(48 days)
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.
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.
This document describes a 510(k) premarket notification for a new soft contact lens, the Menicon One Day Flat Pack (hioxifilcon A) Multifocal Daily Disposable Soft Contact Lens. The information largely focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a detailed study proving performance against explicit acceptance criteria for the new multifocal design.
Based on the provided text, the device meets acceptance criteria primarily by demonstrating substantial equivalence to predicate devices based on material, manufacturing process, and performance characteristics.
Here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" with specific numerical thresholds for the new multifocal lens beyond what is inherent in demonstrating substantial equivalence. Instead, it relies on a comparison of characteristics to predicate devices. The implicit acceptance criteria are that the new device should perform as safely and effectively as the predicate devices.
| Characteristic | Acceptance Criteria (Implicit for Substantial Equivalence to Predicates) | Reported Device Performance (One Day Flat Pack Multifocal) |
|---|---|---|
| Material/Composition | Same as predicate hioxifilcon A lenses (e.g., K080632, K102895) | hioxifilcon A |
| Manufacturing Process | Similar to predicate devices | Same material, similar manufacturing processes as predicates |
| Intended Use (for Spherical) | Daily wear, single use, correction of refractive ametropia (myopia/hyperopia) in aphakic/non-aphakic persons with non-diseased eyes, 94% or >95%) | >94 % |
| Biocompatibility | No new issues of safety and effectiveness related to material. | No additional biocompatibility testing required due to known material. |
| Clinical Safety/Effectiveness | As safe and effective as predicate devices. | No clinical studies were deemed necessary. |
2. Sample Size Used for the Test Set and Data Provenance
- Test set for the new multifocal lens: No specific test set or clinical study was conducted for the new multifocal lens design to assess its direct performance against new acceptance criteria. The document explicitly states: "Clinical studies were unnecessary for this application."
- Data Provenance: The device relies on existing data from predicate devices and the known properties of the hioxifilcon A material. This would be retrospective in the sense of leveraging historical data. The origin of this historical data (e.g., country of origin) is not specified in this document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. No new clinical trials or specific test sets requiring expert ground truth establishment for the new device's performance are described. The evaluation relies on the known safety and effectiveness of the material and previous designs.
4. Adjudication Method for the Test Set
Not applicable. As no specific test set or clinical study was performed for the new multifocal device, no adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study was not conducted as no clinical studies were deemed necessary for this application.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a physical medical device (contact lens), not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" implicitly used for demonstrating substantial equivalence is the established safety and effectiveness of the predicate devices and the hioxifilcon A material, which has been reviewed in multiple prior 510(k) applications (1998-2016). This relies on prior clinical data (from the predicates) and material characterization data.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 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.