(190 days)
Not Found
No
The document describes contact lenses and their materials, with no mention of AI or ML technology.
Yes
The device is indicated for the correction of ametropia, which is a condition that impacts vision. Correcting a physical condition and improving vision classifies it as therapeutic.
No
This document describes contact lenses which are corrective devices for vision, not diagnostic devices used for identifying medical conditions. The "Indications for Use" section clearly states they are for "correction of ametropia".
No
The device description clearly states that the device is a physical contact lens fabricated from specific materials (Acofilcon B or Hioxifilcon B). It does not describe any software component.
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 description clearly states that these are soft contact lenses intended for the correction of vision problems (ametropia, astigmatism, presbyopia) by being placed directly on the eye.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its function is purely optical correction.
The intended use and device description align with a medical device for vision correction, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The IntelliWave1, Sphere (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes. 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 IntelliWave1, Toric (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 5.00 diopters.
The IntelliWave1, Multifocal (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity and are presbyopic requiring add power of up to +4.00 diopters.
The IntelliWave1, Multifocal Toric (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 5.00 diopters and are presbyopic requiring add power of up to +4.00 diopters.
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 IntelliWave2, Sphere (Hioxifilcon B) Soft Contact Lenses for daily, wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes. 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 IntelliWave2, Toric (Hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 5.00 diopters.
The IntelliWave2, Multifocal (Hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity and are presbyopic requiring add power of up to +4.00 diopters.
The IntelliWave2, Multifocal Toric (Ilioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 5.00 diopters and are presbyopic requiring add power of up to +4.00 diopters.
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 (comma separated list FDA assigned to the subject device)
LPL
Device Description
The IntelliWave1, Soft Daily Wear Contact Lenses are fabricated from (Acofilcon B), which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this matcrial allows the lens to become soft and pliable when immersed in an aqueous solution.
The non-ionic lens material, (acofilcon B) is a terpolymer based on high purity Giycerol Methacrylate 2,3-Dihydroxypropyl Methacrylate (GMA), with N-vinyl-2-pyrrolidone (NVP), methy] methacrylate (MMA), and 2-hydroxyethyl methacrylate (2-HEMA) and cross-linked with Diallyl Maleate (DAM). It consists of 51% acofilcon B and 49% water by weight when immersed in normal saline solution buffered with sodium tetraborate. The lens material is available in clear and with a blue visibility-handling tint, Color additive 'Reactive Blue 4' 21 CFR part 73.2121.
The Physical properties of the lens are:
Refractive Index: 1.52 (dry) 1.42 (hydrated)
Light Transmission: greater than 94%
Surface Character: hydrophilic
Water Content: 49 %
Specific Gravity: 1.142 (hydrated)
Oxygen Permeability: 15.89 X 10-11 (cm2/sec) (ml O 2/ml x hPa @ 35°C), (revised Fatt method)
The IntelliWave2, Soft Daily Wear Contact Lenses are fabricated from (Hioxifilcon B), 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, hioxifilcon B is a copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 51% hioxifilcon B and 49% water by weight when immersed in normal saline solution buffered with sodium tetraborate. The lens material is available clear and with a blue visibility handling tint, phthalocyanato (2) - (copper).
The Physical properties of the lens are:
Refractive Index: 1.51 (dry) 1.42 (hydrated)
Light Transmission: greater than 94%
Surface Character: hydrophilic
Water Content: 49 %
Specific Gravity: 1.137 (hydrated)
Oxygen Permeability: 16.40 X 10-11 (cm2/sec) (ml O2/ml x hPa @ 35oC), (revised Fatt method)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The established safety profile (pre-clinical toxicology, clinical study data, manufacturing/chemistry data) of the device is equivalent to the Contaflex GM3 49% and the BENZ-G 3X.
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.
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
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: | K073621 |
|---|---|
| Applicant information: | |
| Date Prepared: | December 21, 2007 |
| Name: | |
| Address | Art Optical Contact Lens, Inc. |
| 3175 3 Mile Road NW | |
| Walker, Michigan 49534 | |
| Contact Person: | |
| Phone number: | Mike Johnson, FCLSA |
| Director of Consultation Services | |
| (616) 559-5167 | |
| Consultant: | |
| Phone number | Med-Vice Consulting, Inc. |
| Martin Dalsing | |
| (970) 243-5490 | |
| Device Information: | |
| Device Classification: | Class II |
| Classification Number: | LPL |
| Classification Name: | Lenses, Soft Contact, Daily Wear |
| Trade Name: | IntelliWave1, Soft Daily Wear Contact Lens (Acofilcon B) |
| IntelliWave2, Soft Daily Wear Contact Lens (Hioxifilcon B) |
1
Equivalent Devices:
The IntelliWave1, Soft Daily Wear Contact Lenses (Acofficon B) and IntelliWave2, Soft Daily Wear Contact Lenses (Hioxifilcon B) are substantially equivalent to the following predicate devices in terms of contact tens. material, intended use and design.
Predicate devices include:
Contaflex GM3 49% manufactured by Contamac Ltd: K024045
BENZ-G 3X manufactured by Benz Research and Development, K964528
IntelliWave1 Device Description:
The IntelliWave1, Soft Daily Wear Contact Lenses are fabricated from (Acofilcon B), which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this matcrial allows the lens to become soft and pliable when immersed in an aqueous solution.
The non-ionic lens material, (acofilcon B) is a terpolymer based on high purity Giycerol Methacrylate 2,3-Dihydroxypropyl Methacrylate (GMA), with N-vinyl-2-pyrrolidone (NVP), methy] methacrylate (MMA), and 2-hydroxyethyl methacrylate (2-HEMA) and cross-linked with Diallyl Maleate (DAM). It consists of 51% acofilcon B and 49% water by weight when immersed in normal saline solution buffered with sodium tetraborate. The lens material is available in clear and with a blue visibility-handling tint, Color additive 'Reactive Blue 4' 21 CFR part 73.2121.
The Physical properties of the lens are:
| Refractive Index | 1.52 (dry) 1.42 (hydrated) |
|---|---|
| Light Transmission | greater than 94% |
| Surface Character | hydrophilic |
| Water Content | 49 % |
| Specific Gravity | 1.142 (hydrated) |
| Oxygen Permeability | 15.89 X 10-11 (cm2/sec) (ml O 2/ml x hPa @ 35°C), (revised Fatt method) |
IntelliWave1 Indications for Use
The IntelliWave1, Sphere (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes. 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.
2
The IntelliWave1, Toric (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased cyes and/or possesses refractive astigmatism not exceeding 5.00 diopters.
The IntelliWave1, Multifocal (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism of .75 diopters or less where the astigmatism docs not interfyre with visual acuity and are presbyopic requiring add power of up to +4.00 diopters.
The IntelliWave1, Multifocal Toric (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 5.00 diopters and are presbyopic requiring add power of up to +4.00 diopters.
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.
IntelliWave2 Device Description:
The IntelliWave2, Soft Daily Wear Contact Lenses are fabricated from (Hioxifilcon B), 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, hioxifilcon B is a copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 51% hioxifilcon B and 49% water by weight when immersed in normal saline solution buffered with sodium tetraborate. The lens material is available clear and with a blue visibility handling tint, phthalocyanato (2) - (copper).
The Physical properties of the lens are:
| Refractive Index | 1.51 (dry) 1.42 (hydrated) |
|---|---|
| Light Transmission | greater than 94% |
| Surface Character | hydrophilic |
| Water Content | 49 % |
| Specific Gravity | 1.137 (hydrated) |
| Oxygen Permeability | $16.40 X 10^{-11}$ (cm2/sec) (ml O2/ml x hPa @ 35oC), (revised Fatt method) |
3
IntelliWave2 Indications for Use
The IntelliWave2, Sphere (Hioxifilcon B) Soft Contact Lenses for daily, wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes. 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 IntelliWave2, Toric (Hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 5.00 diopters.
The IntelliWave2, Multifocal (Hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity and are presbyopic requiring add power of up to +4.00 diopters.
The IntelliWave2, Multifocal Toric (Ilioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 5.00 diopters and are presbyopic requiring add power of up to +4.00 diopters.
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 lons may be cleaned and disinfected using a chemical (not heat) lens care system.
Substantial Equivalence:
The device will be manufactured according to specified process controls and a quality assurance program. The established safety profile (pre-clinical toxicology, clinical study data, manufacturing/chemistry data) of the device is equivalent to the Contaflex GM3 49% and the BENZ-G 3X. Being similar with respect to indications for use, materials, physical construction and safety & effectiveness to the predicate devices, 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.
4
The following matrix illustrates the production method, lens function and material characteristics of the IntelliWavel, Soft Daily Wear Contact Lens (Acofilcon B) and IntelliWave2, Soft Daily Wear Contact Lens (Hioxifilcon B), as well as the predicate devices.
| | IntelliWave
new device | CONTAFLEX GM3 49%
(acofilcon B)
predicate device | BENZ-G3X
(hioxifilcon B)
predicate device |
|------------------------|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | same as
predicate device | 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. |
| Functionality | same as
predicate device | 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. |
| Indications | same as
predicate device | Daily wear, Soft (hydrophilic)
contact lens | Daily wear, Soft (hydrophilic)
contact lens |
| Production
Method | same as
predicate device | Lathe-cut | Lathe-cut |
| FDA Group # | same as
predicate device | Group # 1