NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory

K143678 · Ninepoint Medical, Inc. · NQQ · Feb 6, 2015 · Radiology

Device Facts

• Record ID: K143678
• Device Name: NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory
• Applicant: Ninepoint Medical, Inc.
• Product Code: NQQ · Radiology
• Decision Date: Feb 6, 2015
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Indications for Use

The Nvision VLE 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 Story

NvisionVLE Imaging System provides real-time, two-dimensional, cross-sectional depth visualization of human tissue microstructure. System components include console, optical probe, and inflation accessory kit. Optical probe utilizes fiber optic assembly within stainless steel torque shaft and hypotube; guide sheath features PET balloon and nylon shaft. Physician inserts probe into organ structure; probe rotates in helical pattern to transmit/detect optical signals for image reconstruction. Enhancements include alignment spring, torsionally-stiffer torque coil, and polymer bearing tube to reduce vibration/friction in tortuous anatomy. Device improves probe durability and trackability, reducing signal disruption and incomplete imaging. Output displayed to physician for visualization of tissue microstructure; intended for general imaging; not evaluated for diagnostic differentiation of normal versus abnormal tissue.

Clinical Evidence

Bench testing only. Comparative study of subject device vs. predicate (K120800) using a test fixture simulating probe motion in increasing tortuosity. Primary endpoint: torque coil binding/fiber fracture. Results: 100% (13/13) of enhanced probes passed the most tortuous curve, whereas 87% of control samples failed in the least tortuous curve.

Technological Characteristics

Optical Coherence Tomography/Optical Frequency Domain Imaging system. Components: console, optical probe (fiber optic, stainless steel torque shaft/hypotube), guide sheath (PET balloon, nylon shaft). Enhancements: alignment spring, torsionally-stiffer torque coil, polymer bearing tube. Operates via helical rotation of probe within guide sheath. No changes to fundamental scientific technology or materials from predicate.

Indications for Use

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.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• NvisionVLE Imaging System (K120800)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting hair or fabric. The profiles are arranged in a row, with the first profile being the most prominent and the others receding into the background. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 6, 2015

Ninepoint Medical Incorporated Mr. Scott Blood Senior Director, Quality and Regulatory Affairs One Kendall Square, Suite B7501 Cambridge, Massachusetts, 02139

Re: K143678

Trade/Device Name: Nvision VLE Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: NQQ Dated: January 7, 2015 Received: January 8, 2015

Dear Mr. Blood:

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

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 Warnings section of the device's labeling:

- 1. 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.

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

If you desire specific advice for your device on our labeling regulation (Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

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You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## William HDMaisel -S

William H. Maisel, MD, MPH Director, Office of Device Evaluation (Acting) Deputy Center Director for Science Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known): | This application K143678 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Nvision VLE Imaging System |
| Indications for Use: | The Nvision VLE 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 | X |
|------------------|---|
| 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)

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## Special 510(k) Summary

- 1. Basic Information-Submitter:

| 510(k) Owner: | NinePoint Medical Inc. |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Address: | One Kendall Square, Suite B7501<br>Cambridge, MA 02139<br>[phone] (main number)<br>[phone] (fax) |
| Official Contact: | Scott Blood<br>Sr Director, Quality and Regulatory Affairs<br>[phone]<br>[phone] (fax)<br>[e-mail] |

22 December 2014 Date Summary Prepared:

- 2. Device Name:
Trade Name: NvisionVLE™ Imaging System Common Name: Optical Coherence Tomography Imaging System/Optical Frequency Domain Imaging Classification Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1560 Product Code: NQQ Classification: Class II

- 3. Predicate Devices:
NvisionVLETM Imaging System, K120800

- 4. Device Description:
The NinePoint Medical NvisionVLE™ Imaging System is a general imaging system comprised of the NvisionVLETM Console, NvisionVLETM Optical Probe and the NvisionVLE™ Inflation Accessory Kit.

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- 5. 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.

- 6. Technological Characteristics:
The NinePoint Medical NyisionVLE™ Imaging System cleared under K120800 consists of the NvisionVLET™ Console, the NvisionVLE™ Catheter (marketed as the NvisionVLE™ Optical Probe) and the NvisionVLE™ Inflation Accessorv Kit.

The subject of this Special 510(k) submission is device enhancements to the NvisionVLE™ Catheter only.

The NvisionVLE™ Optical Probe is made up of an optical probe subassembly and a quide 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 the optical signal and detects the reflected optical signal for image reconstruction of the targeted tissue.

The guide sheath is a coaxially-designed balloon sheath. The sheath is composed of a PET balloon and a nylon shaft. The inner lumen of the 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 K120800. Both devices incorporate balloon quide sheaths and torque shaft-based optical probe subassemblies.

The following proposed enhancements address vibration and friction that occur while the system is imaging:

- 1) Adding an alignment spring to aid and improve the efficiency of the assembly of the optical probe subassembly when attaching the distal stainless steel hypotube to the torque coil.
- 2) Identified a torsionally-stiffer torque coil while maintaining identical dimensional and operating characteristics. Improved device trackability

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and durability by reducing optical signal disruption and incomplete imaging in tortuous anatomy.

- 3) Added a thin-walled polymer bearing tube over the torque coil subassembly component of the NvisionVLE™ Optical Probe. Improves vibrational and frictional properties of torque coil.
These enhancements do not affect the intended use or alter the fundamental scientific technology of the device and do not result in any updates to the Risk Management Plan.

The modifications are designed to better absorb the vibrational and friction forces in tortuous anatomies and reduce the stress on the optical fiber. These enhancements will improve the durability of the optical probe and meet the physician's needs over a range of esophageal anatomies.

- 7. Performance data:
A test fixture, Figure 1, was used to evaluate the performance of the current legally marketed device. K120800, versus the device which is the subject of this submission. The testing simulated the probe motion during imaging. All devices were tested through a series of increasing tortuosity until failure occurred.

Image /page/6/Figure/6 description: The image shows a diagram with the text "Increasing Tortuosity" and an arrow pointing downwards. The diagram also shows labels "S1" and "S4" on the left side of the image. The image shows a series of curved lines that appear to be increasing in tortuosity from top to bottom.

Figure 1: Test Fixture

Failure is defined as the binding of the torque coil during use, resulting in the fracture of the optical fiber and failure to transmit signal. During imaging in some tortuous anatomy, vibration and friction forces are exerted on the optical probe and can stress the optical fiber and induce cracks and breaks. There is no increased risk to the patient when this occurs as the optical fiber is completely encased in the optical probe subassembly and Optical Probe sheath. The following tables summarize the results:

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| | Tortuous<br>Curve 1 | Tortuous<br>Curve 2 | Tortuous<br>Curve 3 | Tortuous<br>Curve 4 |
|-----------------------|---------------------|---------------------|---------------------|---------------------|
| K120800 Controls | | | | |
| Sample 1 | Fail | | | |
| Sample 2 | Fail | | | |
| Sample 3 | Fail | | | |
| Sample 4 | Fail | | | |
| Sample 5 | Fail | | | |
| Proposed Enhancements | | | | |
| Sample 1 | Pass | Pass | Pass | Pass |
| Sample 2 | Pass | Pass | Pass | Pass |
| Sample 3 | Pass | Pass | Pass | Pass |
| Sample 4 | Pass | Pass | Pass | Pass |
| Sample 5 | Pass | Pass | Pass | Pass |

Table 1: Initial engineering test samples

## Table 2: Manufacturing build samples

| | Tortuous<br>Curve 1 | Tortuous<br>Curve 2 | Tortuous<br>Curve 3 | Tortuous<br>Curve 4 |
|-----------------------|---------------------|---------------------|---------------------|---------------------|
| K120800 Controls | | | | |
| Sample 1 | Fail | | | |
| Sample 2 | Fail | | | |
| Sample 3 | Pass | Fail | | |
| Sample 4 | Fail | | | |
| Sample 5 | Fail | | | |
| Sample 6 | Fail | | | |
| Sample 7 | Fail | | | |
| Sample 8 | Fail | | | |
| Sample 9 | Pass | Fail | | |
| Sample 10 | Fail | | | |
| Proposed Enhancements | | | | |
| Sample 1 | Pass | Pass | Pass | Pass |
| Sample 2 | Pass | Pass | Pass | Pass |
| Sample 3 | Pass | Pass | Pass | Pass |
| Sample 4 | Pass | Pass | Pass | Pass |
| Sample 5 | Pass | Pass | Pass | Pass |
| Sample 6 | Pass | Pass | Pass | Pass |
| Sample 7 | Pass | Pass | Pass | Pass |

In summary 87% (13/15) of control samples resulted in fiber failure in the least tortuous curve and 13% (2/15) of samples resulted in fiber failure in the

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second least tortuous curve. 100% (13/13) of enhanced probe samples passed the most tortuous curve.

- 8. 510(k) Summary:
NinePoint Medical Inc. has demonstrated that the NvisionVLE™ Imaging System is substantially equivalent to the predicate device listed above.