(233 days)
Not Found
No
The device description and performance studies focus on the physical properties, materials, and manufacturing of a contact lens, with no mention of AI or ML technology.
Yes.
The device is indicated for the correction of visual acuity in persons with non-diseased eyes with myopia and refractive astigmatism, which makes it a therapeutic device as it treats a condition.
No
This device is a contact lens intended for vision correction and cosmetic enhancement, not for diagnosing medical conditions.
No
The device description clearly states it is a physical contact lens made of polymacon, a material, and describes its physical properties and manufacturing process. It is a tangible hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the correction of visual acuity in individuals with myopia and/or to enhance or alter the apparent color of the eye. This is a therapeutic and cosmetic purpose, not a diagnostic one.
- Device Description: The description details the physical properties and materials of a contact lens designed to sit on the surface of the eye and refract light. It does not describe any components or functions related to analyzing samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information.
- Performance Studies: The performance studies focus on the physical, optical, biocompatibility, sterilization, and shelf-life aspects of the contact lens itself, not on its ability to diagnose a condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This contact lens is used in vivo (on the body) for vision correction and cosmetic purposes.
N/A
Intended Use / Indications for Use
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:
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.
Product codes
LPL, MVN
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:
| 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 |
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eyecare practitioners. The device is for prescription use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- 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)
- Ocular Irritation (ISO 10993-10:2010)
- Skin Sensitization (ISO 10993-10:2010)
- Acute System Toxicity (ISO 10993-11:2017)
Sterilization: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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:
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.
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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3
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 Industrial |
| Park, No. 1450, Guanguang Road, Jutang Community, | |
| Fucheng Sub-district, Longhua District, Shenzhen, | |
| Guangdong, China | |
| Contact person | Jiayi Li |
| Phone No. | +86-136 3296 6073 |
| 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
4
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:
| 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 |
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:
5
| 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
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.
6. Substantial Equivalence Comparison
| Comparison
| item | Proposed Device (K220143) | Predicate Device (K141699) | Comment |
|---|---|---|---|
| Manufacturer | Shenzhen Dashicheng Optical | ||
| Technology Co., Ltd. | Vassen Co., Ltd. | None | |
| Product Name | BARBIE (polymacon) Daily Wear | ||
| Soft (Hydrophilic) Contact Lens | VASSEN COLOR (polymacon) | ||
| Daily Wear Soft (hydrophilic) | |||
| Contact Lenses (Clear & Tinted) | None | ||
| Product Code | LPL, MVN | LPL, MVN | Same |
| Regulation | |||
| Number | 21 CFR 886.5925 | 21 CFR 886.5925 | Same |
| Classification | Class II | Class II | Same |
| Prescription Use | Yes | Yes | Same |
| Intended Use / | |||
| Indications for | |||
| Use | 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 | |||
| to 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. | The VASSEN COLOR | ||
| (polymacon) Spherical Soft | |||
| Contact Lenses for daily wear are | |||
| indicated for the correction of | |||
| visual acuity in aphakic and not | |||
| aphakic persons with | |||
| non-diseased eyes with myopia | |||
| or hyperopia. 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 clear or tinted and may | |||
| be used to enhance or alter the | |||
| apparent color of the eye. | |||
| Daily wear replacement | |||
| schedules may vary from patient | |||
| to 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 | 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 |
| Manufacturing | |||
| Process | Fully-molded | Fully-molded | Same |
| Lens Material | Polymacon | Polymacon | Same |
| Material | |||
| Classification | Group I | ||
| Low water content ( 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
9
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).