The Intelliwave4 with HPT, sphere (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with nondiseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

The Intelliwave4 with HPT, toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters.

The Intelliwave4 with HPT, multifocal (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eves with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The IntelliWave4 with HPT, multifocal toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and nonaphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning. disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.

Device Description

The Intelliwave4 with HPT, Silicone Hydrogel Soft Contact Lenses are fabricated from safrofilcon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The non-ionic lens material, (safrofilcon A) is a daily wear silicone hydrogel contact lens that is characterized by high water content. The lens material is composed of silicone monomers cross linked with other monomers, and it optionally incorporates Reactive Blue 246 (21 CFR 73.3106) as an integrated handling tint. The lenses are made by lathe-cut for custom Ry. It consists of 35% safrofilcon A and 65% water by weight when immersed in a buffered saline solution. The (safrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).

The Intelliwave4 with HPT, Silicone Hydrogel Soft Contact Lenses are treated to incorporate Hydra-PEG Technology (HPT)-which is a thin polyethylene glycol (PEG)-based polymer that is covalently (permanently) bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with HPT, the underlying material (safrofilcon A) is completely encapsulated in a thin layer of polymer that results in measurable improvement of the surface characteristics, compared to untreated lenses, including: wettability (dynamic contact receding angle), lubricity (coefficient of friction), and water film stability (WBUT). The resulting layer is hydrophilic and approximately 30nm in thickness.

AI/ML Overview

This document (K152046) is a 510(k) premarket notification for a new class II medical device, the Intelliwave4 with HPT (Hydra-PEG Technology) Silicone Hydrogel Daily Wear Soft Contact Lens. It is not an AI/ML medical device and therefore does not include the detailed information requested in the prompt regarding AI model performance, training sets, ground truth establishment by experts, adjudication methods, or MRMC studies.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (IntelliWave4, K142641) by showing that the addition of Hydra-PEG Technology (HPT) to the contact lens surface, while enhancing certain physical properties, does not change the core functionality, intended use, or safety profile of the device.

However, based on the provided document, I can extract and infer some information relevant to the concept of acceptance criteria and the study that proves the device meets them, specifically concerning the physical and material properties, and clinical performance for equivalence.

Here's an attempt to structure the information based on your prompt, acknowledging the limitations due to the nature of the document:

Device: Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)

This device is not an AI/ML driven diagnostic or assistive tool, but rather a physical medical device (contact lens). Therefore, many of the specific criteria related to AI performance, such as MRMC studies, expert adjudication for ground truth of an algorithm, and effect sizes of AI assistance, are not applicable here. The "acceptance criteria" discussed are related to the physical properties, safety, and effectiveness of a contact lens compared to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical thresholds in the same way an AI model might have for metrics like AUC or sensitivity/specificity. Instead, the "acceptance" is based on demonstrating substantial equivalence to a predicate device, particularly that the new HPT treatment does not negatively impact safety or core performance, and ideally improves certain physical properties of the lens surface.

The table below summarizes the enhanced surface properties of the new device compared to the predicate device, which implicitly serve as a form of "performance acceptance" in the context of demonstrating improvement while maintaining safety. Clinical performance is evaluated for "similar overall performance."

Acceptance Criteria Category (as inferred)	Specific Metric/Property	Predicate Device Performance (IntelliWave4, K142641)	Reported Device Performance (IntelliWave4 with HPT)	Performance Outcome against "Acceptance" (Improvement or Equivalence)
Surface Properties	Wettability - captive bubble contact angle (degrees) (advancing contact angle)	103	46	Improved (123% reduction)
	Inclined Plane Friction/Lubricity (degrees)	35	19	Improved (46% reduction)
	Water Break Up Time – WBUT (seconds)	1.57	5.69	Improved (262% increase)
	Friction/Lubricity at human eyelid – contact lens biointerface ($μ$ kinetic)	0.059	0.043	Improved (27% reduction)
Physical Properties (Material)	Refractive Index (wet)	1.3841	1.3841 (Same as predicate)	Equivalent
	Visible Light Transmission	>98%	>98% (Same as predicate)	Equivalent
	Surface Character	hydrophilic	hydrophilic (Same as predicate)	Equivalent
	Water Content (%)	65%	65% (Same as predicate)	Equivalent
	Specific Gravity	1.102 (hydrated)	1.102 (hydrated) (Same as predicate)	Equivalent
	Oxygen Permeability	46.46 x 10-11	46.46 x 10-11 (Same as predicate)	Equivalent
Clinical Performance	Overall performance (vision, health, comfort, fit)	-	"similar overall performance" to predicate control	Equivalent
Safety	Biocompatibility/Toxicology	Acceptable	Acceptable	Met (non-toxic, non-irritating)
	Sterility	Sterile	Sterile for indicated shelf-life	Met

Note: The "acceptance criteria" for improved properties are implicitly that the new device performs significantly better than the predicate for beneficial characteristics, and for other properties (like water content, oxygen permeability), the criterion is to be substantially equivalent.

2. Sample Size and Data Provenance for Test Set (Clinical Study)

Sample Size for Test Set: 30 patients
Data Provenance: The document does not specify the country of origin. It describes a "bilateral, open-label, parallel group, and randomized daily wear study." It is a prospective clinical study.

3. Number of Experts and Qualifications for Ground Truth

Applicability for this device: Not directly applicable in the typical AI/ML sense of establishing ground truth for image interpretation or diagnosis.
Context for this device: The clinical study evaluated safety and efficacy. The "experts" would be the eye care practitioners supervising the study and assessing clinical outcomes (vision, health, comfort, fit). The document does not specify the number or qualifications of these practitioners, but they would be licensed professionals involved in contact lens prescribing and care.

4. Adjudication Method for the Test Set

Applicability for this device: Not explicitly stated as an adjudication method for a "test set" in the AI/ML context.
Context for this device: The clinical study's design (open-label, parallel group, randomized) implies standard clinical trial methodology for data collection and analysis to ensure unbiased assessment of patient outcomes. Decisions on "ground truth" (e.g., whether a lens fits well, or whether vision is adequate) would be made by the trained clinicians participating in the study as part of their standard practice.

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

Was an MRMC study done? No. This type of study is specifically designed for evaluating the impact of AI on human reader performance for diagnostic tasks.
Effect Size: Not applicable.

6. Standalone (Algorithm Only) Performance

Applicability for this device: Not applicable. This device is a physical contact lens, not a software algorithm. Its "performance" is inherent in its physical and material properties, and its clinical performance when worn by a human.

7. Type of Ground Truth Used

For physical/material properties: Quantitative measurements derived from in vitro tests (e.g., contact angle, friction, WBUT, water content, oxygen permeability). These are objective measurements from laboratory equipment.
For clinical safety and effectiveness: Patient-reported outcomes (comfort), clinician assessments (vision, health, fit), and observations during a clinical study. This is essentially outcomes data and clinical assessment.

8. Sample Size for the Training Set

Applicability for this device: Not applicable. This is not an AI/ML device that requires a "training set" in the computational sense.
Context for this device: The device development would involve R&D, material science, and manufacturing process development, but not a "training set" as understood for AI.

9. How Ground Truth for the Training Set Was Established

Applicability for this device: Not applicable for an AI/ML context.
Context for this device: For physical and material properties, the "ground truth" for development and manufacturing is established through standard laboratory testing methods and material science principles, ensuring the lens meets specified manufacturing tolerances and material compositions. For safety and biocompatibility, this is established through pre-clinical toxicology and biocompatibility tests conducted according to GLP regulations.

Summary

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

November 24, 2015

Art Optical Contact Lens, Inc. Mr. Bret Andre Principal Consultant Eyereg Consulting, Inc. 474 NE 61st Place Hillsboro. Oregon 97124

Re: K152046

Trade/Device Name: Intelliwave4 with HPT, sphere (safrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens Intelliwave4 with HPT, toric (safrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens Intelliwave4 with HPT, multifocal (safrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens Intelliwave4 with HPT, multifocal toric (safrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: October 12, 2015 Received: October 15, 2015

Dear Mr. 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.

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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 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.

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/ResourcesforYou/Industry/default.htm. 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.

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) K152046

Device Name

Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)

Indications for Use (Describe)

The Intelliwave4 with HPT, sphere (safrofilcone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

The Intelliwave4 with HPT, toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic persons with non diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters.

The Intelliwave4 with HPT, multifocal (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic persons with non diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The IntelliWave4 with HPT, multifocal toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.

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:	K152046
Applicant information:
Date Prepared:	07/18/2015
Name:Address	Art Optical Contact Lens, Inc.3175 3 Mile Road NWWalker, Michigan 49534
Contact Person:	Mike Johnson, FCLSADirector of Consultative Services
Phone number:	(616) 559-5167
Consultant:	Bret AndreEyeReg Consulting, Inc.474 NE 61st PLHillsboro, OR 97124
Phone number	(503) 372-5226
Device Information:
Device Classification:	Class II
Product Code:	LPL
Classification Name:	Soft (hydrophilic) Contact Lens (21 CFR 886.5925)

Trade Name:

Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)

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Purpose of 510(k) Submission:

~ New Technology ~

Art Optical proposes to modify the surface of the Intelliwayed Silicone Hydrogel Contact Lens (safrofilcon A)—cleared under 510(k) K142641—to include Hydra-PEG Technology (HPT), which is a thin, polyethylene glycol (PEG)-based polymer designed to enhance the surface properties of the contact lens. Specifically, HPT treated contact lenses demonstrate a measureable improvement in the surface wettability, lubricity, and water break up time (WBUT) in comparison with the untreated lenses. The application of HPT to the surface of Intelliwave4 contact lenses does not change the indications for use in comparison with the untreated lenses, the predicate device (K142641).

Equivalent Devices:

The Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lenses (safrofilcon A) are substantially equivalent to the following predicate devices:

Predicate devices:

"IntelliWave4 (safrofilcon A) Silicone Hydrogel Contact Lens" by Art Optical Contact Lens, Inc. 510(k) number; K142641

Device Description:

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Contact Lens Surface Property	ART OpticalIntelliWave4 with HPT(New Device)1,2,3,4	ART OpticalIntelliWave4(Predicate Device)K142641
Wettability - captive bubble contact angle (degrees)(advancing contact angle)	461	103
Inclined Plane Friction/Lubricity (degrees)	192	35
Water Break Up Time – WBUT (seconds)	5.693	1.57
Friction/Lubricity at human eyelid – contact lens biointerface( $μ$ kinetic)	0.0434	0.059

1 123% reduction in 'wettability' (n=6)*
2 46% reduction in 'inclined plane friction' (n=5)*
3 262% increase in 'WBUT' (n=10)*
4 27% reduction in 'friction at human eyelid-contact lens biointerface' (n=9)*

Statistically significant based on a 95% confidence interval (p <0.05). The values reported in this table are derived from in vitro tests. The clinical benefits of the Hydra PEG coating with regard to wettability and lubricity have not been evaluated.

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 (safrofilcon A) soft hydrophilic contact lens has a spherical 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 and appear somewhat warped, however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

UV Absorber:

In the Intelliwave4 Contact Lens with UV Blocker and center thickness of 0.18mm, a Benzophenone UV absorbing monomer is used to block UV radiation. The UV Blocker is 2-(4-Benzoy)-3hydroxyphenoxy)ethyl acrylate. The UV blocking for Intelliwave4 lenses averages > 99% in the UVB range of 280nm - 315nm and >77% in the UVA range of 316 - 380nm.

The Physical properties of the lens are:

Refractive Index (wet)	1.3841
Visible Light Transmission	>98%
Surface Character	hydrophilic
Water Content	65 %
Specific Gravity	1.102 (hydrated)
Oxygen Permeability	46.46 x 10-11 (cm2/sec) (ml O 2/ml x hPa @ 35°C), (revised Fatt
	method).

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The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 65% water by weight. The lenses will be manufactured in spherical, aspherical, toric, and multifocal configurations with the following features and properties.

12.0 mm to 16.00 mm Chord Diameter ●
Center Thickness ●
Base Curve
Power Range ●
Cylinder Power (Toric) ●
Add Power (Multifocal) ●
0.01 mm to 0.50 mm 8.0 mm to 9.5 mm -20.00D to +20.00D in 0.25 steps -0.25D to -10.00D +0.50D to +3.00D

The lens is supplied sterile in vials containing a buffered saline solution. Vial 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.

Intended Use:

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Testing:

Non-clinical Testing A series of in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the IntelliWave4 with HPT (safrofilcon A) Silicone Hydrogel Soft Contact Lenses packaged in glass vials. 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 IntelliWave4 with HPT (safrofilcon A) Silicone Hydrogel Soft Contact Lenses demonstrate that:

Lenses supplied in glass vials are sterile for the indicated shelf-life, ●
The packaging material and extracts are not toxic and not irritating, and ●
Lens physical and material properties are consistent with currently marketed ● lenses.
Clinical Testing A bilateral, open-label, parallel group, and randomized daily wear study was performed to evaluate the safety and efficacy of the IntelliWave4 with HPT (safrofilcon A) Silicone Hydrogel Soft Contact Lens. The study evaluated 30 patients over a one (1) month period. Clinical evaluation demonstrated similar overall performance to the concurrent predicate control in the clinically relevant areas of vision, health, and comfort and fit when worn for daily wear.

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 IntelliWave4 with HPT, (safrofilcon A) Silicone Hydrogel Daily Wear Soft 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 Silicone Hydrogel, Daily Wear Soft Contact Lens. The benefits to the patient are the same as those for other Silicone Hydrogel contact lenses.

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Substantial Equivalence:

The following matrix illustrates the production method, lens function and material characteristics of the Intelliwave4 with HPT, (safrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens, as well as the predicate devices.

	Art OpticalIntelliWave4 with HPT,Silicone Hydrogel(safrofilcon A)New Device	Art OpticalIntelliWave4,Silicone Hydrogel(safrofilcon A)Predicate Device510(k) K142641
Intended Use	Same as predicate device	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 of irregularcorneal conditions such as keratoconusand post graft fitting.
Functionality	Same as predicate device	The contact lenses act as arefractive medium that focuslight rays from near and distantobjects on the retina
Indications	Same as predicate device	Daily wear. Silicone HydrogelSoft (hydrophilic) Contact Lens
Production Method	Lathe-Cut, custommanufacturedProcessed to include Hydra-PEG surfacing technology	Lathe-Cut, custommanufactured
USAN name	Same as predicate device	safrofilcon A
Water Content (%)	Same as predicate device	65%
Oxygen Permeability	Same as predicate device	46.46 x 10-11 (cm2/sec) (ml O2/mlx hPa @ 35oC), (revised Fattmethod)
Specific Gravity	Same as predicate device	1.102

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.