The LSH (mangofilcon A) Sphere Soft (hydrophilic) Contact Lens 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 Diopters of astigmatism and can obtain satisfactory visual acuity in a power range of +12.00 to -20.00 Diopters.

The LSH (mangofilcon A) Multifocal 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 Diopters of astigmatism and can obtain satisfactory visual acuity in a power range of +12.00 to -20.00 Diopters and have near add requirements up to 3.25 Diopters.

The LSH (mangofilcon A) Toric 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 +12.00 to -20.00 Diopters and a cylinder power range of -0.50 to 2.50 Diopters.

The LSH (mangofilcon A) Toric-Multifocal 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 +12.00 to -20.00 Diopters, a cylinder power range of -0.50 to 2.50 Diopters and an add requirement up to 3.25 Diopters.

The lenses may be disinfected using chemical (not heat) disinfecting systems.

Device Description

The LSH (mangofilcon A) is available as a spherical, multifocal, toric, and toric-All LSH lenses are plasma treated in the dry state prior to initial multifocal lens. hydration.

The lens material, (mangofilcon A), is a non-ionic hydrophilic copolymer that consists of 51% mangofilcon A (N.N-dimethyl acrylamide (NNDMA) polymer with 3-methacryloxy propyltris(trimethylsilyl)siloxane (TRIS)), trifluoroethyl methacrylate (TFEM), 2- hydroxyethyl methacrylate (HEMA), N-vinyl-2-pyrrolidone (NVP), cross-linked with ethyleneglycol dimethacrylate (EGDMA), and 49% water by weight.

Mangofilcon A is available in 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). The UV absorber is 2-(5-chloro-2H-benzotriazole-2-yl)-6-(1,1-dimethylethyl)-4- ethenyl phenol (UVAM).

Mangofilcon A is available in Blue or Aqua visibility tints to assist with handling, and both colors are available with or without UV absorber. The Blue lenses are tinted using 1,4-Bis[4-(2-methacryloxyethy]) phenylamino]anthraquinone (21 CFR 73.3106), and the Aqua lenses are tinted using Phthalocyanine Green (21 CFR 73.312).

The LSH (mangofilcon A) Sphere, Multifocal, Toric, and Toric-Multifocal Soft (hydrophilic) Lenses for Daily Wear are hemispheric flexible shells of the following dimensions.

Diameter(s): Sphere 10.0 mm to 16.0 mm, Multifocal 14.0 mm to 16.0 mm, Toric Not Applicable (N/A), Toric-Multifocal 14.0 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 - 9.7 mm
Powers: Sphere -20.00 D to +12.00 D, Multifocal -20.00 D to +12.00 D, Toric -20.00 D to +12.00 D, Toric-Multifocal -20.00 D to +12.00 D
Cylinder Powers: Sphere N/A, Multifocal N/A, Toric -0.50 D to 2.50 D in steps of 0.25 D, Toric-Multifocal N/A
Axes: Sphere N/A, Multifocal N/A, Toric 0° to 180°, Toric-Multifocal N/A
Add Powers: Sphere N/A, Multifocal +1.00 D to +3.25 D in steps of 0.25 D, Toric N/A, Toric-Multifocal +1.00 D to +3.25 D in steps of 0.25 D

The physical/optical properties of the lenses are:
Oxygen Permeability (Dk) (35°C, Fatt Units): 49
Refractive Index: Dry - 1.470, Hydrated - 1.413
Specific Gravity: Dry - 1.112, Hydrated - 1.109
Linear Expansion Ratio: 1.26
Water Content: 49%
Visible Light Transmittance: 96%T
Plasma Treatment Required: Yes
Shore D Hardness (in blank form): ≥83

AI/ML Overview

This document describes the premarket notification for the LSH (mangofilcon A) Soft (hydrophilic) Contact Lens and its substantial equivalence to a predicate device. The information is extracted directly from the provided text.

Acceptance Criteria and Device Performance Study

The acceptance criteria for the LSH (mangofilcon A) Soft (hydrophilic) Contact Lens are not explicitly stated as distinct numerical criteria that must be met in a table. Instead, the study aims to demonstrate that the new device is "as safe, as effective and performs as well as the predicate device" through a comparison of physical properties and clinical data. Therefore, the "acceptance criteria" are implied to be achieving comparable safety and effectiveness outcomes and similar physical properties to the predicate device.

Table of Acceptance Criteria (Implied) and Reported Device Performance

Property	LSH Latheable Silicone Hydrogel (mangofilcon A) (New Device)	Predicate Device BENZ 3GX (hioxifilcon B)
Oxygen Permeability (Dk) (35°C, Fatt Units)	49	15
Refractive Index (Dry)	1.470	1.507
Refractive Index (Hydrated)	1.413	1.425
Specific Gravity (Dry)	1.112	1.308
Specific Gravity (Hydrated)	1.109	1.136
Linear Expansion Ratio	1.26	1.3
Water Content	49%	49%
Tensile Strength	3.07 M Pa	25g/mm2
% Elongation at Break	470	186
Visible Light Transmittance	96% T	95% T
Plasma Treatment Required	Yes	No
Shore D Hardness (in blank form)	≥ 83	≥ 90
Clinical Safety & Efficacy	Demonstrated safe and effective	Established safe and effective (predicate)

Study Details:

Sample size used for the test set and the data provenance:
- Test set sample size: "Seventy-five (75) patients were enrolled in the study (56 test/19 control)."
- Data provenance: Not explicitly stated, but clinical studies for such devices are typically conducted in the country where the device is seeking regulatory clearance. Given the 510(k) summary submitted to the FDA, it's highly probable the study was conducted in the United States.
- Retrospective or prospective: The clinical study was described as "A three month clinical study was conducted...", indicating a prospective study design.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For contact lens safety and efficacy studies, the "ground truth" is established through direct observation of physiological responses and visual acuity measurements in patients, rather than expert interpretation of images or other data. The study primarily evaluated safety and efficacy through clinical observation by eye care professionals.
Adjudication method for the test set: Not applicable in the context of an adjudication method typical for image-based diagnostic AI studies. Safety and efficacy were assessed through direct clinical observations and measurements over a three-month period.
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: Not applicable. This study is for a contact lens, not an AI-powered diagnostic device, so an MRMC study is not relevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This study is for a physical medical device (contact lens), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device's performance relies on clinical outcomes data from the three-month study, including patient safety (e.g., adverse events, ocular irritation) and efficacy (e.g., satisfactory visual acuity, correction of refractive errors, comfort).
The sample size for the training set: Not applicable. This study is for a contact lens, which does not involve a "training set" in the context of machine learning or AI. The physical properties and design are based on manufacturing processes and material science, not trained algorithms.
How the ground truth for the training set was established: Not applicable, as there is no "training set" for this device.

Summary

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MAY 1 3 2013

LSH (mangofilcon A) Soft (hydrophilic) Contact Lens 510(k) Summary

1. Applicant Information

Lagado Corporation Contact Person: Mark Allen Telephone No .: (303) 789-0933 Fax No.: (303) 789-4506 E-mail: mark@lagadocorp.co Date Prepared: May 1, 2013

2. Device Information

Classification name: Soft hydrophilic contact lens Device classification: Class II Regulation number: 21 CFR 886.5925 Product code: LPL Proprietary name:

LSH (mangofilcon A) Sphere Soft (hydrophilic) Contact Lens LSH (mangofilcon A) Multifocal Soft (hydrophilic) Contact Lens LSH (mangofilcon A) Toric Soft (hydrophilic) Contact Lens LSH (mangofilcon A) Toric-Multifocal Soft (hydrophilic) Contact Lens

3. Predicate Devices

Lagado Corporation claims substantial equivalence to Benz- 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens as cleared for marketing in the United States in K964528 on March 10, 1997.

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4. Description of Device

The LSH (mangofilcon A) is available as a spherical, multifocal, toric, and toric-All LSH lenses are plasma treated in the dry state prior to initial multifocal lens. hydration.

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The LSH (mangofilcon A) Sphere, Multifocal, Toric, and Toric-Multifocal Soft (hydrophilic) Lenses for Daily Wear are hemispheric flexible shells of the following dimensions.

LSH (mangofilcon A)
	Sphere	Multifocal	Toric	Toric-Multifocal
Diameter(s)	10.0 mm to16.0 mm	14.0 mm to 16.0 mm		14.0 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 - 9.7 mm
Powers	-20.00 Dto +12.00 D	-20.00 Dto +12.00 D	-20.00 D to +12.00 D	-20.00 D to +12.00 D
Cylinder Powers	Not Applicable (N/A)		-0.50 D to 2.50 Din steps of 0.25 D
Axes	Not Applicable (N/A)		0° to180°
Add Powers	N/A	+1.00 D to+3.25 Din steps of0.25 D	N/A	+1.00 D to+3.25 Din steps of0.25 D

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Property .	LSH LatheableSiliconeHydrogel
Oxygen Permeability(Dk)(35°C, Fatt Units)	49
Refractive Index	Dry - 1.470Hydrated - 1.413
Specific Gravity	Dry - 1.112Hydrated - 1.109
Linear Expansion Ratio	1.26
Water Content	49%
Visible Light Transmittance	96%T
Plasma Treatment Required	Yes
Shore D Hardness(in blank form)	≥83

The physical/optical properties of the lenses are:

5. Indications for Use

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The lenses may be disinfected using chemical (not heat) disinfecting systems.

6. Performance Data

Non Clinical Data

In support of the LSH (mangofilcon A) Soft (hydrophilic) Contact Lens a series of non clinical testing was conducted. Tests included physical/chemical analysis, shelf life stability testing and toxicology (cytotoxicity, systemic injection and ocular irritation).

Clinical Data

A three month clinical study was conducted to establish the safety and efficacy of the LSH (mangofilcon A) Soft (hydrophilic) Contact Lens for daily wear. Seventy-five (75) patients were enrolled in the study (56 test/19 control). The data from the clinical trial demonstrates that the LSH (mangofilcon A) Soft (hydrophilic) Contact Lens is safe and effective for its intended use. The risks and benefits of the subject device for patients are the same as for other silicone hydrogel contact lenses.

Conclusion

Based upon the test data presented, the LSH (mangofilcon A) Soft (hydrophilic) Contact Lens is as safe, as effective and performs as well as the predicate device. A comparison of the new device and the predicate device is presented in Table 1.

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・・

7. Substantial Equivalence

Lagado Corporation claims that the LSH (mangofilcon A) Soft (hydrophilic) Contact Lens is substantially equivalent to the predicate device, Benz- 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens (K964528).

Based upon clinical and non clinical product testing presented in this application, the LSH (mangofilcon A) Soft (hydrophilic) Contact Lens for daily wear is as safe and effective as the predicate device when used for the requested indications and in accordance with the directions for use.

LSH (mangofilcon A) Soft (hydrophilic) Contact LensComparison Table
PROPERTY	LSH Latheable Silicone Hydrogel (mangofilcon A)	Predicate Device BENZ 3GX (hioxifilcon B )
OXYGEN PERMEABILITY(Dk) (35°C, Fatt Units)	49	15
REFRACTIVE INDEX	Dry - 1.470	Dry - 1.507
	Hydrated - 1.413	Hydrated - 1.425
SPECIFIC GRAVITY	Dry - 1.112	Dry - 1.308
	Hydrated - 1.109	Hydrated - 1.136
LINEAR EXPANSION RATIO	1.26	1.3
WATER CONTENT	49%	49%
TENSILE STRENGTH	3.07 M Pa	25g/mm2
% ELONGATION AT BREAK	470	186
VISIBLE LIGHTTRANSMITTANCE	96 % T	95 % T
PLASMA TREATMENTREQUIRED	Yes	No
Shore D HARDNESS(in Blank form)	≥ 83	≥ 90

Table 1 Comparison to Predicate Device:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/6/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.

May 13, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Lagado Corporation % Ms. Ellen M. Beucler Vice President Foresight Regulatory Strategies, Inc. 187 Ballardvale Street. Suite 180 Wilmington, MA 01887

Re: K120756

Trade/Device Name: LSH (mangofilcon A) Sphere Soft (hydrophilic) Contact Lens LSH (mangofilcon A) Toric Soft (hydrophilic) Contact Lens LSH (mangofilcon A) Multifocal Soft (hydrophilic) Contact Lens LSH (mangofilcon A) Toric-Multifocal Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft hydrophilic contact lens Regulatory Class: Class II Product Code: LPL Dated: May 1, 2013 Received: May 3, 2013

Dear Ms. Beucler:

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.

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Page 2 - Ms. E.M. Beucler

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. 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

DeborahDMEalls-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

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Indications for Use

510(k) Number: K120756

Device Name: LSH (mangofilcon A) Soft (hydrophilic) Contact Lens

Indications for Use:

The LSH (mangofilcon A) Sphere Soft (hydrophilic) Contact Lens is indicated for the correction of myopia in aphakic or non-aphakic patients with non-diseased eyes who exhibit no more than 2.00 Diopters of assignatism and can obtain satisfactory visual acuity in a power range of +12.00 to -20.00 Diopters.

The LSH (mangofilcon A) Multifocal Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic and hyperopic eyes in aphakic patients with non-diseased eyes who exhibit no more than 2.00 Diopters of astigmatism and can obtain satisfactory visual acuity in a power range of +12.00 to -20.00 Diopters and have near add requirements up to 3.25 Diopters.

The LSH (mangofilcon A) Toric Soft (hydrophilic) Contact Lens is indicated for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic persons with non-diseased eyes in a spherical power range of +12.00 to -20.00 Diopters and a cylinder power range of -0.50 to 2.50 Diopters.

The LSH (mangofilcon A) Toric-Multifocal Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic, hyperopic and astigmatic aphakic patients with non-diseased eyes in a spherical power range of +12.00 to -20.00 Diopters, a cylinder power range of -0.50 to 2.50 Diopters and an add requirement up to 3.25 Diopters.

The lenses may be disinfected using chemical (not heat) disinfecting systems.

Prescription Use _________________XX (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Leonid Livshitz-S
2013.05.10 19:19:25 -04'00'

(Division Sign-Off) Division of Ophthalmic and Ear, Nose, and Throat Devices 510(k) Number: K120756

page 1 of 1

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.