FLEXLENS MULTIFOCAL SOFT CONTACT LENS, (HIOXIFILCON A) AND (HIOXIFILCON B) FOR DAILY WEAR

K070308 · X-Cel Contacts · LPL · Mar 12, 2007 · Ophthalmic

Device Facts

• Record ID: K070308
• Device Name: FLEXLENS MULTIFOCAL SOFT CONTACT LENS, (HIOXIFILCON A) AND (HIOXIFILCON B) FOR DAILY WEAR
• Applicant: X-Cel Contacts
• Product Code: LPL · Ophthalmic
• Decision Date: Mar 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

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 Story

Lathe-cut soft contact lens; multifocal design with aspheric front surface and spherical base curve. Material: hioxifilcon A (41% polymer, 59% water) or hioxifilcon B (52% polymer, 48% water). Principle: simultaneous vision optics providing functional vision across distance-to-near range; pupil zone varies based on patient pupil size. Used by eye care professionals for patient vision correction. Lens is machined/polished in dry state; becomes soft/pliable when hydrated in saline. Benefits: provides refractive correction for ametropia and presbyopia.

Clinical Evidence

Bench testing only. Performance data for hioxifilcon A and hioxifilcon B materials referenced from previous 510(k) submissions (K983773 and K964528).

Technological Characteristics

Non-ionic copolymers of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (GMA). Hioxifilcon A: 59% water, 1.404 refractive index, 18x10^-11 Dk. Hioxifilcon B: 48% water, 1.404 refractive index, 15x10^-11 Dk. Lathe-cut manufacturing; aspheric front surface; spherical base curve. Available clear or with phthalocyanato (2) - (copper) blue visibility tint.

Indications for Use

Indicated for daily wear correction of myopia, hyperopia, and/or presbyopia in non-aphakic patients.

Regulatory Classification

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.

Predicate Devices

• Proclear Ultravue Multifocal (K043129)
• Horizon 59 Oasis (hioxifilcon A) Progressive (K043540)
• ESSTECH MULTI Aspheric (multifocal) (hioxifilcon B) Soft Contact Lens (K982904)

Reference Devices

• Benz Research and Development 510(k) # K983773
• Benz Research and Development 510(k) # K964528

Submission Summary (Full Text)

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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 Contacts<br>2775 Premiere Parkway, Suite 600<br>Duluth, GA 30097 |
|---------------|------------------------------------------------------------------------|
|---------------|------------------------------------------------------------------------|

Contact Person: Robert Chambers [phone]

USA Consultant: Kevin Randall GlobalReg Compliance Associates, Inc. 581 Whiles Court Erie, CO 80516 [phone] (direct) [phone] (fax) Email: [e-mail]

| 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<br>(hioxifilcon A) | Proclear Ultravue Multifocal<br>(K043129) |
| | Horizon 59 Oasis (hioxifilcon A)<br>Progressive (K043540) |
| Flexlens Multifocal Soft Contact Lens<br>(hioxifilcon B) | ESSTECH MULTI Aspheric<br>(multifocal) (hioxifilcon B) Soft<br>Contact Lens<br>(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.

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

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.

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).

| 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:

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).

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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 @<br>35°C), (revised Fatt method). |

The physical properties of the hioxifilcon B lens are:

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.

#### V. Intended Use

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.

#### 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 [phone]. 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 [phone] or [phone] 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;

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

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

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