(64 days)
Not Found
No
The document describes a physical contact lens and its clinical performance, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is indicated for correction of refractive errors, not for treating a disease or condition. While it is used for eyes with keratoconus, its stated purpose is vision correction.
No
Explanation: The device is a contact lens intended for vision correction, not for diagnosing medical conditions. It corrects refractive errors and irregular astigmatism.
No
The device is a physical contact lens made of specific materials with defined dimensions and properties, not a software program.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the correction of refractive errors and irregular astigmatism in the eye. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The description details a contact lens that acts as a refracting medium to focus light onto the retina. This is a physical device for vision correction.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze a sample from the body (like blood, urine, or tissue), or provide information about a patient's health status based on in vitro testing.
- Performance Studies: The performance studies focus on safety and effectiveness for vision correction (visual acuity, wearing time, adverse events related to lens wear), not on diagnostic accuracy.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This contact lens does not fit that description.
N/A
Intended Use / Indications for Use
SynergEyes™ KC (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses for keratoconus are indicated for use in the correction of eyes with refractive errors that include hyperopia and myopia 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 +20.00 and -20.00 D in eyes with 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.
Product codes (comma separated list FDA assigned to the subject device)
HQD
Device Description
The SynergEyes™ KC (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens is a 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, -0.50 to -6.00D cylinder.
- with center thickness from 0.18mm to 0.30mm.
- with base curves of 5.50mm to 7.70mm.
- with diameter of 14.50mm.
The lens material (paflufocon D hem-iberfilcon A) is identical to the predicate current material The teller (paners) There are no differences to the chemical composition, formulation, cleared "inder" (100 room "herilization as described in the referenced 510(k).
This lens material for the rigid portion is paflufocon D lathe cut, surrounded by soft hydrophilic This lens material for the nga portion by means of e-beam sterilization. When placed on the Copolymer (fichlinen Fr), ecentiable »), nect 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 rays onto the rolline. The visibility tinted material. This device is equivalent to Keraloconus: In A and M Hybrid Contact Lens is material design and composition, and the the SyneigEyes - A and M Hykeratoconus and manufactured by Ciba Vision Corporation.
The SynergEyes™ KC 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 is bound by a proprietary chemical bonding method.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A one month clinical study of the SynergEyes™ KC Hybrid Contact Lens was conducted to assess safety and effectiveness for vision correction in daily wear that included subjects with keratoconus and irregular astigmatism with refractive errors including myopia, hyperopia, and/or astigmatism. The purpose of the study was to profile the outcome endpoints and patient acceptance of the SynergEyes™ KC Hybrid Contact Lens for the conditions described herein. The primary outcomes for safety was adverse events and loss of visual acuity. The primary outcome for effectiveness was contact lens visual acuity by eye. Additional effectiveness outcomes included percentage of completed subjects and lens wearing time. The primary safety endpoints included visual acuity loss of greater than 2 lines of vision, assessment of serious adverse events, complications, and symptoms, problems, and complaints among others.
The study was designed as a prospective, multi-site, open label study with a 1 month aggregate lens wearing period for each completing subject. Subjects were enrolled at 12 sites and must have satisfied the patient inclusion and exclusion criteria specified in the protocol. Prior lens experience was recorded. Data were collected at baseline, dispensing and follow-up visits of 1 and 2 weeks, and 1 month.as well as unscheduled visits.
The population demographics were similar to previous contact lens studies with a female to male gender ratio of 1.48 to 1.0. The average age of the completed and discontinued subjects was 40.7 and 39.4 respectfully.
There were a total of 62 subjects who were dispensed and evaluated of which 44 (71%) subjects completed, and 18 (29%) subjects were discontinued.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Study: A one month clinical study was conducted.
Sample Size: A total of 62 subjects were dispensed and evaluated, with 44 (71%) completing the study and 18 (29%) discontinuing.
Study Design: Prospective, multi-site, open label study with a 1-month aggregate lens wearing period.
Primary Outcomes: Safety (adverse events, loss of visual acuity) and Effectiveness (contact lens visual acuity by eye). Additional effectiveness outcomes included percentage of completed subjects and lens wearing time.
Key Safety Endpoints: Visual acuity loss greater than 2 lines, serious adverse events, complications, symptoms, problems, and complaints.
Key Results - Safety Assessment:
- 4 adverse events were reported for 2 completed and 2 discontinued subjects (mechanical abrasion, transient changes in intraocular pressures, edema and infiltrates, red eye with infiltrates).
- Slit lamp examinations showed relatively high rates of staining (50.1% completed eyes, 52.0% discontinued eyes), injection (44.7% completed eyes, 42.3% discontinued eyes), and neovascularization (22.6% completed eyes, 14.6% discontinued eyes). Edema was reported for 4.0% completed eyes and 15.4% discontinued eyes.
- Most common symptoms/complaints for completed eyes: discomfort/awareness (26.0%), dryness/scratchiness (12.5%), blurred vision (11.7%), itching/burning (10.6%). Rates were higher for discontinued patients.
Key Results - Efficacy Assessment: - Final visual acuity for completed subjects: 20/20 or better (26.3%), 20/25 or better (55.1%), 20/30 (71.4%), 20/40 or better (83.9%).
- Visual acuity rates for discontinued subjects: 8.4% (20/20 or better), 27.8% (20/25 or better), 47.2% (20/30), and 52.8% (20/40 or better).
- 5 completed eyes and 3 discontinued eyes had VA decreases of more than 2 lines of Snellen VA compared to best corrected VA, which was expected for this population.
- Average daily wearing time for completed patients: 11.4 hours.
Conclusion: The SynergEyes™ KC Hybrid Contact Lens for Keratoconus provided satisfactory performance as expected, demonstrating safe and effective use.
Non-clinical studies:
Conducted under K051035 for the equivalent lens (predicate lens for this device).
- Chemistry and leachability: Residual monomer testing conducted per US and ISO standards; residuals were trace levels and non-toxic.
- Toxicology (cytotoxicity, Ocular Irritation, Systemic Injection): Tested extracts of hybrid lens material; found non-toxic for all three biocompatibility tests.
- Solution Compatibility: 10 lenses subjected to 30-cycle disinfection; compatible with solutions approved for both hydrogel and RGP lenses.
- Microbiology/Sterilization: Finished lenses e-beam sterilized using USP protocol. Initial shelf life established at one year.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K051035, P870024/S36, P870024/S43, K940277, P840004/S7
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
NOV 3 0 2005
SynergEyes™, Inc. Carlsbad, CA 92008
Applicant's Name and Address
SynergEyes™, Inc. 1926 Kelloga Ave. Suite 100 Carlsbad, CA 92008 (760) 476-9410
Contact Person
Richard Lippman, OD FAAO Vice President Ophthalmic Regulatory Products R.P. Chiacchierini & Associates, LLC 15825 Shady Grove Road Suite 30 Rockville, Maryland 20850 (240) 683-3738
1. Identification of device
Common Name: Trade Name:
Classification:
Contact Lens SynergEyes™ KC (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Lens for Keratoconus Daily Wear Soft (hydrophobic) Contact Lens Class II (21 CFR 886.5916)
2. Description of device
Device classification:
The SynergEyes™ KC (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens is a The Oyliogeyes - RO (pananoos 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, -0.50 to -6.00D cylinder .
- with center thickness from 0.18mm to 0.30mm .
- with base curves of 5.50mm to 7.70mm .
- with diameter of 14.50mm .
The lens material (paflufocon D hem-iberfilcon A) is identical to the predicate current material The teller (paners) There are no differences to the chemical composition, formulation, cleared "inder" (100 room "herilization as described in the referenced 510(k).
This lens material for the rigid portion is paflufocon D lathe cut, surrounded by soft hydrophilic This lens material for the nga portion by means of e-beam sterilization. When placed on the Copolymer (fichlinen Fr), ecentiable »), nect 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 rays onto the rolline. The visibility tinted material. This device is equivalent to Keraloconus: In A and M Hybrid Contact Lens is material design and composition, and the the SyneigEyes - A and M Hykeratoconus and manufactured by Ciba Vision Corporation.
The SynergEyes™ KC 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 is bound by a proprietary chemical bonding method.
1
SynergEyes™, Inc. Carlsbad, CA 92008
3. Intended use
SynergEves™ KC (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses for keratoconus are indicated for use in the correction of eyes with refractive errors that include hyperopia and myopia 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 +20.00 and -20.00 D in eyes with irreqular 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 iberfilcon A) was selected to address: material (silicone acrylate- paflufocon D) for the optic portion of the lens and (hemiberfilcon A) for the soft skirt portion of the lens. Additionally for lens design (hybrid RGP/soft), lens group (silicone acrylate RGP and Group I low water non-ionic for the soft material. Further equivalence to predicate devices for indication for use and parameter comparison.
Predicate Devices:
- For the Hybrid (RGP-soft skirt concept) .
| SynergEyes™, Inc.
SoftPerm (synergicon A) Mixed use Lens | K051035
P840004/S7 | Cleared: Sep. 2, 2005
App: 10/14/1993 |
|-------------------------------------------------------------|---------------------------------------------------------------------------------------|------------------------------------------|
| • For the RGP Center Portion: | | |
| Paragon Vision Sciences | P870024/S36 and S43
App: 11/23/1993 and 4/13/2002
K940277
Cleared: 5/9/1994 | |
| • For the Soft Skirt Portion: | | |
| SynergEyes™, Inc.
SoftPerm (synergicon A) Mixed use lens | K051035
P840004/S7 | Cleared: 9/2/2005
App: 10/14/1993 |
5. Characteristics
The physical and dimensional characteristics of the SynergEyes™ Hybrid Contact Lens are compared to the characteristics of the predicate device SoftPerm® Contact Lens in the following table.
| Lens Characteristics | SynergEyes TM K
(paflufocon D-
iberfilcon A)
Hybrid Contact
Lens
(Subject Device) | SynergEyesTM A
and M (paflufocon
D- iberfilcon A)
Hybrid Contact
Lens
K051035
(Predicate Device) | SoftPerm®
(synergicon A)
Contact Lens
P840004/S7
(Predicate Lens) |
|----------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Manufacturer | SynergEyesTM Inc. | SynergEyesTM Inc. | Ciba Vision Care |
| Base Curves | 5.50-7.70mm | 7.10-9.00mm | 7.10-8.10mm |
| RGP Center | 8.40mm | 8.40mm | 8.00mm |
| Posterior Optic Zone | 9.0mm | 7.80mm | 7.00mm |
2
Diameter | |||
---|---|---|---|
Lens Designs | Sphere, Aspheric, | ||
Front Surface | |||
Toric, | Sphere, Aspheric, | ||
Front Surface | |||
Toric, Multifocal | Sphere, Front | ||
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 | |
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 | ||
RGP hem-iberfilcon | |||
A (HEMA, MEMA) | Paflufocon D center | ||
RGP hem-iberfilcon | |||
A (HEMA, MEMA) | Synergicon A | ||
RGP and HEMA | |||
Skirt | |||
Tint | Visibility Blue | Visibility Blue | Clear |
Soft Skirt Water | |||
Content | 27% | 27% | 25% |
Core (RGP) Water | |||
Content | 90% | >90% |
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.
7
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. Above the caduceus, the text "HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern. Below the caduceus, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern.
NOV 3 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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
K052675 Re:
Trade/Device Name: SynergEyes™ KC (paflufocon D hem-iberfilcon A) Hybrid Contact Lens for Keratoconus 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 23, 2005 Received: September 27, 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 general controls provisions of the 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 HI (PMA), it may be subject to such 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.
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); 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.
8
Page 2 - Richard E. Lippman, O.D.
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 (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
9
SYNERGEYES, INC. | SECTION 3 |
---|---|
510(k) Premarket Notification | INDICATION FOR USE STATEMENT |
SYNERGEYES™ (paflufocon | |
D hem-iberfilcon A) HYBRID | |
CONTACT LENS FOR | |
KERATOCONUS | DAILY WEAR CONTACT LENS |
SECTION 2 : INDICATIONS FOR USE STATEMENT
510(k) Number (if known) _K 052675
Device Name: SynergEyes™ KC (paflufocon D hem-iberfilcon A) Hybrid Contact Lens for Keratoconus
Indication for Use
SynergEyes™ KC (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses for keratoconus are indicated for use in the correction of eyes with refractive errors that include hyperopia and myopia 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 +20.00 and –20.00 D in eyes with 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.
(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 ______
(Division Sign-off) | River Warbutor |
---|---|
Division of Ophthalmic Devices | |
510(k) Number | K052675 |