NVISION VLE IMAGING SYSTEM

• K Number: K120800
• Device Name: NVISION VLE IMAGING SYSTEM
• Manufacturer: NINEPOINT MEDICAL, INC.
• Date Cleared: 2013-04-25 ( 405 days)
• Product Code: NQQ , NOQ
• Regulation Number: 892.1560
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: K112770
• Predicate For: K143678

Intended 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 Description

The NinePoint Medical Nvision VLE Imaging System is a general imaging system comprised of the Nvision VLE Console, Nvision VLE Catheter and the Nvision VLE Inflation Accessory Kit.

AI/ML Overview

This 510(k) summary for the NinePoint Medical Nvision VLE Imaging System describes general performance data but does not contain the specific information required to complete your request for acceptance criteria and a study proving quantitative device performance against those criteria.

Here's what the document states and what it lacks:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria (General): The document lists voluntary standards the device will be tested against and comply with. These are primarily safety and regulatory standards, not quantitative performance metrics for image quality or diagnostic accuracy.
  • IEC 60601-1, General Safety
  • IEC 60601-1-2, Electromagnetic Compatibility
  • IEC 60601-1-4, Programmable Electrical Medical Systems
  • IEC 60601-2-18, Endoscope
  • IEC 60601-2-22, Laser Safety
  • IEC 60825-1, Laser Safety
  • ISO 10993-1, Biological Evaluation of Medical Devices
  • ISO 10993-7, Biological Evaluation of Medical Devices, Ethylene Oxide Sterilization residual testing
  • ISO 11135-1, Sterilization of Health Care Products, Ethylene Oxide
• Reported Device Performance: The document states: "In-vitro and clinical testing have been performed and all components, subassemblies and/or full devices and systems have met the required specifications for the completed tests." However, it does not provide any specific quantitative performance results (e.g., sensitivity, specificity, resolution, accuracy, etc.) against any performance-based acceptance criteria for its imaging capabilities. The FDA letter explicitly limits the device's use for diagnostic analysis, stating, "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 indicates that the device's diagnostic performance, which would typically be measured against specific criteria, was not part of this clearance.

Therefore, a table of quantitative acceptance criteria and reported device performance cannot be generated from the provided text.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• The document states "In-vitro and clinical testing have been performed," but it does not provide any details on the sample size of the test set, the provenance of the data (country of origin), or whether the study was retrospective or prospective.

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

• Since no specific performance metrics or diagnostic claims are being made and evaluated, the document does not mention the use of experts to establish ground truth or their qualifications. The FDA explicitly noted that the device's effectiveness for diagnostic analysis has not been evaluated.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Due to the lack of details on a diagnostic performance test set or expert evaluation, no adjudication method is described.

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:

• This document describes an Optical Coherence Tomography (OCT) imaging system, not an AI or CAD system. Therefore, no MRMC comparative effectiveness study involving human readers with or without AI assistance was mentioned.

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

• As this is an imaging system and not an AI algorithm, no standalone algorithm performance study was discussed.

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

• Given the device's current indication as an imaging tool "in the evaluation of human tissue microstructure" and the FDA's explicit statement that its safety and effectiveness for diagnostic analysis "has not been evaluated," the document does not specify a type of ground truth established for diagnostic performance. The "clinical testing" mentioned likely refers to safety and basic image acquisition rather than diagnostic accuracy against a histological or expert-derived ground truth.

8. The sample size for the training set:

• This device is an imaging system, not a machine learning algorithm that requires a training set in the typical sense. Therefore, no training set sample size is mentioned.

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

• As there's no mention of a machine learning training set, this information is not applicable and not provided.

In summary, the provided submission focuses on the substantial equivalence of the Nvision VLE Imaging System to a predicate device based on technological characteristics and compliance with general safety and regulatory standards. It does not include a quantitative performance study measuring imaging or diagnostic accuracy against specific acceptance criteria, nor does it involve AI or machine learning components that would necessitate training and test set specifics as you've requested.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo for NinePoint Medical. Above the company name is a circle made of nine dots. The word "NinePoint" is in a large font, and the word "MEDICAL" is in a smaller font below it.

K 120 800

One Kendall Square, Suite B7501 Cambridge, Massachusetts 02139 ninepointmedical.com

510(k) Summary

APR 2 5 2013

• 1. Basic Information-Submitter:
     510(k) Owner:

Address: '

NinePoint Medical Inc.

One Kendall Square, Suite B7501 Cambridge, MA 02139 [phone] (main number) [phone] (fax)

Official Contact:

Cindy Domecus, R.A.C. (US & EU) Principal, Domecus Consulting Services LLC Consultant to NinePoint Medical, Inc. [phone] [phone] (fax) [e-mail]

Date Summary Prepared:

March 15, 2012

• 2. Device Name:
     Trade Name: Nvision VLE 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 Device: Nvision VLE Imaging System, K112770
• 4. Device Description:

Premarket Notification, Nvision VLE Imaging System NinePoint Medical Inc.

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

Image /page/1/Picture/0 description: The image shows the logo for NinePoint Medical. The logo consists of the words "NinePoint" in a large, bold font, with the word "MEDICAL" in a smaller font below. Above the word "NinePoint" is a circle made up of nine small, star-like shapes. The logo is simple and professional, and the use of the circle of stars may be a reference to the company's name.

One Kendall Square, Suite B7501 Cambridge, Massachusetts 02139 ninepointmedical.com

The NinePoint Medical Nvision VLE Imaging System is a general imaging system comprised of the Nvision VLE Console, Nvision VLE Catheter and the Nvision VLE Inflation Accessory Kit.

• 5. Indications for Use Statement:
     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.
• 6. Technological Characteristics:
     Optical coherence tomography (OCT) is an imaging technique analogous to ultrasound; however, instead of producing an image from the scattering of sound waves, it utilizes optical scattering based on differences in tissue composition to form two-dimensional images. OCT systems use the principles of low coherence interferometry to generate high-resolution images of tissue microstructures. Interferometry and OCT enable the measurement of the optical back-reflected signals, and therefore the morphology of the internal microstructures can be determined by the back-reflected signal from the different depths of the tissue.

The Nvision VLE Imaging System uses a derivative of OCT utilizing swept source technology, referred to as SS-OCT or optical frequency domain imaging, OFDI. OFDI is a derivative development of the time-domain OCT imaging modality, which enables high speed, two-dimensional, cross-sectional, real-time imaging.

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

Image /page/2/Picture/0 description: The image shows the logo for NinePoint Medical. The logo consists of the word "NinePoint" in a serif font, with the word "MEDICAL" in a smaller sans-serif font underneath. Above the word "NinePoint" is a circle made up of nine small circles or dots.

One Kendall Square, Suite B7501 Cambridge, Massachusetts 02139 ninepointmedical.com

• 7. Performance data:
     The NinePoint Medical Nvision VLE Imaging System will be tested against and comply with the following voluntary standards:

IEC 60601-1, General Safety

IEC 60601-1-2, Electromagnetic Compatibility

• IEC 60601-1-4, Programmable Electrical Medical Systems
  IEC 60601-2-18, Endoscope

IEC 60601-2-22, Laser Safety

IEC 60825-1, Laser Safety

• ISO 10993-1, Biological Evaluation of Medical Devices
• ISO 10993-7, Biological Evaluation of Medical Devices, Ethylene Oxide Sterilization residual testing

ISO 11135-1, Sterilization of Health Care Products, Ethylene Oxide

In-vitro and clinical testing have been performed and all components, subassemblies and/or full devices and systems have met the required specifications for the completed tests.

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

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized design resembling a human figure embracing or supporting another, with flowing lines suggesting movement or care.

Public Health Service

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

Ninpoint Medical, Incorporated % Domecus Consulting Sevices, LLC Ms. Cindy Domecus. RAC (US & EU) 1171 Barroilhet Avenue Hillsborough, California-94010-

APR 2 5 2013

Re: K120800

Trade/Device Name: Nine Pointe Medical Inc. Nvision VLE Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: NOQ Dated: March 11, 2013 Received: March 12, 2013

Dear Ms. Domecus:

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.

The Office of select one Device Evaluation or In Vitro Diagnostic Device Evaluation and Safety] 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 provided 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.
     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.

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

Page 2 - Ms. Cindy Domecus, RAC (US & EU)

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-eode of-Federal-Regulations, Title-21, Parts-800-to-898-In-addition-FDA-maypublish 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 (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

You may obtain other general information on your responsibilities under the Act from 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.

Sincerely vours.

Christy foreman

Christy Foreman Director Office of Device Evaluation Center for Devices and Radiological Health Food and Drug Administration

Enclosure

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

Indications for Use

510(k) Number: K120800

Device Name: Nine Pointe Medical Inc. 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 (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Oqdena 2013.03.27 17:00:29 04'00'

(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K120800

Page 1 of 1_

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.