SYNERGEYES PS HYBRID CONTACT LENS

K060102 · Synergeyes, Inc. · HQD · Mar 15, 2006 · Ophthalmic

Device Facts

• Record ID: K060102
• Device Name: SYNERGEYES PS HYBRID CONTACT LENS
• Applicant: Synergeyes, Inc.
• Product Code: HQD · Ophthalmic
• Decision Date: Mar 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SynergEyes™ PS (paflufocon D 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 myopia, astigmatism, and irregular astigmatism in aphakic and not 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 or irregular astigmatism up to 6.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

Device Story

Hybrid contact lens featuring rigid gas permeable (RGP) center (paflufocon D) and soft hydrophilic skirt (hem-iberfilcon A). Lathe-cut design; 14.5mm diameter. Acts as refracting medium to focus light on retina. Used by patients with post-surgical or trauma-related refractive errors. Prescribed by eye care professionals. Lens provides vision correction for irregular corneal surfaces. Benefits include improved visual acuity for patients with complex refractive needs. Disinfection requires chemical systems compatible with both RGP and hydrogel materials.

Clinical Evidence

Three-month prospective clinical study (n=76 dispensed) evaluated safety and effectiveness for post-surgical/trauma refractive correction. Primary endpoints: visual acuity, wearing time, adverse events. Results: 81.3% of completed subjects achieved 20/40 or better VA. Average daily wearing time 10.6 hours. Adverse events included photophobia, corneal abrasion, and keratitis. Discontinuation rate 42.1%, primarily due to comfort and poor outcomes, consistent with the complex patient population.

Technological Characteristics

Hybrid lens: paflufocon D (silicone acrylate) RGP center; hem-iberfilcon A (HEMA/MEMA) soft skirt. 27% water content in skirt. Lathe-cut manufacturing. E-beam sterilization. Diameter 14.5mm. Non-ionic surface. No UV blocking. Chemical disinfection required.

Indications for Use

Indicated for daily wear correction of refractive errors (hyperopia, myopia, astigmatism, irregular astigmatism) in aphakic and non-aphakic, non-diseased eyes following corneal surgery or trauma. Power range: -20.00 to +20.00 D; cylinder up to 6.00 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.

Predicate Devices

• SynergEyes A and M Hybrid Contact Lenses (K051035, K052675)
• SoftPerm (synergicon A) Mixed use Lens (P840004/S7)
• Paragon Vision Sciences HDS material (P870024/S36, S43; K940277)

Submission Summary (Full Text)

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SynergEyes
Carlsbad, CA 92008

Kobo102

# MAR 1 5 2006

# 510(K) SUMMARY

#### Applicant's Name and Address

| | SynergEyes ™, Inc.<br>1926 Kellogg Ave. Suite 100<br>Carlsbad, CA 92008<br>[phone] |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------|
| Contact Person | Richard Lippman, OD FAAO<br>Vice President Ophthalmic Regulatory Products<br>R.P. Chiacchierini & Associates, LLC |
| | 15825 Shady Grove Road Suite 30 |
| | Rockville, Maryland 20850 |
| | [phone] |
| 1. Identification of device | |
| Common Name: | Contact Lens |
| Trade Name: | SynergEyes™ PS (paflufocon D hem-iberfilcon A)<br>Hybrid Daily Wear Lens For Post Surgical and Trauma |
| Classification: | Daily Wear Contact Lens (other material) |
| Device classification: | Class II (21 CFR 886.5916) |

#### 2. Description of device

The SynergEves™ PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens is a combination rigid gas permeable contact lens corneal optic portion 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 .
- . in the range of 0.25 to 6.00 diopters cylinder
- with center thickness from 0.18mm to 0.30mm .
- with base curves of 7.10mm to 9.60mm .
- with diameter of 14.50mm .

The lens material (paflufocon D hem-iberfilcon A) is identical to the predicate current material cleared under K051035 and K052675. There are no differences to the chemical composition, formulation, manufacturing process, packaging and sterilization as described in the referenced 510(k).

This lens material for the rigid portion is paflufocon D lathe cut, surrounded by soft hydrophilic copolymer (hem-iberfilcon A), sterilized by means of e-beam sterilization. When placed on the human cornea, the SynergEyes™Hybrid Contact Lens acts as a refracting medium to focus light rays onto the retina. The device is available as a lathe cut contact lens in the following design for post surgical refractive errors and trauma: multi concentric zones in blue visibility tinted material. This device is equivalent to the SynergEyes™ A and M Hybrid Contact Lens is material design and composition, and the SoftPerm® hybrid RGP manufactured by Ciba Vision Corporation.

The SynergEyes™ PS Hybrid Daily Wear Contact Lens center optical portion is a rigid gas permeable material of (paflulofon-D) polymer. TThe soft skirt is comprised of HEMA (hydroxyethylmethacrylate) of 27% water and 73% polymer.

The junction between the rigid material and soft material is bound by a proprietary chemical bonding method.

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SynergEyes™, Inc. Carlsbad, CA 92008

## 3. Intended use

SynerqEyes™ PS (paflufocon D 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 myopia, astigmatism, and irregular astigmatism in aphakic and not aphakic, nondiseased eves. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with astigmatism or irregular astigmatism up to 6.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

#### 4. Predicate devices

The predicate lens SynergEyes™ A and M (paflufocon D hem iberfiicon A) Hybrid Contact Lenses were selected to address material use and design (rigid lens center and soft lens skirt).

The material portion is equivalent to the predicate lenses. The optic center rigid portion of the lens is a silicone acrylate- paflufocon D used in the cleared predicates K051035 and K052675 as well as referenced HDS material from Paragon Vision Sciences P870024/S36 and 43.

The soft skirt portion of the subject device, hem-iberfilcon A, a Group I low water non-ionic material, is equivalent to its predicate K051045 and K052675.

Further equivalence to predicate devices for indication for use and parameter comparison may be found in the equivalence matrix below.

#### Predicate Devices:

- For the Hybrid (RGP-soft skirt concept): ●

| SynergEyes™™, Inc. | K051035<br>K052675 | Cleared: 9/2/2005<br>Cleared: 11/30/2005 |
|----------------------------------------|--------------------------------------------------------|------------------------------------------|
| SoftPerm (synergicon A) Mixed use Lens | P840004/S7 | App: 10/14/1993 |
| • For the RGP Center Portion: | | |
| SynergEyes™™, Inc. | K051035<br>K052675 | Cleared: 9/2/2005<br>Cleared: 11/30/2005 |
| Paragon Vision Sciences | P870024/S36 and S43<br>(App: 11/23/1993 and 4/13/2002) | |
| | K940277 | Cleared: 5/9/1994 |
| • For the Soft Skirt Portion: | | |
| SynergEyes™™, Inc. | K051035<br>K052675 | Cleared: 9/2/2005<br>Cleared: 11/30/2005 |
| SoftPerm (synergicon A) Mixed use lens | P840004/S7 | App: 10/14/1993 |

#### 5. Characteristics

The physical and dimensional characteristics of the SynergEyes™ PS Hybrid Contact Lens are compared to the characteristics of the predicate devices SynergEyes™ A and M lenses, and SoftPerm® Contact Lens in the following table.

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| | SynergEyes™ PS<br>(paflufocon D-<br>iberfilcon A) Hybrid<br>Contact Lens<br><br>(Subject Device) | SynergEyes™ A and<br>M (paflufocon D-<br>iberfilcon A) Hybrid<br>Contact Lens<br>K051035<br><br>(Predicate Device) | SoftPerm®<br>(synergicon A)<br>Contact Lens<br>P840004/S7<br><br>(Predicate Lens) |
|----------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Lens Characteristics | | | |
| Manufacturer | SynergEyes™ Inc. | SynergEyes™ Inc. | Ciba Vision Care |
| Base Curves | 7.10-9.60mm | 7.10-9.00mm | 7.10-8.10mm |
| RGP Center | 9.00mm | 8.40mm | 8.00mm |
| Posterior Optic Zone<br>Diameter | 8.40mm | 7.80mm | 7.00mm |
| Lens Designs | Sphere, Aspheric,<br>Front Surface Toric, | Sphere, Aspheric,<br>Front Surface Toric,<br>Multifocal | Sphere, Front<br>Surface Toric |
| Diameters: | 14.5mm | 14.5mm | 14.3mm |
| Power Range | -20.00 to + 20.00D | -20.00 to + 20.00D | -13.00 to +6.00D |
| Cylinder Power Range | 0.50 to 6.00D | 0.50 to 10.00D | |
| Add Power for Near | | 0.75 to 3.00D | |
| Center Thickness | 0.18 to 0.30mm | 0.12 to 0.30mm | 0.08mm to 0.28mm |
| Refractive Index (RGP) | 1.442 (Nd @ 25°C) | 1.442 (Nd @ 25°C) | 1.53 |
| Wetting Angle (RGP) | 42° | 42° | 21° CLMA |
| Specific Gravity (RGP) | 1.10 | 1.10 | 1.015 |
| Hardness | 79 | 79 | |
| Indications for Use | Daily Wear | Daily Wear | Daily Wear |
| UV Blocking | No | No | No |
| Material | Paflufocon D center<br>RGP hem-iberfilcon A<br>(HEMA, MEMA) | Paflufocon D center<br>RGP hem-iberfilcon A<br>(HEMA, MEMA) | Synergicon A<br>RGP and HEMA<br>Skirt |
| Tint | Visibility Blue | Visibility Blue | Clear |
| Soft Skirt Water Content | 27% | 27% | 25% |
| Core (RGP) Water Content | < 1% | < 1% | < 0.2% |

## 6. Non clinical studies:

Results from the full series of physical/chemical, toxicological, and sterility tests were conducted under K051035 for the equivalent lens, the predicate lens for this device. No further non-clinical studies were performed for this submission.

## 7. Packaging

The primary lens container for shipping is a sterile enclosed medical grade glass vial capped with a screw cap and sterilized with the e-beam sterilization process. The lens is immersed in a sterile buffered normal saline.

## 8. Clinical data:

A three month clinical study of the SynergEyes™ PS Hybrid Contact Lens was conducted to assess safety and effectiveness for vision correction in daily wear for patients suffering from post surqical refractive error including nearsightedness, astigmatism and irregular astigmatism, or trauma to the eye. The study was designed to evaluate contact lens visual acuity and wearing time; and assess contact lens adverse events and loss of visual acuity.

## Overall Findings:

A total of 76 subjects were dispensed into the study of which 44 (80 eyes) [57.9%] completed the study and 32 subjects (58 eves) [42.1%] were discontinued from the study. An additional 8 subjects were not dispensed lenses.

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SynergEyes™, Inc. Carlsbad, CA 92008

The population demographics were similar to other contact lens studies with a female to male gender ration of 1.3 to 1.0. The average age of the completed and discontinued subjects was 49 and 43.5 respectfully.

## Safety:

Eight (8) adverse events were reported during the study for 4 completed subjects and 3 discontinued subjects. The adverse events included 1 painful light sensitivity (photophobia); 1 loose interrupted suture and infiltrate; 1 abrasion of the cornea upon lens removal; 1 small superficial abrasion; 1 subject (2 eyes) with swelling of the corneas due to inadequate rinsing of hydrogen peroxide disinfection solution from lenses; 1 allergic conjunctivitis; and 1 keratitis intis.

Thirty-two (32) subjects (58 eyes) [42.1%] were discontinued from the study. An additional 8 subjects were never dispensed lenses. The most common reasons for discontinuation were poor outcome with lenses (32.5%), poor comfort (27.5%), poor vision (12.5%), loss of interest (10.0%), non-compliance (10.0%), and handling difficulty (2.5%).

Symptoms, Problems, and Complaints: For the completed eyes, no symptoms were reported at 46.2% of the dispensing visit or follow-up visit examinations and for discontinued eves no symptoms were reported at 28.8% of the dispensing visit or follow-up visit examinations. Symotoms decreased over time for completed eyes but not for discontinued eyes. The most common symptoms reported were discomfort and awareness (28.4% completed, 45.8% discontinued), dryness and scratchiness (23.4%, 22.1%), itchiness and burning (9.3%, 8.9%), and variable vision (8.2%, 13.3%).

#### Efficacy:

Visual Acuity- Final visual acuity for completed subjects was 20/20 or better (20.0%), 20/25 or better (45.0%), 20/30 (68.8%), and 20/40 or better (81.3%). The visual acuity rates for discontinued subjects were 8.6%, 39.7%, 53.4%, and 70.7% respectfully. Vision correction fluctuated as expected with the instability of the corneal curvature from post surgical conditions and trauma under the contact lens contributing to the change. Three (3) completed eyes and 8 discontinued eyes were reported to have VA decreases of more than 2 lines of Snellen VA when comparing the contact lens VA with the best corrected VA. These findings are expected with this population.

For Wearing Time: Over the study period the average daily wearing time reported by completed patients was 10.6 hours per day.

#### Conclusion:

The SynergEyes™ PS Hybrid Contact Lens for Post Surgical refractive error and cases involving trauma provided satisfactory performance as expected. The higher than estimated discontinuation rate was anticipated due to the nature of the subject population with the inclusion of subjects who might otherwise have less successful outcomes with other lens types. Overall, the lens performance demonstrated safe and effective use of the device for its intended use.

#### 9. Conclusions drawn from studies Substantial Equivalence:

Information provided in this 510(k) establishes that the SynergEyes™ PS Hybrid Contact Lens are equivalent in optical, chemical and physical properties of the predicate devices and do not raise any questions of safety and effectiveness. The clinical evaluation demonstrated safe and effective lens performance, and where possible equivalence to historical experience with predicate devices. The device is substantially equivalent to the predicate devices material, SynergEves A and M Hybrid Contact Lens (K051035), Paragon HDS-100 (P870024/S36 and

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S43), and (K940277); and SoftPerm (synergicon A) contact lens (P840004/S7), and indication for use as a hybrid lens material comprised of a rigid center optic portion and a soft skirt portion.

| | SynergEyes™ PS<br>Hybrid Contact Lens | Jurkus<br>(1998) | Chung<br>(2001) |
|----------------------|----------------------------------------|------------------|------------------------------------------------------|
| No. of Lenses (Eyes) | 80 | 21 | 35 |
| No. Patients | 75 | 11 | 28 |
| Gender | 42F/33M | 5F/6M | 11F/17M |
| Mean Age | 49 (Completed) | | 41 + 19 |
| Lens | SynergEyes PS | Saturn II | SoftPerm/Prior RGP<br>users |
| Indication | Myopia, Hyperopia, Irr.<br>Astimgatism | Astigmatism | Keratoconus 22/35<br>(62.9%) and PK 10/35<br>(28.8%) |
| Completions | 44 (57.9%) | 4 (36%) | 17 (66.7%) |
| Discontinuations | 32 (42.1%) | 7 (64%) | 11 (33.3%) |
| For Comfort | 27.5% | 28% | 45.5% |
| For Vision | 12.5% | 28% | 9.1% |

#### Clinical Experience Equivalence to Other Studies

#### Material Equivalence Table

| | SynergEyes™ PS Hybrid<br>Contact Lens for<br>Keratoconus<br>(Subject Device) | SynergEyes™ A and M<br>Hybrid Contact Lens for<br>Daily Wear<br>(K051035) | SoftPerm® Contact<br>Lens<br>P840004/S7 |
|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------|
| PRODUCTION METHOD | Lathing | Lathing | Lathing |
| INTENDED USE | Daily Wear | Daily Wear | Daily Wear |
| MATERIAL | Paflufocon D Center<br>hem-iberfilcon A skirt | Paflufocon D Center<br>hem-iberfilcon A skirt | Synergicon-A |
| Type | Group 1 Low Water | Group 1 Low Water | Group 1 Low Water |
| Surface Charge | Non-ionic | Non-ionic | Non-ionic |
| Color additive | D&C Green 6 | D&C Green 6 | |
| UV additive | No | No | No |
| Dk permeability:<br>1. Revised FATT Polarimetric<br>method with edge correction<br>@ 35°C x 10⁻¹¹ (cm²/sec) (ml<br>O₂/ml x mm Hg) | RGP Center:<br>FATT: 145<br>ISO: 100 | RGP Center:<br>FATT: 145<br>ISO: 100 | RGP Center:<br>ISO: 14 |
| 2. ISO 9913-1 | Soft Skirt: 9.3 | Soft Skirt: 9.3 | Soft Skirt: 5.5 |
| Dk/L- Lens transmissibility:<br>1. Revised FATT<br>(Through power range -20 to<br>+ 20D)<br>2. ISO 9913-1 Polarimetric<br>method : | FATT: 66-77<br>ISO: 46-53 | FATT: 66-77<br>ISO: 46-53 | ISO: 17.5 |
| Light transmittance<br>(380nm to 780nm) | >90% | >90% | 88-92% |

## Risk and Benefits:

The risks of the subject device are the same as those normally attributed to the wearing of RGP and soft (hydrophilic) contact lenses on a daily wear base. The benefits to the patient are the same as those for other RGP and soft (hydrophilic) contact lenses. Overall, the risks and benefits associated with daily wear contact lenses are the same as for other daily wear contact lenses and raise no additional concerns for safety or effectiveness.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2006

SynergEyes, 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

K060102 Re:

K000102
Trade/Device Name: SynergEyes™ PS (paflufocon D hem-iberfilcon A) Hybrid Contact Lens for Post Surgical Refractive Error and Trauma for Daily Wear Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid gas permeable contact lens Regulatory Class: Class II Product Code: HQD Dated: January 13, 2006 Received: January 13, 2006

Dear Dr. Lippman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed 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 commerce prior to May 20, 1976, the enaordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Act (Act) market the device, subject to the general controls provisions of the Act. The You may, ulciclore, market the de reco, include requirements for annual registration, listing of general controls provisions of the 110 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 If your device is classifica (sec above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major regals may be subject to such adultional controls. Extronic may of to 898. In addition, FDA may be found in the Code of Poderal Registing your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination are not mean Please be advised that FDA s issuative of a stobation with other requirements of the Act
that FDA has made a determination that your device complies with other requirements o that FDA has made a decemmanon and your cared by other Federal agencies. You must or any Federal Statutes and regulations annuding, but not limited to: registration and listing (21 comply with an the Act 3 requirements, nevalles on and acturing practice requirements as sett CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Richard E. Lippman, O.D., F.A.A.O.

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.

Sincercly yours,

MB Egelund - MS

Malvina B. Eydelman, M.D Acting Division Director Division of Ophthalmic and Far, 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):__K060102

SynergEyes™ PS (paflufocon D hem-iberfilcon A) Hybrid Contact Device Name: Lens for Post Surgical Refractive Error and Trauma for Daily Wear

For use in the correction of eyes with refractive errors resulting Indications For Use: from corneal surgery or trauma including hyperopia and myopia, astigmatism 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 in eyes with astigmatism or irregular astigmatism up to 6.00D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

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)

Karen Wabnstr

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

510(k) Number K060102

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