(63 days)
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No
The 510(k) summary describes a standard soft contact lens and its physical and optical properties. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The performance studies focus on comparing tinted and untinted versions of the lens based on standard contact lens parameters.
No
Contact lenses for non-diseased eyes are corrective devices, not therapeutic devices.
No
Explanation: The device is a soft contact lens intended for vision correction in non-diseased eyes, not for diagnosing medical conditions.
No
The device is a physical contact lens, which is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "daily wear soft contact lens" for "non-diseased eyes." This is a therapeutic or corrective device, not a diagnostic one.
- Device Description: It describes a contact lens made of a specific material. This is consistent with a medical device for vision correction.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) or providing information for the diagnosis of a disease or condition.
- Performance Studies: The performance studies focus on the physical and optical properties of the contact lens and compare a tinted version to an untinted version. These are relevant to the performance of a contact lens as a vision correction device, not a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This contact lens does not fit that description.
N/A
Intended Use / Indications for Use
"...is indicated for use as a daily wear soft contact lens."
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
"The name of the device, Ocu-Flex-53 (ocufilcon B) Soft (Hydrophilic) Contact Lens... Lens configurations include spherical, toric and aspherical for non-diseased eyes. The tinted version of the Ocu-Flex-53 (ocufilcon B) Soft (Hydrophilic) Contact Lens is substantially equivalent to that of the untinted version..."
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
"non-diseased eyes"
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Color and Light Transmission: "Light transmittance was measured at various wavelengths in the visible region, i.e., from 350 to 700 mm. The minimum tint, or Visitint, showed a maximum transmittance of 97, 2% and a minimum transmission of 82.59%. The same untinted lens showed a maximum transmission of 96.9% and a minimum transmission of 82.5%. Ocu-Flex-53 Lenses, tinted with the maximum intensity of dye showed a maximum transmission of light of 91.2% and a minimum ot 1:75%..." "low concentrations of Reactive Blue Dye 21... would have no adverse effect on light transmissibility but that the maximum intensity of dye should be avoided."
Refractive Index: "The refractive index of Ocu-Flex-53 Tinted Lenses (maximum intensity) is 1.4052 with a standard deviation 0.0009. The untinted version of the same lens has a refractive index of 1.4041... Consequently tinting of Ocu-Flex-53 Contact Lenses with Reactive Blue 21, even at the maximum intensity does not affect the refractive index..."
Water Content: "The average water content of ten (10) Ocu-Flex-53 Contact Lenses, Lot IR, is 52.93%w. After tinting with maximum concentration of dye the average water content of the same 10 lenses is 53.11%w. The increase of 0.34% is well within the tolerance specifications of + 1.0%w."
Linear Swell: "The average linear swell of ten (10) Ocu-Flex-53 Contact Lenses, Lot IR, is 34.41. After tinting the same 10 lenses showed a linear swell of 34.8 or an increase of about 1.0%, which is well within the tolerance specification."
Optical Properties: "The optical properties of ten (10) untinted Ocu-Flex-53 lenses, lot IR, are considered to be excellent, except for Lens no. 1 which was rated only fair. After tinting the same ten (10) lenses were still rated excellent, except for lens #1... These results indicate the tinting with Reactive Dye 21 does not affect the excellent optical parameters of Ocu-Flex-53 Contact Lenses..."
Oxygen Permeability at 35°C: "the untinted Ocu-Flex-53 Lens showed an average transmissibility (DK/L), at 35°C, of 7.6, with a standard deviation of 0.69. After tinting the average transmissibility (DK/L), at 35°C, was 7.7 with a standard deviation of 0.74. Similarly the average permeability of the untinted lenses at 35°C was calculated to be 16.7, with a standard deviation of 2.19 while the same lenses after tinting had an average permeability (DK x 10-1) at 35°C, of 16.8 with a standard deviation of 2.00."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
MAR 2 5 1996
Ocu-Ease Optical Products, Inc. 629 Tennent Avenue Pinole, CA 94564 (510) 724-0384
SUMMARY of SAFETY AND EFFECTIVENESS
The name of the device, Ocu-Flex-53 (ocufilcon B) Soft (Hydrophilic) Contact Lens is classified as a Class II device. It has been F.D.A. approved, see PMA P820051 an Amendments since March 7, 1984, and is indicated for use as a daily wear soft contact lens. Lens configurations include spherical, toric and aspherical for non-diseased eyes. The tinted version of the Ocu-Flex-53 (ocufilcon B) Soft (Hydrophilic) Contact Lens is substantially equivalent to that of the untinted version as demonstrated in this submission. Manufacturing and sterilization procedures have not been changed from the F.D.A. approved procedures already in place. The dye used in the tinted version. Reactive Blue 21, is F.D.A. approved for use with poly(hydroxyethyl methacrylate) copolymers. No technological differences between the predicate device, Ocu-Flex-53 (ocufilcon B) Soft (Hydrophilic) Contact Lens (untinted) and the Ocu-Flex-53 (ocufilcon B) Soft (Hydrophilic) Contact Lens (tinted) were found. For example, all of the physical properties, such as refractive index, light transmission, water content, linear swell and oxygen permeability, are virtually identical for the untinted lens and the tinted version of the predicate device. As shown in the supporting attachments, there are no adverse effects on the physical or optical parameters of the Ocu-Flex-53 tinted lenses.
Overall, all of the performance data verify the substantial equivalence for the tinted and untinted version of the same lens.
Signed Charles McDermott
Charles R. Vermette, President
Date 2/16/76
1
Physical and Optical Properties of Tinted Versus Untinted Lenses
Introduction
All physical, chemical and optical properties were determined at 25℃ ± 1ºC except for oxygen transmissibility, which was measured at 35ºC + 2ºC.
Color and Light Transmission
Color Index Code: Reactive Blue 21. Light transmittance was measured at various wavelengths in the visible region, i.e., from 350 to 700 mm. The minimum tint, or Visitint, showed a maximum transmittance of 97, 2% and a minimum transmission of 82.59%. The same untinted lens showed a maximum transmission of 96.9% and a minimum transmission of 82.5%. Ocu-Flex-53 Lenses, tinted with the maximum intensity of dye showed a maximum transmission of light of 91.2% and a minimum ot 1:75% See STS Final Report, Study No. GLP-1995-605, of 09/11/95 and STS Final Report, Study No. GLP-1995-324 of 06/08/95 for original data (Attachment 2).
These data suggest that low concentrations of Reactive Blue Dye 21, such as would be used in cosmetic tints, would have no adverse effect on light transmissibility but that the maximum intensity of dye should be avoided.
Refractive Index
The refractive index of Ocu-Flex-53 Tinted Lenses (maximum intensity) is 1.4052 with a standard deviation 0.0009. The untinted version of the same lens has a refractive index of 1.4041, which is within the reproducibility of the measurement. Consequently tinting of Ocu-Flex-53 Contact Lenses with Reactive Blue 21, even at the maximum intensity does not affect the refractive index, see Attachment 3.
Water Content
The average water content of ten (10) Ocu-Flex-53 Contact Lenses, Lot IR, is 52.93%w. After tinting with maximum concentration of dye the average water content of the same 10 lenses is 53.11%w. The increase of 0.34% is well within the tolerance specifications of + 1.0%w. See Attachment 4.
Linear Swell
The average linear swell of ten (10) Ocu-Flex-53 Contact Lenses, Lot IR, is 34.41. After tinting the same 10 lenses showed a linear swell of 34.8 or an increase of about 1.0%, which is well within the tolerance specification. See Attachment 4.
2
Optical Properties
The optical properties of ten (10) untinted Ocu-Flex-53 lenses, lot IR, are considered to be excellent, except for Lens no. 1 which was rated only fair. After tinting the same ten (10) lenses were still rated excellent, except for lens #1. which was rated only fair before tinting. See Attachment 4. These results indicate the tinting with Reactive Dye 21 does not affect the excellent optical parameters of Ocu-Flex-53 Contact Lenses listed in Figure 3.
Oxygen Permeability at 35°C
Oxygen Permeabilities at 35°C were calculated from their respective transmissibilities that, in turn, were measured with the aid of a Rehder Development Polarographic Cell and a Schema Versatae Polarographic Amplifier. To minimize the number of uncontrolled variables the permeability of the untinted lenses first was established. The lenses were then tinted and the permeabilities determined again on the same lenses.
Attachment 5 illustrates quite clearly that tinting does not detract from the excellent transmissibility of Ocu-Flex-53 Lenses. For example the untinted Ocu-Flex-53 Lens showed an average transmissibility (DK/L), at 35°C, of 7.6, with a standard deviation of 0.69. After tinting the average transmissibility (DK/L), at 35°C, was 7.7 with a standard deviation of 0.74. Similarly the average permeability of the untinted lenses at 35°C was calculated to be 16.7, with a standard deviation of 2.19 while the same lenses after tinting had an average permeability (DK x 10-1) at 35°C, of 16.8 with a standard deviation of 2.00.
Optical Parameters of Ocu-Flex-53 Tinted Lenses Figure 3
The optical parameters of Ocu-Flex-53 Tinted Lenses and their tolerances are the same as those specified for Ocu-Flex-53 untinted lenses, namely:
Refractive Power: +10.00 diopters to -10.00 diopters with a tolerance of ±0.25 diopters. For powers with more than ±10.00 diopters the tolerance is +0.50 diopters.
Cylinder Power: for less than 2.00 diopters the tolerance is ±0.25 diopters. For more than 2.00 diopters the tolerance is + 0.5 diopters.
Cylinder Axis: tolerance of + 5° as stated on label.
Base Curve: measured in dry state, tolerance ±0.02mm.
3
Diameter: within ±0.15mm of stated value on label.
Center Thickness: within ±0.10mm of thickness stated on label.
Physical Appearance:
Color: very light turquoise (visitint) to darker turquoise.
Surface Quality: there must be no defects such as scratches, chips or gouges.
Edges: free of defects.
Optical Quality: bodies, when viewed under 10X magnification, or greater, with an illuminated background.
In summary, tinting of Ocu-Flex-53 Contact Lenses with Reactive Blue 21 Dye has no adverse effects on either the physical or optical properties, even at relatively high intensities of color. It is noted, however, that at the maximum tint level, 181 ug per lens, light transmittance is greatly reduced at the longer and shorter wavelengths of the visible region. At low, or Visitint levels, however, there is essentially no reduction in light transmittance.