The Tangible Hydrogel with Tangible Polymer (etafilcon A) ASPHERIC Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism.

The Tangible Hydrogel with Tangible Polymer (etafilcon A) TORIC Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who may have 5.00 D or less of astigmatism.

The Tangible Hydrogel with Tangible Polymer (etafilcon A) MULTIFOCAL Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 2.50 D of ADD power and may have 1.00 D or less of astigmatism.

Eye care professionals may prescribe the lenses for daily disposable wear. Lenses shall be discarded upon removal.

Device Description

The Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is available in an aspheric design and manufactured using the castmolding process. The lenses consist of 58% water and 42% etafilcon A. The lens material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which are cross-linked with Trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo-polymerization.

The Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lenses are available in a light blue tint ([Phthalocvaninato(2-)]copper) for visibility and handling. The lenses also contain a Benzotriazole ultraviolet (UV) absorbing monomer to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range (280 to 315 nm), and less than 30% in the UVA range (316 to 380nm).

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (etafilcon A) soft hydrophilic contact lens has an aspheric back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard appear somewhat warped; however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The lenses are supplied sterile in blister packages containing a buffered saline solution. Package labeling is printed with appropriate lot numbering, expiration dating and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterilization process.

AI/ML Overview

Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria for clinical performance in a tabular format as one might find for a diagnostic AI device. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices. The performance of the new device is compared to these predicates across various characteristics to demonstrate similarity.

Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Tangible Hydrogel with Tangible Polymer)
Material/Functionality	Similar material properties (etafilcon A) and intended function as predicate devices.	Metafilcon A contact lens, acts as a refractive medium.
Water Content	58% (UNICON and Saview-Aqua predicates)	58%
Oxygen Permeability	$30.8 \times 10^{-11}$ (UNICON) and $26.3 \times 10^{-11}$ (Saview-Aqua) (cm2/sec) (ml O2/ml-mmHg)	$29.96 \times 10^{-11}$ (cm2/sec) (ml O2/ml-mmHg)
Color	[Phthalocyaninato(2-)]copper (UNICON), Pigment blue 15 (Saview-Aqua)	[Phthalocyaninato(2-)]copper
UV Blocking	Yes (Both Predicates)	Yes
Production Method	Cast-Molded (Both Predicates)	Cast-Molded
Indications	Similar indications for correction of ametropia/presbyopia, daily wear/disposable.	Daily disposable, Aspheric, Toric, Multifocal designs for ametropia and/or presbyopia.
Safety & Effectiveness	Non-toxic, non-irritating, sterile for shelf-life, consistent physical/material properties.	Demonstrated via non-clinical testing.
Clinical Performance	Established clinical performance (through predicate device testing).	Established previously through clinical performance testing (referencing predicate).

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

Sample Size: The document does not specify a separate "test set" sample size for the new device as no independent clinical study was conducted for the device's clinical performance. Instead, it relies on the established clinical performance of the predicate devices.
Data Provenance: The non-clinical testing (toxicology, biocompatibility, sterility, shelf-life, physical/material properties) was conducted in various laboratories under Good Laboratory Practice (GLP) regulations and scientific protocols. The document does not specify the country of origin for these labs.
The clinical effectiveness is established by referencing previous clinical performance testing of the etafilcon A material, which means the data provenance for clinical performance is tied to the previous studies of the predicate devices. This indicates a retrospective reliance on existing data rather than a new prospective clinical study for this specific device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided because no independent clinical study was conducted for this specific device to establish new ground truth. The submission relies on the established clinical performance of the predicate devices. Therefore, there's no mention of experts establishing ground truth for a new test set in this document.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical test set with adjudicated ground truth was utilized for this device submission. The device's clinical effectiveness is based on the established performance of the predicate devices.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. This device is a contact lens, not an AI or imaging diagnostic device where MRMC studies are typically performed. The purpose of this submission is to demonstrate substantial equivalence to existing predicate contact lenses.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study was done. This is not an algorithm or AI-based device, so the concept of "standalone performance" for an algorithm doesn't apply. The device itself (a contact lens) is the product.

7. Type of Ground Truth Used

The "ground truth" for the device's safety and effectiveness relies on:

Non-clinical testing results: These include laboratory measurements (e.g., water content, oxygen permeability), cytotoxicity, irritation, and sterility tests. These tests are the "ground truth" for the device's material properties and initial safety.
Clinical performance established by predicate devices: The document states, "The safety and effectiveness of finished contact lenses manufactured from the etafilcon A material have been established previously through clinical performance testing." This implies that the clinical "ground truth" for this material's performance was established through past clinical trials associated with the predicate devices (e.g., UNICON and Saview-Aqua). This would typically involve patient outcomes, visual acuity measurements, comfort assessments, and adverse event reporting from those prior studies.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device (contact lens), not an AI algorithm trained on a dataset. Therefore, there's no "training set" in the context of machine learning.

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

Not applicable, as there is no "training set" for this type of device.

Summary

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December 13, 2017

Tangible Science LLC % Bret Andre Consultant/Official Correspondent EyeReg Consulting, Inc. 6119 Canter Lane West Linn. OR 97068

Re: K172692

Trade/Device Name: Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL. MVN Dated: November 9, 2017 Received: November 17, 2017

Dear Bret Andre:

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 (reporting of medical devicerelated 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Denise L. Hampton -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 (if known) K172692

Device Name

Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens

Indications for Use (Describe)

Eye care professionals may prescribe the lenses for daily disposable wear. Lenses shall be discarded upon removal.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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:	K172692
Applicant information:
Date Prepared:	November 9th, 2017
Name:Address	Tangible Science LLC173 Jefferson DriveMenlo Park CA 94025
Contact Person:Phone number:	Vic McCray, MDPresident & CEO1-650-241-1045
Consultant:	Bret AndreEyeReg Consulting, Inc6119 Canter LnWest Linn, OR 97068
Phone number	(503) 372-5226

Device Information:

Device Classification:	Class II
Product Code:	LPL, MVN
Classification Name:	Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
Common Name:	Lens, Contact, (Disposable)
Trade Name:	Tangible Hydrogel with Tangible Polymer (etafilconA) Soft (Hydrophilic) Daily Disposable Contact Lens

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Predicate Devices:

Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lenses are substantially equivalent to the following predicate devices:

. "UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear" By UNICON Optical Co., LTD. 510(k) number; K141917 Primary Predicate
"Saview-Aqua 58 UV (etafilcon A) Visibility Tinted Soft (Hydrophilic) . Contact Lens" By St. Shine Optical Co., Ltd. 510(k) number: K132146 Reference Predicate

Device Description:

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The Physical properties of the lens are:

Refractive Index (wet)	1.400
Visible Light Transmission	>98%
Surface Character	hydrophilic
Water Content	58 ±2%
Specific Gravity	1.14 (hydrated)
Oxygen Permeability	29.96 x 10-11 (cm2/sec) (ml O2/ml-mmHg)

The lenses will be manufactured in the aspheric, toric, and multifocal design configurations with the following properties:

• Chord Diameter	12.0 mm to 15.00 mm
• Center Thickness	0.01 mm to 0.20 mm
• Base Curve	7.85 mm to 10.0 mm
• Power Range	+6.00D to -10.00D (in 0.25D steps)
- Cylinder	-0.75D to -2.50D (in 0.25D steps)
- Axis	10° to 180° (in 10° steps)
- Add	+1.00D to +2.50D (in 0.50D steps)

Indication for Use:

The Tangible Hydrogel with Tangible Polymer (etafilcon A) ASPHERIC Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism.

The Tangible Hydrogel with Tangible Polymer (etafilcon A) TORIC Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 5.00 D or less of astigmatism.

Eye care professionals may prescribe the lenses for daily disposable wear. Lenses shall be discarded upon removal.

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Testing:

Non-clinical Testing A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lenses packaged in blister packaging. All non-clinical toxicology tests were conducted in accordance with the GLP regulation. All other testing was conducted according to valid scientific protocols.

Test results of the non-clinical testing on the Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lenses demonstrate that:

Lenses supplied in blister packages are sterile for the indicated shelf-● life.
The finished lenses, packaging material and extracts are non-toxic and non-irritating, and
Lens physical and material properties are consistent with currently ● marketed lenses.

Clinical Testing The safety and effectiveness of finished contact lenses manufactured from the etafilcon A material have been established previously through clinical performance testing.

Conclusions Drawn from Studies

Validity of Scientific Data

Several laboratories under Good Laboratory Practice regulations conducted toxicology studies, Microbiology, chemistry, shelf-life stability studies and followed scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7

Substantial Equivalence

Information presented in this Premarket Notification establishes that the Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the requested indication.

Risks and Benefits

The risks of the subject device are the same as those normally attributed to the wearing of daily wear soft contact lenses. The benefits to the patient are the same as those for other soft contact lenses.

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Substantial Equivalence:

The following matrix illustrates the production method, lens function and material characteristics of the Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, as well as the predicate devices.

	Tangible Hydrogel w/Tangible Polymer (etafilconA) Soft (Hydrophilic) DailyDisposable Contact LensNew Device	UNICON (etafilcon A) Soft(Hydrophilic) Contact Lensfor Daily WearPredicate Device510(k) K141917	Saview-Aqua 58 UV(etafilcon A)Soft (Hydrophilic)Contact LensPredicate Device510(k) K132146
Intended Use	Indicated for the correction ofametropia (myopia and hyperopia)and/or are presbyopic in aphakic ornon-aphakic persons with non-diseased eye who may have 5.00 D orless astigmatism.	Indicated for the correction ofametropia (myopia and hyperopia) inaphakic or non-aphakic persons withnon-diseased eye who may have 1.00D or less astigmatism.	Indicated for daily wear for thecorrection of visual acuity in aphakicand not apjakic persons with non-diseased eyes with myopia orhyperopia. The lens may also beprescribed for management ofirregular corneal conditions such askeratoconus and post graft fitting.
Functionality	The contact lenses act as arefractive medium that focuslight rays from near anddistant objects on the retina	The contact lenses act as arefractive medium that focuslight rays from near anddistant objects on the retina	The contact lenses act as arefractive medium that focuslight rays from near and distantobjects on the retina
Indications	Daily disposable. Soft(hydrophilic) Contact Lens	Daily wear. Soft (hydrophilic)Contact Lens	Daily wear. Soft (hydrophilic)Contact Lens
Production Method	Cast-Molded	Cast-Molded	Cast-Molded
USAN Name	etafilcon A	etafilcon A	etafilcon A
Water Content (%)	58%	58%	58%
Oxygen Permeability	$29.96 x 10^{-11}$ (cm2/sec) (ml02/ml-mmHg)	$30.8 x 10^{-11}$ (cm2/sec) (ml02/ml-mmHg)	$26.3 x 10^{-11}$ (cm2/sec) (ml O2/ml-mmHg)
Color	[Phthalocyaninato(2-)]copper	[Phthalocyaninato(2-)]copper	Pigment blue 15
UV Blocking	Yes	Yes	Yes

Substantial Equivalence Matrix

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.