(187 days)
The ISENS (polymacon) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The ISENS (polymacon) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.
Frequent/Planned Replacement Wear:
Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
Disposable Wear:
Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When Prescribed for Daily Disposable Wear the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.
The ISENS soft contact lenses are hemispherical shells with molded spherical base curves and molded front surfaces. All lenses containing dioptric powers outside +/- 10.00 D and toric lenses are lathe-cut to specified R.J. The ISENS soft contact lenses are fabricated from polymacon, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The nonionic lens material, (polymacon) is a hydrophilic polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 62% polymacon and 38% water by weight when immersed in saline solution. The (polymacon) name has been adopted by the United States Adopted Names Council (USAN).
ISENS lenses are available clear, visibility tinted, and cosmetically tinted. Lenses are tinted with one or a combination of one or more of the following 'listed' color additives: D&C Red 17, D&C Violet 2, D&C Yellow 10, Titanium Dioxide, Iron Oxide (Red), [Phthalocyaninato(2-)] Copper, Phthalocyanine Green, Carbazole Violet, Reactive Blue 19, and C.I. Reactive black 5. Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives, and contain only the amount of color additive needed to accomplish the intended coloring effect. When producing the cosmetic tinted lenses, the manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive color additive in the center of the contact lens (between layers of contact lens material) in a location that corresponds to the iris. As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound reactive color additives. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens. The cosmetic tinting pattern has a standard Clear Pupil diameter of 6.0 mm.
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent or colored optical surface. The (polymacon) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped; it will return to its proper configuration when completely rehydrated in the proper storage solution.
The physical properties of the lens are:
Refractive Index: 1.43
Light Transmission (clear): greater than 96%
Light Transmission (tinted): greater than 96% (at clear region corresponding to pupil, standard 6.0 mm diameter); Opaque or 0-10% (at tinted region corresponding to iris)
Surface Character: hydrophilic
Water Content: 38±2%
Specific Gravity: 1.17 (hydrated)
Oxygen Permeability: 12.48 x 10-11 (cm²/sec)(mlO₂)/(ml x mmHg @ 35°C)) (revised Fatt method)
The hydrophilic characteristics allow aqueous solution to enter the lens, and in its fully hydrated state the lens is approximately 38% water by weight. The lenses will be manufactured in spherical and toric configurations with the following features and properties:
Chord Diameter: 12.80 mm to 15.00 mm
Center Thickness: 0.050 mm to 0.210 mm
Base Curve: 8.0 mm to 9.8 mm
Power Range
Cast-molded: -10.00D to +10.00D in 0.25D steps
Lathe-cut: -20.00D to -10.00D & +20.00D to +10.00D in 0.25D steps
Cylinder Power (Toric): -0.25D to -4.00D in 0.25D steps (lathe-cut)
Cylinder Axis (Toric): 10° to 180° in 10° steps
Cast-molded lenses ISENS lenses are supplied sterile in blister packages with a base made from polypropylene and a laminated foil seal on top. Lathe-cut ISENS lenses are supplied sterile in vials containing saline solution with preservative Polyhexamethylene Biguanide (PHMB). Blister package and vial labeling is printed with the appropriate lot numbering, expiration dating, and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterilization process.
The provided text describes a 510(k) premarket notification for ISENS (polymacon) Spherical and Toric Daily Wear Soft Contact Lenses. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a standalone study proving the device meets those criteria.
Therefore, many of the requested categories cannot be directly extracted from the provided text. However, I can synthesize the available information.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" for a specific study, as well as distinct "reported device performance" from a new study, is not explicitly detailed in the document in the format usually seen for AI/medical imaging device submissions. Instead, the document focuses on demonstrating substantial equivalence to predicate devices. The performance criteria are implicitly related to the established safety and effectiveness of the legally marketed predicate devices and physical/material properties.
However, we can infer some "performance" metrics by looking at the physical properties.
| Characteristic | Acceptance Criteria (Implied/Predicate Range) | Reported Device Performance (ISENS) |
|---|---|---|
| Refractive Index | N/A (compared to predicate values) | 1.43 |
| Light Transmission | >96% (clear); Opaque/0-10% (tinted) | >96% (clear); Opaque/0-10% (tinted) |
| Surface Character | Hydrophilic | Hydrophilic |
| Water Content | 38 ± 2% | 38 ± 2% |
| Specific Gravity | 1.17 - 1.20 (hydrated, from predicates) | 1.17 (hydrated) |
| Oxygen Permeability | 7.93 - 12.48 x 10⁻¹¹ (from predicates) | 12.48 x 10⁻¹¹ |
| Chord Diameter Range | N/A (compared to predicate designs) | 12.80 mm to 15.00 mm |
| Center Thickness Range | N/A (compared to predicate designs) | 0.050 mm to 0.210 mm |
| Base Curve Range | N/A (compared to predicate designs) | 8.0 mm to 9.8 mm |
| Power Range (Spherical) | N/A (compared to predicate designs) | -20.00D to +20.00D |
| Cylinder Power (Toric) | N/A (compared to predicate designs) | -0.25D to -4.00D |
| Cylinder Axis (Toric) | N/A (compared to predicate designs) | 10° to 180° |
| Sterility | Sterile for indicated shelf-life | Sterile for indicated shelf-life |
| Packaging Material | Non-toxic and non-irritating | Non-toxic and non-irritating |
| Physical/Material Props | Consistent with marketed lenses | Consistent with marketed lenses |
Note: The "acceptance criteria" here are inferred from the comparisons made to predicate devices and the statements about consistency. The actual predicate ranges are derived from the "Substantial Equivalence Matrix" (page 5).
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "The clinical performance of the (polymacon) lens material has been previously established, and therefore was not required for this 510(k)." (Page 4).
This indicates that no new clinical "test set" study was conducted for this 510(k) submission to demonstrate the performance of the ISENS device. The data provenance for the material's established performance would, therefore, be from the original studies of the polymacon material, likely going back to the predicate devices or earlier material approvals, which are not detailed here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
As no new clinical "test set" study was conducted, this information is not applicable. Ground truth assessment by experts for performance evaluation was not part of this specific submission.
4. Adjudication Method for the Test Set
Not applicable, as no new clinical "test set" study was conducted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The submission relies on substantial equivalence to predicate devices, and explicitly states that clinical performance of the material was previously established.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done
Not applicable, as this is a contact lens device, not an algorithm or AI system. The "performance" being evaluated is related to physical properties, biocompatibility, and functionality for vision correction, not an AI algorithm.
7. The Type of Ground Truth Used
For the non-clinical testing (in vitro and in vivo toxicology, biocompatibility, sterility, shelf-life, physical/material properties), the "ground truth" would be established by standard scientific protocols, laboratory measurements, and regulatory standards (e.g., GLP regulations, ISO standards for materials, etc.). This is not ground truth in the sense of expert consensus for diagnostic interpretation.
For the claim of safety and effectiveness, the ground truth relies on the established safety and effectiveness of the predicate polymacon contact lenses and the historical data supporting the polymacon material itself.
8. The Sample Size for the Training Set
Not applicable, as the device is not an AI/ML algorithm requiring a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as the device is not an AI/ML algorithm requiring a "training set."
§ 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.