(44 days)
Durasoft 2 Colors, K952620
Not Found
No
The summary describes standard contact lens technology and manufacturing processes, with no mention of AI or ML.
No.
The device is indicated for the correction of visual acuity; it does not treat or cure a disease or condition.
No
This device is a contact lens intended for correcting visual acuity, not for diagnosing conditions.
No
The device description clearly describes a physical contact lens made from hioxifilcon A, a material that is machined, polished, and becomes soft when hydrated. It also mentions the addition of color additives and the physical properties of the lens when hydrated and dried. This is a hardware device, 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 individuals with myopia or hyperopia, and/or astigmatism. This is a therapeutic or corrective function, not a diagnostic one.
- Device Description: The description focuses on the material properties, manufacturing process, and physical characteristics of the contact lenses. It describes how they correct vision and are maintained, not how they are used to diagnose a condition.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the human body (like blood, urine, or tissue) or to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
In summary, the CANTOR & SILVER SX and 5X Tinted Soft Contact Lenses are medical devices intended for vision correction, which falls outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The CANTOR & SILVER 5X Tinted (hioxifilcon 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 leases may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The lenses are disinfected using a hydrogen peroxide lens care system only, and are available in a frequent replacement program.
The CANTOR & SILVER 5X Tinted (hioxifilcon A) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic persons with non-disessed eyes with myopia or hyperopia and/or possesses refractive astigmatism up to 10.00 diopters. The lenses are disinfected using a hydrogen peroxide lens care system only, and are available in a frequent replacement program.
Product codes (comma separated list FDA assigned to the subject device)
86 LPL
Device Description
The CANTOR & SILVER 5X Tinted (hioxifilcon A) Soft (Spherical & Toric) Daily Wear Contact lens are fabricated from hioxifilcon 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 color enhanced soft contact lenses are tinted with "listed" color additives. The color additives are used in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound reactive color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed color reactive additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The finted contact lenses are available in a light, medium or dark shade of the following enhance colors; Blue, Green, Aqua, Yellow, Lavender, Brown, Ultra Violet, and Amber.
The color additive (timing) effect is formed by reacting one or more of the "listed" additives with HEMA based (poly hydroxyethy) methacrylate) soft contact lens. The color additives used are not removed by lens handling and cleaning/disinfecting procedures as recommended. Except for affecting the amount of light transmitted through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens.
In the bydrated state, the lens conforms to the curvature of the eye covering the comea and extending slightly beyond the limbus forming a transparent optical surface. The (hioxifilcon A) soft hydrophilic contact lens 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 non-ionic lens material, hioxifilcon A is an ultra high molecular weight copolymer of 2-bydroxyethyl methacrylate (2-HEMA) and 2,3-Dibydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 42% hioxifiloon A and 58% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The physical properties of the lens are:
| Refractive Index | 1.515 (dry) 1.404 (hydrated) |
|---|---|
| Light Transmission (tinted) | greater than 70% |
| Color Additives | reactive black 5, reactive blue 21, reactive blue 19, reactive blue 4, reactive blue 163, reactive red 11, reactive red 180, reactive yellow 15, reactive yellow 86, or reactive orange 78 |
| Water Content | 58 % ±2% |
| Specific Gravity | 1.308 (dry) 1.136 (hydrated) |
| Oxygen Permeability | 20 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
eye/cornea/limbus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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.
Durasoft 2 Colors, K952620
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.
0
4/21/99
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:
March 12, 1999
Name: Address Cantor & Silver Limited Manor Road, Brackley Northamptonshire England NN13 6ED
Contact Person:
Phone Number: Fax:
Mr. David Cantor Managing Director/President 011 44 1280 702002 011 44 1280 703003
Official Correspondent: And US Consultant
Med-Vice Consulting, Inc. Mr. Martin Dalsing President/CCO 623 Glacier Grand Junction, CO 81503 970.243.5490 970.243.5501
Phone Number: Fax Number:
Device Information:
Regulatory Classification: Class II
86 LPL Product Code:
Trade Name:
CANTOR & SILVER 5X Tinted (hioxifilcon A) Soft (Spherical & Toric) Daily Wear Contact Lens, Tinted.
Classification Name:
Lenses, Soft Contact, Daily Wear
1
Equivalent Device:
The CANTOR & SILVER 5X Tinted (hioxifilcon A) Soft (Spherical & Toric) Daily Wear Contact Lens is substantially equivalent to the predicate device in terms of intended use and design. The predicate device is the Durasoft 2 Colors manufactured by Wesley-Jessen.
Device Description:
The CANTOR & SILVER 5X Tinted (hioxifilcon A) Soft (Spherical & Toric) Daily Wear Contact lens are fabricated from hioxifilcon 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 color enhanced soft contact lenses are tinted with "listed" color additives. The color additives are used in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound reactive color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed color reactive additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The finted contact lenses are available in a light, medium or dark shade of the following enhance colors; Blue, Green, Aqua, Yellow, Lavender, Brown, Ultra Violet, and Amber.
The color additive (timing) effect is formed by reacting one or more of the "listed" additives with HEMA based (poly hydroxyethy) methacrylate) soft contact lens. The color additives used are not removed by lens handling and cleaning/disinfecting procedures as recommended. Except for affecting the amount of light transmitted through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens.
In the bydrated state, the lens conforms to the curvature of the eye covering the comea and extending slightly beyond the limbus forming a transparent optical surface. The (hioxifilcon A) soft hydrophilic contact lens 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.
2
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 non-ionic lens material, hioxifilcon A is an ultra high molecular weight copolymer of 2-bydroxyethyl methacrylate (2-HEMA) and 2,3-Dibydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 42% hioxifiloon A and 58% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The physical properties of the lens are:
| Refractive Index | 1.515 (dry) 1.404 (hydrated) |
|---|---|
| Light Transmission (tinted) | greater than 70% |
| Color Additives | reactive black 5, reactive blue 21, reactive blue 19, reactive blue 4, |
| reactive blue 163, reactive red 11, reactive red 180, reactive yellow 15, | |
| reactive yellow 86, or reactive orange 78 | |
| Water Content | 58 % ±2% |
| Specific Gravity | 1.308 (dry) 1.136 (hydrated) |
| Oxygen Permeability | $20 X 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C), (revised Fatt method) |
INDICATED USE:
The CANTOR & SILVER 5X Tinted (hioxifileon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic persons with non-diseased eyes with myopia or hyperopia. The lenses may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the assigmatism does not interfere with visual acuity. The lenses are disinfected using a hydrogen peroxide lens care system only, and are available in a frequent replacement program.
The CANTOR & SILVER 5X Tinted (hioxifilcon A) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism up to 10.00 diopters. The lenses are disinfected using a hydrogen peroxide lens care system only, and are available in a frequent replacement program.
3
Substantial Equivalence:
The device will be manufactured according to specified process controls and a Quality Management System certified to ISO 9002 and EN46002 by the National Accreditation of Certification Bodies. The device will undergo manufacturing, packaging and sterilization procedures similar to devices currently marketed and distributed by Cantor & Silver Limited in the United States. The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the device is equivalent to the BENZ-G 5X (hioxifilcon A), 510(k) #K952620. The tinting characteristics and parameters of the lens are substantially equivalent to the Durasoft 2 Colors tinted soft contact lens, manufactured Wesley-Jessen. Being similar with respect to indications for use, materials, physical construction and safety & 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.
The following matrix illustrates that the production method, lens function, and the "listed" color additives and timing characteristics of the CANTOR & SILVER 5X Tinted (hioxifilcon A) Soft (Spherical & Toric) Daily Wear Contact Lens are substantially equivalent to the predicate device.
| | Characteristic | CANTOR & SILVER 5X
TINTED | DURASOFT 2 COLORS |
|-----|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.) | PRODUCTION
METHOD | Lathe-Cut | Lathe-Cut |
| 2.) | LENS FUNCTION | Refractive medium that focuses
light rays from near and distant
objects on the retina, while
compensating for refractive error,
including (astigmatism) | Refractive medium that focuses
light rays from near and distant
objects on the retina, while
compensating for refractive error,
including (astigmatism) |
| 3.) | FDA "listed"
colored additives | The reactive colored additives
consist of reactive black 5,
reactive blue 4, reactive blue 19,
reactive 21, reactive blue 163,
reactive yellow 15, reactive yellow
86, reactive orange 78, reactive
red 11 and reactive red 180 | The colored pigments consist of
iron oxides, chromium oxide
greens, titanium dioxide, [phthalo-
cyaninato (2-)] copper, carbazole
violet and phthalocyanine green. |
| a. | 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. |
| 4.) | Color Additive
Characteristics | The color additives used are not
removed by lens handling and
cleansing/disinfecting procedures.
The optical and performance
characteristics are not altered by
the lens coloring process. | The color additives used are not
removed by lens handling and
cleansing/disinfecting procedures.
The optical and performance
characteristics are not altered by
the lens coloring process. |
| 5.) | Colors Offered | Blue, Green, Aqua, Yellow,
Lavender, Brown, Ultra Violet
and Amber | Sky blue, Jade green, Aquamarine
and Violet blue |
Substantial Equivalence Matrix
4
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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures or profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 1933
Mr. Martin Dalsing Med. Vice Consulting, Inc. 623 Glacier Drive Grand Junction, CO
Re: K990757 Trade Name: Cantor & Silver 5X Tinted (hioxifilcon A) Soft Contact Lens Regulatory Class: II Product Code: 86 LPL Dated: April 7, 1999 Received: April 12, 1999
Dear Mr. Dalsing:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
5
Page 2 - Mr. Martin Dalsing
This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE STATEMENT
CANTOR & SILVER 5X TINTED (hioxifilcon A) Soft (Spherical & Toric) Device Name: Daily Wear Contact Lens, Tinted.
INDICATIONS FOR USE:
The CANTOR & SILVER SX Tinted (hioxifilcon 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 leases may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The lenses are disinfected using a hydrogen peroxide lens care system only, and are available in a frequent replacement program.
The CANTOR & SILVER 5X Tinted (hioxifilcon A) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic persons with non-disessed eyes with myopia or hyperopia and/or possesses refractive astigmatism up to 10.00 diopters. The lenses are disinfected using a hydrogen peroxide lens care system only, and are available in a frequent replacement program.
(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
or
Over-The-Counter Use
(Optional Format 1-2-96)
SRRell
(Division Sign-Off) Division of Ophthalmic Devices
510(k) Number K990757