(29 days)
No
The summary describes a physical contact lens and its material properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The "Intended Use / Indications for Use" section states that the device is indicated for the "correction of ametropia (myopia)" and "correction of refractive ametropia (myopia and hyperopia) and presbyopia," which are refractive errors, not diseases or conditions that require therapy. While it provides UV protection, its primary function is vision correction.
No
Explanation: The device is a contact lens intended for correcting vision (ametropia), not for diagnosing a condition.
No
The device description clearly states it is a physical contact lens made from a specific material (linofilcon A) and includes details about its physical properties, composition, and manufacturing. It is a tangible medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The OCuSOFT® AMENITY™ contact lenses are designed to be worn on the eye to correct vision problems (ametropia, astigmatism, presbyopia). They are a therapeutic and corrective device, not a diagnostic tool that analyzes biological samples.
- Intended Use: The intended use clearly states the lenses are for "correction of ametropia" and related conditions. There is no mention of diagnosing or detecting any disease or condition through analysis of biological samples.
- Device Description: The description focuses on the physical properties and materials of the contact lens itself, not on any components or processes related to analyzing biological samples.
Therefore, the OCuSOFT® AMENITY™ contact lenses fall under the category of medical devices, but specifically as a corrective/therapeutic device for vision, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
OCuSOFT® AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by people who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.
OCuSOFT® AMENITY™ (linofilcon A) TORIC DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of ametropia (myopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.
OCuSOFT® AMENITY™ (linofilcon A) MULTIFOCAL DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by people who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.
OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
Product codes (comma separated list FDA assigned to the subject device)
LPL, MVN
Device Description
The OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are a hemispherical shells with molded base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from linofilcon A, which is a random co-polymer of silicone containing monomers and hydrophilic monomers. The lens consists of 62.0% linofilcon A and 38.0% water by weight when immersed in saline solution with added lubricants. The linofilcon A name has been adopted by the United States Adopted Names Council (USAN).
The OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ contain C.I. Reactive Blue No. 19 (21 CFR Part 73.3127) for visibility and handling.
The OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ incorporate a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lenses block >95% in the UVB range (280mm - 315nm), and >70% in the UVA range (316nm - 380nm).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-Clinical Performance Testing:
- Toxicology: In-Vitro Cytotoxicity (ISO 10993-5), Systemic Toxicity (ISO 10993-11), Acute Ocular Irritation (ISO 10993-23). Results indicated non-cytotoxic, no acute systemic toxicity, and no ocular irritation.
- Shelf Life: Testing performed to evaluate stability, sterility, and package integrity over the duration of the labeled expiration date. Data supports proposed shelf life.
- Bench Testing - Manufacturing Verification Testing: Demonstrated ability to manufacture lenses to pre-determined finished product specifications within ANSI Z80.20 tolerance.
Clinical Testing:
- A clinical study was performed to demonstrate the safety and effectiveness of the linofficon A finished contact lenses in K213216.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 12, 2024
Unicon Optical Co., Ltd. Bret Andre Principal Consultant Andre Vision and Device Research 6119 Canter Lane West Linn, OR 97068
Re: K241707
Trade/Device Name: OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™; OCuSOFT AMENITY™ Toric (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™: OCuSOFT AMENITY™ Multifocal (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEALTM
Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: May 21, 2024 Received: June 13, 2024
Dear Bret Andre:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the 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 available 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.
1
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product: and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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 -S
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
3
Indications for Use
510(k) Number (if known) K241707
Device Name
OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™; OCuSOFT AMENITY™ Toric (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™; OCuSOFT AMENITY™ Multifocal (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™
Indications for Use (Describe)
OCuSOFT® AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by people who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.
OCuSOFT® AMENITY™ (linofilcon A) TORIC DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of ametropia (myopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.
OCuSOFT® AMENITY™ (linofilcon A) MULTIFOCAL DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by people who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.
OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should 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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
SPECIAL 510 (k) SUMMARY
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: K241707
I. SUBMITTER
Date Prepared: July 1, 2024
| Name: | UNICON OPTICAL CO., LTD. |
|---|---|
| Address: | No.16, Gongye E. 9th Rd. |
| Hsinchu Science Park, Baoshan Township | |
| Hsinchu County Hsinchu – District, | |
| TAIWAN 30075 |
| Contact Person: | Nick Liao
Director |
|-----------------|---------------------------------------------------------------------------------|
| Phone number: | +886-4-23551233 |
| Consultant: | Bret Andre
EyeReg Consulting, Inc.
6119 Canter Ln.
West Linn, OR 97068 |
| Phone number: | (503) 372-5226 |
II. DEVICE
| Trade Name: | OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES
with HYDRASEAL™;
OCuSOFT AMENITY™ Toric (linofilcon A) DAILY DISPOSABLE CONTACT
LENSES with HYDRASEAL™;
OCuSOFT AMENITY™ Multifocal (linofilcon A) DAILY DISPOSABLE
CONTACT LENSES with HYDRASEAL™ |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common
Name: | Contact Lens, Daily Wear (Disposable) |
| Classification
Name: | Soft (hydrophilic) Contact Lens (21 CFR 886.5925) |
| Regulatory
Class: | Class II |
| Product Code: | LPL; MVN |
5
III. PREDICATE DEVICE
The OCuSOFT AMENITY™ (linofilcon A) CONTACT LENSES with HYDRASEAL™ are substantially equivalent to the following predicate device(s):
- I "Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens" By Unicon Optical Co., Ltd. 510(k) number; K213216 Primary Predicate
- I "Unicon Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens" By Unicon Optical Co., Ltd. 510(k) number; K191929 Reference Predicate
- I "Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens" By Innova Vision Inc. 510(k) number; K213119 Reference Predicate
IV. DEVICE DESCRIPTION
The OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are a hemispherical shells with molded base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from linofilcon A, which is a random co-polymer of silicone containing monomers and hydrophilic monomers. The lens consists of 62.0% linofilcon A and 38.0% water by weight when immersed in saline solution with added lubricants. The linofilcon A name has been adopted by the United States Adopted Names Council (USAN).
The OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ contain C.I. Reactive Blue No. 19 (21 CFR Part 73.3127) for visibility and handling.
The OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ incorporate a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lenses block >95% in the UVB range (280mm - 315nm), and >70% in the UVA range (316nm - 380nm).
The following table lists the material properties and available parameters for the OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™:
6
| Parameter | Range | Tolerance* |
|---|---|---|
| Chord Diameter | 13.00 mm to 15.00 mm | ±0.20 mm |
| Center Thickness | 0.080 mm @ -3.00 D | When ≤ 0.10 mm → ±0.010 mm + 10% |
| When > 0.10 mm → ±0.015 mm + 5% | ||
| Base Curve | 8.00 mm to 9.50 mm | ±0.20 mm |
| Back Vertex Power (F'v) | +20.00D to -20.00D | When 0.00 1.50 D→± 5° |
| Multifocal Power | +0.25 D to +4.00 D | |
| (in 0.25 D steps) | ±0.25D | |
| Surface Appearance | - | Lenses should be clear with no surface defect |
| Oxygen Permeability | ||
| (x 10-11(cm²/sec)(mlO2)/(ml x mmHg)) | 100 | ±20% |
| Light Transmittance - Tinted | ||
| (@ 380-780nm) | 95% | ±5% |
| Ultraviolet Radiation Transmittance |