(327 days)
SynergEyes™ A (paflufocon D hem-iberfilcon A) and SynergEyes™ M (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses are indicated for use in the correction of hyperopic, and astigmatic refractive error including presbyopia, in aphakic and not aphakic, non-diseased eyes. The lenses are indicted for the correction of up to +20.00 and -20.00 D in eves with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.
SynergEyes™ KC (paflufocon D hem-iberfilcon A) and ClearKone™ (paflufocon D hem-iberfilcon A) Daily Wear Hybrid Contact Lenses for keratoconus are in the correction of eyes with refractive errors that include hyperopia and myopia that manifest irregular astigmatism, in aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 6.00 D. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.
SynergEyes™ PS (paflufocon A hem-iberfilcon A) Hybrid Contact Lenses are indicated for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and irregular astigmatism in aphakic and not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with astigmatism up to 6.00 D. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.
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, nondiseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 D. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat), prior to reinsertion, as recommended by the eye care professional.
UltraHealth™ (petrafocon A hem-larafilcon A) Hybrid Contact Lenses for keratoconus are indicated for the correction of hyperopic, myopic and astigmatic refractive error including presbyopia that manifest irregular corneas or irregular astigmatism, in aphakic and not aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.
UltraHealth™ Flat Cornea SiH (petrafocon A) Hybrid Contact Lenses are for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and irregular astigmatism in aphakic and not aphakic, non-diseased eyes, with or without presbyopia. The lenses are indicated for daily wear for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular assigmatism up to 6.00 D. For presbyopia, add powers between +1.00 D. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.
Not Found
This document is a 510(k) premarket notification from the FDA, approving various SynergEyes™ Hybrid Contact Lenses. It outlines the indications for use for different models of these lenses. However, it does not contain information about:
- Acceptance criteria for device performance.
- Details of a study proving the device meets acceptance criteria.
- Sample sizes for test sets or data provenance.
- Experts used to establish ground truth or their qualifications.
- Adjudication methods.
- Results of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect sizes for human readers with/without AI assistance.
- Results of a standalone (algorithm only) performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document is purely a regulatory approval letter stating that the device is substantially equivalent to legally marketed predicate devices, along with the device names and their indications for use. It doesn't delve into the detailed performance studies or the methodologies behind them for acceptance testing.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 15, 2016
Synergeyes, Inc. % Richard Lippman, OD, FAAO Regulatory Consultant R.E. Lippman Regulatory Pathways 1171 Kersey Road Silver Spring, MD 20902
Re: K153714
Trade/Device Name: SynergEyes™ A&M Hybrid Contact Lenses SynergEyes™ KC and ClearKone™ Hybrid Contact Lenses SynergEyesTM PS Hybrid Contact Lenses SynergEyes™ Duette (SiH) Hybrid Contact Lenses SynergEyesTM Ultrahealth™ Hybrid Contact Lenses for Keratoconus Hybrid Contact Lenses SynergEyes™ Ultrahealth™ Flat Cornea Hybrid Contact Lenses for Keratoconus
Regulation Number: 21 CFR 886.5926 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: September 30, 2016 Received: October 7, 2016
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
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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); medical device 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
for 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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510(k) Number (if known) K153714
Device Name
SynergEyes™ A & M Hybrid Contact Lenses
Indications for Use (Describe)
SynergEyes™ A (paflufocon D hem-iberfilcon A) and SynergEyes™ M (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses are indicated for use in the correction of hyperopic, and astigmatic refractive error including presbyopia, in aphakic and not aphakic, non-diseased eyes. The lenses are indicted for the correction of up to +20.00 and -20.00 D in eves with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.
Type of Use (Select one or both, as applicable)
X | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Number (if known)
K153714
Device Name
SynergEves™ KC and ClearKone™ Hybrid Contact Lenses
Indications for Use (Describe)
SynergEyes™ KC (paflufocon D hem-iberfilcon A) and ClearKone™ (paflufocon D hem-iberfilcon A) Daily Wear Hybrid Contact Lenses for keratoconus are in the correction of eyes with refractive errors that include hyperopia and myopia that manifest irregular astigmatism, in aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 6.00 D. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 SubpartC)
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510(k) Number (if known)
K153714
Device Name
SynergEves™ PS Hybrid Contact Lenses
Indications for Use (Describe)
SynergEyes™ PS (paflufocon A hem-iberfilcon A) Hybrid Contact Lenses are indicated for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and irregular astigmatism in aphakic and not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with astigmatism up to 6.00 D. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.
Type of Use (Select one or both, as applicable)
|X | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 SubpartC)
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K153714
Device Name
SynergEyes™ Duette (SiH) Hybrid Contact Lenses
Indications for Use (Describe)
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, nondiseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 D. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat), prior to reinsertion, as recommended by the eye care professional.
Type of Use (Select one or both, as applicable)
|X | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 SubpartC)
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510(k) Number (if known)
K153714
Device Name
SynergEyes™ UltraHealthTM Hybrid Contact Lenses for Keratoconus Contact Lenses
Indications for Use (Describe)
UltraHealth™ (petrafocon A hem-larafilcon A) Hybrid Contact Lenses for keratoconus are indicated for the correction of hyperopic, myopic and astigmatic refractive error including presbyopia that manifest irregular corneas or irregular astigmatism, in aphakic and not aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.
Type of Use (Select one or both, as applicable)
X | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 SubpartC)
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510(k) Number (if known) K153714
Device Name
SynergEyes™ UltraHealth™ Flat Cornea Hybrid Contact Lenses for Keratoconus
Indications for Use (Describe)
UltraHealth™ Flat Cornea SiH (petrafocon A) Hybrid Contact Lenses are for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and irregular astigmatism in aphakic and not aphakic, non-diseased eyes, with or without presbyopia. The lenses are indicated for daily wear for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular assigmatism up to 6.00 D. For presbyopia, add powers between +1.00 D. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.
Type of Use (Select one or both, as applicable)
X | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart )
§ 886.5916 Rigid gas permeable contact lens.
(a)
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.(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.