(48 days)
No
The device description focuses on the physical properties, materials, and dimensions of a contact lens. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are related to material safety and equivalence to predicate devices, not algorithmic performance.
Yes
The device is indicated for "management of conditions such as corneal, iris, or lens abnormalities" and "occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia," which are therapeutic applications.
No
Explanation: The device is a prosthetic contact lens used to enhance or alter eye color, mask abnormalities, correct refractive errors, and for occlusive therapy. Its function is not to diagnose medical conditions.
No
The device description clearly details a physical contact lens made of polymacon, a hydrophilic polymer, with specific dimensions and physical properties. It is a tangible medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Cooper Prosthetic Contact Lens is a physical device that is placed on the surface of the eye. Its intended uses are for:
- Enhancing or altering the apparent color of the eye.
- Ocular masking for conditions like corneal, iris, or lens abnormalities.
- Correcting refractive errors (myopia and hyperopia).
- Occlusive therapy for conditions like diplopia, amblyopia, or extreme photophobia.
- Lack of Specimen Analysis: The device does not involve the collection, preparation, or analysis of any biological specimens from the patient's body. It directly interacts with the eye's surface.
Therefore, the function and intended use of this contact lens clearly fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cooper Prosthetic (polymacon) Soft (hydrophilic) Contact Lens is indicated for daily wear to enhance or alter the apparent color of the eye, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for management of conditions such as corneal, iris, or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia and hyperopia) in aphakic and notaphakic persons that may exhibit astigmatism up to 2.00 diopters that does not interfere with visual acuity or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia.
Product codes
LPL
Device Description
The Cooper Prosthetic Lens (polymacon) Soft (hydrophilic) Contact Lenses are available as spherical lenses. The lens material, polymacon, is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) which is cross linked with ethyleneglycol dimethacrylate. When hydrated, the lens consists of 62.0% HEMA and 38.0% water by weight when immersed in normal saline. The lenses are made by modifying the uncolored polymacon lens by affixing a colored pigment on that portion of the front surface that corresponds to the iris. The colored pigments consist of carbazole violet, chromium oxide green, dihydrodinaphto brown, dihydrodioxo yellow, phthalocyanine green, iron oxide red, iron oxide brown, iron oxide black, phthalocyanine blue, and titanium oxide.
Cooper Prosthetic Lenses are hemispherical shells with the following dimensions:
Diameter: 14.0mm to 15.0mm
Base Curve: 8.0mm to 9.5mm
Center Thickness: 0.05mm to 0.40mm (varies with power)
Lens Powers: -20.00 to +20.00D
The physical/optical properties of the Cooper Prosthetic Lenses are:
Refractive Index: 1.43
Light Transmittance: >90% (open pupil)
Surface Character: Hydrophilic
Water Content: 38%
Oxygen Permeability: 8.0 x 10^-11 (cm^2/sec) (ml O2/ml x mmHg) at 35°C (Fatt 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
eye
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)
Preclinical Information:
The results of toxicology testing, including Ocular Irritation, Cytoxicity and Systemic Toxicity have demonstrated that the subject lens is non-toxic.
An Monomer Extractable Study was conducted to assess the suitability of using an alternative polymacon base lens for Cooper Prosthetic (polymacon) Soft (hydrophilic) Contact Lens. Samples were analyzed to determine the levels of 2-HEMA and EGDMA remaining in the lathe-cut polymacon lens. The test lenses indicated that the levels of residual 2-HEMA and EDGMA found were in compliance with specifications, and equivalent to that seen in the current product.
The physical, optical and chemical properties of the subject lens are equivalent to the predicate device.
Clinical Data:
It was determined that Clinical Studies were not necessary to establish the safety and efficacy of the Cooper Prosthetic (polymacon) Soft (hydrophilic) Contact Lens. This determination was based on the following:
- Cooper Prosthetic (polymacon) Soft (hydrophilic) Contact Lens has demonstrated to be substantially equivalent to the predicate Cooper Prosthetic (polymacon) Soft (hydrophilic) Contact Lens (K984259) and (K010126).
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
K04-2435
Goper Vision &
OCT 2 6 2004
Premarket Notification
Cooper Prosthetic Polymacon
510(k) Summary
1. SUBMITTER:
Submitted on Behalf of:
- Company Name: 트
- Address: 트
- 트 Phone:
- Fax:
2. CONTACT PERSON:
- Company Name: 트
- Address: K
- 트 Phone:
- 트 Fax:
3. DATE SUMMARY PREPARED:
4. DEVICE IDENTIFICATION:
- 프 Trade Name:
CooperVision Manufacturing, Ltd. Unit 2, South Point Hamble SO3 4RF Southampton UK 011 44 2380 605200 011 44 2380 605299
Bonnie Tsymbal
CooperVision, Inc. 711 North Road Scottsville, NY 14546 (585) 264-3210 (585) 889-5688
September 7th, 2004
Cooper Prosthetic (polymacon) Soft (hydrophilic) Contact Lens
- I Common Name:
- 트 Classification
- Device Classification: 다
Hydrophilic Soft Contact Lens Lenses, Soft Contact, Daily Wear 86LPL Class II (21 CFR 886.5925)
5. DEVICE DESCRIPTION:
The Cooper Prosthetic Lens (polymacon) Soft (hydrophilic) Contact Lenses are available as spherical lenses. The lens material, polymacon, is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) which is cross linked with ethyleneglycol dimethacrylate. When hydrated, the lens consists of 62.0% HEMA and 38.0% water by weight when immersed in normal saline. The lenses are made by modifying the uncolored polymacon lens by affixing a colored pigment on that portion of the front surface that corresponds to the iris. The colored pigments consist of carbazole violet, chromium oxide green, dihydrodinaphto brown, dihydrodioxo yellow, phthalocyanine green, iron oxide red, iron oxide brown, iron oxide black, phthalocyanine blue, and titanium oxide.
1
GoperVision D
Premarket Notification
Leo Colors Methafilcon A
Cooper Prosthetic Lenses are hemispherical shells with the following dimensions:
| Diameter: | 14.0mm to 15.0mm |
|---|---|
| Base Curve: | 8.0mm to 9.5mm |
| Center Thickness: | 0.05mm to 0.40mm (varies with power) |
| Lens Powers: | -20.00 to +20.00D |
The physical/optical properties of the Cooper Prosthetic Lenses are:
| Refractive Index: | 1.43 |
|---|---|
| Light Transmittance: | >90% (open pupil) |
| Surface Character: | Hydrophilic |
| Water Content: | 38% |
| Oxygen Permeability: | 8.0 x 10-11 (cm2/sec) (ml O2/ml x mmHg) at 35°C |
| (Fatt method for determination of oxygen permeability) |
6. INTENDED USE:
The Cooper Prosthetic (polymacon) Soft (hydrophilic) Contact Lens is indicated for daily wear to enhance or alter the apparent color of the eye, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for management of conditions such as corneal, iris, or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia and hyperopia) in aphakic and notaphakic persons that may exhibit astigmatism up to 2.00 diopters that does not interfere with visual acuity or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia.
2
7. SUBSTANTIAL EQUIVALENCE:
| Characteristic | Cooper Prosthetic
UK Lathed Base
(New Device) | Cooper Prosthetic
UK Molded Base
K984259 | Cooper Prosthetic
Gelflex Lathed Base
K010126 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Polymacon | Polymacon | Polymacon |
| Material
Classification | Hydrophilic Lens
Group 1 | Hydrophilic Lens
Group 1 | Hydrophilic Lens
Group 1 |
| Indications for Use | Daily Wear
To enhance or alter the
apparent color of the
eye, including ocular
masking, either in
sighted or non-sighted
eyes that require a
prosthetic contact lens
for management of
conditions such as
corneal, iris, or lens
abnormalities. The lens
may also be prescribed
for the correction of
refractive ametropia | Daily Wear
To enhance or alter the
apparent color of the
eye, including ocular
masking, either in
sighted or non-sighted
eyes that require a
prosthetic contact lens
for management of
conditions such as
corneal, iris, or lens
abnormalities. The lens
may also be prescribed
for the correction of
refractive ametropia | Daily Wear
To enhance or alter the
apparent color of the
eye, including ocular
masking, either in
sighted or non-sighted
eyes that require a
prosthetic contact lens
for management of
conditions such as
corneal, iris, or lens
abnormalities. The lens
may also be prescribed
for the correction of
refractive ametropia |
| Water Content | 38% | 38% | 38.6% |
| Light Transmittance | >97% | >97% | >95% |
| Dk (35° C) | 8.0 x 10-11 | 8.0 x 10-11 | 8.0 x 10-11 |
| Refractive Index | 1.43 | 1.43 | 1.43 |
| Powers | -20.00 to +20.00 D | -20.00 to +20.00 D | -20.00 to +20.00 D |
| Colorants | carbazole violet,
chromium oxide
green,
dihydrodinaphto
brown, dihydrodioxo
yellow,
phthalocyanine green,
iron oxide red, iron
oxide brown, iron
oxide black,
phthalocyanine blue,
and titanium oxide | carbazole violet,
chromium oxide
green,
dihydrodinaphto
brown, dihydrodioxo
yellow,
phthalocyanine green,
iron oxide red, iron
oxide brown, iron
oxide black,
phthalocyanine blue,
and titanium oxide | carbazole violet,
chromium oxide
green,
dihydrodinaphto
brown, dihydrodioxo
yellow.
phthalocyanine green,
iron oxide red, iron
oxide brown, iron
oxide black,
phthalocyanine blue,
and titanium oxide |
| Tint Process | Pad Printing
Post Lens Forming | Pad Printing
Post Lens Forming | Pad Printing
Post Lens Forming |
| Manufacturing
Method | Lathe Cut | Cast Molded | Lathe Cut |
3
PRECLINICAL INFORMATION: 8.
The results of toxicology testing, including Ocular Irritation, Cytoxicity and Systemic Toxicity have demonstrated that the subject lens is non-toxic.
An Monomer Extractable Study was conducted to assess the suitability of using an alternative polymacon base lens for Cooper Prosthetic (polymacon) Soft (hydrophilic) Contact Lens. Samples were analyzed to determine the levels of 2-HEMA and EGDMA remaining in the lathe-cut polymacon lens. The test lenses indicated that the levels of residual 2-HEMA and EDGMA found were in compliance with specifications, and equivalent to that seen in the current product..
The physical, optical and chemical properties of the subject lens are equivalent to the predicate device.
9. CLINICAL DATA:
It was determined that Clinical Studies were not necessary to establish the safety and efficacy of the Cooper Prosthetic (polymacon) Soft (hydrophilic) Contact Lens. This determination was based on the following:
- Cooper Prosthetic (polymacon) Soft (hydrophilic) Contact Lens has . demonstrated to be substantially equivalent to the predicate Cooper Prosthetic (polymacon) Soft (hydrophilic) Contact Lens (K984259) and (K010126).
10. CONCLUSION:
The information provided in this 510(k) establishes that the Cooper Prosthetic (polymacon) Soft (hydrophilic) Contact Lens is equivalent in optical, chemical and physical properties of the predicate device and does not raise any questions of safety and effectiveness. Therefore, the device is substantially equivalent to the predicate device.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design featuring three abstract human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 6 2004
CooperVision, Inc. c/o Ms. Bonnie Tsymbal 711 North Road Scottsville, NY 14546
Re: K042435
K042435
Trade/Device Name: Cooper® Prosthetic (polymacon) Soft (hydrophilic) Contact Lens
Trade/Device Name: Cooper® Prosthetic (polymacon) Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Hydrophilic Soft Contact Lens Regulatory Class: Class II Product Code: LPL Dated: September 7, 2004 Received: September 8, 2004
Dear Ms. Tsymbal:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) prematic is substantially equivalent (for the indications for referenced above and nave determined the devices marketed in interstate comments, or to devices that use stated in the encrosure) to iceally many in the Medical Device Amendments, or to devices that prior to May 28, 1976, the enactions with the provisions of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of PMA). You may have been reclassified in accordance with the provice approval application (PMA). You may, Act (Act) that do not require approval of a premail.compossions of the Act. The general therefore, market the device, subject to morements for annual registration, listing of devices, good
controls provisions of the Act include requirements for annual register o controls provisions or the Net morade requirement.
manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Comtrols) or class III (PMA), it If your device is classified (see above) mo Existing major regulations affecting your device can be may be subject to such additions. Title 21, Parts 800 to 898. In addition, FDA may publish found in the Code of Peacharts concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 's Issualice of a succession with other requirements of the Act of that FDA has made a determination that your are how rought institutions of the must comply with any rederal statutes and regulations administ it of of of registration and listing of as as as fasth in the all the Act s requirements, meriding, but not miniture to requirements as set forth in the 807); labelling (21 CFR Part 820); and if applicable, the electronic product
quality systems (QS) regulation (21 CFR Part 820); and if applicable (2001) 1958 quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
This letter will allow you to begin marketing your device as described in your Section 510(k) I his icity will anow you to organization of substantial equivalence of your device to a legally premaired 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 If you desire specific arrant an (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 other general miormation 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. halpi 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
Enclosure
6
Image /page/6/Picture/0 description: The image shows the word "CooperVision" in a stylized font. The word is written in black ink on a white background. To the right of the word is a black square with a white circle inside.
Regulatory Affairs 711 North Road Scottsville, NY 14546 (585) 385-6810 Fax: (585) 889-5688
Indication for Use Statement
510(k) Number:
Cooper® Prosthetic (polymacon) Soft (hydrophilic) Contact Lenses Device Name:
Indication for Use:
The Cooper® Prosthetic (polymacon) Soft (hydrophilic) Contact Lens is indicated for The Cooper(8) Prosuleuc (polymacon) Soft (nyarophilo) Son, including ocular masking,
daily wear to enhance or alter the apparent color of the eye, including for dally wear to ennance of alter the upparent color a prosthetic contact lens for either in signted or norraigned eyes that I citis, or lens abormalities. The lens may also
management of conditions such as corneal, iris, or lens and byporopia) in management of conditions such as corneal) inspective ametropia (myopia and hyperopia) in be prescribed for the correction of refree whiles stigmatism up to 2.00 diopters that
aphakic and not-aphakic persons that may exhibit as such as aphakic and not-aphakic persons that may oxhibit assigning and therapy for conditions such as diplopia, amblyopia or extreme photophobia.
X Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter (Per 21 CFR 801 Subpart C)
PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
$\mathit{m} \mathcal{L} \mathcal{Q}$
510(k) Number.