SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENS

{0}------------------------------------------------ # K 05/035 510 (K) SUMMARY # Applicant's Name and Address | | SynergEyes, Inc.<br>1926 Kellogg Ave.<br>Carlsbad, CA 92008<br>(760) 476 9410 | |-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Richard Lippman, OD FAAO<br>Vice President Ophthalmic Regulatory Products<br>R.P. Chiacchierini & Associates, LLC Suite 30<br>15825 Shady Grove Road<br>Rockville, Maryland 20850<br>(240) 683-3738 | | 1. Identification of device | | #### Contact Lens Common Name: SynergEyes™(paflufocon D hem-iberfilcon A) Hybrid Trade Name: Daily Wear Lens Daily Wear Soft (hydrophobic) Contact Lens Classification: Class II (21 CFR 886.5916) Device classification: ### 2. Description of device The SynergEyes™ A and M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens is a The Syreigeyes ... A and M (palificon B non ibernison) , hydrion surrounded by a soft hydrophilic skirt that straddles the limbus of the eye : - in the power range of -20.00 to +20.00 diopters for sphere, ● - with center thickness from 0.12mm to 0.30mm . - with base curves of 7.10mm to 9.00mm . - with diameter of 14.50mm . - . This lens material for the rigid portion is paflufocon D lathe cut, surrounded by soft hydrophilic This lefts material for the ngla portion is panaloom a largerilization. When placed on the copolymer (nemi-benicon A), stemized by means of orefracting medium to focus light numan contea, the Gynergeyos - Trybha black as a lathe cut contact lens in the following designs: rays offe the relific. "The device is than be on and as a lable visibility tinted material. This device is spielical, tone, mamocal, and asphone ouride in the soft lens skirt manufactured by Ciba Vision Corporation. The SynergEyes™ A and M Hybrid Daily Wear Contact Lens is a rigid gas permeable material of The soft skirt is comprised of HEMA (paflulofon-D) rigid gas permeable polymer. (hydroxyethylmethacrylate) of 27% water and 73% polymer. The junction between the rigid material and soft material is bound by a proprietary chemical bonding method. ### 3. Intended use SynergEyes® A and M (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses for daily wear are Sylelgcyes® A and M (pundloodn's honeropic, myopic and astigmatic refractive error including indicated for use in the concession of inyporopic myspice eyes. The lenses are indicated for daily presuyopla, in aphakic and not aprilike, nor alocused byest with astigmatism up to 6.00 D. For {1}------------------------------------------------ presbyopia, add powers between +1.00 and +4.00D. The lenses may be disinfected using only a presoyopia, add powers between · 1.00 and · 1.00 and · 1.00 lense · Provinsible lenses. # 4. Predicate devices 4. Predicate devices The predicate lenses were selected to address: material (silicone acrylate and many of the lange - Additionally for The predicate lenses were selected to address. matchan (the lens. Additionally for optic portion of the lens and (syllergion) A) for the Soll only Portand Or and Group I low water non-innic lens design (hybrid RGP/soft), lens group (silicone acrylate, data Tens design (nybrid RGP/Soft), lefls group (silleone devices for indication for use and parameter comparison. Predicate Devices: - For the RGP Center Portion: . | Paragon Vision Sciences | P870024/S39 and S43<br>K940277<br>K002845 | |-------------------------------------|-------------------------------------------| | Polymer Technology (B&L) Boston XO: | K000795 | - For the Hybrid (RGP-soft skirt concept) . P840004 Saturn II (synergicon A) Mixed use Lens ### 5. Characteristics 5. Characteristics The physical and dimensional characteristics of the SynergEyes™ Hybrid Contact Lens are The physical and differistial characteristics of the Synorgeyos - Trycher Contact Lens in the following table. | | SynergEyes™<br>(paflufocon D-<br>iberfilcon A) Hybrid<br>Contact Lens | SoftPerm®<br>(synergicon A)<br>Contact Lens<br>(Predicate Lens) | |----------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------| | Lens Characteristics | | | | Manufacturer | SynergEyes™ Inc. | Ciba Vision Care | | Base Curves | 7.10-9.00mm | 7.10-8.10mm | | RGP Center | 8.40mm | 8.00mm | | Posterior Optic Zone<br>Diameter | 7.80mm | 7.00mm | | Lens Designs | Sphere, Aspheric,<br>Front Surface Toric,<br>Multifocal | Sphere, Front<br>Surface Toric | | Diameters: | 14.5mm | 14.3mm | | Power Range | -20.00 to + 20.00D | -13.00 to +6.00D | | Center Thickness | 0.12 to 0.30mm | 0.08mm to 0.28mm | | Refractive Index (RGP) | 1.442 | 1.53 | | Wetting Angle (RGP) | 42° | 21° CLMA | | Specific Gravity (RGP) | 1.10 | 1.015 | | Hardness | 79 | | | Indications for Use | Daily Wear | Daily Wear | | UV Blocking | No | No | | Material | Paflufocon D center | Synergicon A | {2}------------------------------------------------ | | RGP hem-iberfilcon A<br>(HEMA, MEMA) | RGP and HEMA Skirt | |--------------------------|--------------------------------------|--------------------| | Tint | Visibility Blue | Clear | | Soft Skirt Water Content | 27% | 25% | | Core (RGP) Water Content | < 1% | < 0.2% | ### 6. Non clinical studies Non-clinical studies are summarized below: ### Chemistry and leachability - Material property data were generated on the SynergEyes™ and the Paragon HDS 100 . materials. The material properties were substantially equivalent. - The lens care product manufacturers have been previously shown compatible for RGP and . soft (Hydrophilic) lenses with their products. - Son (Tyarophilib) for the SynergEyes™ Hybrid Contact Lens is based upon stability . protocols included with this notification. - protocolories were conducted to determine the residual monomers on the subject device. . # Toxicology, lenses materials I Uncology, lefises materials In accordance with the May 1994 Guidance Document for Daily Wear contact lenses, toxicology in accordance with the May 100 - Caractives M Hybrid Contact Lens. The results are summarized below: #### Cvtotoxicity Test: . Cytotoxicity Tests have been conducted on the subject device according to ISO 10993-5. Gylotoxicily Tests Trave Devices- Tests for Cytotoxicity: In vitro Methods guidelines, was conducted on the test articles, to determine the potential for Cytotoxicity. conduction the tool and the positive controls performed as anticipated. Under the conditions of the study, the test articles were not cytotoxic. #### Acute Systemic Injection Test in the mouse: . An evaluation of the test articles for systemic toxicity in mice after a single intravenous An Evaluation or a single intraperitoneal administration has been conducted according to the ISO 10993-11: Biological Evaluation of Medical Devices. Tests for Systemic Toxicity. 10355-11. Diological Evaluation of Moulous or not the test article extracts. Each test article met the test requirements. #### Ocular Eye Irritation Test in the rabbit: . An evaluation of the ocular irritation of 0.9% NaCl of the subject article after a single instillation in An evaluation of the outling to 1010 has in 10993-10: Biological Evaluation of Medical Devices. Tests for the Irritation and Sensitization. Devidence of ocular irritation was observed in the rabbits. The test article extracts are not considered irritants to the ocular tissue of rabbits. ## Validity of Scientific Data: A contract laboratory using Good Laboratory Practices conducted the Toxicology studies. Chemistry leachables studies were conducted in-house. Certification as to implementation and conduct under Good Laboratory Practices may be found with each report. ### Solution Compatibility Lens materials used in this device are already recognized materials previously approved for use with all approved lens care products. No further testing was conducted. ### Microbiology and sterilization {3}------------------------------------------------ The SynergEyes™ Hybrid Contact Lenses are sterilized using e-Beam sterilization. Additional autonoions i he SynergEyes ™ Tryond Outlact Echsed as 1 year as of the current date. Additional extensions stenlity and stablity has boon ectablished with an approved protocol. ### 7. Packaging 7. Packaging The primary lens container for shipping is a sterile enclosed medical grade glass vial capped with The primary fens containor for enipping of in a sterile buffered normal saline. ### 8. Clinical data - A Clinical Study was performed to establish the safety and efficacy of the SyncrgEyes of the . A Clinical Study Was performed to occubition the clinical investigation of the SynergEyes™Hybrid Contact Lens was conducted on 107 subjects for a period of 3 months. Synergeyes "Hybru Contact Echs was consent document regarding participation in the All subjects read and signed an monthed outhorn document of and international ethical Investigation Which was conducted in ochilemanse to completed the protocol, 46 (43%) Standards und Togalations - Com for discontinuation were as follows: | | Over All Visits | | |---------------------------------------|-----------------|-------| | Reason For Discontinuation | # Subjects | % | | Poor Comfort | 15 | 32.6% | | Loss of Interest | 13 | 28.3% | | Poor Vision | 6 | 13.0% | | Difficulty Handling | 1 | 2.2% | | Other | 3 | 6.5% | | Medical Condition - not study related | 2 | 4.3% | | Non-Compliance | 4 | 8.7% | | Poor Outcome with Lenses | 2 | 4.3% | | Total Eyes | 46 | | The "other" reasons included travel conflicts (1), use of reading glasses inconvenient (1), and subject not happy with lenses (1). - There was one complication reported as "Poor outcome with lenses" during the study, a . There was one complication Topened as The subject was treated and was discontinued. - Safety was assessed by adverse events, positive slit lamp findings, symptoms problems and . Safely was assessed by adverse events, positive on laims him adverse events reported. complaints and changes in keratometric readings. There were no adverse event provided complaints and complaints were minimal with comfort being the most prevalent Symploms problems and complaints were minimal with time. There were no other significant safety finding although the complaint alminioned mas lost during the course of the study. - Efficacy was evaluated by changes in refractive correction, lens visual actury, average . Elicacy was Evanuatou by changes were noted in efficacy upon evaluation of the data. In conclusion, the SynergEyes™ Hybrid Contact Lens material performance is equivalent in PCP In Collidation, the Oyfergeyes - Trybrid - Ochace for this class of materials, as well as for RGP daily and soft daily wear lenses in general. 9. Conclusions drawn from studies Substantial Equivalence: {4}------------------------------------------------ Information provided in this 510(k) establishes that the SynergEyes™Hybrid Contact Lens are reise Information provided in this 210(k) establishes that the others and do not raises and do not raise equivalent in optical, chemical and prysical propertion de monstrated safe and any questions of salery and where possible equivalence to historical experience with effective lens peromance, and where possible oquivalent to the predicate devices material, predicate devices. The device is substantally Cultivation (synergicon A) lense Paragon HDS under For 0024/000 and CTO, and To 10-11-14 and Comprised of a rigid center optic portion and a soft skirt portion. Clinical Equivalence to Predicate Devices Historical Experience | | SynergEyes™<br>Hybrid Contact<br>Lens | Jurkus<br>(1998) | Chung<br>(2001) | |----------------------|---------------------------------------|------------------|-----------------------------------------------------| | No. of Lenses (Eyes) | 214 | 21 | 35 | | No. Patients | 107 | 11 | 28 | | Gender | 72F/32M | 5F/6M | 11F/17M | | Mean Age | 43F/39.9M | | 41 ± 19 | | Lens | SynergEyes™<br>Hybrid | Saturn II | SoftPerm-Prior<br>RGP users | | Indication | Myopia,<br>Hyperopia,<br>Astigmatism | Astigmatism | Keratoconus 22/35<br>(62.9%)<br>PK 10/35<br>(28.6%) | | Completions | 61 (57%) | 4 (36%) | 17 (66.7%) | | Discontinuations | 46 (43%) | 7 (64%) | 11 (33.3%) | | Comfort | 32% | 28% | 45.5% | | Vision | 13% | 28% | 9.1% | Material Equivalence Table | Material Comparison | | | |-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|------------------------| | | SynergEyes™ Hybrid Contact Lens | SoftPerm® Contact Lens | | PRODUCTION METHOD | Lathing | Lathing | | INTENDED USE | Daily Wear | Daily Wear | | MATERIAL | Paflufocon D Center<br>hem-iberfilcon A skirt | Synergicon-A | | Type | Group 1 Low Water | Group 1 Low Water | | Surface Charge | Non-ionic | Non-ionic | | Color additive (Scientific name) | D&C Green 6 | | | UV additive | No | No | | Dk permeability: | RGP Center: | RGP Center: | | 1. Revised FATT Polarimetric<br>method with edge correction<br>@ 35°C x $10^{11}$ (cm²/sec) (ml<br>O2/ml x mm Hg) | FATT: 145<br>ISO: 100 | FATT: 14 | | 2. ISO 9913-1 | Soft Skirt: 9.1 | Soft Skirt: 5.5 | {5}------------------------------------------------ | Dk/L- Lens transmissibility: | FATT: | 66-77 | | | |----------------------------------------------------------|-------|-------|------|--------| | 1. Revised FATT<br>(Through power range -20 to +<br>20D) | ISO: | 46-53 | ISO: | 17.5 | | 2. ISO 9913-1 Polarimetric<br>method : | | | | | | Light transmittance:<br>(380nm to 780nm) | | >90% | | 88-92% | ### Risk and Benefits: The risks of the subject device are the same as those normally attributed to the wearing of RGP The nate of the oublice areas on a daily wear base. The benefits to the patient are the and soft (hydrophillo) vontact lenses on drophilic) contact lenses. Overall, the risks and benefits Same as those for other NOT and out (mychophilis) contact lenses and raise no additional concerns for safety or effectiveness. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The caduceus is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # SEP 2 _ 2005 SynergEves, Inc. C/O Richard E. Lippman, O.D., F.A.A.O. Vice President for Ophthalmic Product Regulatory Affairs P. Chiacchierini & Associates, LLC 15825 Shady Grove Rd., Suite 30 Rockville, MD 20850 K051035 Re: Trade/Device Name: SynergEyes™ (paflufocon D hem-iberfilcon A) Hybrid Contact Lens for Daily Wear Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid gas permeable contact lens Regulatory Class: Class II Product Code: HQD Dated: September 1, 2005 Received: September 1, 2005 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 r ou may, atores, while 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 rr your device to such additional controls. Existing major regulations affecting your device can may or subject to December 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 i lease oc acrised that I Drivision that your device complies with other requirements of the Act that I Dr has intatutes and regulations administered by other Federal agencies. You must or any I 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. {7}------------------------------------------------ # Page 2 - Richard E. Lippman, O.D. This letter will allow you to begin marketing your device as described in your Section 510(k) rms lotter with and wy of substantial equivalence of your device of your device to a legally promated predicate device results in a classification for your dovice 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 it you dobite of Compliance at (301) 827-8910. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, David M. Whipple David M. Whipple Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure 1 {8}------------------------------------------------ | SYNERGEYES, INC. | SECTION 2 | |----------------------------------------------------------------|------------------------------| | 510(k) Premarket Notification | INDICATION FOR USE STATEMENT | | SYNERGEYES (paflufocon D hem-iberfilcon A) HYBRID CONTACT LENS | DAILY WEAR CONTACT LENS | # SECTION 2 : INDICATIONS FOR USE STATEMENT 510(k) Number (if known) _K651035 (5001 Device Name: SynergEyes@ A and M (paflufocon D hem-iberfilcon A) Hybrid Contact Lens # Indication for Use SynergEyes® A and M (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses for daily wear are SynelgEyes® A and M (pandroon D fren ibenneon A), and astigmatic refractive erroringling and Indicated tof the concection of hyperoped my of the enses are indicated for daily presuyopla, in aphakis and not apnake, non dious of of of ever with astigmatism up to 6.00 D. For weal for the correction of up to 120.00 and +4.00D. The lenses may be disinfected using only a presbyopia, add powers between +1.00 and +4.00D. The lenses nay be disinfected presoyopla, add powers between + 1.00 and + 1.000 - we + and rigid gas permeable lenses. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |--------------------------------------------------------|--| |--------------------------------------------------------|--| | Prescription Use | | |------------------|--| |------------------|--| | | OR Over-the -counter-use | |--|--------------------------| |--|--------------------------| | | <div> <p><i>Karer Wabanten</i></p> <p>(Division Sign-off)</p> <p>Division of Ophthalmic Devices</p> </div> | |--|------------------------------------------------------------------------------------------------------------| |--|------------------------------------------------------------------------------------------------------------| | 510(k) Number | K051035/5001 | |---------------|--------------| |---------------|--------------|