(212 days)
Not Found
No
The document describes a standard contact lens with various parameters and material properties. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No.
The device is indicated for the correction of refractive errors (myopia, hyperopia, astigmatism, presbyopia) and not for treating a disease or condition.
No.
The device is a contact lens intended for the correction of refractive errors (myopia, hyperopia, astigmatism, presbyopia), which is a treatment rather than a diagnostic function.
No
The device description clearly describes a physical contact lens made of a specific material (mangofilcon A) with defined physical parameters (diameter, thickness, base curve, etc.). It also mentions manufacturing processes like plasma treatment and includes performance studies related to the physical and chemical properties of the lens. This indicates a hardware medical device, not a software-only one.
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 BIOLENS contact lenses are described as devices for the correction of refractive errors (myopia, hyperopia, astigmatism, presbyopia) by being placed directly on the eye. They are a physical device used for vision correction, not for analyzing biological samples.
- Intended Use: The intended use clearly states the correction of vision problems in patients with non-diseased eyes. It does not mention any diagnostic purpose or analysis of biological samples.
- Device Description: The description focuses on the physical properties and materials of the contact lenses.
- Performance Studies: The performance studies listed are related to the physical and chemical properties of the lens material and its compatibility with the eye and solutions, not diagnostic performance metrics like sensitivity or specificity.
Therefore, the BIOLENS contact lens is a medical device, but it falls under the category of vision correction devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of myopia and hyperopia 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 +20.00 to -20.00 D.
The BIOLENS Toric (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic or non-aphakic persons with non diseased eyes in a spherical power range of +20.00 to -20.00 D and a cylinder power range up to -10.0D.
The BIOLENS Multifocal (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear 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 +20.00 to -20.00 D and have near add requirements up to 3.25 D.
The BIOLENS Toric Multifocal (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear 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 +20.00 to -20.00 D, a cylinder power range up to -4.00 D and an add requirement up to +3.25 D.
BIOLENS lenses may be disinfected using chemical (not heat) disinfecting systems.
BIOLENS UV lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
Product codes
LPL
Device Description
The BIOLENS (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is available in spherical, toric, multifocal, and toric-multifocal designs. Specifically, the BIOLENS models are hemispheric flexible shells of the following parameters:
Diameter(s): 12.0 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): 8.0 mm - 9.5 mm
Powers: -20.00 D to +20.00 D
Cylinder Powers: Not Applicable (N/A) for sphere and multifocal; Up to-10.00 D in steps of 0.25 D for toric; Up to-4.00 D in steps of 0.25 D for toric multifocal
Axis: Not Applicable (N/A) for sphere and multifocal; 1° to 180° for toric; Not specified for toric multifocal
Add Powers: N/A for sphere and toric; +0.50D to +3.25D for multifocal and toric multifocal
All BIOLENS 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 BIOLENS (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 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.
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Image /page/0/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 image of three human profiles facing to the right, stacked on top of each other, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 30, 2015
ABB Ontical Group, LLC c/o Mr. Kevin M. Randall Principal Consultant Compliance Acuity, Inc. P.O. Box 1490 Golden. CO 80402
Re: K142820
Trade/Device Name: BIOLENS (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: March 12, 2015 Received: March 16, 2015
Dear Mr. Randall:
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. 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.
1
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 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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 -A
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
2
Indications for Use
510(k) Number (if known) K142820
Device Name
BIOLENS (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear
Indications for Use (Describe)
The BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of myopia and hyperopia 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 +20.00 to -20.00 D.
The BIOLENS Toric (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic or non-aphakic persons with non diseased eyes in a spherical power range of +20.00 to -20.00 D and a cylinder power range up to -10.0D.
The BIOLENS Multifocal (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear 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 +20.00 to -20.00 D and have near add requirements up to 3.25 D.
The BIOLENS Toric Multifocal (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear 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 +20.00 to -20.00 D, a cylinder power range up to -4.00 D and an add requirement up to +3.25 D.
BIOLENS lenses may be disinfected using chemical (not heat) disinfecting systems.
BIOLENS UV lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/3/Picture/2 description: The image shows the logo for ABB Optical Group. The text "ABB OPTICAL GROUP" is written in a dark blue sans-serif font. Above the text is a light blue curved line that arches over the text, giving the logo a sense of depth and dimension.
I. Submitter Information
| 510(k) Owner: | ABB Optical Group, LLC
1750 N. Loop Road, Ste. #150
Alameda, CA 94502 USA |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Jeff Rinkus, COO
510-483-9400 (office) |
| Consultant &
Submission
Correspondent: | Kevin Randall, Principal Consultant
ComplianceAcuity, Inc.
Golden, CO 80402
(303) 828-0844 (direct)
(303) 828-0835 (fax)
Email: info@complianceacuity.com |
| Date Summary
Prepared: | November 6 , 2014 |
II. Name of Device
| Trade Name: | BIOLENS (mangofilcon A)
Soft (hydrophilic) Contact Lens for
Daily Wear |
|----------------------------|------------------------------------------------------------------------------|
| Common/Usual Name: | Soft (hydrophilic) contact lens |
| Classification Name: | Lenses, Soft Contact, Daily Wear |
| Classification Regulation: | 21 CFR 886.5925 |
| USAN (generic name): | Mangofilcon A |
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Image /page/4/Picture/2 description: The image shows the logo for ABB Optical Group. The text "ABB OPTICAL GROUP" is written in a sans-serif font, with "ABB" being larger than "OPTICAL GROUP". A blue arc is above the text, adding a visual element to the logo.
III. Device Description & Technological Characteristics
The BIOLENS (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is available in spherical, toric, multifocal, and toric-multifocal designs. Specifically, the BIOLENS models are hemispheric flexible shells of the following parameters:
| | BIOLENS
Sphere | BIOLENS
Multifocal | BIOLENS
Toric | BIOLENS
Toric
Multifocal |
|--------------------------------------|----------------------|-----------------------|-------------------------------------|------------------------------------|
| Diameter(s) | 12.0 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) | 8.0 mm - 9.5 mm | | | |
| Powers | -20.00 D to +20.00 D | | | |
| Cylinder Powers | Not Applicable (N/A) | | Up to-10.00 D in
steps of 0.25 D | Up to-4.00 D in
steps of 0.25 D |
| Axis | Not Applicable (N/A) | | 1° to 180° | |
| Add Powers | N/A | +0.50D to
+3.25D | N/A | +0.50D to
+3.25D |
All BIOLENS 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 BIOLENS (mangofilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear are tabulated at the top of the next page:
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Image /page/5/Picture/2 description: The image shows the logo for ABB Optical Group. The logo consists of the text "ABB OPTICAL GROUP" in a dark blue sans-serif font. Above the text is a curved blue line that arches over the text. The background is white.
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 |
IV. Indications for Use
The BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of myopia and hyperopia 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 +20.00 to -20.00 D.
The BIOLENS Toric (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic or non-aphakic persons with non diseased eyes in a spherical power range of +20.00 to -20.00 D and a cylinder power range up to -10.0D.
The BIOLENS Multifocal (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear 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 +20.00 to -20.00 D and have near add requirements up to 3.25 D.
The BIOLENS Toric Multifocal (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear 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 +20.00 to -20.00 D, a cylinder power range up to -4.00 D and an add requirement up to +3.25 D.
BIOLENS lenses may be disinfected using chemical (not heat) disinfecting systems.
BIOLENS UV lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
6
Image /page/6/Picture/2 description: The image shows the logo for ABB Optical Group. The logo features the text "ABB OPTICAL GROUP" in a bold, sans-serif font. A blue arc is positioned above the text, adding a visual element to the logo.
v. Comparison to Legally Marketed Predicates
BIOLENS | LSH | iO2 | |
---|---|---|---|
PROPERTY | (mangofilcon A) | (mangofilcon A) | (mangofilcon A) |
(subject device) | (1º predicate) | (2º predicate) | |
Marketing Status | Not Yet Cleared | K120756 | K133079 |
USAN | Mangofilcon A | Mangofilcon A | Mangofilcon A |
Device Class | II | II | II |
FDA Product Code | LPL | LPL | LPL |
Regulation | 21 CFR 886.5925 | 21 CFR 886.5925 | 21 CFR 886.5925 |
Indications for Use | See section IV of this | Same* as subject | Same* as subject |
510(k) Summary | BIOLENS | BIOLENS | |
Manufacturing Method | Lathe-cut | Lathe-cut | Lathe-cut |
Plasma Treatment? | Yes | Yes | Yes |
Water Content | 49% | 49% | 49% |
Oxygen Transmissibility | 49 (ISO/Fatt) | 49 (ISO/Fatt) | 49 (ISO/Fatt) |
Refractive Index | Dry: 1.470 | Dry: 1.470 | Dry: 1.470 |
Hydrated: 1.413 | Hydrated: 1.413 | Hydrated: 1.413 | |
Specific Gravity | Dry: 1.112 | Dry: 1.112 | Dry: 1.112 |
Hydrated: 1.109 | Hydrated: 1.109 | Hydrated: 1.109 | |
Shore D Hardness | > 83 | > 83 | > 83 |
Tensile Strength | 3.07 M Pa | 3.07 M Pa | 3.07 M Pa |
Elongation at Break | 470% | 470% | 470% |
Light Transmittance | Clear: 96%T | Clear: 96%T | Clear: 96%T |
Tinted: >70%T | Tinted: >70%T | Tinted: >70%T |
- Although UV protection is emphasized in the BIOLENS indications per Agency request, the UV protection offered by the BIOLENS is the same as the predicates.
VI. Summary of Non-Clinical Performance Data
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 |
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Image /page/7/Picture/2 description: The image shows the logo for ABB Optical Group. The logo features the text "ABB OPTICAL GROUP" in a bold, sans-serif font. Above the text is a curved, blue line that arches over the entire logo. The background is a gradient of light blue and white.
VIII. Conclusions Drawn
It is the conviction of ABB Optical Group 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 devices, and that does not raise different questions of safety and effectiveness. Based on these facts, ABB Optical Group therefore concludes that the subject device is as safe and as effective, that is, "substantially equivalent" to, the predicates pursuant to section 513(i) of the Act.