The Miru 1day UpSide (midafilcon A) SPHERICAL Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myperopia) in aphakic and non-aphakic people with disease free eyes who may have 1.50 diopter (D) or less of astigmatism.

The Miru 1day UpSide (midafilcon A) TORIC Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic people with disease free eyes with 3.00 diopter (D) or less of refractive astigmatism.

The Miru 1day UpSide (midafilcon A) MULTIFOCAL Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia) and emmetropia with presbyopia in aphakic and non-aphakic people with disease free eyes who may require a reading addition of 3.00 diopter (D) or less and who may have 1.50 diopter (D) or less of astigmatism.

The Miru 1day UpSide (midafilcon A) should only be worn once and then discarded at the end of each wearing period on a daily basis. The patient should start the next wearing period with fresh lenses should not be cleaned or disinfected and should be discarded after a single use.

Device Description

The Miru 1day UpSide (midafilcon A) is a hydrophilic contact lens which is available as a spherical, toric and multifocal lens. The lens is indicated for daily wear disposable single use.

The non-ionic lens material (midafilcon A) is a random co-polymer containing polydimethyl siloxane macromonomer. It consists of 46% midafilcon A and 54% water by weight when immersed in a buffered saline solution. The lens is available with a pale blue visibility handling tint.

The lens contains a benzotriazole UV absorbing monomer which is used to block UV radiation. The transmittance characteristics for the lens (-3.00D) are less than 5% of UVB radiation and less than 50% of UVA radiation.

AI/ML Overview

This document, K193399, is a 510(k) Premarket Notification for the Miru 1day UpSide (midafilcon A) contact lens. It describes the device, its indications for use, and the data supporting its substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in a tabular format for an AI/ML device. Instead, it presents the results of non-clinical and clinical studies to demonstrate the safety and effectiveness of the contact lens, comparing it to predicate devices. The implicit acceptance criterion for a 510(k) submission is demonstrating substantial equivalence to a legally marketed predicate device.

For a contact lens, performance is typically assessed based on:

Material Properties: Water content, refractive index, oxygen permeability (Dk), UV blocking.
Physical Characteristics: Powers, diameter, base curve, manufacturing method, sterilization, packaging.
Clinical Performance: Visual acuity, comfort, adverse event rates, biocompatibility.

Here's an inferred table based on the "Comparison of Characteristics" and "Performance Data" sections:

Feature/Metric	Acceptance Criteria (Implied by Predicate/Standards)	Miru 1day UpSide (midafilcon A) Performance	Notes
Non-Clinical Data
Biocompatibility	Non-toxic, non-irritating, non-sensitizing	Non-toxic, non-irritating, non-sensitizing	"The results of the non-clinical testing and evaluation demonstrate that the lens material/extracts are non-toxic, non-irritating and non-sensitizing under the experimental conditions."
Material Properties	Consistent with predicate lenses	Consistent with predicate lenses	"and the material properties are consistent with the predicate lens." (The specific material properties are detailed in the comparison table below).
UV Blocking Transmittance	<5% UVB, <50% UVA (for -3.00D lens)	<5% UVB, <50% UVA (for -3.00D lens)	"The transmittance characteristics for the lens (-3.00D) are less than 5% of UVB radiation and less than 50% of UVA radiation."
Light Transmittance	Similar to predicate (>92-96%)	> 92 %	Compared to Visco Si-Hy (94%) and MyDay (96%).
Water Content	Similar to predicate (47-54%)	54%	Compared to Visco Si-Hy (47%) and MyDay (54%).
Refractive Index	Similar to predicate (1.401-1.410)	1.403	Compared to Visco Si-Hy (1.410) and MyDay (1.401).
Dk (Oxygen Permeability)	Similar to predicate (80-120)	64	This is lower than the predicates (Visco Si-Hy: 120, MyDay: 80), but the overall conclusion is still "as safe, as effective and performs as well as the predicate devices," implying this Dk value is acceptable for the intended daily wear, single-use modality. The FDA's determination of substantial equivalence takes into account all factors.
Clinical Data
Efficacy	Lens visual acuity comparable to control lenses	Substantially equivalent to control	"The efficacy outcome measures were lens visual acuity comparisons between the test and the control contact lenses." This suggests the visual performance was not inferior to the control.
Safety	Acceptable adverse event rates, biomicroscopy, subjective acceptance	Substantially equivalent to control	"The safety outcome measures included adverse event rates, biomicroscopy and subjective acceptance." This implies that the rates of adverse events, ocular health assessments (biomicroscopy), and patient comfort/satisfaction were comparable to the control.
Overall Conclusion	As safe, as effective, performs as well as predicates	"as safe, as effective and performs as well as the predicate devices."	This is the ultimate acceptance criterion for a 510(k) submission.

2. Sample Size and Data Provenance for the Test Set:

Sample Size: 148 subjects (male and female) were randomized and dispensed lenses. This implies a test set of approximately 74 subjects for the investigational device (assuming a 1:1 ratio into test and control groups).
Data Provenance: The document does not explicitly state the country of origin. It indicates it was a "three-month randomized controlled clinical study." Since the applicant is Menicon Co., Ltd. in Japan, and the submission is to the U.S. FDA, the study could have been conducted in Japan, the US, or other regions. It was a prospective clinical study.

3. Number of Experts and Qualifications for Ground Truth:

This is a medical device (contact lens) safety and efficacy study, not an AI/ML algorithm study requiring expert consensus for image annotation or diagnosis. Therefore, the concept of "experts establishing ground truth" in the same way as for AI image analysis (e.g., radiologists interpreting images) is not directly applicable.
Clinical Efficacy/Safety Assessment: The evaluations were likely performed by ophthalmologists or optometrists who are qualified to assess visual acuity, conduct biomicroscopy examinations, and monitor adverse events related to contact lens wear. Their qualifications are not specified beyond being "qualified investigators."

4. Adjudication Method for the Test Set:

Not applicable in the context of an AI/ML algorithm's ground truth establishment.
For clinical trials, independent data monitoring committees (DMCS) or clinical event committees (CECs) might be used to adjudicate serious adverse events, but the document doesn't detail this for the study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This was a clinical trial comparing a new contact lens to a control contact lens, not an AI-assisted diagnostic system. Therefore, MRMC studies and the concept of "human readers improving with AI vs. without AI assistance" are irrelevant to this submission.

6. Standalone (Algorithm Only) Performance:

No. This is a physical medical device (contact lens), not an AI/ML algorithm. Therefore, "standalone algorithm performance" is not applicable.

7. Type of Ground Truth Used:

The "ground truth" for this study was established through direct clinical measurements and observations in human subjects, compared against a control (predicate) lens. This includes:
- Objective measures: Visual acuity measurements (e.g., Snellen chart, other standardized tests), biomicroscopy findings (e.g., assessing corneal health, conjunctiva).
- Subjective measures: Patient-reported acceptance and comfort, reporting of symptoms and adverse events.
- Biomaterial properties: In-vitro lab testing of Dk, water content, UV blocking, etc.
In essence, the "ground truth" for a contact lens is its direct impact on a patient's vision, ocular health, and comfort during wear, as assessed by clinical professionals and the patients themselves.

8. Sample Size for the Training Set:

This is a clinical study for a physical device, not an AI/ML algorithm. Therefore, there is no discrete "training set" in the AI/ML sense. Data for device development and optimization (analogous to a training set) would come from extensive R&D, material science experiments, and possibly earlier pilot clinical studies, none of which are explicitly detailed as a 'training set' sample size in this regulatory summary.

9. How Ground Truth for the Training Set Was Established:

As there is no "training set" in the AI/ML sense, this question is not applicable. The development of the contact lens material and design would have been based on established optometric and material science principles, biocompatibility testing, and iterative design processes.

Summary

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June 17, 2020

Menicon Co., Ltd. Li Haosheng, Ph.D. International Regulatory Affairs 3-21-19. Aoi. Naka-ku Nagoya, 460-0006 Japan

Re: K193399

Trade/Device Name: Miru 1day UpSide (midafilcon A) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: May 15, 2020 Received: May 18, 2020

Dear Li Haosheng,

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 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

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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 medical devices and radiation-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)

K193399

Device Name

Miru 1day UpSide (midafilcon A)

Indications for Use (Describe)

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)

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510(k) Summary

Miru 1day UpSide (midafilcon A)

1. Applicant Information

Menicon Co., Ltd. 21-19, Aoi 3, Naka-ku, Nagoya, 460-0006 JAPAN

Contact Person:	Li Haosheng, Ph.D.
Telephone No.:	+81-52-935-1676
Fax No.:	+81-52-935-1633
E-mail:	haosheng-li@menicon.co.jp
Date Prepared:	June 16, 2020

2. Device Information

Classification name:	Soft (hydrophilic) Contact Lens
Device classification:	Class II
Regulation number:	21 CFR 886.5925
Product code:	LPL, MVN
Proprietary name:	Miru 1day UpSide (midafilcon A)

3. Predicate Device

Menicon claims substantial equivalence to K160344 Visco Si-Hy (olifilcon B) Silicone Hydrogel Soft Contact Lens and K131378 CooperVision MyDay (stenfilcon A) Soft Contact Lens.

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4. Description of Device

Menicon Co., Ltd.

The Miru 1day UpSide (midafilcon A) is a hydrophilic contact lens which is available as a spherical, toric and multifocal lens. The lens is indicated for daily wear disposable single use.

5. Indications for Use

The Miru 1day UpSide (midafilcon 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 people with disease free eyes who may have 1.50 diopter (D) or less of astigmatism.

The Miru 1day UpSide (midafilcon A) TORIC Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic people with disease free eyes with 3.00 diopter (D) or less of refractive astigmatism.

The Miru 1day UpSide (midafilcon A) MULTIFOCAL Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic people with disease free eyes who may require a reading addition of 3.00 diopter (D) or less and who may have 1.50 diopter (D) or less of astigmatism.

The Miru 1day UpSide (midafilcon A) should only be worn once and then discarded at the end of each wearing period on a daily basis. The patient should start the next wearing period with fresh lenses. The lenses should not be cleaned or disinfected and should be discarded after a single use.

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6. Performance Data

Non-Clinical Data

A series of in-vitro and in-vivo preclinical tests were performed to assess the safety and effectiveness of the Miru 1day UpSide (midafilcon A). All tests were conducted in accordance with the GLP regulation (21 CFR Part 58) or according to valid scientific protocols.

The results of the non-clinical testing and evaluation demonstrate that the lens material/extracts are non-toxic, non-irritating and non-sensitizing under the experimental conditions, and the material properties are consistent with the predicate lens.

Clinical Data

A three-month randomized controlled clinical study was completed to evaluate the safety and efficacy of the Miru 1day UpSide (midafilcon A) contact lenses for daily wear, single use.

The study evaluated 148 male and female subjects who were randomized and dispensed lenses in a 1:1 ratio into the test and control groups. The efficacy outcome measures were lens visual acuity comparisons between the test and the control contact lenses. The safety outcome measures included adverse event rates, biomicroscopy and subjective acceptance.

The test contact lens was found to be substantially equivalent to the control contact lens for safety and efficacy.

Conclusion

Based upon the data presented, the Miru 1day UpSide (midafilcon A) is as safe, as effective and performs as well as the predicate devices.

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7. Substantial equivalence

Menicon Co., Ltd.

The claim of substantial equivalence to the previously cleared devices is supported by the following tables of Comparison of Characteristics.

	Miru 1day UpSide	Visco Si-Hy	MyDay
510(k)	K193399	K160344	K131378
USAN	midafilcon A	olifilcon B	stenfilcon A
Product Code	LPL, MVN	LPL, MVN	LPL, MVN
Modality	Daily wear,Single Use	Daily wear,Single Use	Daily wear,Single Use
FDA Lens Group	SiHy class 5	SiHy class 5	SiHy class 5
Device Classification	II	II	II
Manufacturing Method	Cast Molded	Cast Molded	Cast Molded
Sterilization	Moist Heat	Moist Heat	Moist Heat
Packaging	Blister Pack	Blister Pack	Blister Pack
Visibility Tint	Reactive Blue #246Reactive Blue #247	Reactive Blue #19	Reactive Blue #246
Light Transmittance	> 92 %	94%	96%
Water Content	54% (USAN specification)	47%	54%
Refractive Index	1.403	1.410	1.401
Dk× 10-11 [(cm²/sec) × (mL O₂)/(mL × mm Hg)]	64	120	80
Powers	- 20.00 to +20.00 D	- 20.00 to +20.00 D	- 20.00 to +20.00 D
Diameter	13.0 to 18.0 mm	13.0 to 15.0 mm	13.0 to 15.5 mm
Base Curve	8.0 to 9.0 mm	8.0 to 9.2 mm	8.4 and 8.7 mm
Optical Design	Spherical, Toric,Multifocal	Spherical, Toric,Multifocal	Aspherical, Toric,Multifocal,Multifocal Toric
Comparison of Characteristics (Indications for Use)
Miru 1day UpSide	Visco Si-Hy	MyDay
The Miru 1day UpSide (midafilcon A)	The Si-Hy Spherical Silicone Hydrogel Soft	MyDay ASPHERE Soft Contact lenses are
SPHERICAL Lens is indicated for daily	Contact Lenses are indicated as daily wear	indicated for the correctionof ametropia
wear single use only for the optical	single use soft contact lens for the	(myopia and hyperopia) in aphakic and
correction of refractive ametropia (myopia	correction of refractive ametropia (myopia	non-aphakic persons with non-diseased
and hyperopia) in aphakic and non-aphakic	and hyperopia) in phakic or aphakic	eyes in powers from -20.00D to +20.00D
people with disease free eyes who may	persons with non-diseased eyes who exhibit	diopters. The lenses may be worn by
have 1.50 diopter (D) or less of	refractive astigmatism of 1.00D or less	persons who exhibit astigmatism of -2.00
astigmatism.	where the astigmatism does not interfere	diopters or less that does not interfere with
The Miru 1day UpSide (midafilcon A)	with visual acuity.	visual acuity.
TORIC Lens is indicated for daily wear	The Si-Hy Toric Silicone Hydrogel Soft	Toric: MyDay (stenfilcon A) Toric Soft
single use only for the optical correction of	Contact Lenses are indicated as daily wear	Contact lenses are indicated for the
refractive ametropia (myopia or hyperopia	for the correction of ametropia (myopia and	correction of ametropia (myopia or
with astigmatism) in aphakic and non-	hyperopia) with astigmatism in aphakic and	hyperopia with astigmatism) in aphakic and
aphakic people with disease free eyes with	non-aphakic persons with non-diseased	non-aphakic persons with non-diseased
3.00 diopter (D) or less of refractive	eyes and whose powers are from -20.00 to	eyes in powers from -20.00 to +20.00
astigmatism.	+20.00 diopters and astigmatic corrections	diopters and astigmatic corrections from -
The Miru 1day UpSide (midafilcon A)	are from -0.75 to -2.25 diopters.	0.25 to -10.00 diopters.
MULTIFOCAL Lens is indicated for daily	The Si-Hy Multifocal Silicone Hydrogel	Multifocal: MyDay (stenfilcon A)
wear single use only for the optical	Soft Contact lenses are indicated as daily	MULTIFOCAL Soft Contact lenses are
correction of refractive ametropia (myopia	wear for the correction of ametropia	indicated for the correction of refractive
and hyperopia) and emmetropia with	(myopia and hyperopia) and emmetropia	ametropia (myopia and hyperopia) and
presbyopia in aphakic and non-aphakic	with presbyopia in aphakic and non-aphakic	emmetropia with presbyopia in aphakic and
people with disease free eyes who may	persons with non-diseased eyes and whose	non-aphakic persons with non-diseased
require a reading addition of 3.00 diopter	powers are from -20.00 to +20.00 diopters	eyes. The lenses may be worn by persons
(D) or less and who may have 1.50 diopter	with add powers from +0.75 to +2.75	who exhibit astigmatism of -2.00 diopters
(D) or less of astigmatism.	diopters. The lenses may be worn by	or less that does not interfere with visual
The Miru 1day UpSide (midafilcon A)	persons who exhibit astigmatism of 1.00	acuity.
should only be worn once and then	diopters or less where the astigmatism does	Multifocal Toric: MyDay (stenfilcon A)
discarded at the end of each wearing period	not interfere with visual acuity.	MULTIFOCAL TORIC Soft Contact lenses
on a daily basis. The patient should start the	Eye care practitioners may prescribe the	are indicated for the optical correction of
next wearing period with fresh lenses. The	lens for daily wear (disposable use) single	distance and near vision in presbyopic
lenses should not be cleaned or disinfected	use. The lenses are to be discarded upon	phakic or aphakic persons with non-
and should be discarded after a single use.	removal. Therefore, no cleaning or	diseased eyes who may have -10.00
	disinfecting is required.	diopters of astigmatism or less.

Comparison of Characteristics (General Information)

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C 10 10

Regulation Number and Section

§ 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.