(133 days)
Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may have 2.00 diopters(D) or less of comeal astigmatism that does not interfere with visual acuity. The contact lenses may be prescribed for daily wear. The eye care practitioner may prescribe the contact lens for either single-use disposable wear or for frequent replacement wear, with cleaning, disinfecting and scheduled replacement. When prescribed for frequent replacement wear, the contact lens may be disinfected using a chemical, heat or hydrogen peroxide disinfecting system. Precision UV lenses help protect against transmission of harmful UV radiation to the comea and into the eye.
Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses are available as clear and locator tinted spherical lenses in the power range from -16.00 to + 10.00 diopters, center thickness from 0.09 - 0.17 mm (minus lenses) and 0.22 - 0.41 mm (plus lenses) with base curves of 8.4 and 8.7mm and a diameter of 14.4mm. The lens material. vasurfilcon A. is a hydrophilic random copolymer of N-vinyl-pyrrolidone (NVP), Methl methacrylate (MMA), Allyl methacrylate (AMA), Ultraviolet absorbing monomer (UVAM) and AIBN (Azo-Iso-butyronitrile) as an initiator. It consists of 74% water and 26% vasurfilicon A.
This document discusses the K982988 submission for the Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses. The submission is a 510(k) premarket notification, which means the device is being compared to a legally marketed predicate device to establish substantial equivalence, rather than providing extensive de novo clinical trial data.
Therefore, the typical structure for a detailed acceptance criteria breakdown, including specific performance metrics, sample sizes, expert qualifications, and ground truth methodologies associated with new clinical studies for device performance, does not directly apply in the same manner as it would for a PMA (Premarket Approval) or de novo submission requiring extensive new clinical efficacy and safety data.
Instead, the core of this submission revolves around demonstrating that the "Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses are identical to previously marketed Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses of the same material" (as stated in Section D). The key point of the K982988 submission is the modification of labeling and indications for use, not a fundamental change in the device itself or its core performance characteristics.
Here's an analysis based on the provided text, addressing your questions where possible within the context of a 510(k) for labeling changes:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) for labeling modifications of an already marketed and substantially equivalent device, the acceptance criteria are not explicitly defined in terms of new performance metrics for the device itself. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device and justifying the updated labeling.
However, the previous approvals (PMA P940013 and 510(k) K961299) would have established performance criteria for the device's physical, optical, chemical, biocompatible, and microbiological properties, as well as clinical safety and effectiveness for its original indications. The current submission relies on these prior approvals.
| Criteria Category / Performance Metric | Acceptance Criteria (Implicit from Predicate Device) | Reported Device Performance (Implicit from Predicate Device) |
|---|---|---|
| Physical Properties | Meets established standards for contact lenses (e.g., diameter, base curve, center thickness) | Device is identical to previously approved Precision UV™ lenses. |
| Optical Properties | Provides specified visual acuity correction (myopia/hyperopia, ≤2.00D corneal astigmatism). | Device is identical to previously approved Precision UV™ lenses. |
| Material Properties (Chemical/Biocompatibility) | Material (vasurfilcon A: 74% water, 26% copolymer) is safe and biocompatible. | Device is identical to previously approved Precision UV™ lenses. |
| Microbiological Safety | Sterile and resistant to microbial growth. | Device is identical to previously approved Precision UV™ lenses. |
| Clinical Safety & Effectiveness | Safe and effective for daily wear, single-use, or frequent replacement with specified disinfecting systems. | Device is identical to previously approved Precision UV™ lenses, supported by prior PMA P940013 and 510(k) K961299. |
| UV Protection (New indication focus) | Helps protect against transmission of harmful UV radiation to the cornea and into the eye. | This is an added claim, supported by "referenced literature (epidemiological studies, non-clinical research reports, studies on the nature of UV energy, etc.)" not new device performance data. |
| Indications for Use | Correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may have 2.00D or less of corneal astigmatism. | Device meets these specifications. |
| Wear Modalities | Suitable for daily wear, single-use disposable wear, or frequent replacement wear with approved disinfection systems. | Device meets these specifications. |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "There were no changes to the lens material or design; however, the associated labeling and indications were changed." This implies that no new clinical test set was used to prove the device's fundamental performance for this specific 510(k) submission. Instead, the submission relies on the existing data and approvals for the predicate device.
The basis for the new labeling claims (specifically UV protection) is described as "referenced literature (epidemiological studies, non-clinical research reports, studies on the nature of UV energy, etc.) submitted under 510(k) premarket notification, K982988, and PMA Supplement, P940013/S6". This indicates that the support for the UV claim comes from existing scientific literature and non-clinical data, rather than a new primary clinical trial. Therefore, specific sample sizes and provenance for a "test set" demonstrating the device's primary clinical performance for this submission are not provided because the device itself hasn't changed.
For the original PMA P940013 and 510(k) K961299, clinical trials would have been conducted with specific sample sizes, and the provenance would likely be multi-center clinical studies, typically prospective. However, these details are not provided in this excerpt.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable for this 510(k) submission as no new clinical test set requiring expert adjudication for ground truth was conducted for the device's core performance. The "experts" involved are likely the regulatory reviewers at the FDA and potentially the internal scientific/medical team at Wesley Jessen, who evaluated the referenced literature for the UV claims.
4. Adjudication Method for the Test Set:
Not applicable, as no new clinical test set requiring adjudication was conducted for this 510(k).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data, and an AI system is evaluated for its assistance. A contact lens is a therapeutic/corrective device, not an interpretative one in this context.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. There is no "algorithm" or AI component to this contact lens.
7. Type of Ground Truth Used:
For the original device approvals (PMA P940013 and 510(k) K961299), the ground truth for clinical safety and effectiveness would have been based on:
- Clinical outcomes data: Measured visual acuity, comfort, adverse event rates, biomicroscopic findings, etc., observed in human subjects.
- Physical/Chemical/Optical standards: Compliance with established laboratory tests for lens properties.
For the new UV claim in this 510(k) K982988, the "ground truth" for the claim's validity is derived from:
- Referenced literature: Epidemiological studies, non-clinical research reports, studies on the nature of UV energy. This implies a scientific consensus on the effects of UV radiation and the ability of certain materials to block it, rather than new primary data from this specific device.
8. Sample Size for the Training Set:
Not applicable. "Training set" refers to data used to train an AI algorithm. This device is a physical product, not an AI.
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.