for contact lenses and being comparable to legally marketed predicate devices.

8. The sample size for the training set

This information is not provided and is not relevant as this is not an AI/ML device.

9. How the ground truth for the training set was established

This information is not provided and is not relevant as this is not an AI/ML device.

Summary

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K070308

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Flexlens Multifocal Soft Contact Lens (hioxifilcon A) and (hioxifilcon B)

MAR 1 2 2007

510(k) Summary Page 1 of 3

I. Submitter Information

510(k) Owner:	X-Cel Contacts2775 Premiere Parkway, Suite 600Duluth, GA 30097
---------------	------------------------------------------------------------------------

Contact Person: Robert Chambers (770) 622-9235

USA Consultant: Kevin Randall GlobalReg Compliance Associates, Inc. 581 Whiles Court Erie, CO 80516 (303) 956-8595 (direct) (303) 828-0835 (fax) Email: kevin@globalregcompliance.com

Date Summary	January 30, 2007
Prepared:

Name of Device II.

Flexlens Multifocal Soft Contact Lens (hioxifilcon A) and . Trade Name: (hioxifilcon B) for Daily Wear
. Common Name: Daily Wear Soft Contact Lens
. Classification Name: Lenses, Soft Contact, Daily Wear
� USAN (generic name): (hioxifilcon A) and (hioxifilcon B)

III. Predicate Devices

Subject Device	Predicate Device(s)
Flexlens Multifocal Soft Contact Lens(hioxifilcon A)	Proclear Ultravue Multifocal(K043129)
	Horizon 59 Oasis (hioxifilcon A)Progressive (K043540)
Flexlens Multifocal Soft Contact Lens(hioxifilcon B)	ESSTECH MULTI Aspheric(multifocal) (hioxifilcon B) SoftContact Lens(K982904)

X-Cel Contacts, Flexlens Multifocal Soft Contact Lens 510(k) - January 30, 2007

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Flexlens Multifocal Soft Contact Lens (hioxifilcon A) and (hioxifilcon B)

510(k) Summary Page 2 of 3

Device Description & Technological Characteristics IV.

· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·

Refractive Index	1.404 (hydrated)
Light Transmission (clear)	greater than 95% T
Light Transmission (tinted)	greater than 95% T
Water Content	59%
Specific Gravity	1.18 (hydrated)
Oxygen Permeability	$18 X 10^{-11}$ (cm2/sec) (ml O₂/ml x mm Hg @ 35°C), (revised Fatt method).

The physical properties of the hioxifilcon A lens are:

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Flexlens Multifocal Soft Contact Lens (hioxifilcon A) and (hioxifilcon B)

510(k) Summary Page 3 of 3

Refractive Index	1.404 (hydrated)
Light Transmission (clear)	greater than 95% T
Light Transmission (tinted)	greater than 95% T
Water Content	48 %
Specific Gravity	1.136 (hydrated)
Oxygen Permeability	15 X 10-11 (cm2/sec) (ml O2/ml x mm Hg @35°C), (revised Fatt method).

The physical properties of the hioxifilcon B lens are:

V. Intended Use

Pre-Clinical Performance Data VI.

Pre-clinical performance data can be referenced for hioxifilcon A and hioxifilcon B in Benz Research and Development's 510(k) # K983773 and # K964528.

X-Cel Contacts, Flexlens Multifocal Soft Contact Lens 510(k) - January 30, 2007

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with flowing lines, symbolizing care and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 2007

X-Cel Contacts c/o Mr. Kevin Randall 581 Whiles Court Erie, CO 80516

Re: K070308

Trade/Device Name: FlexIens Multifocal Soft Contact Lens (hioxifilcon A) and (hioxifilcon B) for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: II Product Code: LPL Dated: February 26, 2007 Received: February 26, 2007

Dear Mr. Randall:

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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Page 2 - Mr. Kevin Randall

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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Eychlmin SimD

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 (if known): K070308

Device Name: Flexlens Multifocal Soft Contact Lens (hioxifilcon A) and (hioxifilcon B) for Daily Wear

Indications For Use;

Prescription Use
X
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Marc Robby
(Division Sign-Off)

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

510(k) Number K07051

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.