(78 days)
No
The 510(k) summary describes a standard soft contact lens made of a specific material. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The description focuses on the material properties, manufacturing process, and clinical performance for vision correction.
No.
The device is indicated for correction of visual acuity (a refractive error), not for treating a disease or condition.
No
Explanation: The device is a soft contact lens intended for the correction of visual acuity (myopia or hyperopia) and refractive astigmatism. It is a corrective device, not one that identifies or characterizes a disease or condition. The clinical study evaluates its safety and efficacy for vision correction, not for diagnosis.
No
The device description clearly states it is a physical contact lens made from specific materials, not software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the correction of visual acuity in the eye. This is a therapeutic and corrective function, not a diagnostic one performed in vitro (outside the body).
- Device Description: The description details the material and physical properties of a contact lens, designed to be placed on the eye.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (like blood, urine, or tissue) or to provide information about a patient's health status or disease.
- Anatomical Site: The device is applied to the eye, which is in vivo (within the body), not in vitro.
IVDs are typically used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This contact lens does not perform any such function.
N/A
Intended Use / Indications for Use
The CONTAFLEX GM3 58 (acofilcon 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 GM3 58% Spherical Soft Contact Lenses are fabricated from acofilcon 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 non-ionic lens material, (acofficon A) is a terpolymer based on high purity Glycerol Methacrylate 2,3-Dihydroxypropyl Methacrylate (GMA), with N-vinyl-2-pyrrolidone (NVP), methyl methacrylate (MMA), and 2-hydroxyethyl methacrylate (2-HEMA) and cross-linked with Diallyl Maleate (DAM). It consists of 42% acofilcon A and 58% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The lens is available in clear and with a blue visibility-handling tint, Color additive ‘Reactive Blue 4’ 21 CFR part 73.2121. The acofilcon 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 (acofilcon 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 58% water by weight. The physical properties of the lens are:
Refractive Index 1.52 (dry) 1.40 (hydrated)
Light Transmission greater than 93%
Water Content 58 %
Specific Gravity 1.103 (hydrated)
Oxygen Permeability 25.50 X 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35 ℃), (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
Clinical Testing: A total of 122 eyes (61 patients) were entered into the study by 5 investigators. 100 eyes (50 patients) completed the study.
Safety: Adverse Events, Positive Slit Lamp Findings, Symptoms/Complaints and Keratometry Changes.
Efficacy: Refractive Changes, Lens Visual Acuity, Lens VA Line Changes, Comfort and Vision, Average Wearing time.
The CONTAFLEX GM3 58 Soft Contact Lens material is equivalent in safety and efficacy to the predicate device, the Benz 55G.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
CONTAMA
510(k) Premarket Notification
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:
Applicant information:
| Date Prepared: | October 2, 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 GM3 58% (acofilcon A) Spherical Soft Contact Lens for Daily Wear (clear and tinted, lathe-cut) |
1
CONTAMAC 510(k) Premarket Notification
Equivalent Devices:
The CONTAFLEX GM3 58% (acofilcon A) Spherical Soft Contact Lenses are substantially equivalent to the following predicate device
Predicate device: "BENZ 55G" manufactured/distributed by Benz Research and Development. 510(k) number; K952620
Device Description:
Image /page/1/Picture/5 description: The image shows a series of numbers and a letter that appear to be created with a splattered or textured effect. The characters are K, 0, 2, 3, 4, and 9. The characters are all black and stand out against a white background. The splattered effect gives the characters a rough and uneven appearance.
The CONTAFLEX GM3 58% Spherical Soft Contact Lenses are fabricated from acofilcon 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 non-ionic lens material, (acofficon A) is a terpolymer based on high purity Glycerol Methacrylate 2,3-Dihydroxypropyl Methacrylate (GMA), with N-vinyl-2-pyrrolidone (NVP), methyl methacrylate (MMA), and 2-hydroxyethyl methacrylate (2-HEMA) and cross-linked with Diallyl Maleate (DAM). It consists of 42% acofilcon A and 58% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The lens is available in clear and with a blue visibility-handling tint, Color additive 'Reactive Blue 4' 21 CFR part 73.2121. The acofilcon 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 (acofilcon 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 58% water by weight. The physical properties of the lens are:
Refractive Index Light Transmission Water Content Specific Gravity Oxygen Permeability
1.52 (dry) 1.40 (hydrated) greater than 93% 58 % 1.103 (hydrated) 25.50 X 1011 (cm2/sec) (ml O2/ml x mm Hg @ 35 ℃), (revised Fatt method).
2
Intended Use:
The CONTAFLEX GM3 58 (acofilcon 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 off75 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be disinfected using a chemical disinfecting system.
Evecare 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 GM3 58 Soft Contact Lens material. The results of all testing demonstrated that the safety and effectiveness of the CONTAFLEX GM3 58 Soft Contact Lens is equivalent to the currently marketed Benz 55G 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 GM3 58 Soft Contact Lens material to the already marketed Benz 55G.
Solution Compatibility
Studies were conducted on blue tinted lens material. Lenses were run through 30 cycles of cleaning and conditioning to establish the compatibility of the lens material with the recommended care regimen. The parameters of the base curve, back vertex power, total diameter and overall lens physical appearance were recorded prior to and upon completion of 30 cycles. Initial and final data were compared. There were no significant changes to lens parameters after 30 complete cycles.
3
510(k) Premarket Notification
Clinical Testing
Below is a summary of the clinical study carried out to evaluate the safety and efficacy of the CONTAFLEX GM3 58 Soft Contact Lens material when used as a daily wear contact lens for the correction of visual acuity.
CONTAMA
A total of 122 eyes (61 patients) were entered into the study by 5 investigators. Prior to entry into this study each patient was required to read and sign a statement of informed consent. All patients who signed a Statement of Informed Consent are accounted for in this report. Of the 122 eves (61 patients enrolled), 100 eyes (50 patients) completed the study.
The safety and efficacy measures for the study were:
Safety: Adverse Events, Positive Slit Lamp Findings, Symptoms/Complaints and Keratometry Changes.
Efficacy: Refractive Changes, Lens Visual Acuity, Lens VA Line Changes, Comfort and Vision, Average Wearing time.
The sponsor concludes that CONTAFLEX GM3 58 Soft Contact Lens material is equivalent in safety and efficacy to the predicate device, the Benz 55G.
Substantial Equivalence:
The CONTAFLEX GM3 58 Soft Contact Lens is substantial equivalence and does not raise different questions of safety and effectiveness than the predicate device identified previously. The difference between the two devices is the USAN name.
The following table depicts the pre-clinical characteristics of the CONTAFLEX GM3 58 material, as well as the predicate device.
4
Substantial Equivalence table
| Pre-Clinical
equivalency / Device | Contaflex GM3 58%
(acofilcon A) | BENZ 55G
(hioxifilcon 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 # 2 >50% Water, Nonionic
Polymers | Group # 2 >50% Water, Nonionic
Polymers |
| 6.) | USAN name | Acofilcon A | Hioxifilcon A |
| 7.) | Water Content | 58.0% | 58.0% |
| 8.) | Oxygen Permeability | 25.5 X 10-11 (cm2/sec)
(ml O2/ml x mm Hg @ 35 degrees
C), (revised Fatt method). | 23.0 X 10-11 (cm2/sec)
(ml O2/ml x mm Hg @ 35 degrees
C), (revised Fatt method). |
| 9.) | Specific Gravity | 1.103 | 1.045 |
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
ood and Drug Administrat 9200 Corporate Boulevard Rockville MD 20850
Medvice Consulting, Inc. c/o Martin Dalsing 623 Glacier Drive Grand Junction, CO 81503
Re: K023349
Trade/Device Name: Contaflex GM3 58% (acofilcon A) Spherical Soft Contact Lens For Daily Wear (clear and tinted, lathe-cut)
Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: October 2, 2002 Received: October 7, 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, 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
6
Page 2 - Martin Dalsing
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. 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) 594-4692. 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
7
510(k) Premarket Notification
INDICATIONS FOR USE STATEME
Device Name
CONTAFLEX GM3 58% (acofilcon A) Spherical Soft Contact Lens for Da Wear (clear and tinted, lathe-cut)
INDICATIONS FOR USE:
The CONTAFLEX GM3 58 (acofficon 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 (Division Sign-Off of Device Evaluation (ODE) | |
|---|---|
| Division of Ophthalmic Ear, Nose and Throat Devices | Daniel W. C. Brown, Ph.D. |
| 510(k) Number | K023349 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.109) | X |
|---|---|
| --------------------------------------- | --- |
or
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Optional Format 1-2-96)