(86 days)
973597
No
The summary describes a standard soft contact lens made from a specific material. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The focus is on the material properties and intended use for vision correction.
No.
Explanation: The device is indicated for the correction of visual acuity in persons with non-diseased eyes, addressing refractive errors like myopia or hyperopia, rather than for treating a disease or condition.
No
Explanation: The device is a soft contact lens intended for the correction of visual acuity, not for diagnosing a disease or condition. Its intended use is therapeutic, providing vision correction, rather than diagnostic, which would involve identifying or characterizing a health issue.
No
The device is a physical contact lens made of methafilcon A, not a software program. The description details the material composition and physical properties of the lens.
Based on the provided text, 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 CONTAFLEX 55 contact lens is a medical device intended to be placed on the eye for the correction of visual acuity. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for correcting visual acuity in individuals with myopia or hyperopia. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The description focuses on the material properties and physical characteristics of the lens itself, not on any analytical or testing capabilities.
Therefore, the CONTAFLEX 55 contact lens falls under the category of a medical device, specifically an ophthalmic device, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CONTAFLEX 55 (methafilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be disinfected using a chemical disinfecting system.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Product codes
LPL
Device Description
The CONTAFLEX 55 Spherical Soft Contact Lenses are fabricated from methafilcon A, 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 ionic lens material. (methafilcon A) is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and Methacrylic Acid, cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% methafilcon A and 55% water by weight when immersed in normal buffered saline solution. The lens is available in clear and with a blue visibility-handling tint, [phthalocyaninato (2-)] copper. The methafilcon A name has been adopted by the United States Adopted Names Council (USAN).
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (methafilcon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 55% water by weight. The physical properties of the lens are:
Refractive Index: 1.405 (hydrated)
Light Transmission (clear): greater than 94%
Light Transmission (tinted): greater than 94%
Water Content: 55 % ± 2%
Specific Gravity: 1.067
Oxygen Permeability: 19.6 X 10-11 (cm²/sec) (ml O₂/ml x mm Hg @ 35°C), (revised Fatt method).
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
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
A series of preclinical testing were performed to demonstrate the safety and effectiveness of the CONTAFLEX 55 Soft Contact Lens material. The results of all testing demonstrated that the safety and effectiveness of the CONTAFLEX 55 Soft Contact Lens is equivalent to the currently marketed Benz methafilcon A contact lens material.
Toxicology:
In-Vitro Cytotoxicity: ISO 10993-5 was conducted in accordance with standards on test article. The test article meets the requirements of the Agarose Overlay Method.
Systemic Toxicity: The lens material meets the requirements of the systemic injection test and is considered non-toxic.
Acute Ocular Irritation: Acute ocular irritation test was performed and produced no ocular irritation.
Shelf Life: Shelf life requirements are satisfied via referencing rights granted to Contamac Ltd. for 510(k) 973597.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
973597
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
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| The assigned 510(k) number is: | K023989 |
|---|---|
| -------------------------------- | --------- |
Applicant information:
Date Prepared:
November 25, 2002
| Name: | CONTAMAC Ltd. | |
|---|---|---|
| Address | Bearwalden Business Park | |
| Saffron Walden | ||
| Essex England CB11 4JX | ||
| Contact Person: | Robert McGregor | |
| Phone number: | 44-1799 542 000 | |
| US Agent: | Medvice Consulting, Inc. | |
| Martin Dalsing | ||
| Phone number | (970) 243-5490 | |
| Fax number | (970) 243-5501 |
Device Information:
| Device Classification: | Class II |
|---|---|
| Classification Number: | LPL |
| Classification Name: | Lenses, Soft Contact, Daily Wear |
| Trade Name: | CONTAFLEX 55 (methafilcon A) Spherical |
Lens for Daily Wear (clear and tinted, lathe-cut)
Soft Contact
1
Equivalent Devices:
The CONTAFLEX 55 (methafilcon A) Spherical Soft Contact Lenses are substantially equivalent to the following predicate device
"BENZ methafilcon A" Predicate device: Manufactured/distributed by Benz Research and Development. 510(k) number: K980418
Device Description:
The CONTAFLEX 55 Spherical Soft Contact Lenses are fabricated from methafilcon A, 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 ionic lens material. (methafilcon A) is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and Methacrylic Acid, cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% methafilcon A and 55% water by weight when immersed in normal buffered saline solution. The lens is available in clear and with a blue visibility-handling tint, [phthalocyaninato (2-)] copper. The methafilcon A name has been adopted by the United States Adopted Names Council (USAN).
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (methafilcon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 55% water by weight. The physical properties of the lens are:
Refractive Index Light Transmission (clear) Light Transmission (tinted) Water Content Specific Gravity Oxygen Permeability
| 1.405 (hydrated) |
|---|
| greater than 94% |
| greater than 94% |
| 55 % ± 2% |
| 1.067 |
| 19.6 X 10-11 (cm²/sec) (ml O₂/ml x mm Hg @ 35°C), (revised Fatt |
| method). |
2
Intended Use:
The CONTAFLEX 55 (methafilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be disinfected using a chemical disinfecting system.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Description of Safety:
A series of preclinical testing were performed to demonstrate the safety and effectiveness of the CONTAFLEX 55 Soft Contact Lens material. The results of all testing demonstrated that the safety and effectiveness of the CONTAFLEX 55 Soft Contact Lens is equivalent to the currently marketed Benz methafilcon A contact lens material. A summary of these results from the preclinical studies is presented below.
Toxicology:
In-Vitro Cytotoxicity: ISO 10993-5 was conducted in accordance with standards on test article. The test article meets the requirements of the Agarose Overlay Method.
Systemic Toxicity: The lens material meets the requirements of the systemic injection test and is considered non-toxic.
Acute Ocular Irritation: Acute ocular irritation test was performed and produced no ocular irritation.
Shelf Life
Shelf life requirements are satisfied via referencing rights granted to Contamac Ltd. for 510(k) 973597. The data presented supports substantial equivalence of this CONTAFLEX 55 Soft Contact Lens material to the already marketed Benz methafilcon A.
Substantial Equivalence:
The CONTAFLEX 55 Soft Contact Lens is substantially equivalent to the predicate device as depicted in the following table, and does not raise different questions of safety and effectiveness than the predicate device identified previously.
The following table depicts the pre-clinical characteristics of the CONTAFLEX 55 material, as well as the predicate device.
3
Substantial Equivalence table
| | Pre-Clinical
equivalency / Device | CONTAFLEX 55
(methafilcon A) | BENZ methafilcon A
(methafilcon A) |
|-----|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.) | Intended Use | Indicated for daily wear for the
correction of visual acuity in
aphakic and not aphakic persons
with non-diseased eyes with
myopia or hyperopia. | Indicated for daily wear for the
correction of visual acuity in
aphakic and not aphakic persons
with non-diseased eyes with
myopia or hyperopia. |
| 2.) | Functionality | After machining from the optical
blank, the contact lenses act as a
refractive medium that focus light
rays from near and distant objects
on the retina. | After machining from the optical
blank, the contact lenses act as a
refractive medium that focus light
rays from near and distant objects
on the retina. |
| 3.) | Indications | Daily wear, Soft (hydrophilic)
contact lens | Daily wear, Soft (hydrophilic)
contact lens |
| 4.) | Production Method | Lathe-cut | Lathe-cut |
| 5.) | FDA Group # | Group # 4 >50% Water, ionic
Polymers | Group # 4 >50% Water, ionic
Polymers |
| 6.) | USAN name | methafilcon A | methafilcon A |
| 7.) | Water Content | 55.0% | 55.0% |
| 8.) | Oxygen Permeability | 19.6 X 10-11 (cm2/sec)
(ml 02/ml x mm Hg @ 35 degrees
C), (revised Fatt method). | 18.3 X 10-11 (cm2/sec)
(ml 02/ml x mm Hg (@ 35 degrees
C), (revised Fatt method). |
| 9.) | Specific Gravity | 1.067 | 1.128 |
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 features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
FEB 2 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Contamac Ltd. c/o Martin Dalsing Medvice Consulting, Inc. Regulatory Consultant and U.S. Agent for Contamac. Ltd. 623 Glacier Drive Grand Junction, CO 81503
Re: K023989
Trade/Device Name: CONTAFLEX 55 (methafilcon A) Spherical Soft Contact Lens for Daily Wear (clear and tinted, lathe-cut) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lenses Regulatory Class: Class II Product Code: LPL Dated: November 25, 2002 Received: December 2, 2002
Dear Mr. Dalsing:
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.
5
Page 2 - Martin Dalsing
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), 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. Kalgi 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
INDICATIONS FOR USE STATEMENT
Device Name: CONTAFLEX 55 (methafilcon A) Spherical Soft Contact Lens for Daily Wear (clear and tinted, lathe-cut)
INDICATIONS FOR USE:
The CONTAFLEX 55 (methafilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be disinfected using a chemical disinfecting system.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
| Prescription Use | x (Per 21 CFR 801.109) |
|---|---|
| 510(k) Number | K023989 |
| Over-The-Counter Use |
(Optional Format 1-2-96)