(252 days)
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No
The provided text describes a contact lens and its intended use, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device, a contact lens, is primarily for vision correction and managing conditions like keratoconus, but it doesn't fit the typical definition of a therapeutic device designed to treat a disease or medical condition.
No
The device is a contact lens intended for correcting vision and managing keratoconus, not for diagnosing medical conditions.
No
The device description and intended use clearly describe a physical contact lens, which is a hardware 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 managing keratoconus and correcting refractive errors (myopia, hyperopia, astigmatism). 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 samples from the human body (like blood, urine, tissue, etc.) or to provide information about a person's health status, disease, or condition through in vitro analysis.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator of whether a device is an IVD.
- Other Sections (Not Found): The absence of information in sections like "Mentions image processing," "Mentions AI, DNN, or ML," "Input Imaging Modality," and performance study details further supports that this is not a diagnostic device.
In summary, the device is a medical device used for vision correction and management of a corneal condition, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The Soft K (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear is indicated for daily wear for persons requiring Koratoooia (myopia and hyperopia) in aphakic and nonaphakic persons that may exhibit refractive and/or corneal irregularity such as irregular astigmatism up to 2.00 D. The lens may be disinfected with a chemical or heat disinfection system.
The Soft K Toric (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear is indicated for daily wear for persons requiring koratoopia (myopia, hyperopia and astigmatism) in aphakic and non-aphakic persons that exhibit refractive and/or corneal irregularity such as irregular astigmatism. The lens 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.)
Not Found
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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 U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2004
Soflex Contact Lens Industries. Ltd. c/o Kevin Walls, RAC Principal Consultant Regulatory Insight, Inc. 13 Red Fox Lane Littleton, CO 80127
Re: K033655
Trade/Device Name: Softex Soft K (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear and Soflex Soft K Toric (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: May 14, 2004 Received: May 18, 2004
Dear Mr. Walls:
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.
1
Page 2 - Kevin Walls, RAC
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 Office of Compliance at (301) 594-4613. 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/dsma/dsmamain.html
Sincerely yours,
Akalyi Rosenthal
A. Ralph Rosenthal, 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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Page 1 of 1
510(k) Number (if known): K033655
Soflex Soft K (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Device Name: Sollex Ooft N (Nylor and the Softex Soft K Toric (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear
Indications for Use: The Soft K (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear is indicated for daily wear for persons Ecris for Bully Woulds management and for the correction of requiring Koratoooia (myopia and hyperopia) in aphakic and nonaphakic persons that may exhibit refractive and/or corneal aptiatio persons that may corneal irregularity such as irregular astigmatism up to 2.00 D that does not interfere with irregular asigmation a may be disinfected with a chemical or heat disinfection system.
The Soft K Toric (xylofilcon A) Soft (hydrophilic) Keratoconus The Bort it Tono (Xaily Wear is indicated for daily wear for persons Contact Lens for Daily management and for the correction of requiring koratoopia (myopia, hyperopia and astigmatism) in refractive and non-aphakic persons that exhibit refractive and/or aphake and non aphan opst-refractive surgery corneal irregularity correal astigmatism. The lens 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)
Tricia Rae Cohen M.D.
Division of Ophthalmic
510(k) Number K033655
Prescription Use
X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)