(194 days)
Not Found
No
The summary describes a physical contact lens and its clinical performance. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for "reduction of myopic refractive error" and "temporary reduction of myopia," which are therapeutic effects addressing a medical condition (myopia).
No
The device is a contact lens used to correct myopia by altering the shape of the cornea, not to diagnose a condition.
No
The device description clearly describes a physical contact lens made of a specific material with defined dimensions and physical properties. It is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reduce myopic refractive error by changing the shape of the cornea. This is a direct interaction with the patient's body to correct vision, not a test performed on a sample taken from the body.
- Device Description: The device is a contact lens, which is a physical object placed on the eye. It does not involve any reagents, assays, or analysis of biological samples.
- Mechanism of Action: The mechanism of action is the physical reshaping of the cornea, not the detection or measurement of substances in a biological sample.
- Clinical Studies: The clinical studies focus on the effect of the lens on visual acuity, refractive error, and corneal shape, which are all related to the physical interaction of the device with the eye.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
CONTEX (siflufocon A) Rigid Gas Permeable OK™ (orthokeratology) contact lenses are indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lens is indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 3.00 diopters. The lens may be disinfected using a chemical disinfection system only. Note: To maintain the orthokeratology effect of myopia reduction lens wear must be continued on a prescribed wearing schedule.
Product codes
86 HQD
Device Description
The CONTEX OKTM (orthokeratology) contact lens is a rigid gas permeable contact lens in a reverse geometry design. The lens material siflufocon A, is a fluoro silicone acrylate polymer which contains D & C Green #6 as a color additive. The CONTEX OKTM (orthokeratology) contact lens has the following dimensions: Chord Diameter................Approximately 6.5 to 13.0 mm Center Thickness for Low Minus Lens..................................0.10 to 0.30 mm for Plus Lens:........................................0.20 to 0.70 mm Base Curve........................................6.50 to 11.00 mm Secondary Curves........................ 0.1 to 2 mm. Flatter or Steeper than Base Curve Peripheral Curves........................ 0.1 to 2 mm. Flatter or Steeper than Base Curve Powers........................................-10.00 to +5.00 Diopters Aspheric Lens Eccentricity ................................................................................................................................................... (Oblate, Prolate or Tangent Conic)
The physical properties of the lens are: Refractive Index...... 1.43 (Nd at 25°C), Light Transmittance... > 92.5% (370-760 nm), Wetting Angle ... 24.0 (Contact Receding Angle), Specific Gravity.... 1.25, Hardness.... 82, Water Content...
§ 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
K9736097
APR - 8 1998
SUMMARY OF SAFETY AND EFFECTIVENESS K973697
CONTEX (siflufocon A) RIGID GAS PERMEABLE OK™ (ORTHOKERATOLOGY) CONTACT LENS
| 1. Submitted by : | Contex, Inc.
4505 Van Nuys Blvd.
Sherman Oaks, CA 91403 |
|-------------------|---------------------------------------------------------------|
| Contact : | NICK STOYAN, PRESIDENT |
Contex, Inc. 4505 Van Nuys Blvd. Sherman Oaks, CA 91403 Phone 1-800-626-6839
March 17, 1998 Date prepared:
- Device:
| Common Name: | CONTEX OKTM (orthokeratology) contact lens |
|---|---|
| Trade Name: | CONTEX (siflufocon A) Rigid Gas Permeable OKTM (orthokeratology) Contact Lens |
| Classification | Class II (Performance Standards) |
| 21 CFR 886.5916 | |
| Rigid gas permeable contact lens | |
| 3. Substantial equivalence | A claim of substantial equivalence is based on preamendment status in which a predicate lens of rigid contact lens material was labeled, promoted and distributed in interstate commerce for the same intended use before May 28, 1976. |
| 4. Device description | The CONTEX OKTM (orthokeratology) contact lens is a rigid gas permeable contact lens in a reverse geometry design. The lens material siflufocon A, is a fluoro silicone acrylate polymer which contains D & C Green #6 as a color additive. The CONTEX OKTM (orthokeratology) contact lens has the following dimensions: |
| Chord Diameter................Approximately 6.5 to 13.0 mm | |
| Center Thickness | |
| for Low Minus Lens..................................0.10 to 0.30 mm | |
| for Plus Lens:........................................0.20 to 0.70 mm | |
| Base Curve........................................6.50 to 11.00 mm | |
| Secondary Curves........................ 0.1 to 2 mm. Flatter or Steeper than Base Curve | |
| Peripheral Curves........................ 0.1 to 2 mm. Flatter or Steeper than Base Curve | |
| Powers........................................-10.00 to +5.00 Diopters |
1
Aspheric Lens Eccentricity ................................................................................................................................................... (Oblate, Prolate or Tangent Conic)
The physical properties of the lens are:
| Refractive Index...... | 1.43 (Nd at 25°) |
|---|---|
| Light Transmittance... | > 92.5% (370-760 nm) |
| Wetting Angle ... | 24.0 |
| (Contact Receding Angle) | |
| Specific Gravity.... | 1.25 |
| Hardness.... | 82 |
| Water Content... | Trade Name: CONTEX OK ™ (siflufocon A) Rigid Gas Permaeble Contact Lens for Orthokeratology Regulatory Class: II Product Code: 86 HQD Dated: March 9, 1998 Received: March 10, 1998 |
Dear Mr. Stoyan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
6
Page 2 - Mr. Nick Stoyan
This letter will allow you to begin marketing your device as described in your 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 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Page 1 of 1 _
510(k) Number (if known): K973697
Device Name: CONTEX OK™ (siflufocon A) Rigid Gas Permaeble Contact Lens for Orthokeratology
The CONTEX OK™ (siflufocon A) Rigid Gas Permaeble Contact Lens for Orthokeratology is indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lens is indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 3.00 diopters. The lens may be disinfected using a chemical disinfection system only.
Note: To maintain the orthokeratology effect of myopia reduction lens wear must be continued on a prescribed wearing schedule.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Orzetta
(Division Sign-Off) Division of Ophthalmic Devices 1973697 510(k) Number_
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)