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.

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 and 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.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding the BIOLENS (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear. It details how the device demonstrates substantial equivalence to predicate devices, focusing on its physical and chemical properties and non-clinical performance data.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics against a defined threshold. Instead, it demonstrates substantial equivalence by comparing the BIOLENS properties to those of two legally marketed predicate devices (LSH and iO2, both made of mangofilcon A). The "reported device performance" in this context refers to the physicochemical properties and other characteristics of the BIOLENS and its predicates.

Characteristic	BIOLENS (subject device)	LSH (1° predicate)	iO2 (2° predicate)
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
Manufacturing Method	Lathe-cut	Lathe-cut	Lathe-cut
Plasma Treatment?	Yes	Yes	Yes
Water Content	49%	49%	49%
Oxygen Transmissibility (Dk)	49 (ISO/Fatt)	49 (ISO/Fatt)	49 (ISO/Fatt)
Refractive Index (Dry)	1.470	1.470	1.470
Refractive Index (Hydrated)	1.413	1.413	1.413
Specific Gravity (Dry)	1.112	1.112	1.112
Specific Gravity (Hydrated)	1.109	1.109	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	96%T	96%T
Light Transmittance (Tinted)	>70%T	>70%T	>70%T

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly specify a "test set" or its "sample size" in a clinical trial context. This submission focuses on physicochemical characterization and non-clinical performance, comparing the new device against existing predicate devices. Therefore, the data provenance is derived from the testing of the BIOLENS (mangofilcon A) and the properties of the predicate devices, which are also mangofilcon A lenses. It's an engineering and material science assessment rather than a clinical study with a patient test set. No country of origin for specific "data" is mentioned, but the submission is to the US FDA. The data would be considered retrospective in the sense that it relies on existing knowledge and characterization of the material (mangofilcon A) and the predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable to the provided document. The submission is a 510(k) premarket notification for a Class II medical device (contact lenses) and relies on demonstrating substantial equivalence through non-clinical data (i.e., material properties and performance characteristics), not on clinical "ground truth" established by experts in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not applicable. There is no explicit "adjudication method" described, as there isn't a test set that requires expert interpretation or clinical outcome assessment in this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a contact lens, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done

This is not applicable. The device is a contact lens, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established physicochemical properties and performance characteristics of the mangofilcon A material and the predicate devices, as determined through various non-clinical tests (e.g., Dk measurements, refractive index, tensile strength). It's based on material science and engineering characterization data. No pathology, expert consensus on clinical images, or outcomes data is mentioned as a "ground truth" source in this context.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of an AI/machine learning model. The submission is for a physical medical device.

9. How the Ground Truth for the Training Set was Established

This is not applicable as there is no "training set" for this device.

Summary

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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.

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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

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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)

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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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, LLC1750 N. Loop Road, Ste. #150Alameda, CA 94502 USA
Contact Person:	Mr. Jeff Rinkus, COO510-483-9400 (office)
Consultant &SubmissionCorrespondent:	Kevin Randall, Principal ConsultantComplianceAcuity, Inc.Golden, CO 80402(303) 828-0844 (direct)(303) 828-0835 (fax)Email: info@complianceacuity.com
Date SummaryPrepared:	November 6 , 2014

II. Name of Device

Trade Name:	BIOLENS (mangofilcon A)Soft (hydrophilic) Contact Lens forDaily 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

	BIOLENSSphere	BIOLENSMultifocal	BIOLENSToric	BIOLENSToricMultifocal
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 insteps of 0.25 D	Up to-4.00 D insteps 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 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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Characteristic	Value
Dk	49(Fatt Units @ 35°C)
REFRACTIVE INDEX	Dry: 1.470Hydrated: 1.413
SPECIFIC GRAVITY	Dry: 1.112Hydrated: 1.109
LINEAR EXPANSION RATIO	1.26
WATER CONTENT	49%
LIGHT TRANSMITTANCE	Clear: 96%TTinted: >70%T
PLASMA TREATMENT REQUIRED	Yes
SHORE D HARDNESS (blank form)	≥ 83

IV. Indications for Use

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.

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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 / UVAbsorber	• 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.

END OF 510(k) SUMMARY

Regulation Number and Section

§ 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.