(53 days)
K992950, P820051
Not Found
No
The 510(k) summary describes a physical contact lens with specific material properties and design options. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The device description focuses on the physical characteristics and manufacturing process.
Yes
The device is indicated for "occlusive therapy conditions such as diplopia, amblyopia or extreme photophobia," which are therapeutic applications.
No
The provided text describes the Ocu-Flex-53 Custom Prosthetic Soft Contact Lenses as a device for cosmetic management of eye conditions, correction of refractive ametropia, and occlusive therapy. It does not mention any diagnostic capabilities.
No
The device description clearly describes a physical contact lens made of a specific material (ocufilcon B) with incorporated pigments. It is a tangible, physical medical device, not software.
No, 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Ocu-Flex-53 Custom Prosthetic Soft Contact Lens is a medical device that is placed on the eye. Its primary functions are:
- Cosmetic: Enhancing or altering eye color, masking disfigurements.
- Vision Correction: Correcting refractive errors (myopia, hyperopia, astigmatism).
- Therapeutic: Occlusive therapy for conditions like diplopia or amblyopia.
- No Sample Analysis: The device does not analyze any biological samples from the patient to provide diagnostic information.
Therefore, based on its intended use and function, the Ocu-Flex-53 Custom Prosthetic Soft Contact Lens is a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Ocu-Flex-53 Custom Prosthetic (ocufilcon B) Soft Contact Lenses are indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for cosmetic management of conditions such as corneal, iris or lens abnormalities; or for persons wishing to change the appearance of their eyes without eye abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia or astigmatism) in aphakic or not-aphakic persons or for occlusive therapy conditions such as diplopia, amblyopia or extreme photophobia.
The lens may be disinfected using a chemical (not heat) disinfection system only.
Product codes (comma separated list FDA assigned to the subject device)
LPL
Device Description
The dimensions of the Ocu-Flex-53 Custom Prosthetic (ocufilcon B) Soft Contact Lens are the same as approved in PMA #P820051.
The physical properties of the lens are:
Refractive Index: 1.41
Light Transmission: varies depending on prosthetic design
Specific Gravity: 1.18
Water Content: 53%
Color Pigment Name: Titanium dioxide
Oxygen Permeability: 18.1 x 10^-11 @ 35°C (Revised Fatt Method)
The lens material (ocufilcon B) is a hydrophilic copolymer of 2-hydroxyethyl methacrylate, methacrylic acid and cross-linked with ethylene glycol dimethacrylate, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The Ocu-Flex-53 Custom Prosthetic (ocufilcon B) Soft (hydrophilic) Contact Lens is a partially or totally white opaque lens that can be painted or printed with an iris or other pattern to mask a disfiguring or unsightly eye condition. The lens may be totally opaque for a non-sighted eye or clear in the center for a sighted eye.
The approved pigment, titanium dioxide, is incorporated into the monomer during polymerization with the help of a coupling agent. The titanium dioxide is evenly distributed throughout the lens and cannot be extracted.
The Ocu-Flex-53 Custom Prosthetic (ocufilcon B) Soft (hydrophilic) Contact Lens is available to the practitioner in the following opaque patterns:
- Clear Lens with Opaque Pupil: pupil sizes available in 2.0mm to i -17.5mm.
- . . Solid Opaque Lens: a solid opaque (white lens). Available to full lens diameter.
- Solid Opaque with Clear Pupil: opaque diameter range 2.0mm to full lens diameter. Clear pupil diameter range 2.0mm to 8.0mm
- Solid Annular Opaque with Clear Pupil & Clear Edge: clear pupil sizes r available in 2.0mm to 8.0mm. Annular opacity available to 15.5mm
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
practitioner
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): 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.
K992950, P820051
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.
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APR 2 6 2002
Image /page/0/Picture/2 description: The image shows the logo for Ocu-Ease Optical Products, Inc. The logo features a stylized "OE" in a bold, sans-serif font. The words "Ocu-Ease" are written above "Optical Products, Inc.", with a line separating the two phrases. The text is in a simple, clean font.
629 Tennent Avenue Pinole, California 94564 Telephone: 510-724-0384 (NAT'L) 800-521-8984 Facsimile: 800-OCU-EASE · e-mail: custom@ocuease.com visit us on the web: www.ocuease.com
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted This cummary of STS (1) equirements of SMDA 1990 and 21 CFR 807.92.
Assigned 510(k) Number:
K020690
Applicant Information:
Date Prepared:
Name: Address: April 16, 2002
Ocu-Ease Optical Products, Inc. 629 Tennent Avenue Pinole, CA. 94564
Contact Person:
Charles R. Vermette, President
Phone: (510)724-0384 Fax: (510)724-4842
Phone/Fax Number:
Device Information:
Device Classification:
Classification Number:
Classification Name:
Device Trade Name:
Class II
LPL
Lenses, Soft Contact, Daily Wear
Ocu-Flex-53 Custom Prosthetic (ocufilcon B) Soft Contact Lens
1
Equivalent Devices:
The Ocu-Flex-53 Custom Prosthetic (ocufilcon B) Soft Contact Lens is substantially equivalent to the predicate devices identified below in terms of intended use and design.
Predicate Device: (substantially equivalent to indication use)
- Custom Prosthetic Soft Lens (hefilcon A) 1. Manufactured by Prosthetic Soft Lens Corp. Englewood, CO. 510(k) #K992950
- Ocu-Flex-53 (ocufilcon B) Soft Contact Lens 2. Ocu-Ease Optical Prod. Pinole, CA. PMA#P820051
Device Description:
The dimensions of the Ocu-Flex-53 Custom Prosthetic (ocufilcon B) Soft Contact Lens are the same as approved in PMA #P820051.
The physical properties of the lens are:
| Refractive Index | 1.41 |
|---|---|
| Light Transmission | varies depending on prosthetic design |
| Specific Gravity | 1.18 |
| Water Content | 53% |
| Color Pigment Name | Titanium dioxide |
| Oxygen Permeability | $18.1 \times 10^{-11}$ @ 35°C (Revised Fatt Method) |
The lens material (ocufilcon B) is a hydrophilic copolymer of 2-hydroxyethyl methacrylate, methacrylic acid and cross-linked with ethylene glycol dimethacrylate, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The Ocu-Flex-53 Custom Prosthetic (ocufilcon B) Soft (hydrophilic) Contact Lens is a partially or totally white opaque lens that can be painted or printed with an iris or other pattern to mask a disfiguring or unsightly eye condition. The lens may be totally opaque for a non-sighted eye or clear in the center for a sighted eye.
2
The approved pigment, titanium dioxide, is incorporated into the monomer during polymerization with the help of a coupling agent. The titanium dioxide is evenly distributed throughout the lens and cannot be extracted.
The Ocu-Flex-53 Custom Prosthetic (ocufilcon B) Soft (hydrophilic) Contact Lens is available to the practitioner in the following opaque patterns:
- Clear Lens with Opaque Pupil: pupil sizes available in 2.0mm to i -17.5mm.
- . . Solid Opaque Lens: a solid opaque (white lens). Available to full lens diameter.
- Solid Opaque with Clear Pupil: opaque diameter range 2.0mm to full lens diameter. Clear pupil diameter range 2.0mm to 8.0mm
- Solid Annular Opaque with Clear Pupil & Clear Edge: clear pupil sizes r available in 2.0mm to 8.0mm. Annular opacity available to 15.5mm
Statement of Intended Use:
The Ocu-Flex-53 Custom Prosthetic (ocufilcon B) Soft Contact Lenses are indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for cosmetic management of conditions such as corneal, iris or lens abnormalities; or for persons wishing to change the appearance of their eyes without eve abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia or astigmatism) in aphakic or notaphakic persons or for occlusive therapy conditions such as diplopia, amblyopia or extreme photophobia.
The lens may be disinfected using a chemical (not heat) disinfection system only.
Substantial Equivalence:
The device will be manufactured according to specified process controls and a quality assurance program. The device will undergo manufacturing, packaging and sterilization procedures similar to devices currently marketed and distributed by Ocu-Ease Optical Products, Inc. The established safety profile (preclinical toxicology and manufacturing/chemistry data) of the device is equivalent to the Ocu-Flex 53 (ocufilcon B) Soft (Hydrophilic) Contact Lens for daily wear PMA P820051, and the Prosthetic (hefilcon A) Soft Lens, 510(k) K992950. Being similar with respect to materials, physical construction and safety and effectiveness to the predicate device, this meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness than the predicate devices identified above.
3
Substantial Equivalence Matrix
| | Characteristic | Ocu-Flex-53 Custom Prosthetic (ocufilcon
B) Soft Contact Lens Soft Contact Lenses | Predicate Device:
Ocu-Flex-53 (ocufilcon B)
Soft Contact Lens |
|-----|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.) | PRODUCTION
METHOD | Lathe-cut | Lathe-cut |
| 2.) | INTENDED USE | Daily Wear, Soft (hydrophilic) contact lens | Daily Wear, Soft (hydrophilic)
contact lens |
| 3.) | INDICATION | To enhance and/or alter the apparent eye
color. The lens may also be prescribed for
the correction of refractive ametropia (myopia
hyperopia or astigmatism) or for occlusive
therapy conditions such as diplopia,
amblyopia or extreme photophobia. | Correction of visual acuity in
aphakic and not-aphakic
persons with non-diseased
eyes with myopia, hyperopia
and astigmatism |
| 4.) | FDA "LISTED"
COLOR
ADDITIVES | Titanium dioxide | Reactive blue 19, reactive blue
21 and Reactive yellow 15 |
| 5.) | USES AND
RESTRICTIONS | The color additives listed above may be used
to color contact lenses in amounts not to
exceed the minimum reasonably required to
accomplish the intended coloring effect. | The color additives listed
above may be used to color
contact lenses in amounts not
to exceed the minimum
reasonably required to
accomplish the intended
coloring effect. |
| 6.) | Colors Offered | Opaque | Azure, Baby-blue, Turquoise |
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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 stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 26 2002
Ocu-Ease Optical Product, Inc. Charles R. Vermette, President 629 Tennent Avenue Pinole, CA 94564
Re: K020690
Trade/Device Name: Ocu-Flex-53 Custom Prosthetic (ocufilcon B) Soft Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: February 25, 2002 Received: March 4, 2002
Dear Mr. Vermette:
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 for answer and 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.
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.
5
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. Ralph 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
6
Ocu-Ease Optical Products, Inc. 510(k) Premarket Notification Ocu-Flex-53 Custom Prosthetic (ocufilcon B) Soft Contact Lens
INDICATIONS FOR USE STATEMENT
Page 1 of 1
Device Name:
Ocu-Flex-53 Custom Prosthetic (ocufilcon B) Soft Contact Lens
INDICATIONS FOR USE:
The Ocu-Flex-53 Custom Prosthetic (ocufilcon B) Soft Contact Lenses are indicated for daily wear to enhance or alter the apparent eye collar masking, enther in sighted daily wear to ennance of aller the upparent of o continue management of conditions of nor-signed eyes that require a prostitions contactions wishing to change the appearance of Such as Corneal, this of ters abnormaliation, or for portalized for the correction of then eyes without by abnomialites: "The rentigmatism) in aphakic or not-aphakic persons or for refractive anticipia (myopia, ny post diplopia, amblyopia or extreme photophobia.
The lens may be disinfected with a chemical (not heat) disinfection system.
Hancel W.D. Brown Ph.D
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
K020690
510(k) Number
(Please Do NoT WRITE BELOW THIS LINE - Continue on ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Ophthalmic Devices
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)