BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available tinted and used to enhance or alter the apparent color of the eye.

Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.

Frequent/Planned Replacement Wear:

Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

Disposable Wear:

Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When prescribed for Daily Disposable Wear, the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.

Device Description

BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens is a spherical lens. It is fabricated from polymacon which has been adopted by the United Stated Adopted Names Council (USAN). The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The nonionic lens material, polymacon, is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) cross-linked with ethylene glycol dimethacrylate (EGDMA), initiated by 2, 2'-azobisisobutyronitrile (AIBN). The lens consists of 62% polymacon and 38% water by weight when immersed in standard saline solution.

BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens is available cosmetic tinted to enhance or alter the apparent color of the eye. It is tinted in an annular pattern, providing a clear optic zone, using a combination of one or more of the following 'listed' color additives: Reactive black 5, Iron oxides, Solvent Yellow 18, Titanium dioxide, Carbazole violet, Pigment Blue 36, Phthalocyanine green.

The proposed lenses contain only the amount of color additives to accomplish the intended coloring effect. The proposed color lenses are manufactured by sandwiching the pattern layer containing color additives between two layers of lens materials (polymacon). As part of the manufacturing process, the color lenses are thoroughly washed to remove the unbound reactive color additives. Because of the 'sandwich' structure, the color additives will not be removed by lens handling and cleaning/disinfecting procedures. The cosmetic tinting pattern has a minimum clear pupil diameter of 6.0 mm.

In the hydrated state, BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus, and it acts as a refracting media to focus light rays on the retina. 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 compatible with the eye.

BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens is available in the spherical configuration with the following features and properties: Total diameter: 13.50 mm to 14.50 mm, step:0.10 mm; Base curve: 8.00 mm to 9.00 mm, step: 0.10 mm; Center thickness: 0.050 mm to 0.120 mm; Back vertex power: -10.00D to 0.00D, step: 0.25D.

The physical properties of the proposed lens are: Refractive index: 1.435; Light Transmission: ≥95% (at clear region corresponding to pupil, minimum 6.0 mm diameter); Surface character: Hydrophilic; Water content: 38%; Oxygen permeability: 9.01×10-11 (cm²/s) [ml O₂/(ml·mmHg)] at 35°C (revised Fatt method).

BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens is supplied sterile in the foil blister pack containing standard saline solution.

AI/ML Overview

The provided text describes the submission of a 510(k) premarket notification for a soft contact lens, implying a comparison to a predicate device rather than a study proving the device meets acceptance criteria in the sense of a diagnostic or AI device study.

Therefore, the requested information elements related to AI/diagnostic device studies (such as sample size for test sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth type for training sets, or training set sample size) are not applicable or extractable from this document.

However, I can extract the non-clinical performance tests conducted and state what they aim to show. These could be considered "acceptance criteria" in a broad sense for the physical and chemical properties of the contact lens.

Here's the information based on your request, adapted to the context of a contact lens submission:

Acceptance Criteria and Device Performance for BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens

This submission is for a medical device (contact lens), and the described "tests" are performance tests for physical, optical, physicochemical, mechanical, and biocompatibility properties to demonstrate substantial equivalence to a predicate device, rather than a clinical study with diagnostic acceptance criteria as might be seen for an AI/diagnostic device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" with "reported device performance." Instead, it lists the types of performance tests conducted and states that "the test results showed that the proposed device meets the requirements." It also provides some specific physical properties of the proposed device as part of the device description. Below is a compilation of the properties and what the testing aimed to achieve, aligning with what would be required for such a device.

Acceptance Criterion (Type of Test/Property)	Reported Device Performance (or Outcome)	Reference Standard/Method
Physical Parameters	"meets the requirements"	ISO 18369-2:2017
Total diameter (Range)	13.50 mm to 14.50 mm	ISO 18369-2:2017
Base curve (Range)	8.00 mm to 9.00 mm	ISO 18369-2:2017
Center thickness (Range)	0.050 mm to 0.120 mm	ISO 18369-2:2017
Optical Parameter	"meets the requirements"	ISO 18369-2:2017
Back vertex power (Range)	-10.00D to 0.00D	ISO 18369-2:2017
Light transmission	≥95% (at clear region corresponding to pupil, minimum 6.0 mm diameter) / "meets the requirements"	ISO 18369-3:2017
Refractive index	1.435 / "meets the requirements"	ISO 18369-3:2017
Water content	38% ±2 % / "meets the requirements"	ISO 18369-3:2017
Extractables	"meets the requirements"	Not specified
Oxygen permeability	9.01×10-11 (cm²/s) [ml O₂/(ml·mmHg)] at 35°C / "meets the requirements"	ASTM D882-18, revised Fatt method
Mechanical Properties	"meets the requirements"	ISO 18369-4:2017
Modulus	0.90 MPa	ISO 18369-4:2017
Tensile Strength	0.71 MPa	ISO 18369-4:2017
Elongation at break	110%	ISO 18369-4:2017
Toughness (Work)	0.79 N·mm	ISO 18369-4:2017
Biocompatibility	No biocompatibility issues	ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017
Cytotoxicity	Tested and passed	ISO 10993-5:2009
Ocular Irritation	Tested and passed	ISO 10993-10:2010
Skin Sensitization	Tested and passed	ISO 10993-10:2010
Acute System Toxicity	Tested and passed	ISO 10993-11:2017
Sterility	Sterility Assurance Level (SAL) of 10-6 validated	ISO 17665-1:2006, ISO/TS 17665-2:2009
Shelf Life	5 years shelf-life assured	ISO 11987:2012

The following questions are not applicable to this document as it pertains to a contact lens 510(k) submission which explicitly states "This 510(k) submission does not utilize clinical study for establishing substantial equivalence therefore this section does not apply." The submission focuses on non-clinical performance and biocompatibility to demonstrate equivalence to a predicate device.

Sample sized used for the test set and the data provenance: Not applicable. Non-clinical tests were performed on the device itself or its components.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 8, 2022

Shenzhen Dashicheng Optical Technology Co., Ltd. % Grace Liu Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square Shenzhen, Guangdong 518000 China

Re: K220143

Trade/Device Name: BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: August 3, 2022 Received: August 3, 2022

Dear Grace Liu:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation titled, "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 https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220143

Device Name

BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens

Indications for Use (Describe)

BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens are indicated for the correction of visual acuity in aphakic and not-aphakic persons with myopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available tinted and used to enhance or alter the apparent color of the eye.

Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.

Frequent/Planned Replacement Wear:

Disposable Wear:

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 - K220143

1. Contact Details

1.1 Applicant information

Applicant Name	Shenzhen Dashicheng Optical Technology Co., Ltd.
Address	101, 201 and 301, Unit 3, Building 1, Wanjiening IndustrialPark, No. 1450, Guanguang Road, Jutang Community,Fucheng Sub-district, Longhua District, Shenzhen,Guangdong, China
Contact person	Jiayi Li
Phone No.	+86-136 3296 6073
E-mail	lijiayi6073@dingtalk.com
Date Prepared	2022-01-11

1.2 Submission Correspondent

Image /page/3/Picture/5 description: The image shows a logo with a green circle containing a stylized white tiger head. Above the circle are three pairs of green wings, symmetrically arranged. Below the circle, there are four Chinese characters, also in green, which appear to be the name of the organization or company associated with the logo.

	Shenzhen Joyantech Consulting Co., Ltd.
	1713A, 17th Floor, Block A, Zhongguan Times Square,
	Nanshan District, Shenzhen, Guangdong Province, China
Phone No.	+86-755-86069197
Contact person	Grace Liu; Field Fu;
Contact person's e-mail	grace@cefda.com; field@cefda.com
Website	http://www.cefda.com

2. Device Information`

Trade name	BARBIE (polymacon) Daily Wear Soft (Hydrophilic)Contact Lens
Common name	Soft (Hydrophilic) Contact Lens
Classification	II
Classification name	Lenses, Soft Contact, Daily Wear
Product code	LPL, MVN
Regulation No.	21 CFR 886.5925

3. Legally Marketed Predicate Device

Trade Name	VASSEN COLOR (polymacon) Daily Wear Soft (hydrophilic)Contact Lenses (Clear & Tinted)
510(k) Number	K141699
Product Code	LPL, MVN
Manufacturer	Vassen Co., Ltd.

4. Device Description

BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens is a spherical lens. It is fabricated from polymacon which has been adopted by the United Stated Adopted

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Names Council (USAN). The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

Color additive	Listing No.
Reactive black 5	21 CFR 73.3121
Iron oxides	21 CFR 73.3125
Solvent Yellow 18	21 CFR 73.3122
Titanium dioxide	21 CFR 73.3126
Carbazole violet	21 CFR 73.3107
Pigment Blue 36	21 CFR 73.3110a
Phthalocyanine green	21 CFR 73.3124

BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens is available in the spherical configuration with the following features and properties:

Total diameter:	13.50 mm to 14.50 mm, step:0.10 mm
Base curve:	8.00 mm to 9.00 mm, step: 0.10 mm
Center thickness:	0.050 mm to 0.120 mm
Back vertex power:	-10.00D to 0.00D, step: 0.25D

The physical properties of the proposed lens are:

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Refractive index:	1.435
Light Transmission:	≥95% (at clear region corresponding to pupil, minimum 6.0 mm diameter)
Surface character:	Hydrophilic
Water content:	38%
Oxygen permeability:	9.01×10-11 (cm²/s) [ml O₂/(ml·mmHg)] at 35°C (revised Fatt method)

BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens is supplied sterile in the foil blister pack containing standard saline solution.

5. Intended Use/Indication for Use

Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.

Frequent/Planned Replacement Wear:

Disposable Wear:

6. Substantial Equivalence Comparison

Comparisonitem	Proposed Device (K220143)	Predicate Device (K141699)	Comment
Manufacturer	Shenzhen Dashicheng OpticalTechnology Co., Ltd.	Vassen Co., Ltd.	None
Product Name	BARBIE (polymacon) Daily WearSoft (Hydrophilic) Contact Lens	VASSEN COLOR (polymacon)Daily Wear Soft (hydrophilic)Contact Lenses (Clear & Tinted)	None
Product Code	LPL, MVN	LPL, MVN	Same
RegulationNumber	21 CFR 886.5925	21 CFR 886.5925	Same
Classification	Class II	Class II	Same
Prescription Use	Yes	Yes	Same
Intended Use /Indications forUse	BARBIE (polymacon) Daily WearSoft (Hydrophilic) Contact Lensare indicated for the correction ofvisual acuity in aphakic andnot-aphakic persons withnon-diseased eyes with myopia.The lens may be worn bypersons who exhibit refractiveastigmatism of 0.50 diopters orless where the astigmatism doesnot interfere with visual acuity.The lens is available tinted andused to enhance or alter theapparent color of the eye.Daily wear replacementschedules may vary from patientto patient and should be decidedby eyecare practitioners inconsultation with their patients.Frequent/Planned ReplacementWear:Eyecare practitioners mayprescribe any of the above lensesfor frequent/planned replacementwear, with cleaning, disinfectionand scheduled replacement.When prescribed forfrequent/planned replacementwear, the lens may be disinfectedusing a chemical disinfectingsystem.Disposable Wear:Eyecare practitioners mayprescribe any of the above lensesfor Daily Disposable Wear. Whenprescribed for Daily DisposableWear, the lenses are not to beused with disinfecting systems asthey are to be discarded after asingle use.	The VASSEN COLOR(polymacon) Spherical SoftContact Lenses for daily wear areindicated for the correction ofvisual acuity in aphakic and notaphakic persons withnon-diseased eyes with myopiaor hyperopia. The lens may beworn by persons who exhibitrefractive astigmatism of 0.50diopters or less where theastigmatism does not interferewith visual acuity. The lens isavailable clear or tinted and maybe used to enhance or alter theapparent color of the eye.Daily wear replacementschedules may vary from patientto patient and should be decidedby eyecare practitioners inconsultation with their patients.Frequent/Planned ReplacementWear:Eyecare practitioners mayprescribe any of the above lensesfor frequent/planned replacementwear, with cleaning disinfectionand scheduled replacement.When prescribed forfrequent/planned replacementwear, the lens may be disinfectedusing a chemical disinfectingsystem.Disposable Wear:Eyecare practitioners mayprescribe any of the above lensesfor Daily Disposable Wear. Whenprescribed for Daily DisposableWear the lenses are not to beused with disinfecting systems as	Similar
		they are to be discarded after a single use.
Functionality	The contact lenses act as a refractive medium that focus light rays from near and distant objects on the retina.	The contact lenses act as a refractive medium that focus light rays from near and distant objects on the retina.	Same
Lens Design	Spherical	Spherical	Same
ManufacturingProcess	Fully-molded	Fully-molded	Same
Lens Material	Polymacon	Polymacon	Same
MaterialClassification	Group ILow water content (<50%),Nonionic	Group ILow water content (<50%),Nonionic	Same
Color Additives	Reactive Black 5Iron OxidesSolvent Yellow 18Titanium DioxideCarbazole VioletPigment Blue 36Phthalocyanine Green	C.I. Reactive black 5Iron Oxide (Red)D&C Yellow 10Titanium DioxideD&C Green 6C.I. Reactive Blue 19	Different
Storage Solution	Standard saline solution	Standard saline solution	Same
PrimaryPackaging	Foil blister pack	Foil blister pack	Same
Total Diameter	13.50 mm to 14.50 mm	13.00 mm to 15.00 mm	Similar
Base Curve	8.00 mm to 9.00 mm	8.0 mm to 9.0 mm	Same
CenterThickness(varies withpower)	0.050 mm to 0.120 mm	0.06 mm to 0.17 mm	Similar
Power Range	-10.00D to 0.00D	-10.00D to +3.00D	Similar
Water Content	38% ±2 %	38% ±2 %	Same
LightTransmission	≥95%	≥95%	Same
Refraction Index	1.435	1.439	Different
OxygenPermeability	9.01×10-11 (cm²/s) [mlO2/(ml·mmHg)] at 35°C(revised Fatt method)	10.55×10-11 (cm²/s) [mlO2/(ml·mmHg)] at 35 °C(revised Fatt method)	Different
Modulus	0.90 MPa	0.91 MPa	Different
Tensile Strength	0.71 MPa	0.63 MPa	Different
Elongation atbreak	110%	106%	Different
Toughness	0.79 N·mm	0.78 N·mm	Different
(Work)
Sterilization	Moist Heat Sterilization	Moist Heat Sterilization	Same
Biocompatibility	Biocompatible	Biocompatible	Same

Table 1 Substantial Equivalence Comparison

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The proposed device has the similar indication for use as the predicate device as well as comparable technical and biocompatibility properties and characteristics, and the differences don't raise any additional questions for safety and effectiveness, therefore, the proposed device is substantially equivalent to the predicate device.

7. Non-clinical Testing

All tests were conducted in accordance with the FDA guidance - Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, Revised May 1994. The non-clinical performance tests had been performed to demonstrate the safety and effectiveness of BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens and the substantial equivalence to the predicate device.

A Performance Testing

The physical, optical, physicochemical and mechanical performance tests were performed in accordance with ISO 18369-2:2017, ISO 18369-3:2017, ISO 18369-4:2017 and ASTM D882-18, and the test results showed that the proposed device meets the requirements.

Physical parameters (Total diameter, Base curve, Center thickness)
Optical parameter (Back vertex power) ।
Light transmission
Refractive index
Water content
Extractables i
Oxygen permeability
Mechanical properties -

> Biocompatibility Testing

The following biocompatibility tests were performed respectively on the contact lens, storage solution and primary packaging, and the test results showed that the proposed device has no biocompatibility issues.

Cytotoxicity (ISO 10993-5:2009) i
Ocular Irritation (ISO 10993-10:2010) -
Skin Sensitization (ISO 10993-10:2010) -
Acute System Toxicity (ISO 10993-11:2017)
A Sterilization

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A Sterility Assurance Level (SAL) of 10-6 has been validated in accordance with the requirements of ISO 17665-1:2006 and ISO/TS 17665-2:2009.

> Shelf Life

Accelerated aging testing has been performed to assure the shelf-life of 5 years in accordance with ISO 11987:2012.

8. Clinical Testing

This 510(k) submission does not utilize clinical study for establishing substantial equivalence therefore this section does not apply.

9. Conclusions

The results of comparing the design specifications and non-clinical testing between the proposed device and the legally marketed predicate device (K141699) show that they are Substantially Equivalent (SE).

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.