(42 days)
Horizon™ 49 (hioxifilcon B) Spherical, Horizon™ 49 (hioxifilcon B) Toric, Horizon™ 49 (hioxifilcon B) Bi-con, Horizon™ 49 (hioxifileon B) Bi-con Toric, Horizon™ 49 (hioxifilcon B) Progressive, Horizon™ 49 (hioxifilcon B) Progressive Toric for daily wear are indicated for the correction of refractive ametropia (myopia, hyperopic, astigmatism and presbyopia) in aphakic and not-aphakic persons with non-diseased eyes.
The lenses may be disinfected using chemical systems only.
The Westcon Horizon™ 49 (hioxifilcon B) soft contact lenses for daily wear that are manufactured from hioxifilcon B lens blanks are lathe cut into a hemispherical shell that are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves that conform to the shape of the radius of the cornea and center over the apex of the cornea to provide correction of refractive ametropia (myopia, hyperopic, astigmatism and presbyopia) in aphakic and notaphakic persons with non-diseased eyes.
The non-ionic lens material, hioxifilcon B, is a copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydrosypropyl Methacrylate (Glycerol Methacrylate, GMA). It consists of 52% hioxifilcon B and 48% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The Westcon Horizon™ 49 (hioxifilcon B) is made out of hioxifilcon B and is available in clear and with a blue visibility-handling tint, phthalocyanato (2) -(copper).
The Westcon Horizon™ 49 (hioxifilcon B) is a lathe-cut soft lens. In the dry (unhydrated) state the lens is machined and polished. In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. In the hydrated state, the Westcon Horizon™ 49 (hioxifilcon B), when placed on the cornea, acts as a refracting medium to focus light rays on the retina.
The progressive optics in the Horizon™ 49 progressive designs utilize the simultaneous vision concept which offers functional vision from distance to near throughout the viewing range. The pupil zone on the front surface varies with the size of the patient's pupil.
Here's an analysis of the provided information, describing the acceptance criteria and the study used to demonstrate compliance for the Westcon Horizon™ 49 (hioxifilcon B) Soft Contact Lens for Daily Wear.
Acceptance Criteria and Device Performance for Westcon Horizon™ 49 (hioxifilcon B) Soft Contact Lens
Based on the provided K080686 510(k) Summary, the device demonstrates substantial equivalence to "Horizon™59 (hioxifilcon A)" (K043540) and "Benz-G 3X (hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses for Daily Wear in Clear and with a Blue Visibility Tint" (K964528).
1. Table of Acceptance Criteria and Reported Device Performance
The provided document primarily focuses on the physical properties of the lens material (hioxifilcon B), which are intrinsic to the device's design and manufacturing rather than directly reported "performance" in a clinical study sense beyond basic material specifications. The acceptance criteria here are implicitly those that define the material characteristics to ensure safety and effectiveness, similar to the predicate devices.
| Acceptance Criteria (Implicit from Material Specifications) | Reported Device Performance (Westcon Horizon™ 49) |
|---|---|
| Refractive Index (Hydrated) | 1.425 |
| Light Transmission (Clear) | Greater than 95% T |
| Light Transmission (Tinted) | Greater than 95% T |
| Water Content | 48 % |
| Specific Gravity (Hydrated) | 1.136 |
| Oxygen Permeability ($D_k$) | $15 X 10^{-11}$ (cm2/sec) (ml O2/ml x mm Hg @35°C), (revised Fatt method) |
| Lens Material Composition | 52% hioxifilcon B, 48% water (by weight) |
| Co-polymer components | 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydrosypropyl Methacrylate (GMA) |
| Color additive (if tinted) | Phthalocyanato (2) - (copper) (legally marketed) |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not describe a specific clinical "test set" or a prospective clinical study directly conducted for the Westcon Horizon™ 49 device to establish its performance. Instead, it relies on the concept of substantial equivalence to predicate devices.
The key statement is under "VI. Pre-Clinical Performance Data":
"Pre-clinical performance data can be referenced for hioxifilcon B in Benz Research and Development's 510(k) K964528."
This indicates that the performance and safety of the hioxifilcon B material have been previously established through studies submitted for the predicate device K964528. Therefore, the "test set" for the material characteristics would be from the studies referenced in K964528. The current submission (K080686) does not provide details on the sample size or provenance of that prior data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Given that this 510(k) relies on substantial equivalence and references pre-clinical data from a predicate device (K964528) for the material, there is no mention of experts establishing a ground truth for a test set in the context of the K080686 submission itself. The data for material characteristics (e.g., refractive index, water content) are typically derived from laboratory measurements and standardized testing, not expert consensus on clinical outcomes in this specific submission's context.
4. Adjudication Method for the Test Set
As no specific "test set" for evaluating performance in a clinical trial is described for this 510(k) (K080686), there is no adjudication method explicitly stated. The process relies on comparing the device's design, materials, and intended use to those of legally marketed predicate devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done for the Westcon Horizon™ 49 device as described in this 510(k) summary. These types of studies are typically for devices that aid human readers in interpretation (e.g., AI for medical imaging), which is not relevant for a soft contact lens.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done or is not applicable to a soft contact lens, which is a physical medical device rather than an algorithm or software.
7. The Type of Ground Truth Used
For the material properties listed, the "ground truth" would be established through laboratory measurements and standardized analytical testing (e.g., measuring refractive index, water content, oxygen permeability as per established industry and regulatory methods).
For the overall safety and effectiveness assertion, the "ground truth" relies on the established safety and effectiveness of the predicate devices (K043540 and K964528), specifically the hioxifilcon B material, as proven in their own submissions.
8. The Sample Size for the Training Set
There is no mention of a "training set" in this 510(k) submission. This term typically applies to machine learning or AI-based devices. For a physical medical device like a contact lens, the development process involves material formulation, manufacturing, and testing, not a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" mentioned, this question is 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.