(133 days)
Not Found
No
The document describes a physical contact lens and its materials, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies focus on clinical outcomes related to the lens's physical properties and patient comfort/vision.
No.
The product is a contact lens intended to correct vision (myopic, hyperopic, astigmatism, presbyopia) and is not described as treating any disease or medical condition.
No
Explanation: The device is a contact lens used for vision correction (myopia, hyperopia, presbyopia, astigmatism), not for diagnosing a condition or disease.
No
The device description clearly describes a physical contact lens made of rigid gas permeable and soft hydrophilic materials. It is a tangible 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 a contact lens for correcting vision problems (myopia, presbyopia, astigmatism). This is a therapeutic and corrective function, not a diagnostic one performed in vitro (outside the body).
- Device Description: The description details the physical characteristics and materials of a contact lens designed to be placed on the eye.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
The device is a medical device, specifically a contact lens, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SynergEyes® A and M (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses for daily wear are indicated for use in the concession of inyperopic 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 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.
Product codes (comma separated list FDA assigned to the subject device)
HQD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eye
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A Clinical Study was performed to establish the safety and efficacy of the SyncrgEyes. The clinical investigation of the SynergEyes™Hybrid Contact Lens was conducted on 107 subjects for a period of 3 months. All subjects read and signed a consent document regarding participation in the clinical investigation which was conducted in accordance with all applicable international ethical standards and regulations.
Reasons for discontinuation among the 46 (43%) subjects who did not complete the protocol were:
- Poor Comfort: 15 subjects (32.6%)
- Loss of Interest: 13 subjects (28.3%)
- Poor Vision: 6 subjects (13.0%)
- Difficulty Handling: 1 subject (2.2%)
- Other: 3 subjects (6.5%) (included travel conflicts, use of reading glasses inconvenient, subject not happy with lenses)
- Medical Condition - not study related: 2 subjects (4.3%)
- Non-Compliance: 4 subjects (8.7%)
- Poor Outcome with Lenses: 2 subjects (4.3%)
There was one complication reported as "Poor outcome with lenses" during the study. The subject was treated and discontinued.
Safety was assessed by adverse events, positive slit lamp findings, symptoms problems and complaints, and changes in keratometric readings. No adverse events were reported. Complaints were minimal, with comfort being the most prevalent. No other significant safety findings were noted.
Efficacy was evaluated by changes in refractive correction, lens visual activity, and average. No significant changes were noted in efficacy.
Conclusion: The SynergEyes™ Hybrid Contact Lens material performance is equivalent to PCP in this class of materials, as well as for RGP daily and soft daily wear lenses in general.
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.
P870024/S39, S43, K940277, K002845, K000795, P840004
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
K 05/035 510 (K) SUMMARY
Applicant's Name and Address
| | SynergEyes, Inc.
1926 Kellogg Ave.
Carlsbad, CA 92008
(760) 476 9410 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Richard Lippman, OD FAAO
Vice President Ophthalmic Regulatory Products
R.P. Chiacchierini & Associates, LLC Suite 30
15825 Shady Grove Road
Rockville, Maryland 20850
(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
- 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
K940277
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
- 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™
(paflufocon D-
iberfilcon A) Hybrid
Contact Lens | SoftPerm®
(synergicon A)
Contact Lens
(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
Diameter | 7.80mm | 7.00mm |
| Lens Designs | Sphere, Aspheric,
Front Surface Toric,
Multifocal | Sphere, Front
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
(HEMA, MEMA) | RGP and HEMA Skirt |
|--------------------------|--------------------------------------|--------------------|
| Tint | Visibility Blue | Clear |
| Soft Skirt Water Content | 27% | 25% |
| Core (RGP) Water Content | 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 | |
|---|---|
| -- | -------------------------- |
| Karer Wabanten (Division Sign-off) Division of Ophthalmic Devices | |
|---|---|
| -- | ------------------------------------------------------------------------------------------------------------ |
| 510(k) Number | K051035/5001 |
|---|---|
| --------------- | -------------- |