(211 days)
The iVue is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retinal nerve fiber layer, optic disk, cornea, and anterior chamber of the eye as an aid in the diagnosis and management of ocular diseases. The iStand is an optional accessory to the iVue which allows qualitative in-vivo imaging in cooperative, supine patients.
The iVue OCT with iStand is a mobile computer controlled ophthalmic imaging system. The device scans the patient's eye using a low coherence interferometer to measure the reflectivity of the retinal tissue. The cross sectional retinal tissue structure is composed of sequence of A-scans. It has a traditional patient and instrument interface like most ophthalmic devices. The computer has a graphic user interface for acquiring and analyzing the image.
iVue offers three scans: Retina, Glaucoma, and Cornea. For the Cornea scan, a lens must be attached to the front of the device for proper scanning. This lens is called the CAM-L (Cornea Anterior Module - Long).
The optional addition of the iStand is designed to provide effective transportation of the iVue OCT when used under normal operational conditions. The mobile floor stand (iStand) with boom arm allows the iVue OCT System the ability to operate in different locations and allows the patient to be in a supine position during examination.
The K103266 submission describes the iStand, an optional accessory that provides mobility and supine patient accessibility to the Optovue iVue Optical Coherence Tomography (OCT) system. The effectiveness section of the 510(k) indicates that the iStand is an accessory and does not affect the energy level and safety of the device.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Stability (IEC 60601-1) | The iVue OCT with iStand meets the stability requirements of IEC 60601-1. |
| Safety | The addition of the iStand accessory to the iVue OCT system is an accessory and does not affect the energy level and safety of the device |
| Effectiveness | The substantial equivalence comparison to the predicate device in terms of intended use, operating principle, function, material, and energy source are unchanged on the effectiveness of the device. Performance data demonstrates that the iVue OCT System with the iStand is as safe and effective as iVue OCT. |
2. Sample Size Used for the Test Set and Data Provenance
The document reports performance data from a TUV Certification Testing and Report (ref: 30883520.011) that was performed in accordance with IEC 60601-1 Amendment 1 and 2. It does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The device is a physical accessory and not a diagnostic algorithm that processes clinical data, so a "test set" in the traditional sense of clinical data samples is not applicable for this particular type of submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this 510(k) submission. The iStand is a physical accessory for an existing medical device, and its performance criteria relate to safety and mechanical stability (e.g., IEC 60601-1 standards), not the diagnostic output of the OCT system itself. Therefore, "ground truth" established by clinical experts for a test set is not relevant here.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. Adjudication methods are relevant for clinical studies where expert consensus is needed to establish ground truth for diagnostic or prognostic endpoints.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI or diagnostic imaging algorithms to assess the impact on human reader performance. The iStand is a physical accessory, and its safety and effectiveness are evaluated based on engineering standards and substantial equivalence to a predicate device, not through comparative clinical reading studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study in the context of an algorithm or diagnostic capability was not done. The iStand is a mechanical accessory, not a standalone algorithm. The "effectiveness" mentioned in the submission refers to the accessory not diminishing the existing effectiveness of the predicate iVue OCT system.
7. The Type of Ground Truth Used
The "ground truth" for the iStand's performance is based on engineering standards and regulatory compliance. Specifically, the stability criteria were assessed against IEC 60601-1 Amendment 1 and 2. For "effectiveness," the ground truth is established through demonstrating substantial equivalence to the predicate iVue OCT system, meaning the iStand does not alter the fundamental operation, safety, or effectiveness of the iVue OCT system as an imaging device.
8. The Sample Size for the Training Set
This information is not applicable. The iStand is a physical accessory, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
§ 886.1570 Ophthalmoscope.
(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.