(230 days)
Not Found
No
The document describes contact lenses and their physical properties and intended uses. There is no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
The device is indicated for correcting visual acuity, which is a therapeutic function, and also for providing improved comfort for contact lens wearers experiencing mild discomfort or symptoms related to dryness due to Evaporative Tear Deficiency or Aqueous Tear Deficiency, which are therapeutic claims.
No
The device is a contact lens used for vision correction (therapeutic), not for detecting or diagnosing medical conditions. The "Intended Use / Indications for Use" section clearly states its purpose is for "correction of visual acuity."
No
The device description clearly states the device is a "hemispherical shell" composed of a polymer, which is a physical object (contact lens), not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the correction of visual acuity in individuals with various refractive errors (myopia, hyperopia, astigmatism, presbyopia). This is a direct therapeutic or corrective function, not a diagnostic one.
- Device Description: The device is a contact lens, a physical object designed to alter the way light enters the eye to improve vision. It does not perform any tests on biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of Diagnostic Function: The text describes the lens's physical properties and how it corrects vision. There is no mention of it being used to detect, measure, or analyze any substance or characteristic in vitro for diagnostic purposes.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This contact lens does not fit that description.
N/A
Intended Use / Indications for Use
Proclear Multifocal Toric (omaficon B) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic which, possess astigmatism to -5.75 diopters or less, and are presbyopic.
Proclear Multifocal XR (omafilcon B) Soft (Hydrophilic) Contact Lenses are indicated for . daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic and are presbyopic. The lenses may be worn by persons who exhibit astigmatism of 0.75 diopters or less that does not interfere with visual acuity.
Proclear Toric XR (omafilcon B) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with nondiseased eyes that are myopic or hyperopic which possess astigmatism corrections to -5.75 diopters.
Proclear Sphere and Asphere: (omafilcon B) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in non-aphakic persons with non- diseased eyes that are myopic or hyperopic and exhibit astigmatism of 2.00D or less that does not interfere with visual acuity.
Proclear. Toric: (omafilcon B) Soft (hydrophilic) Contact Lenses are indicated for daily wear for-the-correction-of-visual-acuity-in-non-aphakic-persons-with-non-diseased-eves-thatare myopic or hyperopic .- The lens may be worn by persons who - have astigmatism of 5.00D or less.
Proclear Multifocal: (omafilcon B) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in non-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.
Proclear (omafilcon B) Soft (hydrophilic) Contact 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 eye care practitioners in consultation with their patients.
Product codes (comma separated list FDA assigned to the subject device)
LPL, MVN
Device Description
The Proclear lens is composed of polymer of 2-hydroxy-ethylmethacrylate and 2-metacryloloyoxyethyl phosphorylcholine cross linked with ethylene glycol dimethacrylate. The lenses are tinted blue from edge to edge for visibility purposes. The Proclear (omafilcon B) Soft (hydrophilic) contact lenses are a hemispherical shell. The design and toxicological properties of the devices with the modified formula to increase the water content to 62% are unchanged from predicate 510ks.
Proclear Toric and Proclear Toric XR (omafilcon B) Soft (Hydrophilic) Contact Lenses are back surface toric.
Proclear Multifocal and Proclear Multifocal XR (omafilcon B) Soft(Hydrophilic) Contact Lenses are available as a multifocal lens with an aspherical front surface and spherical back surface for the correction of visual acuity in presbyopic persons who are myopic or hyperopic. The multifocal lens has two multifocal zones, as well as the edge shape being optimized to provide comfort without sacrificing tensile strength.
Proclear Multifocal Toric (omafilcon B) Soft (Hydrophilic) Contact Lens front surface is aspherical, with the anterior surface having a toric generated surface for the purpose of correcting vision in an eye that is astigmatic.
Proclear Sphere and Asphere: (omofilcon B) Soft (hydrophilic) Contact Lenses. The sphere lenses have spherical optical zone and asphere lens have an aspherical optical zone. This aspheric optical zone design (front surface) controls and limits the amount of longitudinal spherical aberration generated by the lens across the power range.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
eye care 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)
Physicochemical Studies: Results of physical, optical and chemical properties were performed and indicate no significant change to the physicochemical properties of the lenses. Tested Characteristics included Total Extractables, Water Content, Dk, Light Transmission, Refractive Index tested per ISO 18369-4:2006 Ophthalmic Optics – Contact Lenses – Part 4: Physicochemical Properties of Contact Lens Materials: Section 4.2. Results: Pass.
Biocompatibility: Cytotoxicity, Ocular Irritation, and Systemic Toxicity studies were performed in support of this modification. The results indicate there are no toxicity issues with the modified lens.
Clinical Studies: No clinical studies were conducted.
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.
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
510k Summary of Safety and Effectiveness - K123202
May 1, 2013
Applicant:
Applicant Contact:
CooperVision, Inc. 6150 Stoneridge Mall Road, Suite 370 Pleasanton, CA 94588 USA
Karin Gastineau Director, Global Regulatory Affairs 925-621-3732 (phone) 925-621-2488 (fax) Email: kgastineau@coopervision.com
Date Summary Prepared:
Device Trade Names:
Common/Usual Name:
Classification Name:
Predicate Devices:
Proclear Toric XR Proclear Multifocal XR Proclear Multifocal Toric Proclear Sphere and Asphere Proclear Toric Proclear Multifocal
omafilcon B Soft (Hydrophilic) Contact Lens
Daily Wear Soft (Hydrophilic) Contact Lens
Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal Toric, Proclear Sphere and Asphere, Proclear Toric, Proclear Multifocal (K110099, K112302)
Device Description:
The Proclear lens is composed of polymer of 2-hydroxy-ethylmethacrylate and 2-metacryloloyoxyethyl phosphorylcholine cross linked with ethylene glycol dimethacrylate. The lenses are tinted blue from edge to edge for visibility purposes. The Proclear (omafilcon B) Soft (hydrophilic) contact lenses are a hemispherical shell. The design and toxicological properties of the devices with the modified formula to increase the water content to 62% are unchanged from predicate 510ks.
Proclear Toric and Proclear Toric XR (omafilcon B) Soft (Hydrophilic) Contact Lenses are back surface toric.
Proclear Multifocal and Proclear Multifocal XR (omafilcon B) Soft(Hydrophilic) Contact Lenses are available as a multifocal lens with an aspherical front surface and spherical back surface for the correction of visual acuity in presbyopic persons who are myopic or hyperopic. The
MAY 3 0 2013
1
multifocal lens has two multifocal zones, as well as the edge shape being optimized to provide comfort without sacrificing tensile strength.
Proclear Multifocal Toric (omafilcon B) Soft (Hydrophilic) Contact Lens front surface is aspherical, with the anterior surface having a toric generated surface for the purpose of correcting vision in an eye that is astigmatic.
Proclear Sphere and Asphere: (omofilcon B) Soft (hydrophilic) Contact Lenses. The sphere lenses have spherical optical zone and asphere lens have an aspherical optical zone. This aspheric optical zone design (front surface) controls and limits the amount of longitudinal spherical aberration generated by the lens across the power range.
Indications for Use
Proclear Multifocal Toric (omafilcon B) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic which, possess astigmatism to -5.75 diopters or less, and are presbyopic.
Proclear Multifocal XR (omafilcon B) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic and are presbyopic. The lenses may be worn by persons who exhibit astigmatism of 0.75 diopters or less that does not interfere with visual acuity.
Proclear Toric XR (omgfilcon B) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic which possess astigmatism corrections to -5.75 diopters.
Proclear Sphere and Asphere: (omafilcon B) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in non-aphakic persons with nondiseased eyes that are myopic or hyperopic and exhibit astigmatism of 2.00D or less that does not interfere with visual acuity.
Proclear Toric: (omofilcon B) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in non-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who have astigmatism of 5.00D or less.
Proclear Multifocal: (omafilcon B) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, and astigmatism) and presbyopia in non-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.
2
Proclear (omafilcon B) Soft (hydrophilic) Contact 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 eye care practitioners in consultation with their patients.
FREQUENT PLANNED REPLACEMENT WEAR
When prescribed for frequent planned replacement wear the lenses are to be cleaned, rinsed and disinfected each time they are removed from the patients' eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lenses may be disinfected using a chemical disinfection system.
DISPOSABLE WEAR
When prescribed for Daily Disposable Wear the lens is to be discarded after each removal.
Physicochemical Studies
Results of physical, optical and chemical properties were performed and indicate no significant change to the physicochemical properties of the lenses.
| Tested Characteristics | Results |
|---|---|
| Total Extractables, Water Content, Dk, Light | |
| Transmission, Refractive Index tested per ISO 18369- | |
| 4:2006 Ophthalmic Optics – Contact Lenses – Part 4: | |
| Physicochemical Properties of Contact Lens | |
| Materials: Section 4.2 | Pass |
Biocompatibility
Cytotoxicity, Ocular Irritation, and Systemic Toxicity studies were performed in support of this modification. The results indicate there are no toxicity issues with the modified lens.
Clinical Studies
No clinical studies were conducted.
Conclusion Drawn from Studies
Validity of Scientific Data
All biocompatibility studies were conducted by contract laboratories under Good Manufacturing Practice regulations. Physiochemical studies were conducted by CooperVision following scientific protocols.
3
Substantial Equivalence
Information presented in this Premarket Notification establishes that the CooperVision Proclear daily wear contact lenses are substantially equivalent to the predicate devices.
| Substantial Equivalence Comparison | ||
|---|---|---|
| Characteristic | Subject Devices | |
| (38% omafilcon B, 62% water) | Predicate Devices | |
| (41% omafilcon A, 59% water) | ||
| Product Names | Proclear Toric | |
| Proclear Toric XR | ||
| Proclear Multifocal | ||
| Proclear Multifocal XR | ||
| Proclear Multifocal Toric | ||
| Proclear Sphere | ||
| Proclear Asphere | Proclear Toric | |
| Proclear Toric XR | ||
| Proclear Multifocal | ||
| Proclear Multifocal XR | ||
| Proclear Multifocal Toric | ||
| Proclear Sphere | ||
| Proclear Asphere | ||
| Indications for Use | Same | Same |
| Material USAN Name | omafilcon B | omafilcon A |
| FDA Category (Group) | Non-lonic | |
| High Water | Non-lonic | |
| High Water | ||
| Manufacturing Method | Finished Inside | |
| Polymerization System | Finished Inside | |
| Polymerization System | ||
| Curing | Thermal Cure | Thermal Cure |
| Sterilization | Moist Heat (steam) | Moist Heat (steam) |
| Packaging | Blister Pack | Blister Pack |
| Package Saline Buffers and | ||
| Surfactant | Phosphate buffers | |
| PEG200 and Tween 80 | Phosphate buffers | |
| PEG200 and Tween 80 | ||
| Refractive Index | $1.390 \pm 0.005$ | $1.395 \pm 0.005$ |
| Oxygen Permeability x 10-11 | 27.00 ± 20% | 21.05 ± 20% |
| Light Transmission | >90% | >90% |
| Base Curve | 8.0 to .9.3 mm | 8.0 to 9.3 mm |
| Diameter | 13.6 to 15.2 mm | 13.6 to 15.2 mm |
| Power | -20.00 to +20.00 | -20.00 to +20.00 |
| Water Content | 62% ± 2% | 59% ± 2% |
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
May 30, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Karin Gastineau Director. Global Regulatory Affairs CooperVision, Inc. 6150 Stoneridge Mall Road Pleasanton, CA 94588
Re: K123202
Trade/Device Name: Proclear (omafilcon B) Soft (Hydrophilic) Contact Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL, MVN Dated: April 30, 2013 Received: May 2, 2013
Dear Ms. Gastineau:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
5
Page 2 - Ms. Karin Gastineau
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Y. Alexander -S
for Malvina B. Eydelman, M.D.
-Director-Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
510(k) Number (if known): K123202
Device Name: Proclear (omafilcon B) Soft (Hydrophilic) Contact Lens
Indications for Use:
.
Proclear Multifocal Toric (omaficon B) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic which, possess astigmatism to -5.75 diopters or less, and are presbyopic.
Proclear Multifocal XR (omafilcon B) Soft (Hydrophilic) Contact Lenses are indicated for . daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic and are presbyopic. The lenses may be worn by persons who exhibit astigmatism of 0.75 diopters or less that does not interfere with visual acuity.
Proclear Toric XR (omafilcon B) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with nondiseased eyes that are myopic or hyperopic which possess astigmatism corrections to -5.75 diopters.
Proclear Sphere and Asphere: (omafilcon B) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in non-aphakic persons with non- diseased eyes that are myopic or hyperopic and exhibit astigmatism of 2.00D or less that does not interfere with visual acuity.
Proclear. Toric: (omafilcon B) Soft (hydrophilic) Contact Lenses are indicated for daily wear for-the-correction-of-visual-acuity-in-non-aphakic-persons-with-non-diseased-eves-thatare myopic or hyperopic .- The lens may be worn by persons who - have astigmatism of 5.00D or less.
Proclear Multifocal: (omafilcon B) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in non-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.
Proclear (omafilcon B) Soft (hydrophilic) Contact 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 eye care practitioners in consultation with their patients.
Page 1 of 2
7
FREQUENT PLANNED REPLACEMENT WEAR
When prescribed for frequent planned replacement wear the lenses are to be cleaned, rinsed and disinfected each time they are removed from the patients' eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lenses may be disinfected using a chemical disinfection system.
DISPOSABLE WEAR
When prescribed for Daily Disposable Wear the lens is to be discarded after each removal.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE - ON - ANOTHER PAGE - OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/7/Picture/9 description: The image shows the text "Marc-Robboy" at the top. Below that, the date and time "2013:05:20 10:52:21" is displayed. The text "-04'00'" is at the bottom left.
(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices 510(k) Number K123202