(78 days)
Not Found
No
The document describes contact lenses and their material properties, with no mention of AI or ML technology.
No
The device is a contact lens indicated for the correction of visual defects (myopia, hyperopia, presbyopia, astigmatism), which are optical conditions, not diseases requiring therapeutic treatment.
No
This device is a contact lens intended for correcting refractive errors (myopia, hyperopia, presbyopia, astigmatism), not for diagnosing medical conditions.
No
The device description clearly states it is a physical contact lens made of a specific material (mangofilcon A) and describes its physical properties and designs. There is no mention of software as the primary component or function.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a contact lens for the correction of vision problems (myopia, hyperopia, astigmatism, presbyopia). It is a therapeutic device used to alter the refractive properties of the eye.
- Device Description: The description details the physical characteristics and material of a contact lens.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health. IVDs are used to perform tests on samples from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Anatomical Site: While the device interacts with the eye, it is not performing a diagnostic test on a sample from the eye.
Therefore, the iO2 Sphere, ASTERA Multifocal iO2, iO2Toric, and ASTERA Multifocal Toric iO2 contact lenses are medical devices, but they fall under the category of therapeutic devices rather than in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The iO2 Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of myopia and hyperopia in aphakic or non-aphakic patients with nondiseased eyes who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +30.00 to -30.00 D.
The ASTERA Multifocal iO2 (mangofilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic and hyperopic eyes in aphakic or non-aphakic patients with non-diseased eyes who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +30.00 to -30.00 D and have near add requirements up to 3.25 D.
The iO2Toric (mangofilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of refractive ametropia (myopia, and astigmatism) in aphakic or non- aphakic persons with non diseased eyes in a spherical power range of +30.00 to 30.00 D and a cylinder power range up to -10.0D.
The ASTERA Multifocal Toric iO2 (mangofilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic. hyperopic and astigmatic aphakic or non- aphakic patients with non-diseased eyes in a spherical power range of 430.00 to -30.00 D. a cylinder power range up to -10.00 D and an add requirement up to 3.25 D.
iO2 lenses may be disinfected using chemical (not heat) disinfecting systems.
Product codes
LPL
Device Description
The iO2 (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is available in spherical, multifocal, toric, and toric-multifocal designs. Specifically, the iO2 Sphere, iO2 Toric, ASTERA Multifocal iO2, and ASTERA Multifocal Toric iO2 models are hemispheric flexible shells of the following parameters:
Diameter(s): 10.0 mm to 16.0 mm
Center Thickness (Low Minus Lens): 0.07 mm dry
Center Thickness (Plus Lens): Up to 0.50 mm
Base Curve(s): 6.5 mm - 9.9 mm
Powers: -30.00 D to +30.00 D
Cylinder Powers: Not Applicable (N/A) for Sphere/Multifocal, Up to -10.00 D in steps of 0.25 D for Toric/Multifocal Toric
Axis: Not Applicable (N/A) for Sphere/Multifocal, 1° to 180° for Toric/Multifocal Toric
Add Powers: N/A for Sphere/Toric, P1/ to +1.50, P2/ +1.75 to +2.25, P3/ +2.50 up for Multifocal/Multifocal Toric
All iO2 lenses are plasma treated in the dry state prior to initial hydration. The lens material (mangofilcon A) is a non-ionic hydrophilic copolymer that consists of 51% mangofilcon A and 49% water by weight. Mangofilcon A is available clear (no tint) with or without a UV absorber to block a significant amount of the UV radiation occurring between 200 and 400 nm (UVA and UVB). Mangofilcon A is also available in Blue or Aqua visibility tints to assist with handling. Both colors are available with or without the UV absorber.
The physicochemical properties of iO2 (mangofilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear are:
Dk: 49 (Fatt Units @ 35°C)
REFRACTIVE INDEX: Dry: 1.470, Hydrated: 1.413
SPECIFIC GRAVITY: Dry: 1.112, Hydrated: 1.109
LINEAR EXPANSION RATIO: 1.26
WATER CONTENT: 49%
LIGHT TRANSMITTANCE: Clear: 96%T, Tinted: >70%T
PLASMA TREATMENT REQUIRED: Yes
SHORE D HARDNESS (blank form): ≥ 83
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
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)
A combination of relevant non-clinical analysis and testing has been assured, including:
• Chemical composition of finished lenses
• Purity of initial monomers
• Shelf Life
• Leachability of Residual Monomers
• Leachability of Color Additives / UV Absorber
• Biocompatibility testing
• Preservative Uptake and Release
• Color and light transmittance
• Refractive index
• Water content
• Oxygen transmissibility
• Specific gravity
• Mechanical Testing & Hardness
• Lens/Solution Compatibility
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows a logo for Alden Optical. The logo consists of a stylized "A" shape above the words "ALDEN" and "OPTICAL", which are stacked vertically. The logo is black and white and has a slightly distressed or textured appearance.
DEC 1 7 2013
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
. ·
I. Submitter Information
| 510(k) Owner: | Alden Optical Laboratories, Inc.
6 Lancaster Pkwy
Lancaster, NY 14086 USA |
| --------------- | --------------------------------------------------------------------------------- |
|---|
- Contact Person: Mr. Charley Creighton 716-937-9181 (office) 716-937-3303 (fax)
| Consultant &
Submission
Correspondent: | Kevin Randall, Principal Consultant
ComplianceAcuity, Inc.
Golden, CO 80403
(303) 828-0844 (direct)
(303) 828-0835 (fax)
Email: info@complianceacuity.com |
| ---------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Date Summary September 27, 2013 Prepared:
II. Name of Device
| Trade Name: iO2 (mangofilcon A) Soft (hydrophilic) | |||
|---|---|---|---|
| Contact Lens for Daily Wear | |||
| Common/Usual Name: Soft (hydrophilic) contact lens | |||
| Classification Name: Lenses, Soft Contact, Daily Wear | |||
| USAN (generic name): Mangofilcon A |
510(k) Summary Page I of 5
1
Image /page/1/Picture/0 description: The image shows a logo for Alden Optical. The logo consists of a stylized triangle shape above the words "ALDEN OPTICAL". The triangle shape has a small triangle in the center. The text and shapes are black and the background is white.
III. Device Description & Technological Characteristics
The iO2 (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is available in spherical, multifocal, toric, and toric-multifocal designs. Specifically, the iO2 Sphere, iO2 Toric, ASTERA Multifocal iO2, and ASTERA Multifocal Toric iO2 models are hemispheric flexible shells of the following parameters:
| | iO₂ Sphere | ASTERA
Multifocal
iO₂ | iO₂ Toric | ASTERA
Multifocal
Toric iO₂ |
|--------------------------------------|----------------------|----------------------------------------------------|-------------------------------------|----------------------------------------------------|
| Diameter(s) | 10.0 mm to 16.0 mm | | | |
| Center Thickness
(Low Minus Lens) | 0.07 mm dry | | | |
| Center Thickness
(Plus Lens) | Up to 0.50 mm | | | |
| Base Curve(s) | 6.5 mm - 9.9 mm | | | |
| Powers | -30.00 D to +30.00 D | | | |
| Cylinder Powers | Not Applicable (N/A) | | Up to-10.00 D
in steps of 0.25 D | |
| Axis | Not Applicable (N/A) | | 1° to 180° | |
| Add Powers | N/A | P1/ to +1.50
P2/ +1.75 to +2.25
P3/ +2.50 up | N/A | P1/ to +1.50
P2/ +1.75 to +2.25
P3/ +2.50 up |
All iO2 lenses are plasma treated in the dry state prior to initial hydration.
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:
:
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The lens material (mangofilcon A) is a non-ionic hydrophilic copolymer that consists of 51% mangofilcon A and 49% water by weight. Mangofilcon A is available clear (no tint) with or without a UV absorber to block a significant amount of the UV radiation occurring between 200 and 400 nm (UVA and UVB). Mangofilcon A is also available in Blue or Aqua visibility tints to assist with handling. Both colors are available with or without the UV absorber.
The.physicochemical properties of iO2 (mangofilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear are tabulated at the top of the next page:
510(k) Summary Page 2 of 5
2
Image /page/2/Picture/0 description: The image shows a logo for Alden Optical. The logo consists of a stylized eye-like symbol above the words "ALDEN" and "OPTICAL", which are stacked vertically. The text is in a simple, sans-serif font, and the overall design is clean and professional.
| Characteristic | Value |
|---|---|
| Dk | 49 |
| (Fatt Units @ 35°C) | |
| REFRACTIVE INDEX | Dry: 1.470 |
| Hydrated: 1.413 | |
| SPECIFIC GRAVITY | Dry: 1.112 |
| Hydrated: 1.109 | |
| LINEAR EXPANSION RATIO | 1.26 |
| WATER CONTENT | 49% |
| LIGHT TRANSMITTANCE | Clear: 96%T |
| Tinted: >70%T | |
| PLASMA TREATMENT REQUIRED | Yes |
| SHORE D HARDNESS (blank form) | ≥ 83 |
iO2 (mangofilcon A) Physicochemical Properties
IV. Indications for Use
i
. .
The iO2 Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of myopia and hyperopia in aphakic or non-aphakic patients with nondiseased eyes who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +30.00 to -30.00 D.
The ASTERA Multifocal iO2 (mangofilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic and hyperopic eyes in aphakic or non-aphakic patients with non-diseased eyes who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +30.00 to -30.00 D and have near add requirements up to 3.25 D.
The iO2Toric (mangofilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of refractive ametropia (myopia, and astigmatism) in aphakic or non-aphakic persons with non diseased eyes in a spherical power range of +30.00 to
30.00 D and a cylinder power range up to -10.0D.
The ASTERA Multifocal Toric iO2 (mangofilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic. hyperopic and astigmatic aphakic or non-aphakic patients with non-diseased eyes in a spherical power range of 430.00 to -30.00 D. a cylinder power range up to -10.00 D and an add requirement up to 3.25 D.
iO2 lenses may be disinfected using chemical (not heat) disinfecting systems.
510(k) Summary Page 3 of 5
3
Image /page/3/Picture/0 description: The image shows a logo for Alden Optical. The logo features a stylized letter 'A' inside a curved shape, positioned above the words 'ALDEN' and 'OPTICAL', which are stacked vertically. The text is in a bold, sans-serif font, and the overall design is simple and modern.
V. Comparison to Legally Marketed Predicate
| PROPERTY | iO2(mangofilcon A)
(subject device) | LSH (mangofilcon A)
(predicate device) |
|-------------------------|----------------------------------------|-------------------------------------------|
| Marketing Status | Not Yet Cleared | K120756 |
| USAN | Mangofilcon A | Mangofilcon A |
| Device Class | II | II |
| FDA Product Code | LPL | LPL |
| Regulation | 21 CFR 886.5925 | 21 CFR 886.5925 |
| Intended Use | Same as predicate LSH | Same as subject iO2 |
| Manufacturing Method | Lathe-cut | Lathe-cut |
| Plasma Treatment? | Yes | Yes |
| Water Content | 49% | 49% |
| Oxygen Transmissibility | 49 (ISO/Fatt) | 49 (ISO/Fatt) |
| Refractive Index | Dry: 1.470
Hydrated: 1.413 | Dry: 1.470
Hydrated: 1.413 |
| Specific Gravity | Dry: 1.112
Hydrated: 1.109 | Dry: 1.112
Hydrated: 1.109 |
| Shore D Hardness | ≥83 | ≥ 83 |
| Tensile Strength | 3.07 M Pa | 3.07 M Pa |
| Elongation at Break | 470% | 470% |
| Light Transmittance | Clear: 96%T
Tinted: >70%T | Clear: 96%T
Tinted: >70%T |
Summary of Non-Clinical Performance Data VI.
- A combination of relevant non-clinical analysis and testing has been assured, including:
| • Chemical composition of finished lenses | • Color and light transmittance |
|---|---|
| • Purity of initial monomers | • Refractive index |
| • Shelf Life | • Water content |
| • Leachability of Residual Monomers | • Oxygen transmissibility |
| • Leachability of Color Additives / UV | |
| Absorber | • Specific gravity |
| • Biocompatibility testing | • Mechanical Testing & Hardness |
| • Preservative Uptake and Release | • Lens/Solution Compatibility |
510(k) Summary Page 4 of 5
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Image /page/4/Picture/0 description: The image shows a logo for Alden Optical. The logo features the words "ALDEN OPTICAL" in a stacked format, with "ALDEN" on top and "OPTICAL" below. Above the text is a stylized graphic element that resembles an eye or a lens shape. The logo is in black and white and has a slightly distressed or vintage appearance.
VIII. Conclusions Drawn
:
..
イ・・・・・ :
・・・
ﺎ. .
It is the conviction of Alden Optical Laboratories that the information and data submitted in this premarket notification substantiate our ability to manufacture a contact lens with a safety and effectiveness profile that is substantially equivalent to the predicate device, and that does not raise different questions of safety and effectiveness. ·Based on these facts, Alden therefore concludes that the subject device is as safe and as effective, that is, "substantially equivalent" to, the predicate pursuant to section 513(i) of the Act.
END OF 510(k) SUMMARY
510(k) Summary Page 5 of 5
..:
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure with three wavy lines below it.
Public Health Service
February 19, 2014
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Alden Optical Laboratories. Inc. % Mr. Kevin Randall, RAC ComplianceAcuity, Inc. 16576 W. 53d Way Golden, CO 80403
Re: K133079
Trade Name: iO2 (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: II Product Code: LPL Dated: November 5, 2013 Received: November 6, 2013
Dear Mr. Randall:
This letter corrects our substantially equivalent letter of December 17, 2013.
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
6
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kesia Y. Alexander -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K133079
Device Name: iO2 (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear
Indications For Use:
The iO2 Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of myopia and hyperopia in aphakic or non-aphakic patients with nondiseased eves
who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +30.00 to -30.00 D.
The ASTERA Multifocal iO2 (mangofilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic and hyperopic eyes in aphakic or nonaphakic patients with non-diseased eyes who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +30.00 to -30.00 D and have near add requirements up to 3.25 D.
The iO2Toric (mangofilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of refractive ametropia (myopia, and astigmatism) in aphakic or non- aphakic persons with non diseased eyes in a spherical power range of +30.00 to -30.00 D and a cylinder power range up to -10.0D.
The ASTERA Multifocal Toric iO2 (mangofilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic, hyperopic and astigmatic aphakic or non- aphakic patients with non-diseased eyes in a spherical power range of +30.00 to -30.00 D, a cylinder power range up to -10.00 D and an add requirement up to 3.25 D.
iO2 lenses may be disinfected using chemical (not heat) disinfecting systems.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Page 1 of _ 2 __
8
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joseph C. Hutter -S 2013.12.13 13:18:08 -05'00'
(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices
510(k) Number_K133079_
Page 2 of _2