The Nvision VLETM Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, crosssectional, real-time depth visualization.

Device Description

The NinePoint Medical Nvision VLE™ Imaging System is a general imaging system The Niler offit Wediod Nivision VLE TM Console, NVISion VLE™ Catheter and the Nvision VLE™ Inflation Accessory Kit.

AI/ML Overview

The submission describes a labeling change for the Nvision VLE™ Imaging System, specifically an increase in the maximum recommended inflation pressure for the catheter balloon from 5 psi to 30 psi. The study conducted to support this change is a burst pressure test of the balloons.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Minimum burst pressure for catheter balloons	Approximately 64.8 psi
Device must withstand increased inflation pressure (30 psi)	Device's minimum burst pressure (64.8 psi) is greater than 2x the new maximum inflation pressure (30 psi).

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Samples from two balloon manufacturing lots were characterized. The exact number of individual balloons tested is not specified beyond "samples from two lots."
Data Provenance: The data is prospective, as the burst pressure testing was performed specifically to support this labeling change. The country of origin of the data is not explicitly stated, but given the submission is to the FDA in the US, it is likely that the testing was conducted either in the US or in a manner compliant with US regulatory standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. This study does not involve human experts establishing ground truth for image interpretation or clinical outcomes. It is an engineering performance test assessing the physical integrity of a component.

4. Adjudication Method for the Test Set:

Not applicable. This is a direct measurement of physical properties (burst pressure) and does not involve adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No. This is not an MRMC comparative effectiveness study. It is a performance test of a device component's physical characteristic.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is an imaging system, but the study described is a component-level performance test, not an evaluation of the imaging algorithm's standalone performance. The submission refers to a "labeling change only," implying the imaging algorithm itself was cleared in the predicate device (K112770).

7. The Type of Ground Truth Used:

The ground truth used is the measured burst pressure of the catheter balloons. This is a direct physical measurement.

8. The Sample Size for the Training Set:

Not applicable. There is no machine learning "training set" for this type of engineering performance test.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth established in this context. The "ground truth" for the burst pressure test is the physical measurement itself.

Summary

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12119

JUL 25 2012 Section 7 510(k) Summary

510(k) Summary

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

NinePoint Medical Inc.

Address:

One Kendall Square, Suite B7501 Cambridge, MA 02139 (617) 250-7190 (main number) (617) 250-7199 (fax)

Official Contact:	Cindy Domecus, R.A.C. (US & EU)
	Principal, Domecus Consulting Services LLC
	Consultant to NinePoint Medical, Inc.
	(650) 343-4813
	(650) 343-7822 (fax)
	DomecusConsulting@comcast.net

Date Summary Prepared:

April 12, 2012

1. Device Name:
  Trade Name: Common Name: Classification Name: Requlation Number: Product Code: Classification:

Nvision VLETM Imaging System (OCT) Optical Coherence Tomography Imaging System Ultrasonic pulsed echo imaging system 21 CFR 892.1560 NOQ Class II

1. Predicate Device:
  Nvision VLE Imaging System - K112770
Device Description: র্বা
The NinePoint Medical Nvision VLE™ Imaging System is a general imaging system The Niler offit Wediod Nivision VLE TM Console, NVISion VLE™ Catheter and the Nvision VLE™ Inflation Accessory Kit.

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1. Indications for Use Statement:
  The Nvision VLETM Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, crosssectional, real-time depth visualization.
1. Technological Characteristics:
  The technological characteristics of this device are identical to the predicate device cleared under K112770. Both devices incorporate balloon guide sheaths made of identical materials and construction. The subject of this application is a labeling change only, to increase the inflation pressure from 5 psi to a maximum of 30 psi.

7. Performance data:

Burst pressure testing of the balloons as manufactured was performed. Samples from two balloon manufacturing lots were characterized and the burst pressure performed.

The results of the burst testing when analyzed using a one-sided limit statistical test show that the cleared product has minimum burst pressure of approximately 64.8 on the subject of this application is a labeling change only to increase the inflation pressure from 5 psi to a maximum of 30 psi, greater than 2x less than the minimum burst pressure.

8. 510(k) Summary:

NinePoint Medical Inc. has demonstrated that the Nvision VLE™ Imaging System is substantially equivalent to the predicate device listed above.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three wing-like strokes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters.

Public Health Service

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

JUL 2 5 2012

NinePoint Medical, Incorporated % Domecus Consulting Services, LLC Ms. Cindy Domecus, R.A.C. (US & EU) Principal, Domecus Consulting Services, LLC Consultant to NinePoint Medical, Incorporated 1171 Barroihet Avenue Hillsborough, California 94010

Re: K121195

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: June 26, 2012 Received: June 27, 2012

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) 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

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Page 2- Ms. Cindy Domecus, R.A.C. (US & EU)

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Eunel Keith

r Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Device Office of Device Evaluation Center for Devices and Radiological Health

Enclosure .

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Section 6 Indications for Use Statement

510(k) Number (if known):

Device Name:

Indications for Use:

This Application

Nvision VLE Imaging System

The Nvision VLE Imaging System is indicated for use as an imaging tool in the evaluation of human 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)

Nikki Ogden Turner

Division Sign-Off) · vision of Surgical, Orthopedic, d Restorative Devices

(k) Number K121195

6-1

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.