NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER

K121195 · Ninepoint Medical, Inc. · NQQ · Jul 25, 2012 · Radiology

Device Facts

• Record ID: K121195
• Device Name: NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER
• Applicant: Ninepoint Medical, Inc.
• Product Code: NQQ · Radiology
• Decision Date: Jul 25, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

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 Story

Nvision VLE Imaging System is a general imaging system consisting of a console, catheter, and inflation accessory kit. It provides two-dimensional, cross-sectional, real-time depth visualization of human tissue microstructure. The device is used by clinicians to evaluate tissue. This specific submission represents a labeling change to increase the maximum inflation pressure of the balloon guide sheath from 5 psi to 30 psi. The system utilizes optical coherence tomography (OCT) technology to capture images. The increased inflation pressure capability allows for improved performance while maintaining safety, as verified by burst pressure testing showing the minimum burst pressure is significantly greater than the new maximum operating pressure.

Clinical Evidence

Bench testing only. Burst pressure testing was performed on samples from two balloon manufacturing lots. Results confirmed a minimum burst pressure of approximately 64.8 psi, which is greater than 2x the new maximum inflation pressure of 30 psi.

Technological Characteristics

Optical Coherence Tomography (OCT) imaging system. Components include console, catheter, and balloon guide sheath. Balloon materials and construction are identical to the predicate device. Maximum inflation pressure increased to 30 psi. Burst pressure testing confirms safety margin >2x operating pressure.

Indications for Use

Indicated for use as an imaging tool for the evaluation of human tissue microstructure via 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

• Nvision VLE Imaging System (K112770)

Submission Summary (Full Text)

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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 [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:

April 12, 2012

- 2. 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

- 3. 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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- 5. 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.

- 6. 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 [phone] or [phone] 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

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