(86 days)
The CONTAFLEX 38 (polymacon) 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.
The CONTAFLEX 38 Spherical Soft Contact Lenses are fabricated from polymacon, 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 nonionic lens material, (polymacon) is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 62% polymacon and 38% 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 polymacon 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 (polymacon) 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 38% water by weight.
Here's an analysis of the provided text regarding the acceptance criteria and study for the CONTAFLEX 38 (polymacon) Spherical Soft Contact Lens:
1. Table of Acceptance Criteria and Reported Device Performance:
The document focuses on demonstrating substantial equivalence to a predicate device ("BENZ 38") rather than defining explicit, separate acceptance criteria for the new device. The "acceptance criteria" are implied by the need for the CONTAFLEX 38 to exhibit comparable pre-clinical characteristics to the BENZ 38.
| Acceptance Criteria (Implied by Predicate Equivalence) | Predicate Device (BENZ 38) Performance | CONTAFLEX 38 Performance |
|---|---|---|
| Intended Use | Daily wear for aphakic/non-aphakic persons, myopia/hyperopia correction | Daily wear for aphakic/non-aphakic persons, myopia/hyperopia correction |
| Functionality | Refractive medium focusing light rays on retina | Refractive medium focusing light rays on retina |
| Indications | Daily wear, Soft (hydrophilic) contact lens | Daily wear, Soft (hydrophilic) contact lens |
| Production Method | Lathe-cut | Lathe-cut |
| FDA Group # | Group # 1 <50% Water, nonionic Polymers | Group # 1 <50% Water, nonionic Polymers |
| USAN name | polymacon | polymacon |
| Water Content | 39.0% | 40.4% |
| Oxygen Permeability | 7.61 X 10⁻¹¹ (cm²/sec)(ml O₂/ml x mm Hg @ 35°C) | 7.93 X 10⁻¹¹ (cm²/sec)(ml O₂/ml x mm Hg @ 35°C) |
| Specific Gravity | 1.169 | 1.170 |
| In-Vitro Cytotoxicity | Not explicitly stated for predicate in table, but implied as acceptable | Meets ISO 10993-5 (Agarose Overlay Method standards) |
| Systemic Toxicity | Not explicitly stated for predicate in table, but implied as acceptable | Meets systemic injection test, considered non-toxic |
| Acute Ocular Irritation | Not explicitly stated for predicate in table, but implied as acceptable | No ocular irritation produced |
| Shelf Life | Not explicitly stated for predicate in table, but reference to K973597 accepted | Satisfied via referencing rights to K973597 |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes preclinical testing to demonstrate the safety and effectiveness of the material. However, it does not provide specific sample sizes or information about the provenance (country of origin, retrospective/prospective) for these preclinical tests. The tests mentioned are:
- In-Vitro Cytotoxicity (ISO 10993-5): No sample size specified.
- Systemic Toxicity: No sample size specified.
- Acute Ocular Irritation: No sample size specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not mention the use of experts to establish a "ground truth" for the test set in the context of clinical performance or diagnostic accuracy. The studies described are pre-clinical material characterization and toxicology studies.
4. Adjudication Method for the Test Set:
Not applicable. The studies described are preclinical and do not involve human interpretation or adjudication of test results in the way a clinical diagnostic study would.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance:
Not applicable. This is a pre-clinical submission for a medical device (contact lens material), not an AI-powered diagnostic system. No MRMC study was conducted or is relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is not an AI-driven device.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
The "ground truth" for the preclinical studies would be established by the results of the standardized biological and physical tests themselves, as per the specified test methodologies (e.g., ISO 10993-5 for cytotoxicity). For material properties (water content, oxygen permeability, specific gravity), the "ground truth" is derived from direct measurements using recognized scientific methods.
8. The Sample Size for the Training Set:
Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set described in the document.
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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: | K023987 |
|---|---|
| -------------------------------- | --------- |
Applicant information:
Date Prepared:
November 25, 2002
| Name: | CONTAMAC Ltd. |
|---|---|
| Address | Bearwalden Business ParkSaffron WaldenEssex 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 38 (polymacon) Spherical Soft Contact Lens for Daily Wear (clear and tinted, lathe-cut) |
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CONTAMA
Equivalent Devices:
The CONTAFLEX 38 (polymacon) Spherical Soft Contact Lenses are substantially equivalent to the following predicate device
"BENZ 38" Predicate device: Manufactured/distributed by Benz Research and Development. 510(k) number: K961103
Device Description:
The CONTAFLEX 38 Spherical Soft Contact Lenses are fabricated from polymacon, 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 nonionic lens material, (polymacon) is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 62% polymacon and 38% 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 polymacon 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 (polymacon) 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 38% water by weight. The physical properties of the lens are:
| Refractive Index | 1.438 (hydrated) |
|---|---|
| Light Transmission (clear) | greater than 94% |
| Light Transmission (tinted) | greater than 94% |
| Water Content | 38% ± 2% |
| Specific Gravity | 1.170 |
| Oxygen Permeability | 7.93 X 10⁻¹¹ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C), (revised Fatt method). |
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Intended Use:
The CONTAFILEX 38 (polymacon) 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 38 Soft Contact Lens material. The results of all testing demonstrated that the safety and effectiveness of the CONTAFLEX 38 Soft Contact Lens is equivalent to the currently marketed Benz polymacon 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 38 Soft Contact Lens material to the already marketed Benz polymacon.
Substantial Equivalence:
The CONTAFLEX 38 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 38 material, as well as the predicate device.
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Substantial Equivalence table
| Pre-Clinicalequivalency / Device | CONTAFLEX 38(polymacon) | BENZ 38(polymacon) | |
|---|---|---|---|
| 1.) | Intended Use | Indicated for daily wear for thecorrection of visual acuity inaphakic and not aphakic personswith non-diseased eyes withmyopia or hyperopia. | Indicated for daily wear for thecorrection of visual acuity inaphakic and not aphakic personswith non-diseased eyes withmyopia or hyperopia. |
| 2.) | Functionality | After machining from the opticalblank, the contact lenses act as arefractive medium that focus lightrays from near and distant objectson the retina. | After machining from the opticalblank, the contact lenses act as arefractive medium that focus lightrays from near and distant objectson 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 # 1 <50% Water, nonionicPolymers | Group # 1 <50% Water, nonionicPolymers |
| 6.) | USAN name | polymacon | polymacon |
| 7.) | Water Content | 40.4% | 39.0% |
| 8.) | Oxygen Permeability | 7.93 X 10-11 (cm2/sec)(ml O2/ml x mm Hg @ 35 degreesC), (revised Fatt method). | 7.61 X 10-11 (cm2/sec)(ml O2/ml x mm Hg @ 35 degreesC), (revised Fatt method). |
| 9.) | Specific Gravity | 1.170 | 1.169 |
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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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an image of an eagle with three lines extending from its head, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 2003
Contamac, Ltd. c/o Martin Dalsing Regulatory Consultant and U.S. Agent for Contamac. Ltd. Medvice Consulting, Inc. 623 Glacier Drive Grand Junction, CO 81503
Re: K023987
Trade/Device Name: CONTAFLEX 38 (polymacon) 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, 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.
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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 kalpi 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
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INDICATIONS FOR USE STATEMENT
CONTAFLEX 38 (polymacon) Spherical Soft Contact Lens for Daily Wear Device Name: (clear and tinted, lathe-cut)
INDICATIONS FOR USE:
The CONTAFLEX 38 (polymacon) 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) | |||
|---|---|---|---|
| [Signature] | |||
| (Division Sign-Off) | |||
| Division of Ophthalmic Ear, Nose and Throat Devises | |||
| Prescription UseX(Per 21 CFR 801.109) | 510(k) Number | K023987 | 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.