(140 days)
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No
The document describes a physical medical device (contact lens) and its clinical performance. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The device is indicated for correction of hyperopic, myopic, and astigmatic refractive error, which directly addresses and corrects a medical condition (refractive error), classifying it as a therapeutic device.
No
Explanation: The device, a contact lens, is intended for correcting refractive errors and presbyopia, acting as a refracting medium to focus light. It does not diagnose any conditions.
No
The device description clearly describes a physical contact lens made of specific materials (petrafocon A and hem-larafilcon A) with defined physical parameters (power range, cylinder powers, center thickness, base curves, diameter, add powers). This is a hardware medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "correction of hyperopic, myopic and astigmatic refractive error including presbyopia... in non-diseased eyes." This describes a therapeutic or corrective function, not a diagnostic one.
- Device Description: The description details the physical properties and materials of a contact lens designed to "act as a refracting medium to focus light rays onto the retina." This is consistent with a vision correction device.
- Lack of Diagnostic Function: There is no mention of the device being used to test, examine, or diagnose any condition or sample from the human body. IVDs are used to perform tests on biological samples (like blood, urine, tissue) or to provide information about a person's health status or condition.
The device is a contact lens, which is a medical device used for vision correction.
N/A
Intended Use / Indications for Use
SynergEyes® SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lenses for daily wear are indicated for use in the correction of hyperopic, myopic and astigmatic refractive error including presbyopia, in aphakic and not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00D. 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™ SiH (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lens is a combination of high Dk rigid gas permeable contact lens corneal option surrounded by a soft hydrophilic silicone-hydrogel skirt (periphery) that straddles the limbus of the eye :
- in the power range of -20.00 to +20.00 diopters for sphere,
- . cylinder powers up to 6.00 diopters for astigmatism
- with center thickness from 0.12mm to 0.30mm .
- with base curves of 7.10mm to 9.00mm
- with diameter of 14.50mm
- Add Powers 1.00 to 4.00 (multifocal)
This lens material for the rigid portion is petrafocon A, an upgrade high Dk silicone base RGP material, lathe cut, surrounded by soft hydrophilis silicone-hydrogel copolymer (hem-larafilizon A), sterilized by means of e-beam sterilization. When placed on the human cornea, the SynergEyes™ SiH Hybrid Contact Lens acts as a refracting medium to focus light rays onto the The device is available in the following indications: spherical, toric, and multifocal, with retina. spherical or aspheric surfaces in violet visibility tim the RGP center, and multing, will may device is substantially equivalent to the SyneryEyes™ A and M (paflufocon D hem-iberfilion A) Hybrid Daily Wear Contact Lens predicate devices manufactured by the sponsor, Synerglyes, Inc.
The SynergEyes™ Sill Hybrid Daily Wear Contact Lens center is a highly oxygen permeable (Dk 130) rigid gas material of (petrafocon A). The soft skirt is comprised of silicone-hydrogel copolymer (hem-larafilcon A) of 33% water and 73% polymer.
The junction between the rigid material is bound by a proprietary chemical bonding method.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
eyes, human cornea
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
A three month daily wear clinical study was performed on the subject device. The study was a prospective, unmasked, open label study of a total of 98 subjects, in an approximate 2:1 ratio of test to control.
The test lens was the SynergEyes™ SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lens, and the control lens was the SynergEyes™ A (paflufocon D hem-iberficon A) Hybrid Contact Lens. The study was performed at 8 investigational sites, and was designed to demonstrate that the test lens performed no worse than the control lens on a daily basis.
Eighty seven (87) subjects were randomized and dispensed lenses. The ratio of dispensed Test cohort subjects to dispensed Control cohort subjects was 1.81 to 1. The 90 day study period was completed by 73.2% (41 out of 56) dispensed Test cohort subjects and 87.1% (27 out of 31) dispensed Control cohort subjects.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical studies:
A battery of pre-clinical studies were performed on the subject device in accordance with the Guidance for Daily Wear Contact Lenses, May 1994. Toxicology Studies were conducted under GLP and determined that the SynergEyes™ SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lenses were biocompatible for the intended use in accordance with ISO 10993 Standard for the following tests:
- . Cytotoxicity
- . Acute Ocular Irritation
- . Systemic Injection
- . Guinea Pig Maximization
- . 22 Day Ocular Irritation Study in Rabbits
Physico-chemical Studies including physical, optical and chemical properties as identified in Daily Wear Guidance for Contact Lenses demonstrated equivalent performance to the predicate device as witnessed in the chart listed above.
All pre-clinical and non-clinical studies demonstrated that the final lens subject to extractions and simulated in the above tests performed as expected with no findings related to safety that would be considered as unsafe for human use in the indications set forth for daily wear.
Clinical data:
A three month daily wear clinical study was performed on the subject device. The study was a prospective, unmasked, open label study of a total of 98 subjects, in an approximate 2:1 ratio of test to control.
The test lens was the SynergEyes™ SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lens, and the control lens was the SynergEyes™ A (paflufocon D hem-iberficon A) Hybrid Contact Lens. The study was performed at 8 investigational sites, and was designed to demonstrate that the test lens performed no worse than the control lens on a daily basis.
Eighty seven (87) subjects were randomized and dispensed lenses. The ratio of dispensed Test cohort subjects to dispensed Control cohort subjects was 1.81 to 1. The 90 day study period was completed by 73.2% (41 out of 56) dispensed Test cohort subjects and 87.1% (27 out of 31) dispensed Control cohort subjects.
Nineteen (19) subjects discontinued from the study (15 Test and 4 Control) with the most common reason for discontinuation reported as Subject Decision for the Test cohort (40% or 6/15) and Discomfort for the Control cohort (75% or 3/4). One Test cohort subject was discontinued for , Adverse Event and 1 Test cohort subject was discontinued for Positive Slit Lamp.
A total of 5 adverse events were reported for 5 eyes during the study with 4 adverse events reported for the Test cohort and 1 adverse event reported for the Control cohort. Three (3) of the 5 adverse events (2 Test/ 1 Control) were reported as serious adverse events. Of the 2 Test cohort serious adverse events, 1 was a minor abrasion where the investigator noted a grade 1 (trace) infiltrate and 1+ cells in the anterior chamber, all of which had cleared in 4 days. The second serious adverse event was a microbial keratitis which was treated and cleared. The single serious adverse event reported for the Control cohort was liver failure related to the use of homeopathic products.
Slit lamp findings reported during the study were compared between the Test and the Control cohorts and related to the baseline rates as well. Results of the slit lamp examinations showed the Test cohort eyes presenting with more staining overall when compared to the Control cohort examinations. All other slit lamp findings were reported a similar rates and severities when looking at the overall visit combined findings for both the Test and the Control cohorts.
Symptoms problems and complaints were compared between the Test and the Control cohorts and reviewed against the baseline proportions as well. The Test cohort eyes reported proportionately greater symptoms (1.1% for itching/burning to 16.1% for dryness) when compared to the Control cohort eyes except for excessive tearing (essentially equal) and variable vision (3.6% Control). Most of the differences in symptoms rates were small (3.7% or less) except for halos (8.6% Test) and dryness (16.1% Test).
Snellen visual acuity with contact lenses remained stable throughout the study for both the test and the control cohorts with only 2 Test cohort eyes and 2 Control cohort eyes reporting 2 or line drops of Snellen lens visual acuity with the contact lenses at the final visit.
Average daily wearing times were similar between the two cohorts and remained stable during the study and averaged between 11.6 to 13.0 hours per day for the Test cohort and 12.1 to 12.8 hours per day for the Control cohort.
Lens deposit evaluations and fitting evaluations provided similar results between the two cohorts. Lens replacements indicated that the Test lenses were replaced more frequently for parameter change and the Control lenses were replaced more frequently for discomfort.
In conclusion, the evaluation of primary safety variables and effectiveness of the test product SynergEyes™ SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lens, support a conclusion of substantial equivalence between the test and control lens evaluated in the study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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, K052560, K033919, K970746
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.
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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).
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§ 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
510 (K) SUMMARY
MAY 20 2009
Applicant's Name and Address
SynergEyes, Inc. 2232 Rutherford Road Carlsbad, CA 92008 (760) 476 9410 (760) 476-9340 FAX
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 rel@rpcaconsulting.com
1. Identification of device
Common Name: Trade Name:
Contact Person
Classification: Device classification:
Contact Lens SynergEyes™ SiH(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens Daily Wear Rigid Gas Permeable Contact Lens Class II (21 CFR 886.5916)
2. Description of device
The SynergEyes™ SiH (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lens is a combination of high Dk rigid gas permeable contact lens corneal option surrounded by a soft hydrophilic silicone-hydrogel skirt (periphery) that straddles the limbus of the eye :
- in the power range of -20.00 to +20.00 diopters for sphere,
- . cylinder powers up to 6.00 diopters for astigmatism
- with center thickness from 0.12mm to 0.30mm .
- with base curves of 7.10mm to 9.00mm
- � with diameter of 14.50mm
- Add Powers 1.00 to 4.00 (multifocal)
This lens material for the rigid portion is petrafocon A, an upgrade high Dk silicone base RGP material, lathe cut, surrounded by soft hydrophilis silicone-hydrogel copolymer (hem-larafilizon A), sterilized by means of e-beam sterilization. When placed on the human cornea, the SynergEyes™ SiH Hybrid Contact Lens acts as a refracting medium to focus light rays onto the The device is available in the following indications: spherical, toric, and multifocal, with retina. spherical or aspheric surfaces in violet visibility tim the RGP center, and multing, will may device is substantially equivalent to the SyneryEyes™ A and M (paflufocon D hem-iberfilion A) Hybrid Daily Wear Contact Lens predicate devices manufactured by the sponsor, Synerglyes, Inc.
The SynergEyes™ Sill Hybrid Daily Wear Contact Lens center is a highly oxygen permeable (Dk 130) rigid gas material of (petrafocon A). The soft skirt is comprised of silicone-hydrogel copolymer (hem-larafilcon A) of 33% water and 73% polymer.
1
SynergEyes™, Inc. Carlsbad, CA 92008
The junction between the rigid material is bound by a proprietary chemical bonding method.
3. Intended use
SynergEyes® SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lenses for daily wear are indicated for use in the correction of hyperopic, myopic and astigmatic refractive error including presbyopia, in aphakic and not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.
4. Predicate device
For Design: Predicate- K051035 SynergEyes™ A & M (paflufocon D hem-iberfilcon A) Hybrid Contact Lens
The SynergEyes™ SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lens design is based on the SynergEyes™ (paflufocon D hem-iberfilcon A) Hybrid Contact Lens. The designs of both lenses are based on a rigid gas permeable center optic and a soft hydrogel skirt with a special proprietary bonding process to join the center and the peripheral portions at the junction of the optic edge where it joins the peripheral ring.
For Material Similarities: Predicate- K051035, K052560, K033919, K970746
The SynergEyes™ SiH (petrafocon A hem-larafiicon A) Hybrid Contact Lens has a rigid gas permeable center optic portion which is a high Dk (Dk 130) silicone based polymer (petrafocon A) surrounded by a silicone-hydrogel high Dk (Dk 84.2) soft skirt. The predicate lens, the SynergEyes™ A (paflufocon D hem-iberfilcon A) Hybrid Contact Lens has the center materialfluorosilicone acrylate, Paragon HDS material (Dk 100) permeability, surrounded by a hemabased polymer soft ring with Dk 9.1. The materials in both the subject device and predicate device are characterized as Group I low water, non-ionic in nature for their soft portions as the water content for the subject device is 33% and the predicate device is 25.0%. The water content for the rigid portion of both lenses is