MICROCATHETER

K112124 · Navilyst Medical, Inc. · DQO · Aug 19, 2011 · Cardiovascular

Device Facts

• Record ID: K112124
• Device Name: MICROCATHETER
• Applicant: Navilyst Medical, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Aug 19, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NMI Microcatheter is intended for use in small vessels and superselective anatomy during diagnostic and interventional procedures in the peripheral vasculature. Upon access of the desired region, the microcatheter can be used for the controlled and selective infusion of diagnostic, therapeutic and embolic materials. All products must be used in accordance with the original manufacturer's instructions for use. The catheter is not intended for use in coronary or neuro- vasculature.

Device Story

NMI Microcatheter is a diagnostic/interventional catheter for peripheral vasculature; used in small vessels and superselective anatomy. Device consists of a shaft, proximal hub, and radiopaque distal marker; provided with shaping mandrel, rotating hemostatic valve, guidewire, insertion tool, and torque device. Operates via fluoroscopic visualization to guide placement; allows controlled, selective infusion of diagnostic, therapeutic, or embolic materials. Used by physicians in clinical settings. Benefits include precise delivery of materials to target peripheral sites.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Radiopaque shaft with hydrophilic coating on distal end; 3.0F/2.8F or 3.0F/2.4F configurations. Includes shaping mandrel, rotating hemostatic valve, guidewire, insertion tool, and torque device. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for use in small vessels and superselective anatomy during diagnostic and interventional procedures in the peripheral vasculature for infusion of diagnostic, therapeutic, and embolic materials. Contraindicated for use in coronary or neuro-vasculature.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• Boston Scientific Renegade Hi-Flo Microcatheter (K000177)
• Boston Scientific Renegade STC Microcatheter (K023861)

Submission Summary (Full Text)

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K112124 page 1 of 2

# AUG 1 9 2011

# 510(k) SUMMARY

Date Prepared: August 17, 2011

#### A. Sponsor

Navilyst Medical, Inc 26 Forest Street Marlborough, MA 01752

#### B. Contact

Wanda Carpinella Sr. Manager Global Regulatory Affairs 508-658-7929

#### C. Device Name

Trade Name: Common/Usual name: Classification Name:

Classification

#### D. Predicate Device(s)

Trade Name/510(k) Notification:

Vice President, Global Regulatory Affairs 508-658-7945

### NMI MC

Lorraine M. Hanley

Microcatheter Diagnostic Intravascular Catheter 21 CRF §870.1200, ProCode DQO Class II

Boston Scientific Renegade Hi-Flo Microcatheter

K000177 Boston Scientific Renegade STC Microcatheter

### E. Device Description

The proposed MC is offered in two French size configurations. The first configuration has an outside diameter of 3.0F/2.8F (tapers proximally to distally) and has a nominal inside diameter of 0.027" along the entire catheter length. The second configuration has an outside diameter of 3.0F/2.4F (tapers proximally to distally) and has a nominal insider diameter of 0.021" along the entire catheter length.

K023861

Both MC configurations consist of a shaft and proximal hub assembly. The radiopaque shaft transitions from a stiffer proximal region to a flexible 30cm distal end. A radiopaque marker is located 1mm from the catheter's distal end to identify the location of the distal tip under fluoroscopic visualization. The distal end of the catheter's outer surface is hydrophilic coated. The microcatheter is provided with a shaping mandrel and a rotating hemostatic valve. The microcatheter kit additionally includes a guidewire, a guidewire insertion tool and a torque device.

### F. Intended Use

The NMI Microcatheter is intended for use in small vessels and supreselective anatomy during diagnostic and interventional procedures in the peripheral vasculature. Upon access of the desired region, the microcatheter can be used for the controlled and selective infusion of diagnostic, therapeutic and embolic materials. All products delivered through the microcatheter must be used in accordance with the original manufacturer's instruction for use. The catheter is not intended for use in coronary or neuro- vasculature.

## G. Technology Characteristics

The proposed device has similar materials, design and components and technological characteristics as currently marketed microcatheters.

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K1121241 page 2 of 2

# H. Performance Data

The NMI MC is substantially equivalent to the specified predicate device based on comparison of technological characteristics and the results of non-clinical tests, which included:

- Coating performance ●
- Trackability .
- Pressure testing
- Dimensional verification .
- Radiopacity .
- . Kink resistance
- Flow rate .
- Tip shapability .
- Compatibility tests �
- Particulate generation .
- Luer performance ●
- Biocompatibility per ISO 10993-1 �

#### Conclusion I.

The results of the non-clinical testing and a comparison of similarities and differences demonstrate that the proposed and predicate devices are substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The seal is black and white and appears to be a low-resolution image.

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

Navylist Medical, Inc. c/o Ms. Wanda Carpinella 26 Forest St. Marlborough, MA 01752

AUG 1 9 2011

Re: K112124

Trade/Device Name: NMI Microcatheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II (two) Product Code: DQO Dated: 21 July 2011 Received: 25 July 2011

Dear Ms. Carpinella:

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.

ff 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,

\$\mu\$

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K 112124 page 1 of 1

# Indications for Use

510(k) Number (if known): K / / 2 12 4

Device Name: Microcatheter

Indication For Use:

The NMI Microcatheter is intended for use in small vessels and superselective anatomy during diagnostic and interventional procedures in the peripheral vasculature. Upon access of the desired region, the microcatheter can be used for the controlled and selective infusion of diagnostic, therapeutic and embolic materials. All products must be used in accordance with the original manufacturer's instructions for use. The catheter is not intended for use in coronary or neuro- vasculature.

| Prescription Use<br>(21 CFR Part 801 Subpart D) | X |
|-----------------------------------------------------|---|
| And/Or | |
| Over the Counter Use<br>(21 CFR Part 801 Subpart C) | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|------------------------------------|---------|
| Division of Cardiovascular Devices | |
| 510(k) Number | K112124 |