(104 days)
The VivaScope® System is intended to acquire, store, retrieve, display and transfer in vivo images of tissue, including blood, collagen and pigment, in exposed unstained epithelium and the supporting stroma for review by physicians to assist in forming a clinical judgment.
The VivaScope® System is a reflectance confocal microscope, full color macroscopic imager, and software that captures images of in vivo tissue specimens from the exposed surface of the tissue, through the unstained epithelium and into the superficial supporting stroma. It provides non-invasive in vivo images of the epithelium and supporting stroma. The VivaScope® System does NOT provide automated analysis or diagnosis of the images it produces. It is capable of imaging cells in the epidermis of skin and the fibrous tissue (primarily collagen and fibrin) in the dermis. In addition, it is possible to visualize circulation of blood cells (including both erythrocytes and leukocytes) in capillaries and other small vessels.
The VivaScope® System produces horizontal sections of the skin using safe. low power infrared laser light at nominal wavelength of 830 nm (CDRH laser Class 1). Horizontal sections make it straightforward to view the various lavers of the skin in sequence, from the outer surface of the stratum corneum, through the granular, spinous and basal lavers, to the level of the superficial reticular dermis.
The VivaScope® System produces high resolution images of the skin using confocal laser scanning microscopy. The key feature of confocal microscopy is the ability to produce in-focus images of thick specimens called "optical sectioning". The system is able to accomplish this by having the point source laser light, the illuminated spot in the sample, and the pinhole all lie in optically conjugate focal planes. The size of the pinhole (located in front of the photodiode) is matched to the size of the illuminated spot to reject out of focus light allowing for imaging of thin optical sections.
The VivaScope® System can image, display, store, retrieve, import and export in vivo confocal and macroscopic color images using the VivaScan® operating software and supporting PC hardware. Images are saved and stored using standard lossless image compression algorithms. Images are communicated to other devices using DICOM standard functionality that is incorporated into the VivaScan® operating software.
The VivaScope® System is comprised of four (4) major functional components: an imager, a display, a PC and a cart. A VivaScope® System will have either a VivaScope® arm mounted imaging head or a VivaScope® handheld imaging head, or both, and optionally, a VivaCam® full color macroscopic imaging head.
This document describes a 510(k) submission for the VivaScope® System, an in vivo confocal reflectance microscope.
Acceptance Criteria and Device Performance
The provided document does not contain a table of acceptance criteria nor reported device performance data in the manner typically expected for demonstrating clinical efficacy or diagnostic accuracy. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and safety testing.
The "Performance Data" section states: "Validation data to confirm the visualization of blood collagen and pigment in the images produced by the VivaScope were submitted for the predicate. No similar data were generated for the modified device because the fundamental scientific technology did not change." This indicates that the performance criteria for visualization were met by the predicate, and since the core technology is unchanged, these criteria are considered met by the modified device.
The performance data presented are primarily regarding safety and compliance with engineering standards:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Safety | Tested according to IEC 60601-1 Ed. 3.1 (Compliance implied) |
| EMC/EMI Safety | Tested according to IEC 60601-1-2 Ed. 4 (Compliance implied) |
| Laser Safety | Tested according to IEC 60825-1 Ed. 3 (Compliance implied) |
| Image Visualization (Blood, Collagen, Pigment) | Met by predicate device (VivaScope® System K080788); fundamental scientific technology unchanged in modified device. |
Study Information
The document does not describe a clinical study with a test set, ground truth, or statistical analysis of diagnostic performance for the modified VivaScope® System. The regulatory approach taken here is substantial equivalence to a predicate device, arguing that the changes are minor and do not affect the fundamental scientific technology or intended use.
Therefore, the following information points cannot be provided from the given text:
- Sample size used for the test set and the data provenance: Not applicable, no new clinical test set described for diagnostic performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no new clinical test set described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, no new clinical test set described.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device does NOT provide automated analysis or diagnosis.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device does NOT provide automated analysis or diagnosis.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the predicate device, visualization data were submitted. The type of ground truth for that visualization is not specified in this document.
- The sample size for the training set: Not applicable. The device does not involve AI or machine learning that would require a training set.
- How the ground truth for the training set was established: Not applicable. The device does not involve AI or machine learning.
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.