(135 days)
Not Found
Not Found
No
The provided text describes a contact lens and its intended use, with no mention of AI or ML technology.
No
The device is a contact lens indicated for the correction of refractive errors, which is a vision correction device and not a therapeutic device.
No
The device, Duette™ SiH Hybrid Contact Lenses, is indicated for correcting refractive errors (hyperopic, myopic, astigmatic, presbyopia) and not for diagnosing a disease or condition.
No
The device description clearly identifies the device as "Hybrid Contact Lenses," which are physical medical devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a contact lens for correcting refractive errors in the eye. This is a therapeutic and corrective function, not a diagnostic one.
- Lack of Diagnostic Activity: There is no mention of the device being used to test or analyze samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator of whether a device is an IVD.
- No Mention of Diagnostic Processes: The document does not mention any processes related to analyzing biological samples or providing diagnostic information.
In summary, the Duette™ SiH Hybrid Contact Lenses are a medical device used for vision correction, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
Duette 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 not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.
Product codes
HQD
Device Description
Not Found
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
Prescription Use
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)
Not Found
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.
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image contains the text "Public Health Service". The text is written in a simple, sans-serif font. The words are arranged horizontally, with "Public" and "Health" on the first line and "Service" on the second line. The text is black against a white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
APR 1-8 2012
SynergEyes, Incorporated c/o Richard E. Lippman, O.D. VP Ophthalmic Product Regulatory Affairs Official Correspondent to SynergEyes, Inc. R.P. Chiacchierini & Associates, LLC 15825 Shady Grove Road, Suite 30 Rockville, MD 20850
Re: K113586
Trade/Device Name: Duette SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lenses Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Codes: HQD Dated: March 26, 2012 Received: March 28, 2012
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
Page 2 - Dr. Richard Lippman
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours,
Kesia Alexander
Image /page/1/Picture/8 description: The image contains a signature. The signature is written in cursive and appears to be the letter 'f' or 'j'. The signature is black and is on a white background. The signature is simple and elegant.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known):
Duette™ SiH (petrafocon A hem-larafilcon A) Hybrid Contact lens
Indications For Use:
Device Name:
Duette™ 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 not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.
Prescription Use (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)
Marc Robbay
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K113586