(162 days)
Spherical and Aspheric
Ethos Aquell (Hioxifilcon A) Spherical and Aspheric One-Day Soft (Hydrophilic) Contact Lenses (59% Water) are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +10.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.
Toric
Ethos Aquell (Hioxifilcon A) Toric One-Day Soft (Hydrophilic) Contact Lenses (59% Water) are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +10.00 to -20.00 diopters and astigmatic corrections from -0.50 to -6.00 diopters.
The lenses are intended for single-use disposable wear.
The Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) are clear, visibility-tinted and include UV blocker-containing. The lens is available in spherical, aspherical and toric designs. It is an non-ionic hydrogel lens Hioxifilcon derived from of 2-Hydroxyethylmethacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (GlycerolMethacrylate, GMA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and made by photo-polymerization. It consists of 41% Hioxifilcon A and 59% water by weight when immersed in buffered solution. There are two types of buffer solution. one is borate solution (Saline 2); another one is borate solution with sodium hyaluronate (Saline 1). The lens polymer further contains a benzotriazole UV absorbing monomer and thus is able to block UV radiation. The lens is visibly tined with "Reactive Blue19" color additive, 21 CFR part 73.3121.
This document is a 510(k) summary for a contact lens, not an AI/ML medical device. Therefore, the information typically required for an AI/ML device's acceptance criteria and study proving it meets those criteria (such as sample size for test/training sets, expert consensus, MRMC studies, etc.) is not present.
The document focuses on demonstrating substantial equivalence to a previously cleared predicate device, which is the standard pathway for many medical devices, including contact lenses. This involves showing similar technological characteristics and performance through non-clinical testing.
Here's an analysis of the provided text in relation to the requested information, highlighting why certain points cannot be addressed:
1. A table of acceptance criteria and the reported device performance
The document provides a comparative table of technological characteristics between the proposed device ("Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)") and a predicate device (K040303). This isn't strictly "acceptance criteria" in the sense of performance metrics for an AI/ML algorithm, but rather a comparison for demonstrating substantial equivalence.
| Characteristic | Proposed Device (Ethos Aquell) | K040303 Predicate |
|---|---|---|
| Production Method | Cast-Molded | Cast-Molded |
| USAN Name | Hioxifilcon A | Hioxifilcon A |
| Material Classification | Group 2 (high water non-ionic) | Group 2 (high water non-ionic) |
| Water Content (%) | 59% | 59% |
| Refractive Index | 1.400 | 1.404 |
| Oxygen Permeability (edge corrected) @ 35°C | 20.6 x 10-11 (cm²/sec)(mlO2/ml-mmHg) | 18 x 10-11 (cm²/sec)(mlO2/ml-mmHg) |
| Transmittance: Visible light @ 380~780nm | > 95% | > 95% |
| Transmittance: UVA @ 380-315nm | < 50% | N/A |
| Transmittance: UVB @ 315-280nm | < 5% | N/A |
| Lens design | Spherical and Aspheric, Toric | Spherical, Toric |
| Indications for Use | Correction of refractive ametropia (myopia, hyperopia, astigmatism) in aphakic/non-aphakic persons with non-diseased eyes. Daily wear. | Correction of visual acuity (myopia, hyperopia, astigmatism) in aphakic/non-aphakic persons with non-diseased eyes. Daily wear. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "Clinical studies for Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) of the present device are not required for the premarket notification," because the USAN name and process are the same as previously cleared predicate devices.
Instead, non-clinical testing was performed. The document lists the types of non-clinical tests (e.g., Physicochemical Properties, Biocompatibility Testing, Shelf Life Test, Sterility Test), but does not provide sample sizes for these tests or data provenance (country of origin, retrospective/prospective). These types of details are usually found in the full submission, not the public 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as no clinical study or human expert review of "test sets" (in the AI/ML sense) was conducted or required for this 510(k) submission. The evaluation is based on material properties and non-clinical performance, and substantial equivalence to a predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring expert adjudication was part of this submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is for an AI/ML device, not a contact lens.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for an AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For a contact lens, "ground truth" relates to material specifications and performance standards (e.g., ensuring water content is 59%, or that oxygen permeability meets a certain threshold). These are established physical and chemical properties, not clinical "ground truth" derived from patient data or expert consensus in the diagnostic sense. The document states that non-clinical performance tests were conducted "in accordance with the May 1994 FDA guidance title Premarket Notification 510(K) Guidance Document for Class II Contact Lenses." This guidance defines the expected methods and standards for these physical and chemical property assessments.
8. The sample size for the training set
Not applicable. This is for an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is for an AI/ML device.
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October 21, 2020
Plexus Optix, Inc. % Estela Lin Regulatory Affair Senior Engineer Pegavision Corporation 2F-1, No. 5, Shing Yeh St. Taoyuan, Guishan Dist. 33341 Taiwan
Re: K201268
Trade/Device Name: Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL. MVN Dated: September 15, 2020 Received: September 18, 2020
Dear Estela Lin:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device 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-safety-reportingcombination-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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-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/medicaldevices/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) K201268
Device Name
Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
Indications for Use (Describe)
Spherical and Aspheric
Ethos Aquell (Hioxifilcon A) Spherical and Aspheric One-Day Soft (Hydrophilic) Contact Lenses (59% Water) are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +10.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.
Toric
Ethos Aquell (Hioxifilcon A) Toric One-Day Soft (Hydrophilic) Contact Lenses (59% Water) are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +10.00 to -20.00 diopters and astigmatic corrections from -0.50 to -6.00 diopters.
The lenses are intended for single-use disposable wear.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
The following 510(K) Summary is being submitted as required by 21CFR 807.92(a).
Establishment Information
| Plexus Optix, Inc. | |
|---|---|
| Company: | 3333 Quality Drive |
| Rancho Cordova, CA 95670 | |
| Contact: | Dave Delle Donne, SVP Commercial Markets |
| Phone: | 916-8514989 |
| Email: | dave.delledonne@vsp.com |
Application Correspondent
PEGAVISION CORPORATION
| Company: | 2F-1 No.5, Shing Yeh St., Guishan Dist., Taoyuan City 333,Taiwan |
|---|---|
| Contact Person: | Estela Lin, Regulatory Affair Senior Engineer |
| Phone: | 886-3-329-8808 |
| Fax: | 886-3-329-8897 |
| Email: | EstelaLin@pegavision.com |
| Date Prepared: | April 09, 2020 |
Identification of Device
| Trade Name: | Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic)Contact Lenses (59% Water) |
|---|---|
| Common Name: | Soft (hydrophilic) Contact Lenses (daily wear) |
| Classification Name: | Lenses, Soft Contact, Daily Wear 21CFR. 886.5925, ProductCode LPLLens. Soft Contact (Disposable). 21CFR. 886.5925,Product Code MVN |
| FDA Classification: | Class II |
| Predicate Device Name: | K040303 Hydrogel Vision Corporation59% Extreme H2O (hioxifilcon A) Soft Contact Lens forDaily Wear (cast-molded, with a visibility tint) |
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Description of Device
The Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) are clear, visibility-tinted and include UV blocker-containing. The lens is available in spherical, aspherical and toric designs. It is an non-ionic hydrogel lens Hioxifilcon derived from of 2-Hydroxyethylmethacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (GlycerolMethacrylate, GMA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and made by photo-polymerization. It consists of 41% Hioxifilcon A and 59% water by weight when immersed in buffered solution. There are two types of buffer solution. one is borate solution (Saline 2); another one is borate solution with sodium hyaluronate (Saline 1). The lens polymer further contains a benzotriazole UV absorbing monomer and thus is able to block UV radiation. The lens is visibly tined with "Reactive Blue19" color additive, 21 CFR part 73.3121.
Indications for use
Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
Spherical and Aspheric
Ethos Aquell (Hioxifilcon A) Spherical and Aspheric One-Day Soft (Hydrophilic) Contact Lenses (59% Water) are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +10.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.
Toric
Ethos Aquell (Hioxifilcon A) Toric One-Day Soft (Hydrophilic) Contact Lenses (59% Water) are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +10.00 to -20.00 diopters and astigmatic corrections from -0.50 to -6.00 diopters.
The lenses are intended for single-use disposable wear.
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Technological characteristics studies
The technological characteristics of Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) and Predicate Device (K040303) are illustrated in the following Table.
| Proposed Device | K040303 Predicate | |
|---|---|---|
| Production Method | Cast-Molded | Cast-Molded |
| USAN Name | Hioxifilcon A | Hioxifilcon A |
| Material Classification | Group 2high water non-ionic | Group 2high water non-ionic |
| Water Content (%) | 59% | 59% |
| Refractive Index | 1.400 | 1.404 |
| Oxygen Permeability(edge corrected) @ 35°C | 20.6 x 10-11(cm²/sec)(mlO2/ml-mmHg) | 18 x 10-11(cm²/sec)(mlO2/ml-mmHg) |
| TransmittanceVisible light @380~780nm | > 95% | > 95% |
| TransmittanceUVA @ 380-315nmUVB @ 315-280nm | < 50%< 5% | N/AN/A |
| Lens design | Spherical and AsphericToric | SphericalToric |
| Indications for Use | Indicated for daily wear for thecorrection of refractive ametropiain aphakic and/or non-aphakicpersons with non-diseased eyes thatare myopia or hyperopia and/orastigmatism. | Indicated for daily wear for thecorrection of visual acutiy inaphakic or not-aphakic personswith non-diseased eyes that aremyopia or hyperopia and/orastigmatism. |
Summary of Clinical Study
Hioxifilcon A lenses have been used widely. Their safety and effectiveness have been well documented. Their safety and effectiveness can be further exemplified by three lenses cleared by FDA.
-
59% Extreme H2O (hioxifilcon A) Soft Contact Lens for Daily Wear (cast-molded, with a visibility tint)
K040303 Submitted by Hydrogel Vision Corporation -
59% Extreme H2O (hioxifilcon A) Soft Contact Lens K992692 Submitted by Benz Research and Development
-
BENZ-G 5X (hioxifilcon A) Soft (Spherical) Daily Wear Contact Lens K983773 Submitted by Benz Research and Development
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Clinical studies for Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) of the present device are not required for the premarket notification, as the USAN name and process are the same as the above-mentioned predicate devices.
Non-clinical Study
All tests were conducted in accordance with the May 1994 FDA guidance title Premarket Notification 510(K) Guidance Document for Class II Contact Lenses. The non-clinical performance tests had been performed to demonstrate the safety and effectiveness of Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water).
Non-Clinical testing performed includes:
- Physicochemical Properties
- -Refractive Index
- Oxygen Permeability -
- Water content -
- Extractables -
- Mechanical Property -
- -Light Transmittance
- Biocompatibility Testing
Contact Lens: 59% Hioxifilcon A Soft Contact Lens [Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)]
- Cytotoxicity Test (according to ISO 10993-5) ।
- -Maximization Sensitization Test (according to ISO 10993-10)
- -Ocular Irritation Test (according to ISO 10993-10)
- Acute Systemic Toxicity Test (according to ISO 10993-11) -
Package Solution: Saline 1
- Cytotoxicity Test (according to ISO 10993-5) -
- Ocular Irritation Test (according to ISO 10993-10) -
Primary Packaging: Foil and PP Blister
- Cytotoxicity Test (according to ISO 10993-5) ।
- Ocular Irritation Test (according to ISO 10993-10) ।
- -Acute Systemic Toxicity Test (according to ISO 10993-11)
- Shelf Life Test and Sterility Test ●
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Substantial Equivalence Statement
The physical and chemical properties of Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) (Proposed Device) are similar with the commercial soft lens (K040303). It's consistent with 59% Extreme H2O (hioxifilcon A) Soft Contact Lens for Daily Wear (cast-molded, with a visibility tint) (K040303).
In addition, Ethos Aquell lens contains a UV absorber which is the same as that used in Aquamax (K161739). Ethos Aquell lenses were manufactured by the same photo curing process as that of Aquamax (K161739).
We've conducted manufacturing verification studies for the two alternate lens designs (Spherical/Aspheric and Toric) to ensure that lenses meet prescribed specification with established tolerances according to the 1994 FDA Contract Lens Guidance for diameter, power, and base curve.
In conclusion, the information submitted in this premarket notification supports the substantial equivalency, the Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water), with the same established safety profile and effectiveness as the predicate devices - 59% Extreme H2O (hioxifilcon A) Soft Contact Lens for Daily Wear (cast-molded, with a visibility tint) (K040303).
§ 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.