(252 days)
The Soft K (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear is indicated for daily wear for persons requiring Keratoconia management and for the correction of 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 that does not interfere with irregular astigmatism and 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 Keratoconia management and for the correction of myopia, hyperopia and astigmatism in aphakic and non-aphakic persons that exhibit refractive and/or post-refractive surgery corneal irregularity corneal astigmatism. The lens may be disinfected with a chemical or heat disinfection system.
Not Found
This is a 510(k) premarket notification for a medical device (contact lenses). These types of documents do not typically include detailed studies with acceptance criteria, sample sizes, expert qualifications, or ground truth methodologies as might be found for AI/ML device submissions.
Instead, the FDA determines "substantial equivalence" to legally marketed predicate devices based on similarities in intended use, technological characteristics, and safety/effectiveness data. The document confirms that the device has been found substantially equivalent.
Therefore, the specific information requested in your prompt for acceptance criteria and a study proving device performance (as would be applicable for AI/ML or novel devices) is not present in this document. The "performance" in this context refers to the device meeting the same standards as existing, legally marketed contact lenses through non-clinical or clinical data that demonstrates similar design and performance characteristics.
The document does include:
- Trade/Device Name: Soflex 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
- Indications for Use: Detailed in the "Page 1 of 1" section (document {2}).
- Regulatory Class: Class II
- Product Code: LPL
To answer your specific questions in the context of this document:
- A table of acceptance criteria and the reported device performance: This document does not contain such a table. The "acceptance criteria" for a 510(k) are typically met by demonstrating substantial equivalence to a predicate device, which would involve showing that the new device is as safe and effective as the predicate.
- Sample size used for the test set and the data provenance: Not applicable/not provided in this document. Information on clinical or non-clinical testing would have been submitted in the 510(k) application, but the summary letter does not detail these aspects.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. This type of information is more relevant for diagnostic devices requiring expert interpretation of results.
- Adjudication method for the test set: Not applicable/not provided.
- 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. This device is a contact lens, not an AI-powered diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical contact lens.
- The type of ground truth used: Not applicable/not provided. Performance data would relate to lens fit, vision correction, comfort, and safety, typically compared to predicate lenses.
- The sample size for the training set: Not applicable/not provided. Training sets are relevant for AI/ML models, not for physical medical devices like contact lenses.
- How the ground truth for the training set was established: Not applicable/not provided.
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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.
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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)
§ 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.