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510(k) Data Aggregation
(119 days)
The iSight, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.
The iSight, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.
The iSight, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The iSight, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eves and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The iSight, irregular cornea (efrofilcon A) Silicone Hvdrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning. disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
The iSight Silicone Hydrogel Soft Contact Lenses are fabricated from efrofilcon A, 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 non-ionic lens material, (efrofilcon A) is a daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates D&C Green 6 as an integrated handling tint. The lenses are made by lathe-cut for custom RX. It consists of 26% efrofilcon A and 74% water by weight when immersed in a 0.9% saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).
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. The (efrofilcon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the 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 however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The provided document describes a contact lens (iSight, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)) seeking 510(k) clearance, asserting substantial equivalence to existing predicate devices. The information focuses on non-clinical testing and leveraging prior clinical data from an equivalent device rather than conducting a new clinical study.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests (Implicit) | Reported Device Performance |
|---|---|---|
| Material Properties | Refractive Index | 1.38 |
| Light Transmission | > 97% | |
| Surface Character | Hydrophilic | |
| Water Content | 74 % | |
| Specific Gravity | 1.048 (hydrated) | |
| Oxygen Permeability | 59.8 x 10⁻¹¹ (cm²/sec) (ml O₂/ml x hPa @ 35°C), (revised Fatt method). Note: Page 5 table lists 60 x 10⁻¹¹ | |
| Physical Dimensions | Chord Diameter | 12.0 mm to 16.00 mm |
| Center Thickness | 0.01 mm to 0.50 mm | |
| Base Curve | 8.0 mm to 9.5 mm | |
| Power Range | -20.00D to +20.00D in 0.25 step | |
| Cylinder Power (Toric) | -0.25D to -12.00D | |
| Cylinder Power (Multifocal Toric) | -0.25D to -4.00D | |
| Add Power (Multifocal) | +0.50D to +4.00D | |
| Biocompatibility/Safety | Sterility | Lenses supplied in glass vials are sterile for the indicated shelf-life. |
| Non-toxicity/Non-irritation | Packaging material and extracts are not toxic and not irritating. | |
| Equivalence to Predicate | Identical manufacturing process | Identical manufacturing process (lathe-cut versus lathe-cut) as predicate K100221. |
| Clinical performance | Previously established (not required for this 510(k)). | |
| Material characteristics | "identical to the cleared Intelliwave3 (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens, cleared under K100221." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a traditional "test set" in the context of an AI/ML clinical study. Instead, it relies on a combination of non-clinical (in vitro and in vivo toxicology/biocompatibility) testing and a claim of substantial equivalence to a previously cleared device.
- Non-clinical testing: "A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed." No specific sample sizes for these tests are mentioned.
- Clinical data: "The clinical performance of the (efrofilcon A) lens material has been previously established, and therefore was not required for this 510(k)." This indicates that new clinical data specific to this device was not generated or tested. Data provenance for prior clinical studies is not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The document does not describe a test set requiring expert ground truthing in the context of an AI/ML device. The "ground truth" for the non-clinical tests would be established by laboratory standards and validated methods for physical properties and toxicity.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a test set with human assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This 510(k) pertains to a contact lens, not an AI/ML diagnostic or assistive device for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a contact lens, not an algorithm, so standalone performance is not relevant in the AI/ML sense. The "standalone" performance here relates to the physical and chemical properties of the lens itself, which were evaluated through non-clinical testing.
7. The Type of Ground Truth Used
- Non-clinical testing: The ground truth for physical properties (e.g., refractive index, water content, oxygen permeability) would be established through standardized laboratory measurement protocols. For biocompatibility and toxicology, the ground truth would be established against accepted safety standards and protocols (e.g., GLP regulations, ISO standards for medical devices).
- Clinical data: For the previously established clinical performance of the material, the ground truth would have been patient outcomes data from those prior studies, observed by clinical investigators.
8. The Sample Size for the Training Set
Not applicable. This document describes a medical device (contact lens) and its non-clinical evaluation, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is not an AI/ML device, so there is no training set or associated ground truth establishment.
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(60 days)
The iSight™ Imaging Catheter is intended for ultrasound examination of coronary intravascular pathology ONLY. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
The iSight™ imaging catheter consists of two subassemblies: Catheter body and Imaging core. The catheter body is comprised of three sections: Distal section - Guidewire lumen and Imaging Core lumen, Proximal section - Imaging Core lumen only, and Telescoping section - Imaging Core lumen only. The distal section has a guidewire lumen and an imaging core lumen. The guidewire lumen is lined with polytetrafluoroethylene (PTFE) and a hydrophilic coating [Bioslide™ BL] is applied to the distal section. A radiopaque (RO) marker is embedded in the catheter tip. The catheter sheath gradually tapers from 2.5F to 1.5F. The proximal section is a single lumen tube with attached molded strain relief. An insertion depth indicator is located on the proximal section. The working length is 135 cm. The iSight™ catheter is 5F guide catheter compatible. The telescoping section remains outside the guide catheter and allows for 15 cm of linear translation of the imaging core. It contains a flush port with a one-way valve. The telescope section has 16 gold marks, spaced at 1-cm increments. The imaging core is composed of a flexible, rotating drive cable with an outward looking 40 MHz ultrasonic transducer at the distal end. An electromechanical connector interface at the proximal end connects to the Motor Drive Unit (MDU). The iSight™ catheter is compatible with the MD-4 and MD-5 Motor Drive Units and the ClearView Ultra™, Galaxy™ , Galaxy 2 ™ , and iLAB™ systems.
The Boston Scientific Corporation iSight™ Imaging Catheter underwent a series of non-clinical tests to demonstrate its safety and effectiveness and its substantial equivalence to the predicate device, the Atlantis™ SR Pro2 Coronary Imaging Catheter.
1. Acceptance Criteria and Reported Device Performance:
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bench Testing | Device must exceed performance requirements in physical integrity, functionality, and performance. | Performed a variety of tests including dimensional testing, bond tensile testing, and performance testing of the sheath and telescoping assembly, imaging core assembly, and final sterile device. The device "exceeds the performance requirements." |
| Biological Safety Testing | Catheter must be acceptable for its intended use based on biocompatibility and microbiological assessment. | Subjected to biocompatibility tests per EN ISO 10993 and microbiological assessment (bioburden, pyrogen/endotoxin, sterility assurance, latex testing). Results "demonstrate that the catheter is acceptable for its intended use." |
| Acoustic Output Testing | Acoustic output must be below FDA Track 1 limits as described in the FDA Guidance for Diagnostic Ultrasound Systems and Transducers (September 30, 1997). | Acoustic Output test results for the iSight™ Imaging Catheter "are below the FDA Track 1 limits." |
| Packaging Validation | Packaging system must meet predetermined acceptance criteria for integrity per EN 868. | "Test results demonstrate that the packaging met all of the pre-determined acceptance criteria." |
2. Sample Size and Data Provenance for Test Set:
The provided documentation does not specify a separate "test set" in terms of patient data or clinical images for evaluating the device's diagnostic performance. The evaluation was primarily based on non-clinical (bench, biological, acoustic, and packaging) testing. Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable here as no clinical studies are referenced for performance evaluation.
3. Number and Qualifications of Experts for Ground Truth:
Not applicable. The ground truth for the non-clinical tests was established by comparison to engineering specifications, biological safety standards (EN ISO 10993), FDA guidance documents for acoustic output, and packaging integrity standards (EN 868). There were no experts establishing ground truth in the context of interpreting medical images or clinical outcomes for a test set.
4. Adjudication Method for Test Set:
Not applicable. As described above, there was no expert adjudication involved as the tests were non-clinical and based on objective measurements against established standards and specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned or performed. The device's substantial equivalence was established through non-clinical testing comparing its characteristics and performance to a predicate device.
6. Standalone Performance Study (Algorithm only without human-in-the-loop performance):
This device is an imaging catheter (hardware), not an AI algorithm. Therefore, "standalone (i.e. algorithm only without human-in-the-loop performance)" is not applicable. The performance evaluated was of the physical device and its components.
7. Type of Ground Truth Used:
The ground truth for the non-clinical tests was based on:
- Engineering Specifications: For dimensional, bond tensile, and other performance aspects of bench testing.
- International Standards (e.g., EN ISO 10993, EN 868): For biological safety and packaging validation.
- Regulatory Guidance (FDA Guidance, Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers): For acoustic output limits.
- Predicate Device Characteristics: The modifications to the iSight™ Imaging Catheter were compared to the Atlantis™ SR Pro2 Coronary Imaging Catheter to ensure maintenance or enhancement of performance through non-clinical means.
8. Sample Size for the Training Set:
Not applicable. This device is a physical medical device, not an AI model or algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, for the same reason as point 8.
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