NvisionVLE Imaging System, NvisionVLE Optical Probe by NinePoint Medical, Inc.

The NvisionVLE Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal tissue microstructure, by providing two-dimensional, cross-sectional, real-time depth visualization.

Device Description

The NinePoint Medical NvisionVLE® Imaging System is a high-resolution volumetric imaging system based on optical coherence tomography (OCT). In an analogous fashion to ultrasound imagery, OCT images are formed from the time delay and magnitude of the signal reflected from the tissue of interest. The NvisionVLE® Imaging System employs an advanced form of OCT known as swept-source OCT (SS-OCT), or Optical Frequency Domain Imaging (OFDI), in combination with a scanning optical probe to acquire high-resolution, crosssectional, real-time imagery of tissue called Volumetric Laser Endomicroscopy (VLE).

The device consists of the following main components and accessories: (i) a mobile NvisionVLE Console with an integrated computer and two touchscreen interfaces; (ii) proprietary NvisionVLE Software used to acquire, process, and visualize VLE images; (iii) a single-use, sterile NvisionVLE Optical Probe that is inserted through the working channel of an endoscope: (iv) a single-use, sterile NvisionVLE Inflation System that is used to inflate the balloon as required, to facilitate placement; and (v) a Probe Lock Accessory to prevent longitudinal motion of the Probe within the endoscope.

AI/ML Overview

This document is an FDA 510(k) clearance letter for the NvisionVLE Imaging System. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results for a new AI/ML-based device.

Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets them (especially those related to AI/ML performance metrics like sensitivity, specificity, MRMC studies, or training/test set details for AI) are not present in this type of regulatory document.

However, I can extract information related to the device's functional and non-clinical performance, which serve as its "acceptance criteria" in the context of this 510(k) pathway.

Here's a breakdown based on the provided document:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Functional/Non-Clinical)	Reported Device Performance (as tested)
Image Quality: Confirmation of proper image on the Console	Met: Confirmed proper image on the Console.
Optical Performance: Acceptable probe lateral resolution, back reflection, and transmission rate	Met: Demonstrated acceptable probe lateral resolution, back reflection, and transmission rate.
Mechanical Integrity: Mechanical integrity of the probe/sheath tip, demonstrated through tensile testing	Met: Passed tensile testing, demonstrating mechanical integrity of the probe/sheath tip.
Functional Operation: Functional testing to ensure the probe loads and withdraws properly	Met: Performed functional testing, and the probe loads and withdraws properly.
(Compliance with Voluntary Standards)	(Complies with various IEC, ISO, ANSI/AAMI standards for biological evaluation, sterilization, electrical safety, EMC, software, and usability, as listed in Section 7 of the 510(k) summary.)

Note on "Acceptance Criteria" for this specific 510(k): For this Special 510(k), the "acceptance criteria" are primarily focused on demonstrating that the modification (addition of balloon-less low-profile optical probes) does not adversely affect the fundamental safety and effectiveness of the device, and that it maintains the performance characteristics expected of the original cleared device. There are no clinical diagnostic performance metrics (e.g., sensitivity, specificity for disease detection) because the device's cleared indication for use explicitly states that its safety and effectiveness for diagnostic analysis (differentiating normal vs. specific abnormalities) has not been evaluated.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified for any specific functional or non-clinical test. The testing described is general "functional testing" and "tensile testing" which implies a sufficient number of samples were tested to ensure design verification, but specific numbers are not disclosed in this summary.
Data Provenance: Not applicable in terms of patient data. The testing involves device components and systems (e.g., probes, consoles). This is non-clinical performance data, likely gathered at the manufacturer's testing facilities.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This 510(k) describes non-clinical and functional testing of device characteristics, not clinical performance or diagnostic accuracy assessed by experts.

4. Adjudication method for the test set:

Not applicable. This is not a clinical study involving human interpretation of results.

5. 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:

No. This is explicitly stated: "The safety and effectiveness of this device for diagnostic analysis (i.e. differentiating normal versus specific abnormalities) in any tissue microstructure or specific disease has not been evaluated." This device is an imaging tool to visualize microstructure, not a diagnostic AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. The device is for human visualization of microstructure. It does not perform standalone diagnostic analysis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical tests described, the "ground truth" would be engineering specifications and established test methodologies (e.g., correct image display, specified resolution ranges, material strength limits, proper mechanical function). This is not a clinical ground truth like pathology.

8. The sample size for the training set:

Not applicable. This document is for a medical imaging device, not an AI/ML product developed with a training set of data.

9. How the ground truth for the training set was established:

Not applicable. (See #8)

Summary of what this document does tell us about "acceptance criteria":

For the NvisionVLE Imaging System, particularly concerning this Special 510(k) for new probe configurations, the acceptance criteria are entirely based on functional and non-clinical performance. The study "proving" the device meets these criteria involved a battery of engineering and bench tests, including:

Image quality confirmation on the console.
Quantitative measurements of optical performance (lateral resolution, back reflection, transmission rate) to ensure they meet specified levels.
Mechanical integrity testing of components (e.g., tensile testing of probes).
Verification of proper device operation (e.g., probe loading and withdrawal).
Compliance with recognized voluntary consensus standards for quality, safety, and manufacturing.

The FDA's clearance indicates that these non-clinical tests demonstrate the modified device is "as safe and effective as the predicate device" and does "not raise any new or different questions of safety or effectiveness." It is crucial to reiterate that the device's cleared indication for use specifically states that its diagnostic capability for differentiating abnormalities has not been evaluated, meaning it's primarily a visualization tool.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure. To the right of the symbol is a blue square containing the acronym "FDA" in white letters. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

October 16, 2018

NinePoint Medical, Inc. Eman Namati President & CEO 12 Oak Park Drive Bedford, Massachusetts 01730

Re: K182261

Trade/Device Name: NvisionVLE Imaging System, NvisionVLE Optical Probe Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: NOO Dated: August 20, 2018 Received: August 21, 2018

Dear Eman Namati:

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 and the limitations described below. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/pmn.cfm_identifies_combination_product submissions. The general controls provisions of the Act include requirements for annual registration, isting 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 vou. however, that device labeling must be truthful and not misleading.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warning section of the device's labeling:

{1}------------------------------------------------

The Nyision VLE Imaging System is intended to provide an image of the tissue microstructure. The 1. safety and effectiveness of this device for diagnostic analysis (i.e. differentiating normal versus specific abnormalities) in any tissue microstructure or specific disease has not been evaluated.
Furthermore, the indication for use "The Nvision System is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal tissue microstructure, by providing two-dimensional, cross sectional, realtime depth visualization" must be prominently displayed in all abeling, including pouch box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about mediation-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

{2}------------------------------------------------

(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,

FDA

William H. Maisel -S

William H. Maisel, MD, MPH Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

510(k) Number (if known):	This application K182261
Device Name:	NvisionVLE Imaging System
Indications for Use:	The NvisionVLE Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal tissue microstructure, by providing two-dimensional, cross-sectional, real-time depth visualization.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-the -Counter Use

(Part 21 CFR 801 Subpart D)

(21CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

{4}------------------------------------------------

1. Basic Information-Submitter:

510(k) Owner:	NinePoint Medical Inc.
Address:	12 Oak Park DriveBedford, MA 01730(617) 250-7190 (main number)(617) 250-7199 (fax)
Official Contact:	Eman Namati, PhDPresident and CEONinePoint Medical, Inc.(617) 250-7190 (main number)(617) 250-7199 (fax)enamati@ninepointmedical.com

Date Summary Prepared: 20 August 2018

1. Device Name:
  Trade Name: NvisionVLE® Imaging System Common Name: Optical Coherence Tomography Imaging System Classification Name: Ultrasonic pulsed echo imaging system Requlation Number: 21 CFR 892.1560 Product Code: NQQ Classification: Class II
1. Predicate Devices:
  NvisionVLE® Imaging System, K143678
1. Device Description:
  The NinePoint Medical NvisionVLE® Imaging System is a high-resolution volumetric imaging system based on optical coherence tomography (OCT). In an analogous fashion to ultrasound imagery, OCT images are formed from the time delay and magnitude of the signal reflected from the tissue of interest. The NvisionVLE® Imaging System employs an advanced form of OCT known as swept-source OCT (SS-OCT), or Optical Frequency Domain Imaging (OFDI),

{5}------------------------------------------------

in combination with a scanning optical probe to acquire high-resolution, crosssectional, real-time imagery of tissue called Volumetric Laser Endomicroscopy (VLE).

1. Indications for Use Statement:
  The NvisionVLE™ Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal tissue microstructure, by providing two-dimensional, cross sectional, real-time depth visualization.

Labeling limitation: The Nvision VLE Imaging System is intended to provide an image of the tissue microstructure. The safety and effectiveness of this device for diagnostic analysis (i.e.differentiating normal versus specific abnormalities) in any tissue microstructure or specific disease has not been evaluated.

1. Technological Characteristics:
  The subiect of this Special 510(k) submission is a device enhancement to provide balloon-less Low-profile Optical Probes in multiple configurations which include 20mm, 14mm and Short Working Distance (SWD) focal length optics. There are no new materials introduced with this change.

The NvisionVLE™ Optical Probe is made up of an optical probe subassembly and a guide sheath. The optical probe subassembly is a fiber optic probe assembly secured inside a flexible, stainless steel torque shaft. The distal optics are housed in a stainless steel hypotube which is attached to the torque shaft. The proximal end of the optical fiber and torque shaft terminate in a standard fiber optic connector and catheter connector which interfaces with the system console. The optical probe subassembly transmits and focuses the optical light and detects the reflected light for image reconstruction.

The guide sheath is a coaxially-designed balloon sheath. The sheath is composed of a PET balloon and a nylon shaft, or is provided without the balloon for the Low-profile Optical Probe models. The inner lumen of the

{6}------------------------------------------------

sheath is sealed, enclosing the optical probe subassembly. The guide sheath is positioned within the organ structure of interest and allows the probe to rotate in a helical pattern while positioned in the inner lumen allowing for image reconstruction of the targeted tissue.

The technological characteristics of this device are unchanged from the predicate device cleared under K143678. The balloon-less version of the probe does not affect the intended use or alter the fundamental scientific technology of the device.

1. Non-Clinical Performance data:
  Functional testing of the Low-profile Optical Probes included:
Confirmation of the proper image on the Console
Acceptable probe lateral resolution, back reflection, and transmission . rate
Mechanical integrity of the probe/sheath tip demonstrated through . tensile testing
. Functional testing to ensure the probe loads and withdraws properly

The NvisionVLE Imaging System has also been tested against and complies with the following voluntary standards:

ConsensusStandard	Description
ANSI/AAMI/ISO10993-7	Biological evaluation of medical devices: Part 7:Ethylene oxide sterilization residuals
	ANSI/AAMI/ISO10993-1
ANSI/AAMI/ISO11135:2014
	IEC 60601-1
IEC 60601-1-2	Medical Electrical Equipment, Part 1-2, GeneralRequirement for Basic Safety and EssentialPerformance - Collateral StandardElectromagnetic Compatibility -Requirements andTests
ISO 62304	Software Development Life Cycle

{7}------------------------------------------------

IEC 60601-2-18	Medical Electrical Equipment – Part 2-18:Particular requirements for basic safety andessential performance of endoscopic equipment
IEC 60601-2-22	Medical Electrical Equipment – Part 2-22:Particular requirements for the basic safety andessential performance of surgical, cosmetic,therapeutic and diagnostic laser equipment.
IEC 60825-1	Safety of Laser Products – Part 1: EquipmentClassification and requirements
IEC 60601-1-6	Medical electrical equipment Part 1-6General requirements for basic safety andessential performance - Collateral Standard:Usability
IEC 62366-1	Medical devices -- Part 1: Application of usabilityengineering to medical devices

1. Substantial Equivalence:
  The NvisionVLE Imaging System has the same intended use and same indication, principles of operation, and technological characteristics as the predicate device. The minor differences with the Low-profile Optical Probe do not raise any new or different questions of safety or effectiveness.

Nonclinical performance testing demonstrates that the NvisionVLE Imaging System is as safe and effective as the predicate device and is therefore considered substantially equivalent.

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.