(154 days)
No
The summary describes a standard soft contact lens with no mention of AI/ML technology in its design, function, or testing.
No.
The device is indicated for the correction of visual acuity, which is a refractive purpose, not a therapeutic one for disease treatment.
No
The device is a contact lens intended for correcting visual acuity, not for diagnosing eye conditions.
No
The device description clearly states that the device is a physical contact lens made from a specific material, containing water and pigment, and supplied in a blister package. It is a tangible hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body.
- Device Function: The OPTIXON I-DAY contact lens is a medical device that is placed on the surface of the eye (the cornea) to correct vision. It does not analyze any bodily fluids or tissues.
- Intended Use: The intended use is for the correction of visual acuity, not for diagnosing a condition or providing information about a person's health based on in vitro analysis.
Therefore, based on the provided information, the OPTIXON I-DAY contact lens is a medical device, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
OPTIXON 1- DAY are indicated for single-use, disposable daily wear for the correction of visual acuity in non-aphakic persons with non-diseased eyes that are myopic and exhibit astigmatism of 1.00D or less that does not interfere with visual acuity.
Product codes
LPL, MVN
Device Description
OPTIXON 1- DAY (omafilcon A)is daily disposable soft contact lenses(single use) produced from the HEMA-MPC copolymer material. MPC is similar to phospholipids (e.g., phosphatidylcholine)
The contact lenses contain 59% water by weight and is sold in the blister package immersed in packaging saline. RB 246 pigment conforms to 21 CFR Part 73.3106 is used to provide the handling blue tint for the lens.
The device is a corneal contact lens having a total diameter more than the visible iris diameter and is designed to be worn in its entirety on the cornea. The device has an aspheric front curve (external curve) which is tri-curve and spherical base curve (internal curve).
The contact lenses are hydrophilic, soft and it is supplied in sterile state.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cornea (eyes)
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)
Physiochemical Studies: Conducted according to ISO 18369-4:2006 (Ophthalmic Optics-Contact Lenses-Part 4: Physiochemical properties of contact lens materials) and ISO 18369-3:2006 (Ophthalmic Optic-Contact Lenses-Part 3: Measurement methods). Key results: The physical, optical and chemical properties of the lens are within established specifications for the lenses.
Toxicology Studies: In-vivo and in-vitro studies. Key results: Lenses are non-toxic and biocompatible with the ocular environment.
Cytotoxicity test: Passed, According to EN ISO 10993- 5 :2009.
Skin sensitization test: Passed, According to EN ISO 10993-10 :2010.
Ocular irritation test: Passed, According to EN ISO 10993-10 :2010.
Acute Systemic Toxicity: Passed, According to ISO 10993-11 : 2017.
Clinical Test: None required due to the technological characteristics, formulation, manufacturing and sterilization processes being the same as the predicate devices.
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 contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 18, 2020
Optixon Inc. % Eunbae Cho General Manager IGC Co., Ltd. Rm. 501, Daeryung techno town 7th, #638, Seobusaet-gil, Geumcheon-gu Seoul, Republic of Korea 08504
Re: K201013
Trade/Device Name: Optixon 1-Day Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: August 13, 2020 Received: August 17, 2020
Dear Eunbae Cho:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201013
Device Name OPTIXON 1- DAY
Indications for Use (Describe)
OPTIXON I- DAY are indicated for single-use, disposable daily wear for the correction of visual acuity in non-aphakic persons with non-diseased eyes that are myopic and exhibit astigmatism of 1.00D or less that does not interfere with visual acuity.
Type of Use (Select one or both, as applicable)
| Depository Use (Part 21 CFR 601 Subpart D) |
|---|
| Own-Use Sample (21 CFR 601 Subpart D) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
Preparation Date: Sep 10, 2020
A.510k Number: K201013
B. Applicant: Company name: OPTIXON Inc
Address: 105/106 ho, 164, Obonq-ro, Buk-Gu, Daequ, Rep. of Korea
C. Proprietary and Established Names: OPTIXON Inc Address: 105/106 ho, 164, Obong-ro, Buk-Gu, Daegu, Rep. of Korea
D. Regulatory Information
- Classification Name: lenses, soft contact, daily wear
- Common / Usual Name: Soft (hydrophilic) contact lens
- Proprietary Name: OPTIXON 1- DAY
- Classification / Product Code: Class 2 / LPL (21 CFR 886.5925)
E. Indications for Use
OPT IXON 1- DAY are indicated for single-use, disposable daily wear for the correction of visual acuity in non-aphakic persons with non-diseased eyes that are myopic and exhibit astigmatism of 1.00D or less that does not interfere with visual acuity.
F. Description
OPTIXON 1- DAY (omafilcon A)is daily disposable soft contact lenses(single use) produced from the HEMA-MPC copolymer material. MPC is similar to phospholipids (e.g., phosphatidylcholine)
The contact lenses contain 59% water by weight and is sold in the blister package immersed in packaging saline. RB 246 pigment conforms to 21 CFR Part 73.3106 is used to provide the handling blue tint for the lens.
The device is a corneal contact lens having a total diameter more than the visible iris diameter and is designed to be worn in its entirety on the cornea. The device has an aspheric front curve (external curve) which is tri-curve and spherical base curve (internal curve).
The contact lenses are hydrophilic, soft and it is supplied in sterile state.
4
G. Substantial Equivalence Information
-Predicate Device-1 SE Number: K162223 Product name: Aveo (omafilcon A) 1-Day Aspheric Soft (Hydrophilic) Contact Lenses Company: Supervision Optimax Sdn Bhd
-Predicate Device-2 SE Number: K 112302 Product name: Proclear lens Company: CooperVision, Inc.
| Manufacturer | OPTIXON Inc | Supervision Optimax
Sdn Bhd | CooperVision, Inc |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | OPTIXON 1-DAY | Aveo (omafilcon A)
1-DAY Aspheric Soft
(Hydrophilic) Contact
Lens | Proclear (omafilcon A)
Soft Contact Lenses |
| 510(k) No. | - | K162223 | K 112302 |
| Intended Use | OPTIXON 1- DAY are
indicated for single-use,
disposable daily wear for
the correction of visual
acuity in non-aphakic
persons with
non-diseased eyes that
are myopic and exhibit
astigmatism of 1.00D or
less that does not
interfere with visual
acuity. | Aveo (omafilcon A) 1-Day
Aspheric Soft
(Hydrophilic) Contact
Lenses are indicated for
daily wear for the
correction of visual acuity
in not aphakic persons
with nondiseased eyes
that are myopic or
hyperopic and exhibit
astigmatism of 1.00D or
less that does not
interfere with visual
acuity. The contact lenses
are intended for daily
wear, single use and are
to be discarded at the end
of the day. | Proclear Asphere
omafilcon A) Soft
Contact lenses are
indicated for daily wear
for the correction of
visual acuity in
nonaphakic persons
with non-diseased eyes
that are myopic or
hyperopic and exhibit
astigmatism of 2.00D or
less that does not
interfere with visual
acuity. |
| Modality | Daily Wear | Daily Wear | Daily Wear |
| Material
USAN Name | omafilcon A | omafilcon A | omafilcon A |
| FDA Category | Group II | Group II | Group II |
| (Group) | Non-ionic, High water | Non-ionic, High water | Non-ionic, High water |
| Manufacturing
Method | Cast Molded | Cast Molded | Finished Inside
Polymerization System
II |
| Curing | Thermal Cure | Thermal Cure | Thermal Cure |
5
| Sterilization | Moist heat sterilization | Moist heat sterilization | Moist heat sterilization |
|---|---|---|---|
| Visibility Tint | Reactive Blue Dye 246 | Reactive Blue Dye 246 | VAT Blue 6 |
| Water | |||
| Content | 59% ± 2% | 59% ± 2% | 59% ± 2% |
| Package | |||
| Saline | Phosphate | ||
| Saline | Phosphate | ||
| Saline | Phosphate Buffers | ||
| PEG200 and Tween 80 | |||
| Oxygen | |||
| Permeability | |||
| (Dk) x10-11 | 25.68 | 25.68 | 21.05 |
| Light | |||
| transmission | 98% | 98% | >90% |
| Base Curve | 8.4mm to 8.8mm | 8.4mm to 8.8mm | 8.0mm to 9.3mm |
| Diameter Øт | 14.0 to 14.4mm | 14.0mm to 14.4mm | 13.6mm to 15.2mm |
| Power | -0.50D to - 10.0D | -10.00 to +6.00 | -20.00 to +20.00 |
H. Substantial Equivalent Based on Assessment of Non-Clinical Performance Data
Physiochemical Studies
The physiochemical studies were conducted according to ISO 18369-4:2006 Ophthalmic Optics-Contact Lenses-Part 4: Physiochemical properties of contact lens materials and ISO 18369-3:2006 Ophthalmic Optic-Contact Lenses-Part 3: Measurement methods. The physical, optical and chemical properties of the lens are within established specifications for the lenses.
Toxicology Studies
Toxicology (in-vivo and in-vitro) studies reports show that the lenses are non-toxic and biocompatible with the ocular environment.
| Cytotoxicity test | According to EN ISO 10993- 5 :2009 | Passed |
|---|---|---|
| Skin sensitization test | According to EN ISO 10993-10 :2010 | Passed |
| Ocular irritation test | According to EN ISO 10993-10 :2010 | Passed |
| Acute Systemic Toxicity | According to ISO 10993-11 : 2017 | Passed |
I. Clinical Test
The technological characteristics, formulation, manufacturing and sterilization processes are the same as the predicate device Aveo (omafilcon A) 1-DAY Aspheric Soft (Hydrophilic) Contact Lens K162223 and Proclear (omafilcon A) Soft Contact Lenses K 112302. Therefore, no clinical studies were required to demonstrate the safety or effectiveness of the subject device.
J. Conclusion
OPTIXON 1-DAY is substantially equivalent to the predicate device. Aveo (omafilcon A) 1-DAY Aspheric Soft (Hydrophilic) Contact Lens K162223 and Proclear (omafilcon A) Soft Contact Lenses K 112302 in term of optical property, Physiochemical and pre-clinical toxicology. They
6
are produced from the same material (omafilcon A), have the same functional and scientific technology, lens characteristics and the intended use is identical. It is concluded that the lenses are as safe, as effective and perform as well as the predicate devices.