(206 days)
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No
The summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses solely on the intended use and materials of a contact lens.
No
The device corrects refractive ametropia by providing vision correction, which is not considered a therapeutic function.
No
The device is a contact lens intended for correcting refractive ametropia, not for diagnosing medical conditions.
No
The 510(k) summary describes rigid gas permeable contact lenses, which are physical medical devices, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this is a Rigid Gas Permeable Contact Lens. Contact lenses are medical devices that are placed on the surface of the eye to correct vision. They do not involve testing samples from the body.
- Intended Use: The intended use is for the "correction of refractive ametropia" in patients with specific eye conditions. This is a therapeutic and corrective function, not a diagnostic one.
Therefore, based on the provided information, the Rose K Post Graft Rigid Gas Permeable Contact Lens is a medical device, but it is not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Rose K Post Graft Rigid Gas Permeable Contact Lens (hexafocon A), and Rose K Post Graft Rigid Gas Permeable Contact Lens (enflufocon B) are indicated for the correction of refractive ametropia in aphakic and nonaphakic persons with keratoconus or who have undergone a penetrating keratoplasty.
Product codes
HQD
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
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Key Metrics
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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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§ 886.5916 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 shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three stylized birds in flight. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 0 2002
Mr. Ian Jennings Rose K. International, LTD 60 St. Andrews TCE Hamilton, New Zealand
Re: K013646
Trade/Device Name: Rose K Post Graft Rigid Gas Permeable Contact Lens (hexafocon A or enflufocon B)
Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: May 14, 2002 Received: May 16, 2002
Dear Mr. Jennings:
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 aso button in all encreates) of the Medical Device Amendments, or to devices that provision in they 20, 1978, and cordance 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 rr your de rive to such additional controls. Existing major regulations affecting your device can be finar of subject to sten acant 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 - Mr. Ian Jennings
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotes with are way of substantial equivalence of your device of your device to a legally promated nodicate 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours,
A. Ralph 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
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Name and Address of Company
P.O. Box 9307 HAMILTON NEW ZEALAND. ROSE K INTERNATIONAL LTD Indications for Use Statement
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K013646 |
| Device Name: | THE ROSE K POST GRAFT (hexaforon A or Enflufocon B)RIGID GAS PERMEABLE CONTACT LENS |
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ence of CDRH, Office of Device Evaluation (
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510(k) Number K013646