(148 days)
Not Found
No
The summary describes a standard contact lens with no mention of AI or ML technology in its design, function, or intended use.
No.
The device is a contact lens intended for the correction of refractive ametropia (myopia), which is a form of vision correction and not typically considered a therapeutic treatment for a disease or condition. Its purpose is to correct a vision defect, not to treat, cure, or prevent a disease.
No
Explanation: The device is a contact lens intended for correcting refractive ametropia (myopia), which is a treatment or correction, not a diagnostic procedure.
No
The device description clearly states the device is a contact lens made of a physical material (methafilcon A) and supplied in blister packers, indicating it is a physical medical device, not software.
No, 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, tissue) to provide information about a person's health. They are used outside of the body.
- Contact Lens Function: This device is a contact lens. Its function is to be placed on the eye to correct vision. It does not perform any tests on bodily samples.
- Intended Use: The intended use clearly states it's for "correction of refractive ametropia (myopia)". This is a therapeutic/corrective function, not a diagnostic one.
- Device Description: The description focuses on the material and physical properties of the lens, not on any components or processes related to analyzing biological samples.
Therefore, based on the provided information, the EASY DAY contact lens is a medical device, but it falls under the category of a therapeutic or corrective device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
EASY DAY (methafilcon A) 1-Day Soft ( Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia) in not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 0.75 diopters that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from 0 ~ - 12.00D. The lens is indicated for single use daily disposable wear and patients are instructed to discard the lens after each removal.
Product codes (comma separated list FDA assigned to the subject device)
LPL
Device Description
EASY DAY (methafilcon A) 1-Day Soft (hydrophilic) contact lens is available as a single vision aspherical lens. The lens material, methafilcon A is a copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA) cross-linked with ethylene glycol dimethacrylate (EGDMA). The lens with visible tint is tinted blue using reactive blue 4K to make the lens more visible for handling. Lenses are supplied sterile in sealed blister packers containing buffered 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
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)
The EASY DAY (methafilcon A) 1-Day Soft (hydrophilic) Contact Lenses for Daily Wear were tested at least 30 evaluable subjects' eyes separately for 1 month. Nearly a hundred percent of the participants' vision was corrected and nearly all were satisfied with the lens wearing and care of lenses. In general, these products are good and safe for customers.
A series of nonclinical performance tests were performed to demonstrate the safety and effectiveness of the EASY DAY (methafilcon A) 1-Day Soft (hydrophilic) Contact Lens for Daily Wear, and establish substantial equivalence to predicate lenses. All testing was conducted in accordance with the May 1994 FDA guideline titled Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses, and in conformance to applicable device regulations.
Technological characteristics studies:
Diameter range:14.20 ±0.2mm
Power range: -0.0 D to -12.00 D
Center Thickness: 0.06~0.100mm varies with power
Refractive index: 1.409 ±0.005
Light transmittance: >92%
Water content: 53 to 57 %
Oxygen permeability (edged corrected): 19.7±20% { 10++1(cm2/sec)(mlO2/ml-mmHg) }
Biocompatibility: Irritation test in the rabbit eye and Systemic toxicity studies indicate the extracts would be considered as non-toxic and nor irritated. The Cytotoxicity testing demonstrates the lens is not cytotoxic under the conditions of the study.
Microbiology: Steam sterilization process has been validated to deliver a minimum SAL of 10°, thereby complying with the requirement of FDA Group 4. There is shelf-life stability data supporting that the lens remains sterile through the expiration date claimed for the product.
Leachability: Studies were conducted to determine the leachable materials from the finished lens. The results show that, at the levels of the detection reported, there are no leachable monomers and addictive residues.
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.
Not Found
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
K13093
510 (k) Summary SUMMARY OF SAFETY AND EFFECTIVENESS FOR EASY DAY (methafilcon A )1-Day Soft (hydrophilic) Contact Lens for Daily Wear
Prepared Date: Aug. 20, 2013
| Prepared Date: | Aug. 20, 2013 |
|---|---|
| Submitter Information: | |
| Company: | Jiangsu Horien Contact Lens Co., Ltd. |
| No.88 Danfu RD, Situ Town, Danyang City,Jiangsu Province, | |
| China.,212331 | |
| Contact Person: | Jinhua Hu |
| Manager of Registration Division | |
| Phone: | 86-511-86809314 |
| FAX: | 86-511-86206366 |
| AUG 3 0 2013 |
| Identification of Device: | |
|---|---|
| Classification Name: | Lens, Contact, (Disposable) |
| Trade Name: | EASY DAY (methafilcon A) 1-Day Soft (hydrophilic) Contact |
| Lens | |
| Common or usual Name: | Soft (hydrophilic) Contact lens (daily wear) |
| FDA Classification: | Class II |
Predicate Device:
FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVUE, COOPERFLEX (methafilcon A ) Soft (hydrophilic) Contact Lens cleared via K000384 COOPERVISION, INC.
Indications for Use
EASY DAY (methafilcon A) 1-Day Soft ( Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia) in not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 0.75 diopters that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from 0 ~ - 12.00D. The lens is indicated for single use daily disposable wear and patients are instructed to discard the lens after each removal.
Description of Device
EASY DAY (methafilcon A) 1-Day Soft (hydrophilic) contact lens is available as a single vision aspherical lens. The lens material, methafilcon A is a copolymer of 2-hydroxyethyl
1
methacrylate (HEMA) and methacrylic acid (MAA) cross-linked with ethylene glycol dimethacrylate (EGDMA) . The lens with visible tint is tinted blue using reactive blue 4K to make the lens more visible for handling. Lenses are supplied sterile in sealed blister packers containing buffered saline solution.
Summary of Clinical Study:
The EASY DAY (methafilcon A) 1-Day Soft (hydrophilic) Contact Lenses for Daily Wear were tested at least 30 evaluable subjects' eyes separately for 1 month. Nearly a hundred percent of the participants' vision was corrected and nearly all were satisfied with the lens wearing and care of lenses. In general, these products are good and safe for customers.
Nonclinical Studies:
A series of nonclinical performance tests were performed to demonstrate the safety and effectiveness of the EASY DAY (methafilcon A) 1-Day Soft (hydrophilic) Contact Lens for Daily Wear, and establish substantial equivalence to predicate lenses - FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVUE, COOPERFLEX (methafilcon A ) Soft (hydrophilic) Contact Lens (K000384). All testing was conducted in accordance with the May 1994 FDA guideline titled Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses, and in conformance to applicable device regulations. The evidence of substantial equivalent to the predicate lens described as follow:
- a) Technological characteristics studies
EASY DAY (methafilcon A) 1-Day Soft (hydrophilic) Contact Lens for Daily Wear designs in the following parameter ranges:
Diameter range:14.20 ±0.2mm
Power range: -0.0 D to -12.00 D
Center Thickness: 0.06~0.100mm varies with power
Lenses have the following properties:
Refractive index: 1.409 ±0.005
Light transmittance: >92%
Water content: 53 to 57 %
Oxygen permeability (edged corrected): 19.7±20% { 10++1(cm2/sec)(mlO2/ml-mmHg) }
There characterizations of EASY DAY (methafilcon A) 1-Day Soft (hydrophilic) Contact Lenses are equivalent and comparable to those of predicate lenses.
b) Biocompatibility
"In accordance with the May 1994 FDA guideline titled Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses, toxicity studies have been conducted on the model: EASY DAY (methafilcon A) 1-Day Soft (hydrophilic) Contact Lens
2
for Daily Wear. The Irritation test in the rabbit eye and Systemic toxicity studies indicate the extracts would be considered as non-toxic and nor irritated. The Cytotoxicity testing demonstrates the lens is not cytotoxic under the conditions of the study.
c) Microbiology
Steam sterilization process has been validated to deliver a minimum SAL of 10°, thereby complying with the requirement of FDA Group 4. There is shelf-life stability data supporting that the lens remains sterile through the expiration date claimed for the product.
d) Leachability
Studies were conducted to determine the leachable materials from the finished lens. The results show that, at the levels of the detection reported, there are no leachable monomers and addictive residues.
Substantial equivalence Statement:
Testing performed on the EASY DAY (methafilcon A) I-Day Soft (hydrophilic) Contact Lens for Daily Wear indicated that it can support the efficiency and security use as well as the predicate devices- FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC. ONEVUE, COOPERFLEX (methafilcon A ) Soft (hydrophilic) Contact Lens (K000384), when used in accordance with the instructions for use. It is due to the facts that the risks and benefits of the subject device are the same as soft contact lenses for to the daily wear.
In conclusion, it is Jiangsu Horien's EASY DAY (methafilcon A )1-Day Soft (hydrophilic) Contact Lens conviction that data submitted in this 510(k) to validate the claim of substantial equivalency, substantiates our ability to manufacture a soft contact lens, the EASY DAY (methafilcon A) 1-Day Soft (hydrophilic) Contact Lens for Daily Wear, with the same established safety profile and effectiveness as the predicate device-- FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVUE, COOPERFLEX (methafilcon A ) Soft (hydrophilic) Contact Lens (K000384).
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
August 30, 2013
Jiangsu Horien Contact Lens Co., Ltd. % Ms. Jennifer Reich Harvest Consulting Corp 2904 N. Boldt Drive, Flagstaff, AZ 86001
Re: K130931
Trade/Device Name: EASY DAY(methafilcon A ) 1-Day Soft (Hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact lens (daily wear) Regulatory Class: Class II Product Code: LPL Dated: July 29, 2013 Received: July 19, 2013
Dear Ms. Reich:
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. 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.
4
Page 2 - Ms. Jennifer Reich
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Y. Alexander -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: K130931
Device Name: EASY DAY (methafilcon A) I-Day Soft ( Hydrophilic) Contact Lens
Indications for Use:
EASY DAY (methafilcon A) I-Day Soft ( Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia) in not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 0.75 diopters that does not interfere with visual acuity. The lensmay be prescribed in spherical powers ranging from 0 ~ - 12.00D.
The lens is indicated for single use daily disposable wear and patients are instructed to discard the lens after each removal.
Prescription Use______________________________________________________________________________________________________________________________________________________________ X (part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Leonid Livshitz · -2 2013.08.23 : '00'04- 17:19:55 (Division Sign-Off) Division of Ophthalmic and Ear, Nose, and Throat Devices
510(k) Number:
page 1 of _ l ________________________________________________________________________________________________________________________________________________________________