SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS

K113586 · Synergeyes, Inc. · HQD · Apr 18, 2012 · Ophthalmic

Device Facts

• Record ID: K113586
• Device Name: SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS
• Applicant: Synergeyes, Inc.
• Product Code: HQD · Ophthalmic
• Decision Date: Apr 18, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 886.5916
• Device Class: Class 2

Intended Use

Duette™ SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lenses for daily wear are indicated for use in the correction of hyperopic, myopic and astigmatic refractive error including presbyopia, in aphakic not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

Device Story

Duette SiH is a hybrid contact lens consisting of a rigid gas permeable (RGP) center and a hydrogel skirt. Designed for daily wear to correct refractive errors including myopia, hyperopia, astigmatism, and presbyopia. The device is prescribed by eye care professionals for patients with non-diseased eyes. The lens provides the visual acuity benefits of an RGP lens with the comfort of a soft lens. Patients self-administer the lenses daily and perform maintenance using compatible chemical disinfection systems. The device functions as a physical refractive correction tool.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review.

Technological Characteristics

Hybrid contact lens comprising a rigid gas permeable (petrafocon A) center and a hydrogel (hem-larafilcon A) skirt. Designed for daily wear. Requires chemical disinfection compatible with both RGP and hydrogel materials.

Indications for Use

Indicated for daily wear correction of hyperopic, myopic, and astigmatic refractive error, including presbyopia, in aphakic and non-aphakic, non-diseased eyes. Corrects up to +20.00 D with astigmatism up to 6.00 D; add powers +1.00 to +4.00 D.

Regulatory Classification

Identification

A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

APR 1-8 2012

SynergEyes, Incorporated c/o Richard E. Lippman, O.D. VP Ophthalmic Product Regulatory Affairs Official Correspondent to SynergEyes, Inc. R.P. Chiacchierini & Associates, LLC 15825 Shady Grove Road, Suite 30 Rockville, MD 20850

Re: K113586

Trade/Device Name: Duette SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lenses Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Codes: HQD Dated: March 26, 2012 Received: March 28, 2012

Dear Dr. Lippman:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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## Page 2 - Dr. Richard Lippman

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours,

Kesia Alexander

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Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

K113586

510(k) Number (if known):

Duette™ SiH (petrafocon A hem-larafilcon A) Hybrid Contact lens

Indications For Use:

Device Name:

Duette™ SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lenses for daily wear are indicated for use in the correction of hyperopic, myopic and astigmatic refractive error including presbyopia, in aphakic not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

Prescription Use (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 Robbay

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

510(k) Number K113586