NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER

K112770 · Ninepoint Medical, Inc. · NQQ · Dec 16, 2011 · Radiology

Device Facts

• Record ID: K112770
• Device Name: NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER
• Applicant: Ninepoint Medical, Inc.
• Product Code: NQQ · Radiology
• Decision Date: Dec 16, 2011
• Decision: SESE
• Submission Type: Traditional
• 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 by providing two-dimensional, cross- sectional, real-time depth visualization.

Device Story

Nvision VLE Imaging System utilizes optical coherence tomography (OCT) to provide real-time, two-dimensional, cross-sectional visualization of human tissue microstructure. System components include a console, catheter, and inflation accessory kit. Operates via low coherence interferometry and swept-source technology (SS-OCT/OFDI); optical scattering from tissue depths is measured to determine internal morphology. High-speed, high-sensitivity imaging enables clinicians to evaluate tissue microstructure. Used in clinical settings; intended for prescription use.

Clinical Evidence

In-vitro and clinical testing were performed. All components, subassemblies, and systems met required specifications for completed tests. No specific sensitivity, specificity, or AUC metrics were provided in the summary.

Technological Characteristics

Optical Coherence Tomography (OCT) / Optical Frequency Domain Imaging (OFDI) system. Utilizes swept-source technology and low coherence interferometry. Components: Console, catheter, inflation accessory kit. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-4 (programmable electrical medical systems), IEC 60601-2-18 (endoscope), IEC 60601-2-22/60825-1 (laser safety), and ISO 10993-1/7 (biocompatibility). Sterilization via ethylene oxide (ISO 11135-1).

Indications for Use

Indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization in humans.

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

• Imalux OCT Imaging System (K033783)
• Imalux OCT Niris System (K042894)
• Imalux OCT Probe Sheath (K041077)
• Tomophase OCTIS (K102599)

Submission Summary (Full Text)

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k112770

DEC 1 6 2011

Image /page/0/Picture/2 description: The image shows the logo for NinePoint Medical. The logo consists of the word "NinePoint" in a large, bold font, with the word "MEDICAL" in a smaller font underneath. Above the word "NinePoint" is a circle made up of small dots. The logo is simple and professional, and the use of the circle of dots adds a touch of visual interest.

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

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

Date Summary Prepared: 21 September 2011

- 2. Device Name:
Trade Name: Nvision VLE Imaging System (OCT) 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:
Imalux OCT Imaging System - K033783 Imalux OCT Niris System - K042894 Imalux OCT Probe Sheath - K041077 Tomophase OCTIS - K102599

> Premarket Notification, Nvision VLE Imaging System Proprietary and Confidential Information of NinePoint Medical Inc.

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One Kendall Square, Suite B7501 ambridge. Massachusetts 02139 nine point medical. com

- 4. 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.

- 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 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.

All of the predicate OCT systems employ low coherence interferometry as the basis of the system. The systems use broadband optical sources with either superluminescent diodes or swept sources, high dynamic range detection and either fixed or scanning reference arms. The scanned reference arms were utilized in the Imalux, time domain OCT systems, while the advent of fixed reference arm and swept source OCT technology (Tomophase and NinePoint Medical) has permitted high speed and high sensitivity image capability. The Tomophase predicate device (K102599) and the Nvision VLE Imaging System use a derivative of OCT utilizing swept source technology, referred to as SS-OCT or optical frequency domain imaging, OFDI. OFDI is a derivative

> Premarket Notification, Nvision VLE Imaging System Proprietary and Confidential Information of NinePoint Medical Inc.

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

development of the time-domain OCT imaging modality, which enables high speed, two-dimensional, cross-sectional, real-time imaging.

## 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:

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

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Image /page/3/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged around the circumference of the circle.

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

DEC 1 6 2011

NinePoint Medical, Inc. % Domecus Consulting Services, LLC Ms. Cindy Domecus 1171 Barroihet Avenue Hillsborough, California 94010

Re: K112770

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: NOO Dated: December 09, 2011 Received: December 12, 2011

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

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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/Resourcesfor You/Industry/default.htm.

> Sincerely yours, Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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112770

## Section 5 Indications for Use Statement

510(k) Number (if known):

K112770 This application

Device Name:

Indications for Use:

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 twodimensional, cross sectional, real-time depth visualization.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

(21CFR 807

</12770

Over-the -Counter Use

(Part 21 CFR 801 Subpart D) Subpart C)

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | <div style="text-align: right;"> <i>Nil RPOglen</i> <br/> <i>for mxm</i> </div> |
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| (Division Sign-Off) | |
| Division of Surgical, Orthopedic, | |
| and Restorative Devices | |

510(k) Number_ Premarket Notification, Nvision VLE Imaging System Proprietary and Confidential Information of NinePoint Medical Inc.