(20 days)
Not Found
Not Found
No
The summary describes contact lenses and their material properties, with no mention of AI or ML.
No.
The device acts as a refracting medium to correct refractive errors (myopia, hyperopia, and astigmatism) and improve visual acuity, rather than treating or curing a disease or condition.
No
Explanation: The device is a contact lens intended for correcting refractive errors (myopia, hyperopia, astigmatism), not for diagnosing medical conditions.
No
The device description clearly describes a physical contact lens made of a specific polymer material, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the lenses are for the "correction of refractive ametropia" and "correction of visual acuity." This is a therapeutic or corrective function, not a diagnostic one.
- Device Description: The description explains how the lens acts as a "refracting medium to focus light rays on the retina." This further reinforces its role in correcting vision, not diagnosing a condition.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the human body (like blood, urine, or tissue) or to provide information for the diagnosis, monitoring, or treatment of a disease or condition based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This contact lens is applied to the body to correct a physical condition (refractive error).
N/A
Intended Use / Indications for Use
Tetrafilcon A lenses are intended for use as a daily wear lens for the correction of refractive ametropia (myopic, hyperopic and astigmatism) in not-aphakic persons with non-diseased eyes.
The Preference® standard, CooperHT™, CooperHT™, CV 43™, Vantage® and Vantage® Accents (tetrafilcon A) Hydrophilic Contact Lenses are indicated for daily wear for the correction of visual acuity by not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lenses can be worn by persons who exhibit astigmatism of 2.50 diopters or less that does not interfere with visual acuity.
The PreferenceToric™ and Cooper Toric™ hydrophilic contact lenses are indicated for daily wear use by not-aphakic persons with non-diseased eyes that are myopic or hyperopic, who exhibit astigmatism up to 9.00 diopters and can obtain satisfactory visual acuity, in a spherical range of -20.00 to +12.00.
Product codes (comma separated list FDA assigned to the subject device)
86LPL
Device Description
All tetrafilcon A Soft (hydrophilic Contact Lenses are hemispherical shells and are available as a spherical or astigmatic lens. When place on the cornea, the hydrated lens acts as a refracting medium to focus light rays on the retina.
The lens material is a hydrophilic random terpolymer of 2-hydroxyethyl methacrylate, N-vinylpyrrolidone and methylmethacrylate joined in a three dimensional network of terpolymer chains by divinylbenzene cross links.
When produced with a handling tint, the dye C.I. Reactive Blue 163 is chemically bound to the polymer to impart a light blue tint on the lens. The handling tint increases the visibility of the lens when not worn on the eye.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests:
Physical and chemical testing was performed on the lenses made by Aspect using an in-monomer tint as called for in the May 1994 Premarket Notification (510(k) Guidance Document for Daily Wear Contact Lenses. Water content, light transmittance, refractive index and mechanical properties were tested. Toxicity was determined by Cytotoxicity, Ocular Irritation Study and Acute Systemic Study.
Conclusion:
The determination of substantial equivalence is based in the results if non-clinical testing. Review of all test data demonstrates that tetrafilcon A lenses manufactured at Aspect Vision, Ltd. with an in-monomer tint, are equivalent to the predicated post-hydration tinted lenses. The in-monomer tinted lenses have the same design, indication and directions for use. CooperVision, Inc. concludes, therefore, that the in-monomer tinted lenses are substantially equivalent to the post-hydration tinted lenses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
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).
Not Found
§ 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
3/15/99
K 990606
510(K) Summary
- Submitter
| 's Name: | CooperVision, Inc. |
|---|---|
| 711 North Road | |
| Scottsville, NY 14546 | |
| Phone: (716) 385-6810 | |
| FAX: (716) 889-5688 |
-
- Contact person:
Bonnie Tsymbal Phone: (716) 264-3210 FAX:
- Contact person:
3. Date Summary Prepared:
4. Name of Device:
| Trade Name: | Preference® standard
Preference® Toric
Cooper HT™
Cooper Toric™
CV 43™
Vantage™
Vantage™ Accents |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------|
| Common Name: | Soft Contact Lens |
| Classification Code: | 86LPL |
| Classification Name: | Lenses, Soft Contact, Daily Wear |
| 5. Legally Marketed Device: | Same as Trade Name |
6. Description of Device:
All tetrafilcon A Soft (hydrophilic Contact Lenses are hemispherical shells and are available as a spherical or astigmatic lens. When place on the cornea, the hydrated lens acts as a refracting medium to focus light rays on the retina.
The lens material is a hydrophilic random terpolymer of 2-hydroxyethyl methacrylate, N-vinylpyrrolidone and methylmethacrylate joined in a three dimensional network of terpolymer chains by divinylbenzene cross links.
When produced with a handling tint, the dye C.I. Reactive Blue 163 is chemically bound to the polymer to impart a light blue tint on the lens. The handling tint increases the visibility of the lens when not worn on the eye.
1
510(k) Summary (continued)
7. Intended Use:
Tetrafilcon A lenses are intended for use as a daily wear lens for the correction of refractive ametropia (myopic, hyperopic and astigmatism) in not-aphakic persons with non-diseased eyes.
8. Technological Characteristics:
The technological characteristics of tetrafilcon A lenses manufactured with a in-monomer tint are the same as the predicate device tinted after hydration.
9. Summary of Non-Clinical Tests:
Physical and chemical testing was performed on the lenses made by Aspect using an in-monomer tint as called for in the May 1994 Premarket Notification (510(k) Guidance Document for Daily Wear Contact Lenses. Water content, light transmittance, refractive index and mechanical properties were tested. Toxicity was determined by Cytotoxicity, Ocular Irritation Study and Acute Systemic Study.
10. Conclusion:
The determination of substantial equivalence is based in the results if non-clinical testing. Review of all test data demonstrates that tetrafilcon A lenses manufactured at Aspect Vision, Ltd. with an in-monomer tint, are equivalent to the predicated post-hydration tinted lenses. The in-monomer tinted lenses have the same design, indication and directions for use. CooperVision, Inc. concludes, therefore, that the in-monomer tinted lenses are substantially equivalent to the post-hydration tinted lenses.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an emblem that features a stylized human figure with three lines extending upwards, resembling a bird in flight. The emblem is a symbol representing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 1999
Ms. Bonnie Tsymbal Regulatory Associate COOPERVISION, Inc. 711 North Road Scottsville, New York 14546
Re: K990606
Trade Name: The Preference ® Standard, CooperClear ™, CV43 ™, Vantage ® and Vantage ® Accents, (tetrafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear (Spherical and Toric, Clear and Handling Tint with In- Monomer-Tinting Process, Cast-molded) Regulatory Class: II Product Code: 86 LPL Dated: February 22, 1999 Received: February 23, 1999
Dear Ms. Tsymbal:
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 .
3
Page 2 - Ms. Bonnie Tsymbal
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 Roerl Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the CooperVision logo. The logo consists of the word "CooperVision" in a stylized font, with the "C" in "Cooper" being a double circle. To the right of the wordmark is a black square containing a white stylized eye shape.
711 North Road Scottsville New York 14546 (716) 385-6810 Fax (716) 889-5688
Indications for Use Statement
K990666 510(k) Number:
Device Name:
Preference® standard Preference Toric™ Cooper Toric™ CooperHTTM CV 43mm Vantage® Vantage® Accents
Indications for Use:
The Preference® standard, CooperHT™, CooperHT™, CV 43™, Vantage® and Vantage® Accents (tetrafilcon A) Hydrophilic Contact Lenses are indicated for daily wear for the correction of visual acuity by not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lenses can be worn by persons who exhibit astigmatism of 2.50 diopters or less that does not interfere with visual acuity.
The PreferenceToric™ and Cooper Toric™ hydrophilic contact lenses are indicated for daily wear use by not-aphakic persons with non-diseased eyes that are myopic or hyperopic, who exhibit astigmatism up to 9.00 diopters and can obtain satisfactory visual acuity, in a spherical range of -20.00 to +12.00.
(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
Eis
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K990606