(49 days)
SynergEyes"16 A and M (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses for daily wear are indicated for use in the correction of hyperopic, myopic and astigmatic refractive crror 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 D and +4.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.
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 10,00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.
SynergEyes 106 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 eves 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.
SynergEyes TM - A, M, KC, and PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens
This FDA 510(k) clearance letter for the SynergEyes Hybrid Contact Lenses does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and a study proving device performance. This document is a clearance letter, indicating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, not a scientific study report.
Here's a breakdown of what can be extracted and what is missing:
The core of the request is to describe the acceptance criteria and a detailed study proving the device meets those criteria, specifically for an AI/ML context. This document is for a medical device (contact lenses) and does not involve AI/ML. Therefore, most of the requested fields related to AI/ML study design (test sets, ground truth, experts, MRMC, standalone performance, training sets) are not applicable or cannot be found in this document.
Information Extracted from the Provided Text:
- Device Name: SynergEyes (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses for Daily Wear
Table of Acceptance Criteria and Reported Device Performance:
Based on the document, there are no explicit acceptance criteria or reported device performance metrics in the format usually provided for AI/ML or efficacy studies. The "acceptance" here is the FDA's determination of substantial equivalence, which is based on demonstrating the device is as safe and effective as a predicate device, not necessarily on meeting specific numerical performance targets outlined in this letter.
The "Indications for Use" section defines what the lenses are for, which can be seen as the intended performance scope, but not numerical acceptance criteria.
| Acceptance Criteria (Not explicitly stated in numerical terms for performance in this document) | Reported Device Performance (Not quantitative performance data for this device in this document) |
|---|---|
| Safe and effective as predicate device (implicit for 510(k) clearance) | Not explicitly reported in this document beyond being substantially equivalent to a predicate. |
| Correction of hyperopic, myopic, and astigmatic refractive error (including presbyopia) | Device is indicated for these uses. |
| Daily wear | Device is indicated for daily wear. |
| Correction up to +20.00 and -20.00 D in eyes with astigmatism up to 6.00 D (for A and M models) | Device is indicated for this range. |
| Add powers between +1.00 D and +4.00 D (for presbyopia) | Device is indicated for this range. |
| Correction of irregular astigmatism up to 10.00 D (for KC model) | Device is indicated for this range. |
| Correction of irregular astigmatism up to 6.00 D (for PS model) | Device is indicated for this range. |
| Disinfection using chemical disinfecting system compatible with both hydrogel and RGP lenses | Lenses require this type of disinfection. |
Missing Information (Not present in this 510(k) clearance letter):
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not described. The 510(k) process relies on equivalence to predicate devices, and while testing would have been done by the manufacturer, the details of those studies are not in this clearance letter.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not described as this is not an AI/ML study.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as this is not an AI/ML study. Performance for contact lenses would typically involve clinical trials assessing visual acuity, comfort, fit, and physiological response, but these details are not in this clearance letter.
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 0 2008
SynergEyes, Inc. c/o Richard Lippman, O.D. Vice President for Ophthalmic Product Regulatory Affairs R.P. Chiacchierini & Associates, LLC 15825 Shady Grove Road, Suite 30 Rockville MD 20850
Re: K081034
Trade/Device Namc: SynergEyes (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses for Daily Wear
Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid gas permeable contact lens Regulatory Class: Class II Product Code: HQD Dated: April 11, 2008 Received: April 11, 2008
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 III (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.
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Page 2 - Richard 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Malvina B. Eggleston, und
Malvina B, Eydelman, M.D Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| SYNERGEYES, INC. | SECTION 4 |
|---|---|
| 510(k) Premarket Notification | INDICATIONS FOR USE STATEMENT |
| SynergEyes TM A (paflufocon D hem-iberfilcon A) | Daily Wear Contact Lens |
|---|---|
| Hybrid Contact lens for Ametropia | |
| SynergEyes TM M (paflufocon D hem-iberfilcon A) | |
| Hybrid Contact lens for Presbyopia | |
| SynergEyes TM KC (paflufocon D hem-iberfilcon A) | |
| Hybrid Contact lens for Keratoconus | |
| SynergEyes TM PS (paflufocon D hem-iberfilcon A) | |
| Hybrid Contact lens for Post Surgery and Trauma |
SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known)______________________________________________________________________________________________________________________________________________________
Device Names: SynergEyes TM - A, M, KC, and PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens
Indications for Use
SynergEyes"16 A and M (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses for daily wear are indicated for use in the correction of hyperopic, myopic and astigmatic refractive crror 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 D and +4.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.
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 10,00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.
SynergEyes 106 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 eves 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 | X |
| OR | |
| Over-the-counter-use | |
| (Division Sign-off) | |
| 510(k) Number | K081034 |
§ 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.