(48 days)
Not Found
No
The 510(k) summary describes standard contact lenses and their material properties. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device's intended use is for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia, which are refractive errors and not diseases requiring therapeutic intervention.
No
Explanation: The device is a soft contact lens intended for optical correction of refractive errors, not for diagnosing medical conditions.
No
The device description clearly states it is a physical contact lens made of hioxifilcon A material, not software.
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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The provided text describes contact lenses. These are medical devices that are placed directly on the eye to correct vision. They do not analyze biological specimens.
- Intended Use: The intended use clearly states the lenses are for "optical correction of refractive ametropia" and "presbyopia." This is a functional correction of vision, not a diagnostic test.
Therefore, based on the provided information, the One Day Flat Pack (hioxifilcon A) Spherical and Multifocal Lenses are not IVDs. They are medical devices used for vision correction.
N/A
Intended Use / Indications for Use
One Day Flat Pack (hioxifilcon A) Spherical Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes who may have 1.00 diopter (D) or less of astigmatism that does not interfere with visual acuity.
One Day Flat Pack (hioxifilcon A) Multifocal Lens is indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in aphakic and non-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 D or less and who may have 1.00 D or less of astigmatism that does not interfere with visual acuity.
One Day Flat Pack (hioxifilcon A) Spherical and Multifocal Lenses are intended to be worn once and then discarded at the end of each wearing period on a daily basis. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
Product codes
LPL
Device Description
The One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lenses are daily wear disposable soft contact lenses available as spherical and multifocal lens designs. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The One Day Flat Pack Daily Disposable Contact Lens packaging system is designed to reduce lens handling by always presenting the lens anterior side up upon opening, which ensures correct lens orientation for proper insertion. The non-ionic lens material. (hioxifilcon A) is a random copolymer of 2- hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) cross-linked with ethylene glycol dimethacrylate.
It consists of 43 % hioxifilcon A and 57 % water by weight when immersed in a buffered saline solution. The lens is available with a blue visibility-handling tint, color additive Reactive Blue # 19, 21 CFR part 73.3121.
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)
Non-Clinical Data: Soft (hydrophilic) contact lenses composed of hioxifilcon A have been reviewed by the Food and Drug administration in eleven premarket 510(k) applications during the time period of 1998 to 2016. This application expands the indications for use for the One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact lens to include a multifocal lens design. The change in lens design does not raise any new issues of safety and effectiveness of the hioxifilcon A material therefore no additional biocompatibility testing was required for this application.
Clinical Data: Clinical studies were unnecessary for this application. One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact lenses are manufactured from the same material using similar manufacturing processes as the predicate devices.
Conclusion: Based upon the data presented, the One Day Flat Pack (hioxifilcon A) Multifocal Contact lens is as safe, as effective and performs as well 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.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Menicon Co., Ltd. % Ellen Beucler Vice President Foresight Regulatory Strategies, Inc. 187 Ballardvale Street, Suite 250 Wilmington, MA 01887
Re: K180819
Trade/Device Name: One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: March 28, 2018 Received: March 29, 2018
Dear Ellen Beucler:
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. 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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Scott E. Steffen -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
2
Indications for Use
510(k) Number (if known)
| Device Name | K180819 |
|---|---|
| ------------- | --------- |
Device Name
Menicon One Day Flat Pack (hioxifilcon A) Spherical and Multifocal Soft Contact Lenses
Indications for Use (Describe)
One Day Flat Pack (hioxifilcon A) Spherical Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes who may have 1.00 diopter (D) or less of astigmatism that does not interfere with visual acuity.
One Day Flat Pack (hioxifilcon A) Multifocal Lens is indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in aphakic and non-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 D or less and who may have 1.00 D or less of astigmatism that does not interfere with visual acuity.
One Day Flat Pack (hioxifilcon A) Spherical and Multifocal Lenses are intended to be worn once and then discarded at the end of each wearing period on a daily basis. 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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Image /page/3/Picture/1 description: The image shows the text "Menicon Co., Ltd." The text is in a simple, sans-serif font and is left-aligned. The background is plain white, which makes the text stand out clearly. The text likely represents the name of a company.
510(k) Summary
One Day Flat Pack (hioxifilcon A) Multifocal
Daily Disposable Soft Contact Lens
1. Applicant Information
Menicon Co., Ltd.
21-19, Aoi 3, Naka-ku, Nagoya, Aichi 460-0006 JAPAN
| Contact Person: | Kenichi Tanaka |
|---|---|
| Telephone No.: | +81-52-935-1676 |
| Fax No.: | +81-52-935-1633 |
| E-mail: | kenichi-tanaka@menicon.co.jp |
| Date Prepared: | May 15, 2018 |
2. Device Information
| Classification name: | Soft (hydrophilic) Contact Lens |
|---|---|
| Device classification: | Class II |
| Regulation number: | 21 CFR 886.5925 |
| Product code: | LPL |
| Proprietary name: | One Day Flat Pack (hioxifilcon A) Multifocal |
| Daily Disposable Soft Contact Lens |
3. Predicate Devices
Menicon claims substantial equivalence to K080632 Clear 1-Day (hioxifilcon A) Soft Contact Lens, K102895 One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens and K161739 Aquamax (etafilcon A) Soft Contact Lens.
4. Description of Device
The One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lenses are daily wear disposable soft contact lenses available as spherical and multifocal lens designs. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
4
Image /page/4/Picture/1 description: The image contains the logo and name of the company "Menicon Co., Ltd.". The logo is a stylized letter "M" in red and green. The company name is written in a simple, sans-serif font.
The One Day Flat Pack Daily Disposable Contact Lens packaging system is designed to reduce lens handling by always presenting the lens anterior side up upon opening, which ensures correct lens orientation for proper insertion. The non-ionic lens material. (hioxifilcon A) is a random copolymer of 2- hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) cross-linked with ethylene glycol dimethacrylate.
It consists of 43 % hioxifilcon A and 57 % water by weight when immersed in a buffered saline solution. The lens is available with a blue visibility-handling tint, color additive Reactive Blue # 19, 21 CFR part 73.3121.
5. Indications for Use
One Day Flat Pack (hioxifilcon A) Spherical Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes who may have 1.00 diopter (D) or less of astigmatism that does not interfere with visual acuity.
One Day Flat Pack (hioxifilcon A) Multifocal Lens is indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in aphakic and non-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 D or less and who may have 1.00 D or less of astigmatism that does not interfere with visual acuity.
One Day Flat Pack (hioxifilcon A) Spherical and Multifocal Lenses are intended to be worn once and then discarded at the end of each wearing period on a daily basis. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
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Image /page/5/Picture/2 description: The image contains the logo for Menicon Co., Ltd. On the left is a circular logo with a white design on a red and green background. To the right of the logo is the text "Menicon Co., Ltd." in a simple, sans-serif font.
6. Performance Data
Non-Clinical Data
Soft (hydrophilic) contact lenses composed of hioxifilcon A have been reviewed by the Food and Drug administration in eleven premarket 510(k) applications during the time period of 1998 to 2016. This application expands the indications for use for the One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact lens to include a multifocal lens design. The change in lens design does not raise any new issues of safety and effectiveness of the hioxifilcon A material therefore no additional biocompatibility testing was required for this application.
Clinical Data
Clinical studies were unnecessary for this application. One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact lenses are manufactured from the same material using similar manufacturing processes as the predicate devices.
Conclusion
Based upon the data presented, the One Day Flat Pack (hioxifilcon A) Multifocal Contact lens is as safe, as effective and performs as well as the predicate devices. A comparison of the new device and the predicate devices is presented in Table 1.
7. Substantial Equivalence
The claim of substantial equivalence to the previously cleared devices is supported by the following Comparison of Characteristics in Table 1.
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| | One Day Flat Pack
Multifocal | One Day Flat Pack
Spherical | Pegavision Aquamax | Clear Lab 1 Day |
|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | New | K102895 | K161739 | K080632 |
| USAN | hioxifilcon A | hioxifilcon A | etafilcon A | hioxifilcon A |
| Product Code | LPL | LPL | LPL, MVN | LPL, MVN |
| Intended Use | Daily wear, single use,
contact lens for the correction
of visual acuity in aphakic and
non-aphakic persons with non-
diseased eyes with myopia or
hyperopia | Daily wear, single use,
contact lens for the correction
of visual acuity in aphakic and
non-aphakic persons with non-
diseased eyes with myopia or
hyperopia | Daily wear, frequent
replacement, contact lens for
the correction of visual acuity
in aphakic and non-aphakic
persons with non-diseased
eyes with myopia or
hyperopia | Daily wear, single use,
contact lens for the correction
of visual acuity in aphakic and
non-aphakic persons with non-
diseased eyes with myopia or
hyperopia |
| Lens Designs | Spherical
Aspherical
Multifocal | Spherical | Spherical
Aspherical
Toric
Multifocal | Spherical |
| Oxygen Permeability
x 10-11 (cm²/sec) (mL 0₂/(mL
x mm Hg)) | 25.38 | 25.38 | 19.73 | 25.38 |
| Water Content* | 57% | 57% | 58% | 59.77 % |
| Refractive Index* | 1.409 | 1.409 | 1.402 | 1.4011 |
| Light Transmittance | >94 % | >94 % | >95 % | >95 % |
Table 1 Comparisons Of Characteristics
- at 20 ° c
Based upon the comparison the One Day Flat Pack (hioxifilcon A) Multifocal Daily Disposable Soft Contact Lenses are substantially equivalent to the predicate devices.