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.

Device Description

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.

AI/ML Overview

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.

Summary

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Section 6: 510(k) Summary

Submitter: Caliber Imaging and Diagnostics, Inc. 50 Methodist Hill Drive, Suite 1000 Rochester, New York 14623 Telephone (585) 239-9800 Fax (585) 239-9806
Contact: Joel Radford Quality Assurance Manager Telephone (585) 239-9800 Fax (585) 239-9806
January 17, 2018 Date Prepared:
VivaScope® System Proprietary Name:
Common Name: In vivo confocal reflectance microscope

Surgical Lamp (21 CFR 878.4580, Product Code PSN) Classification Name:

510(k) Number and Product Code of Predicate Device

VivaScope® System 510(k) Number: K080788 Product Code: PSN CFR Section: 878.4580

Intended Use/Indication for Use

The modified VivaScope® System has the same intended use as the previously cleared VivaScope System, i.e., it is an in vivo confocal reflectance microscope that uses reflected light to capture images of the skin. The modified VivaScope System has the following Indication for Use:

Device Description

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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.

Technological Characteristics

The modified VivaScope System has the same fundamental scientific technology as the predicate device. The main differences between the modified VivaScope System and the predicate are as follows:

. Display: The predicate device has a LCD display, which is no longer commercially available. The modified VivaScope System has a 23 inch, multi-touch, energy efficient backlit LED display.
Handheld Imager: The Handheld Imager in the modified device has a different body ● style; the internal engine and optics in the modified device are the same as in the predicate.

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. Medical Grade Cart: The medical grade cart for the modified VivaScope has a different style/design with a vertically mounted computer compartment, different locations for mounts for the Handheld Imager and VivaCam images, and compartments for disposables.
. Arm Mounted Imager: In the modified device, a resonant scanner is used in the Arm Mounted Imager in lieu of a polygon scanner that is used in the predicate's Arm Mounted Imager. This resonant scanner is the same as the resonant scanner that is used in the Handheld Imager in both the modified device and the predicate. The resonant scanner provides the same high-resolution image that is provided by polygon scanner but allows for a smaller, more ergonomic design of the Arm Mounted Imager.
. Tissue Interface: In the modified device, a single-use (disposable), one-piece tissue cap with a "molded-in" polycarbonate window is used with the arm-mounted imaging head. This replaces the stainless steel tissue ring with a disposable polycarbonate window in the predicate.
Isolation Transformer: IEC 60601-1 Ed. 3.1 published a change to leakage current limits ● that allows for removal of the isolation transformer in the modified device.
Windows Compatibility: Windows XP (that is used in the predicate) is no longer ● supported by Microsoft, Inc. The modified device uses Windows 10 OS (Microsoft, Inc.). Windows 10 OS is the most current operating system provided by Microsoft, and allows for routine updates and patches, installed by the user, to remediate vulnerabilities associated with controlled risk of patient harm.
Software: The predicate has a frame rate of 9 fps on the arm mounted imager, and 6 fps ● on the handheld imager; the modified device has a frame rate of 6 fps on both the arm mounted imager and the handheld imager. In addition, the "capture confocal" button on the screen that is used to capture the real-time image currently displayed on the screen was replaced by a camera icon with the same function.

Performance Data

The VivaScope was subjected to verification and safety testing to ensure that it complies with relevant industry and safety standards and conforms to its specifications. Testing of the VivaScope included:

Electrical Safety was tested according to IEC 60601-1 Ed. 3.1
EMC/EMI was tested according to IEC 60601-1-2 Ed. 4 ●
Laser Safety was tested according to IEC 60825-1 Ed. 3 ●

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.

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Conclusion

The modified VivaScope® System has the same intended use and fundamental technology as the previously cleared VivaScope System. The minor technological differences between the 510(k)cleared and the modified devices do not raise new questions of safety and effectiveness, and the modified device is at least as safe and effective as the previously cleared VivaScope System. As a result, the modified VivaScope System described in this submission is substantially equivalent to the predicate device.

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Image /page/4/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 3, 2018

Caliber Imaging & Diagnostics, Inc. Joel Radford QA/RA Manager 50 Methodist Hill Dr. Suite 1000 Rochester, New York 14623

Re: K180162

Trade/Device Name: VivaScope System Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical Lamp Regulatory Class: Class II Product Code: PSN Dated: April 3, 2018 Received: April 3, 2018

Dear Joel Radford:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Regulation Number and Section

§ 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.