(53 days)
No
The description focuses on the physical properties and materials of a contact lens, with no mention of AI or ML technology.
No
The device is indicated for vision correction and improved comfort related to dryness, not for treating a disease or condition.
No
This device is a contact lens designed for vision correction, not for diagnosing medical conditions.
No
The device description clearly describes a physical contact lens made of specific materials and with defined physical dimensions and properties. There is no mention of software as the primary component or function of the device.
Based on the provided information, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Proclear Compatibles Multifocal contact lens is a medical device intended for correcting vision by being placed directly on the eye. It does not analyze biological samples to provide diagnostic information.
- Intended Use: The intended use clearly states the correction of refractive errors and presbyopia, and potentially improving comfort related to dryness. These are therapeutic and comfort-related functions, not diagnostic ones.
Therefore, this device falls under the category of a medical device, specifically a contact lens, and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Proclear Compatibles Multifocal (omafilcon A) Soft Hydrophilic Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in aphakic and/or not aphakic persons with non-diseased eyes. The lens may be worn by persons who have astigmatism of 2.00D or less that does not interfere with visual acuity.
These lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).
Daily wear replacement schedules may vary from patient to patient and should be decided by eyecare practitioners in consultation with their patients. The lenses are to be cleaned, rinsed and disinfected each time they are removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system.
Product codes
LPL
Device Description
The Proclear Compatibles Multifocal (omafilcon A soft (hydrophilic) contact lens is available as hemispherical flexible shell which covers the cornea and may cover a part of the adjacent sciera. Lens material, omafilcon A is a random copolymer of hydroxyethylmethacrylate and 2-methacryloyloxyethyl phosphorycholine crosslinked with ethylene glycol dimethacrylate. The lenses are tinted from edge to edge for visibility purposes with the color additive, Reactive Blue No. 4.
Proclear Compatibles Multifocal contact lens is hemispherical shell of the following dimensions:
- Diameter: 14.2mm to 15.0mm
- Base curve: 8.0mm to 9.5mm
- Center Thickness: 0.15mm to 0.96mm varies with power
- Powers: -20.00 to +20.00 D
- Add powers: +0.50 to +4.00 D
The physical properties of the lens are:
- Refractive Index: 1.38
- Light Transmittance 62%
- Surface Character: Hydrophilic
- Water Content: 62%
- Oxygen Permeability: 27 x 10-11 (cm2/sec){ml O2/ml x mmHq) at 35° C (modified ISO method for determination of oxygen permeability)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cornea and may cover a part of the adjacent sciera.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
eyecare practitioners
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Premarket Notification Prodear Compatibles Multifocal - Omafficon A 510(k) Summar
NOV - 7 2003
K0328'73
510(k) Summary; Addresses requirements by the Safe Medical Devices Act of 1990 to summarize the safety and effectiveness information upon which the substantial equivalence for alternate lens design configuration determination is based.
1. Submitter Information
CooperVision, Inc. 1215 Boissevain Ave Norfolk VA 23507
Contact person: Lisa Hahn Director of Quality and Regulatory Affairs Phone: (757) 664-2421 Fax:
2. Identification of Device
Classification name: Daily Wear Soft Hydrophilic Contact Lenses
Proprietary name: Proclear Compatibles Multifocal (omafilcon A) Soft (Hydrophilic) Contact Lenses
Device classification: Class II (21 CFR 886.5925)
3. Predicate Devices
Proclear Compatibles (omafilcon A) Premarket Notification # K970095 Frequency 55 Multifocal (methafilcon A) Premarket Notification # K002625
4. Indications for Use
Proclear Compatibles Multifocal (omafilcon A) Soft Hydrophilic Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in aphakic and/or not aphakic persons with non-diseased eyes. The lens may be worn by persons who have astigmatism of 2.00D or less that does not interfere with visual acuity.
These lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).
1
Daily wear replacement schedules may vary from patient to patient and should be decided by eyecare practitioners in consultation with their patients. The lenses are to be cleaned, rinsed and disinfected each time they are removed from the patient's eye and discarded after the recommended wearing period prescribed by the eve care practitioner. The lens may be disinfected using a chemical disinfection system.
5. Device Description
The Proclear Compatibles Multifocal (omafilcon A soft (hydrophilic) contact lens is available as hemispherical flexible shell which covers the cornea and may cover a part of the adjacent sciera. Lens material, omafilcon A is a random copolymer of hydroxyethylmethacrylate and 2-methacryloyloxyethyl phosphorycholine crosslinked with ethylene glycol dimethacrylate. The lenses are tinted from edge to edge for visibility purposes with the color additive, Reactive Blue No. 4.
Proclear Compatibles Multifocal contact lens is hemispherical shell of the following dimensions:
| • Diameter: | 14.2mm to 15.0mm |
|---|---|
| • Base curve: | 8.0mm to 9.5mm |
| • Center Thickness: | 0.15mm to 0.96mm |
| varies with power | |
| • Powers: | -20.00 to +20.00 D |
| • Add powers: | +0.50 to +4.00 D |
1.38
62%
ਰੇਟੋਅ
the power of
The physical properties of the lens are:
- . Refractive Index:
- Light Transmittance .
- Surface Character: Hydrophilic . ・
- Water Content ●
- Oxygen Permeability .
27 x 10-11 (cm2/sec){ml O2/ml x mmHq) at 35° C (modified ISO method for determination of oxygen permeability)
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol of three human profiles merging into a single form, resembling a bird in flight. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 7 2003
CooperVision, Inc. c/o Lisa Hahn Director of Quality and Regulatory Affairs 1215 Boissevain Ave. Norfolk, VA 23507
Re: K032873
Trade/Device Name: Proclear Compatibles Multifocal (omafilcon A) Soft Contact Lenses For Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Daily wear soft (hydrophilic) contact lenses Regulatory Class: Class II Product Code: LPL Dated: September 12, 2003 Received: September 15, 2003
Dear Ms. Hahn:
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. Iisting 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.
3
Page 2 - Lisa Hahn
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FI)A 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,
A Károlyi Kórház
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
4
510(k) Number: K032873
Proclear Compatibles Multifocal Device name:
Indications for use:
Proclear Compatibles Multifocal (omafilcon A) Soft Hydrophilic Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, and astigmatism) and orestivonia in aphakic and/or not aphakic persons with non-diseased eyes. The lens may be worn by persons who have astigmatism of 2.00D or less that does not interfere with visual acuity.
These lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).
Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients. The lenses are to be cleaned, rinsed and disinfected each time they are removed from the patient's eye and discarded after the recommended wearing period prescribed by the sye care practitioner. The lens may be disinfected using a chemical disinfection system.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANTOHER PAGE IF NEEDED
Concurrence of CDRH, office of Device Evaluation (ODE)
J. Savola
(Division Sign-Off) Division of Ophthalmic Ear. Nose and Throat Devises
510(k) Number K032873
Prescription Use
(per 21 CFR 801.109)
OR
Over-The Counter