(231 days)
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Not Found
No
The provided text describes contact lenses for keratoconus management and correction of refractive errors. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML in the device itself or its intended use.
No
The device corrects refractive errors and manages keratoconus, but it does not treat a disease or restore a bodily function beyond visual correction.
No
The device is a contact lens indicated for the correction of refractive ametropia and astigmatism, which is a treatment rather than a diagnostic function.
No
The device description is not found, but the intended use clearly describes a "lens," which is a physical medical device, 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 (myopia, hyperopia, astigmatism) in individuals with keratoconus. 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 diagnose a condition, measure a substance in the body, or provide information for diagnostic purposes.
- Anatomical Site: The device is applied to the eye, which is an external anatomical site for vision correction, not for obtaining biological samples for in vitro analysis.
IVD devices are typically used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The NOVAKONE SPHERICAL lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia) in aphakic and not aphakic persons with otherwise non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.
The NOVAKONE TORIC lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia) and astigmatism in aphakic and not aphakic persons with otherwise non-diseased eyes and who possess refractive astigmatism not exceeding 10 Diopters.
The lenses may be prescribed for either conventional wear or planned replacement modalities, and may be disinfected with a chemical or heat disinfection system.
Product codes
LPL
Device Description
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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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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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.
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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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§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of 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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with three curved lines forming its wings and a wavy line representing its body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Alden Optical Labs., Inc. C/O Charles H. Creighton CEO 13295 Broadway Alden, NY 14004
APR 2 6 2011
Re: K102557
Trade/Device Name: NOVAKONE Spherical and NOVAKONE Toric Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: March 22, 2011 Received: March 23, 2011
Dear Mr. Creighton:
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.
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
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Page 2 - Mr. Charles H. Creighton
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
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 Statement
| Device Names: | NOVAKONE SPHERICAL
NOVAKONE TORIC |
|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The NOVAKONE SPHERICAL lens is indicated for daily
wear for persons requiring keratoconus management for
the correction of refractive ametropia (myopia, hyperopia)
in aphakic and not aphakic persons with otherwise non-
diseased eyes. The lens may be worn by persons who
exhibit refractive astigmatism of 1.50 diopters or less
where the astigmatism does not interfere with visual
acuity. |
| | The NOVAKONE TORIC lens is indicated for daily wear for
persons requiring keratoconus management for the
correction of refractive ametropia (myopia, hyperopia) and
astigmatism in aphakic and not aphakic persons with
otherwise non-diseased eyes and who possess refractive
astigmatism not exceeding 10 Diopters.
The lenses may be prescribed for either conventional wear
or planned replacement modalities, and may be disinfected
with a chemical or heat disinfection system. |
| (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 |
signature
(Dission Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K102557