(53 days)
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.
The Ocu-Flex-53 Custom Prosthetic (ocufilcon B) Soft 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 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 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 lens is available in opaque patterns including Clear Lens with Opaque Pupil, Solid Opaque Lens, Solid Opaque with Clear Pupil, and Solid Annular Opaque with Clear Pupil & Clear Edge.
The provided text is a 510(k) summary for a medical device called "Ocu-Flex-53 Custom Prosthetic (ocufilcon B) Soft Contact Lens." This type of submission to the FDA is for demonstrating substantial equivalence to a predicate device, not for proving the device meets acceptance criteria through a novel study.
The document does not contain any information about a study designed to prove the device meets specific acceptance criteria. Instead, it focuses on establishing substantial equivalence to previously approved devices based on materials, manufacturing, intended use, and physical properties. Therefore, I cannot construct a table of acceptance criteria and reported device performance from this document, nor can I provide information about sample sizes, ground truth establishment, expert adjudication, or MRMC studies.
Here's what I can infer from the document regarding the device and its characteristics, which in a different context might be parts of a performance specification:
- Intended Use/Indications for Use: The key "performance" aspect described is its intended use.
- Daily wear to enhance or alter apparent eye color, including ocular masking.
- For cosmetic management of conditions like corneal, iris, or lens abnormalities (sighted or non-sighted eyes).
- For persons wishing to change the appearance of their eyes without abnormalities.
- Correction of refractive ametropia (myopia, hyperopia, astigmatism) in aphakic or not-aphakic persons.
- Occlusive therapy for conditions such as diplopia, amblyopia, or extreme photophobia.
- Material: ocufilcon B (a hydrophilic copolymer).
- Physical Properties (these are listed as characteristics, not performance against criteria):
- 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)
- Disinfection Method: Chemical (not heat) disinfection system only.
- Prosthetic Design Options: Clear Lens with Opaque Pupil, Solid Opaque Lens, Solid Opaque with Clear Pupil, Solid Annular Opaque with Clear Pupil & Clear Edge.
Conclusion based on the provided document:
No specific study proving the device meets quantitative "acceptance criteria" is described. The document's purpose is to establish substantial equivalence to predicate devices, not to present a new clinical or performance study with defined acceptance criteria and statistical results. Therefore, most of the questions cannot be answered from the given text.
{0}------------------------------------------------
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 (ocufilconB) Soft Contact Lens Soft Contact Lenses | Predicate Device:Ocu-Flex-53 (ocufilcon B)Soft Contact Lens | |
|---|---|---|---|
| 1.) | PRODUCTIONMETHOD | 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 eyecolor. The lens may also be prescribed forthe correction of refractive ametropia (myopiahyperopia or astigmatism) or for occlusivetherapy conditions such as diplopia,amblyopia or extreme photophobia. | Correction of visual acuity inaphakic and not-aphakicpersons with non-diseasedeyes with myopia, hyperopiaand astigmatism |
| 4.) | FDA "LISTED"COLORADDITIVES | Titanium dioxide | Reactive blue 19, reactive blue21 and Reactive yellow 15 |
| 5.) | USES ANDRESTRICTIONS | The color additives listed above may be usedto color contact lenses in amounts not toexceed the minimum reasonably required toaccomplish the intended coloring effect. | The color additives listedabove may be used to colorcontact lenses in amounts notto exceed the minimumreasonably required toaccomplish the intendedcoloring effect. |
| 6.) | Colors Offered | Opaque | Azure, Baby-blue, Turquoise |
:
: 上一篇:
:
.
{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 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)
§ 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.