The SynergEyes® SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lenses are indicated for use in the correction of hyperopic, myopic and astigmatic refractive error including presbyopia, in aphakic and not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +25.00 and -25.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 D and +4.00 D.

The SynergEyes® SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear 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 otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +25.00 and -25.00 Din eves with irregular astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D.

The SynergEyes® SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lenses are indicated for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and myopia, astigmatism and irregular astigmatism in aphakic, non-diseased eyes with or without presbyopia. The lenses are indicated for daily wear for the correction of up to +25.00 and -25.00 Din eyes with astigmatism or irregular astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using only a chemical (not heat) disinfecting system compatible with both silicone-hydrogel and rigid gas permeable lenses.

Device Description

The SynergEves® SiH with Hydra-PEG Hybrid Daily Wear Contact Lens is a combination of high Dk rigid gas permeable contact lens-at the central optical portion of the lens corresponding to the cornea-and soft hydrophilic silicone-hydrogel skirt-straddling the limbus of the eye peripherally. The lenses are manufactured by lathe cutting process for custom Rx, and fabricated from petrafocon A (rigid, central portion) and hem-larafilcon A (soft, peripheral portion). The soft skirt is comprised of silicone hydrogel copolymer (hem-larafilcon A). The lens consists of 28% water and 72% (petrafocon A and hem-larafilcon A). The (petratocon A and hem-larafilcon A) names have been adopted by the United States Adopted Names Council (USAN). When placed on the human cornea, the SynergEyes® SiH with Hydra-PEG Hybrid Daily Wear Contact Lens acts as a refractive medium to focus light rays onto the retina.

The SynergEyes® SiH with Hydra-PEG Hybrid Daily Wear Contact Lens incorporates a violet visibility tint in the rigid gas permeable center, and a UV absorber. The device is available in the spherical, aspheric, multifocal (progressive), post-surgical, & irregular cornea design configurations with the following properties:
• Chord Diameter 13.0 mm to 25.00 mm
• Center Thickness 0.050 mm to 0.500 mm
• Base Curve 5.50 mm to 9.50 mm
• Power Range (sphere) -25.00D to +25.00D
• Add Power +1.00D to +4.00D

The Physical properties of the lens are:
Refractive Index (wet) RGP Center 1.442 Soft Skirt 1.435
Luminous Transmittance (tinted) (380nm to 780) 87% 97%
Surface Character hydrophobic hydrophilic
Water Content 28 ± 2%
Specific Gravity 1.15 N/A
Oxygen Permeability (revised Fatt method) 130 84

The SynergEyes® SiH with Hydra-PEG Hybrid Daily Wear Contact Lens is treated to incorporate Hydra-PEG Technology (HPT)-which is a thin polyethylene glycol (PEG)-based polymer that is covalently (permanently) bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with HPT, the underlying material (petrafocon A hem-larafilcon A) is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (dynamic contact receding angle) compared to untreated lenses. The resulting layer is hydrophilic and approximately 30nm in thickness.

The lens is supplied sterile in vials containing a buffered saline solution. Vial labeling is printed with appropriate lot numbering, expiration dating and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterilization process.

AI/ML Overview

This document describes the premarket notification (510(k)) for the SynergEyes® SiH with Hydra-PEG Hybrid Daily Wear Contact Lens. The core of the submission revolves around demonstrating substantial equivalence to previously cleared predicate devices. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the data and analyses presented to the FDA to establish this substantial equivalence, particularly focusing on how the new Hydra-PEG technology impacts the lens properties.

The document does not describe a traditional AI/ML model's acceptance criteria or performance study in the way one might evaluate a diagnostic algorithm. Instead, it focuses on the physical and chemical properties of a medical device (contact lens) and its clinical safety and effectiveness through comparisons to existing devices.

Here's an interpretation based on the provided text for the requested information, understanding that "acceptance criteria" here relates to demonstrating comparable performance and safety, primarily in terms of wettability improvement:

Overview of Device and Purpose of Submission:

The SynergEyes® SiH with Hydra-PEG Hybrid Daily Wear Contact Lens is a modification of existing SynergEyes® SiH lenses to include Hydra-PEG Technology (HPT). HPT is a polyethylene glycol (PEG)-based polymer designed to improve the wettability of the contact lenses. The submission aims to demonstrate that this modification does not change the design or indications for use, and that the lens with HPT is substantially equivalent to the predicate devices while offering improved wettability.

1. Table of Acceptance Criteria and Reported Device Performance

For a contact lens, acceptance criteria for physical properties typically involve demonstrating that the new device performs at least as well as, or better than, the predicate device in key safety and performance metrics. The primary criterion highlighted for the new technology (Hydra-PEG) in this submission is improved wettability.

Acceptance Criterion (Implicit for Equivalence)	Reported Device Performance (SynergEyes® SiH with Hydra-PEG)	Predicate Device Performance (SynergEyes® SiH - Uncoated)
Improved Wettability (Lower Contact Angle)	21.75° (Average captive bubble advancing contact angle)	33.50° (Average captive bubble advancing contact angle)
Equivalent Design/Indications for Use	Same as predicate (correction of hyperopic, myopic, astigmatic refractive error, presbyopia, irregular corneas, post-surgical/trauma)	Same
Equivalent Manufacturing Process	Lathe-Cut, custom manufactured	Lathe-Cut, custom manufactured
Equivalent Material Properties (base material)	petrafocon A hem-larafilcon A (RGP center and soft skirt)	petrafocon A hem-larafilcon A
Equivalent Oxygen Permeability (Dk)	130 (RGP Center), 84 (Soft Skirt)	(Implicitly similar or same, as material is the same)
Non-toxicity / Biocompatibility	Confirmed through in vitro and in vivo testing	Presumed for predicate
Sterility / Shelf-life Stability	Confirmed through testing	Presumed for predicate

Note on "Acceptance Criteria": This document primarily focuses on demonstrating substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device. For the Hydra-PEG modification, the key "acceptance" is that it improves wettability without negatively impacting other critical safety and performance parameters, and that its overall safety and efficacy are maintained as per the predicate device.

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

Sample Size for Wettability Test: n = 20 lenses (for the statistical comparison of mean contact angle between coated and uncoated lenses).
Data Provenance: Not explicitly stated regarding country of origin or specific study sites. The non-clinical toxicology and biocompatibility tests were conducted "in vitro and in vivo" and "in accordance with the GLP regulation." The clinical safety and effectiveness were "previously established" for the base hybrid contact lenses and for contact lenses treated with Hydra-PEG, suggesting reliance on existing data rather than a new, dedicated clinical trial for this specific 510(k) submission. Therefore, it's retrospective in the sense of leveraging prior data, but the wettability test itself was likely a specific laboratory test for this submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This submission is for a medical device (contact lens), not an AI/ML diagnostic system. Therefore, the concept of "experts establishing ground truth" in the diagnostic image interpretation sense does not apply directly. The "ground truth" for device performance is based on quantifiable physical properties (e.g., contact angle, water content, oxygen permeability) measured through validated laboratory methods, and clinical safety and efficacy data from previous studies.

4. Adjudication Method for the Test Set

Not applicable in the context of device physical property testing or clinical safety and efficacy data for a contact lens. Adjudication methods are relevant for subjective interpretations of data, particularly in medical image analysis.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

This was not done. MRMC studies are typically performed for diagnostic devices (e.g., AI algorithms for medical imaging) to assess reader performance with and without AI assistance. This submission is for a therapeutic device (contact lens) where the primary mechanism of action is physical correction of vision and surface properties, not diagnostic interpretation.

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

Not applicable. This is not an algorithm, but a physical medical device. The "standalone performance" refers to the intrinsic performance of the lens itself (e.g., wettability, refractive correction, safety profile).

7. The Type of Ground Truth Used

The "ground truth" (or basis for claiming safety and effectiveness and substantial equivalence) for this device includes:

Quantitative Physical Property Measurements: Laboratory measurements of properties like contact angle (wettability), refractive index, luminous transmittance, water content, specific gravity, and oxygen permeability. These are objective, measurable parameters.
Non-clinical Toxicology and Biocompatibility Data: Results from in vitro and in vivo tests confirming the safety of the materials and the finished lens, in accordance with GLP regulations.
Clinical Safety and Effectiveness Data (Referenced): "[T]he clinical safety and effectiveness has been previously established for hybrid contact lenses manufactured from (petrafocon A hem-larafilcon A) and contact lenses treated with Hydra-PEG." This implies reliance on existing clinical data for the base material and the Hydra-PEG technology itself, rather than a new, dedicated clinical trial for this specific lens permutation.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML model that requires a "training set." The development of the Hydra-PEG technology and the contact lens material would involve R&D and optimization, but not in the sense of an AI model's training data.

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

Not applicable, as it's not an AI/ML model.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

August 1, 2016

SynergEyes, Inc. % Mr. Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Ln. West Linn, OR 97068

Re: K160938

Trade/Device Name: SynergEyes® SiH with Hydra-PEG (petrafocon A Hem-larafilcon A) Hybrid Daily Wear Lens Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HOD Dated: June 20, 2016 Received: June 23, 2016

Dear Mr. Andre:

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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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 devicerelated 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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Indications for Use

510(k) Number (if known) K160938

Device Name

SynergEyes® SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lens

Indications for Use (Describe)

The SynergEyes® SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lenses are indicated for use in the correction of hyperopic, myopic and astigmatic refractive error including presbyopia, in aphakic and not aphakic, non-diseased eyes. The lenses are indicated for the correction of up to +25.00 and -25.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 D and +4.00 D.

Type of Use (Select one or both, as applicable)
	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

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510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:	K160938
Applicant information:
Date Prepared:	April 27th, 2016
Name:Address	SynergEyes, Inc.5927 Priestly Drive, Suite 210Carlsbad, CA 92008
Contact Person:	James Kirchner, O.D.President/CEO
Phone number:	(877)733-2012
Consultant:	Bret AndreEyeReg Consulting, Inc.6119 Canter Ln.West Linn, OR 97068
Phone number	(503) 372-5226

Device Information:

Device Classification:	Class II
Product Code:	HQD
Classification Name:	Daily Wear Rigid Gas Permeable Contact Lens(21 CFR 886.5916)
Trade Name:	SynergEyes® SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lens

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Purpose of 510(k) Submission:

~ New Technology ~

The SynergEves® SiH (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lensescleared under 510(k) K083921 and K113586-are modified to include Hydra-PEG Technology (HPT), which is a thin, polyethylene glycol (PEG)-based polymer designed to improve the wettability of the contact lenses. Specifically, HPT treated contact lenses demonstrate a measureable improvement in the contact angle in comparison with the untreated lenses. The application of HPT to the surface of SynergEyes® SiH contact lenses does not change the design or indications for use in comparison with the untreated lenses, the predicate device (K083921 and K113586).

Predicate Devices:

The SynergEyes® SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lenses are substantially equivalent to the following predicate devices:

"SynergEyes® SiH (petrafocon A hem-larafilcon A)" By SynergEyes, Inc. 510(k) number; K083921 and K113586 -primary predicate

"IntelliWave4 with HPT (safrofilcon A)" by Art Optical Contact Lens, Inc. 510(k) number; K152046 -reference predicate

"UltraHealth® SiH (petrafocon A hem-larafilcon A)" By SynergEyes, Inc. 510(k) number: K142510 -reference predicate

Device Description:

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with the following properties:

• Chord Diameter	13.0 mm to 25.00 mm
• Center Thickness	0.050 mm to 0.500 mm
• Base Curve	5.50 mm to 9.50 mm
• Power Range (sphere)	-25.00D to +25.00D
• Add Power	+1.00D to +4.00D

The Physical properties of the lens are:

	RGP Center	Soft Skirt
Refractive Index (wet)	1.442	1.435
Luminous Transmittance(tinted) (380nm to 780)	87%	97%
Surface Character	hydrophobic	hydrophilic
Water Content	28 ± 2%
Specific Gravity	1.15	N/A
Oxygen Permeability(revised Fatt method)	130	84

Wettability -- captive bubble contact angle (degrees) (advancing contact angle)*
Lens	Average	Stdev
SynergEyes® SiH with Hydra-PEG (New Device)	21.75°	2.2
SynergEyes® SiH (Uncoated) (Predicate Device)	33.50°	9.5

Hydra-PEG coated lenses demonstrate a 35% improvement in wettability vs. uncoated lenses (n = 20). Statistically significant difference for mean contact angle with respect to lenses had a lower average contact angle than the un-coated lenses (ANOVA, p=0.000)

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Intended Use:

The SynergEyes® SiH with Hydra-PEG (petrafocon A) Hybrid Daily Wear Contact Lenses for keratoconus are indicated for the correction of hyperopic, myopic and astigmatic refractive error including presbyopia that manifest 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 +25.00 and -25.00 D in eyes with irregular astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D.

The SynergEyes® SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lenses are indicated for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and myopia, astigmatism and irregular astigmatism in aphakic and not aphakic, non-diseased eyes with or without presbyopia. The lenses are indicated for daily wear for the correction of up to +25.00 and -25.00 D in eyes with astigmatism or irregular astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D.

Testing:

Non-clinical Testing	A series of in vitro and in vivo preclinical toxicology and biocompatibility testswere performed to assess the safety and effectiveness of the SynergEyes® SiHwith Hydra-PEG Hybrid Daily Wear Contact Lens packaged in glass vials.All non-clinical toxicology tests were conducted in accordance with the GLPregulation. All other testing was conducted according to valid scientific protocols.Test results of the non-clinical testing on the SynergEyes® SiH with Hydra-PEGHybrid Daily Wear Contact Lens demonstrate that:
	Lenses supplied in glass vials are stable for the indicated shelf-life, The finished lenses with Hydra-PEG are not toxic and not irritating, and Lens physical and material properties are consistent with currently marketed lenses.
Clinical Testing	The clinical safety and effectiveness has been previously established for hybridcontact lenses manufactured from (petrafocon A hem-larafilcon A) and contactlenses treated with Hydra-PEG.

Non-clinical Testing

A series of in vitro and in vivo preclinical toxicology and biocompatibility testswere performed to assess the safety and effectiveness of the SynergEyes® SiHwith Hydra-PEG Hybrid Daily Wear Contact Lens packaged in glass vials.All non-clinical toxicology tests were conducted in accordance with the GLPregulation. All other testing was conducted according to valid scientific protocols.Test results of the non-clinical testing on the SynergEyes® SiH with Hydra-PEGHybrid Daily Wear Contact Lens demonstrate that:

Lenses supplied in glass vials are stable for the indicated shelf-life, The finished lenses with Hydra-PEG are not toxic and not irritating, and Lens physical and material properties are consistent with currently marketed lenses.

Clinical Testing

The clinical safety and effectiveness has been previously established for hybridcontact lenses manufactured from (petrafocon A hem-larafilcon A) and contactlenses treated with Hydra-PEG.

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Conclusions Drawn from Studies

Validity of Scientific Data

Several laboratories under Good Laboratory Practice regulations conducted toxicology studies, Microbiology, chemistry, shelf-life stability studies and followed scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7

Substantial Equivalence

Information presented in this Premarket Notification establishes that the SynergEyes® SiH with Hydra-PEG Hybrid Daily Wear Contact Lens is as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the requested indication.

Risks and Benefits

The risks of the subject device are the same as those normally attributed to the wearing of hybrid daily wear contact lenses. The benefits to the patient are the same as those for other hybrid contact lenses.

Substantial Equivalence:

Comparison to Predicate Device(s):

The SynergEyes® SiH with Hydra-PEG Hybrid Daily Wear Contact Lens is substantially equivalent to the SynergEves® SiH (cleared under K083921 and UltraHealth® SiH (cleared under K142510) in terms of the following:

contact lens material (petrafocon A hem-larafilcon A)
lathe cut manufacturing process
manufacturing facility
sterilization process and final packaging
designs and indications

The SynergEyes® SiH with Hydra-PEG Hybrid Daily Wear Contact Lens is substantially equivalent to the IntelliWave4 with HPT (cleared under K152046) in terms of the following:

processed to incorporate Hydra-PEG coating
The following matrix illustrates the production method, lens function and material characteristics of the SynergEyes® SiH with Hydra-PEG Hybrid Daily Wear Contact Lens, as well as the predicate devices.

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	SynergEyes® SiH withHydra-PEG (petrafocon Ahem-larafilcon A)New Device	SynergEyes® SiH, andUltraHealth® SiH(petrafocon Ahem-larafilcon A)(uncoated)Predicate Device(K142510, K083921 andK113586)	Art OpticalIntelliWave4 with HPT,Silicone Hydrogel(safrofilcon A)Predicate Device(K152046)
Intended Use	Indicated for daily wear for thecorrection of visual acuity in aphakicand not aphakic persons with non-diseased eyes with myopia or hyperopiaand/or presbyopia. The lens may alsobe prescribed for management ofirregular corneal conditions such askeratoconus and post graft fitting.	Indicated for daily wear for thecorrection of visual acuity in aphakicand not aphakic persons with non-diseased eyes with myopia orhyperopia and/or presbyopia. Thelens may also be prescribed formanagement of irregular cornealconditions such as keratoconus andpost graft fitting.	Indicated for daily wear for thecorrection of visual acuity in aphakicand not aphakic persons with non-diseased eyes with myopia orhyperopia and/or presbyopia. Thelens may also be prescribed formanagement of irregular cornealconditions such as keratoconus andpost graft fitting.
Functionality	The contact lenses act as arefractive medium that focuslight rays from near and distantobjects on the retina	The contact lenses act as arefractive medium that focuslight rays from near anddistant objects on the retina	The contact lenses act as arefractive medium that focuslight rays from near anddistant objects on the retina
Indications	Daily Wear	Daily Wear	Daily Wear
Production Method	Lathe-Cut, custommanufactured	Lathe-Cut, custommanufactured	Lathe-Cut, custommanufactured
USAN name	petrafocon A hem-larafilcon A	petrafocon A hem-larafilcon A	safrofilcon A
Water Content (%)	28±2%	28±2%	65±2%
Wettability(captive bubbleadvancing contact angle)	21.75°	33.50°	46°
Specific Gravity	1.150	1.150	1.102
Includes Hydra-PEGSurface Coating	Yes	No	Yes

Substantial Equivalence Matrix

Regulation Number and Section

§ 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.