NMI COAXIAL MICROINTRODUCER SET

K123445 · Navilyst Medical, Inc. · DRE · Apr 1, 2013 · Cardiovascular

Device Facts

• Record ID: K123445
• Device Name: NMI COAXIAL MICROINTRODUCER SET
• Applicant: Navilyst Medical, Inc.
• Product Code: DRE · Cardiovascular
• Decision Date: Apr 1, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1310
• Device Class: Class 2

Intended Use

The NMI Coaxial Microintroducer Set is used for the percutaneous introduction of a guidewire into the vascular system.

Device Story

NMI Coaxial Microintroducer Set facilitates vascular access; consists of 21G needle (4cm or 7cm, optional echogenic tip), guidewire (stainless steel or Nitinol, optional radiopaque tip), and sheath/dilator assembly (4F or 5F, regular or stiff). Used by clinicians in clinical settings to introduce guidewires into vascular system. Device provides mechanical pathway for subsequent catheter placement. Benefits include reliable vascular access for diagnostic or therapeutic procedures.

Clinical Evidence

Bench testing only. Testing performed in accordance with ISO 11070 (Sterile, Single-Use Intravascular Catheter Introducers) and ISO 594-2 (Conical Fittings 6% Luer Taper). Tests included tensile, leak, radiopacity, dimensional verification, compatibility, luer performance, and biocompatibility per ISO 10993-1.

Technological Characteristics

Components: 21G needle, stainless steel or Nitinol guidewire, sheath/dilator assembly. Materials: Stainless steel, Nitinol. Standards: ISO 11070, ISO 594-2, ISO 10993-1. Sterile, single-use. Mechanical device; no energy source or software.

Indications for Use

Indicated for percutaneous introduction of a guidewire into the vascular system for patients requiring vascular access.

Regulatory Classification

Identification

A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.

Predicate Devices

• Vaxcel™ Mini-Stick Coaxial Dilator Set (K974640)

Submission Summary (Full Text)

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

Page 1/2

# 510(k) Summary for the NMI Coaxial Microintroducer Set

APR 0 1 2013

Date prepared: 19-October-2012

A. Sponsor

Navilyst Medical, Inc 26 Forest Street Marlborough, MA 01752

#### B. Contact

Michael Hanley Specialist, Global Regulatory Affairs 508-263-9714

#### C. Device Name

Trade Name: Common/Usual name: Classification: Classification Name:

### D. Predicate Device(s)

Predicate Name: Predicate 510(k):

Director. Global Regulatory Affairs 508-658-7929

Wanda Carpinella

NMI Coaxial Microintroducer Set Vessel Dilator / Introducer Sheath Class II-21CFR§870.1310-ProCode: DRE Vessel dilator for percutaneous catheterization

Vaxcel™ Mini-Stick Coaxial Dilator Set K974640

#### E. Device Description

NMI Coaxial Microintroducer Sets are offered with a 21 gauge needle (4 CM or 7 CM length with or without Echogenic tip), different guidewire configurations (0.018" stainless steel wire body or a Nitinol wire body and with or without Radiopaque tip), and a sheath and dilator assembly (4F X 10 CM regular or stiff, 5F X 10 CM regular or stiff, and 5F X 15 CM stiff), enable users to gain vascular access.

#### F. Intended Use

The NMI Coaxial Microintroducer Set is used for the percutaneous introduction of a guidewire into the vascular system.

### G. Technological Characteristics

The proposed device has similar materials, design and components and technological characteristics as predicate.

#### H. Performance Data

The proposed Coaxial Microintroducer Set is substantially equivalent to the specified predicate device based on a comparison of technological characteristics and the results of non-clinical test performed in accordance with ISO 11070: Sterile, Single-Use Intravascular Catheter Introducers:1999 and ISO 594-2: Conical Fittings 6% (Luer) Taper for Syringes, Needles, Certain Medical Equipment - Part 2 (1998), which included:

- . Tensile Testing
- . Leak Testing
- . Radiopacity Testing

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

- Dimensional verification .
- . Compatibility Testing
- . 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.

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

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular arrangement of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle with its wings spread.

April 1, 2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Navilyst Medical, Inc. Wanda Carpinella 26 Forest Street Marlborough, MA 01752 US

Re: K123445

> Trade/Device Name: NMI Coaxial Microintroducer set Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator for Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: March 4, 2013 Received: March 12, 2013

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.

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 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.

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

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.htmfor 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. Bram D厚yckerman

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

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

# Indications for Use

K123445 510(k) Number (if Known):

Device Name:

NMI Coaxial Microintroducer Set

Indications for Use:

The NMI Coaxial Microintroducer Set is used for the percutaneous introduction of a guidewire into the vascular system.

Prescription Use (21 CFR 801 Subpart D) 风 And/Or

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)

# Bra 2013