NMI IC

K101326 · Navilyst Medical, Inc. · LJS · Sep 2, 2010 · General Hospital

Device Facts

• Record ID: K101326
• Device Name: NMI IC
• Applicant: Navilyst Medical, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Sep 2, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NMI Intravascular Catheter (IC) is indicated for short or long-term vascular access (including peripheral) to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications and nutrients, the sampling of blood, for central venous pressure monitoring, and for power injection of contrast media.

Device Story

NMI IC is an intravascular catheter for central venous access; features open-ended lumen, luer lock adapters, extension tubes with clamps, and suture wings. Available in single and multi-lumen configurations with depth indicators and reverse tapered shaft to aid insertion site hemostasis. Used by clinicians in hospital settings for intravenous therapy, blood sampling, pressure monitoring, and power injection of contrast media. Device facilitates delivery of fluids/medications and diagnostic monitoring. Substantial equivalence established via comparison to predicate power-injectable catheters.

Clinical Evidence

Bench testing only. Performance assessed per EN ISO 10555-1/3 (catheter requirements), IEC 60601-2-34 (invasive blood pressure monitoring), AAMI TIR 9 (clinical systems for blood pressure monitoring), and AAMI/ANSI/ISO 10993-1 (biological evaluation).

Technological Characteristics

Intravascular catheter with open-ended lumen, luer lock adapters, extension tubes, and suture wings. Features reverse tapered shaft and depth indicators. Multi-lumen versions include colored clamps and luer adapters for differentiation. Complies with EN ISO 10555-1, EN ISO 10555-3, IEC 60601-2-34, and AAMI/ANSI/ISO 10993-1. Sterile, single-use.

Indications for Use

Indicated for patients requiring short or long-term vascular access to the central venous system for fluid/medication/nutrient administration, blood sampling, central venous pressure monitoring, and power injection of contrast media.

Regulatory Classification

Identification

A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”

Predicate Devices

• Xcela Power Injectable PICC (K070002)
• Central Venous Catheter (K003839)
• Bard Power PICC (K070996, K051991)
• Bard PowerLine Central Venous Catheter (K051991)
• Bard PowerHickman™ Catheter (K061179)
• Cook Spectrum and Spectrum Glide Central Venous Catheters (K081113)

Submission Summary (Full Text)

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# K101326

Date prepared: August 20, 2010

SEP

2 2010

- A. Sponsor
Navilyst Medical, Inc 26 Forest Street Marlborough, MA 01752

B. Contact Nicholas Condakes Manager, Regulatory Affairs 508-658-7931

# C. Device Name Trade Name: Common/Usual name: Classification Name:

Classification Panel:

.

- D. Predicate Device(s) Trade Name: Common/Usual name: Classification Name: Premarket Notification(s): Classification Panel:
Lorraine M. Hanley Director, Global Regulatory Affairs 508-658-7945

- NMI IC Intravascular Catheter Short and Long-Term Intravascular Catheter 21CFR §880.5970, Class II General Hospital
510(k) SUMMARY 21 CFR 807.92

Navilyst Medical, Inc. Xcela Power Injectable PICC Intravascular Catheter Short & Long-Term Intravascular Catheter; 21CFR §880.5970, Class II K070002 General Hospital Navilyst Medical, Inc. Central Venous Catheter Intravascular Catheter Short & Long-Term Intravascular Catheter; 21CFR §880.5970, Class II K003839 General Hospital Bard Power PICC Intravascular Catheter Short & Long-Term Intravascular Catheter; 21CFR §880.5970, Class II K070996, K051991 General Hospital Bard PowerLine Central Venous Catheter Intravascular Catheter

Short and Long-Term Intravascular Catheter; 21CFR §880.5970, Class II K051991

General Hospital

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Bard PowerHickman™ Catheter

Intravascular Catheter

Short and Long-Term Intravascular Catheter; 21CFR 5880.5970, Class II K061179

# General Hospital

Cook Spectrum and Spectrum Glide Central Venous Catheters Intravascular Catheter; 21CFR §880.5200, Class II K081113

General Hospital

#### Device Description E.

The NMI IC has an open ended lumen with proximally located luer lock adapters(s), extension tube(s) with clamp(s) and suture wing for catheter securement; available in single and multi-lumen with burnif(s) and the reverse tapered shaft to aid in staunching bleeding at the insertion site. The comingulations, when a revelod with depth indicators along its length. The lumens are differentiated by proximally located colored clamps and luer adapter(s) marked with lumen size. Maximum power injection flow rates are indicated on the clamp(s). The proposed NMI IC will be offered in kits with other legally marketed products.

#### F. Intended Use

The NMI IC is indicated for short or long-term vascular access (including peripheral) to the central venous system for intravenous therapy, including but not limited to the administration of fluids, venous system for maravelleds therapy, and any for central venous pressure monitoring, and for power injection of contrast media.

### G. Technology Characteristics

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

#### H. Performance Data

The NMI IC was assessed in accordance with the following FDA guidance document and international standards:

- EN ISO 10555-1:1996, AMD 1: 1999, AMD 2: 2004, Sterile, Single use intravascular catheters . Part 1: General Requirements
- EN ISO 10555-3:1997 COR 2002, Sterile, Single-Use Intravascular Catheters Part 3: Central . Venous Catheters
- FDA's "Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-. Term Intravascular Catheters dated March 16, 1995"
- IEC 60601-2-34:2000-10- Medical Electrical Eguipment Part 2-34: Particular Requirements for . ICC 00001-2-54.2000-10 Theated Bloomed. By Invasive Blood Pressure Monitoring Equipment
- A AMI TIR 9: 1992- Evaluation of Clinical Systems for Invasive Blood Pressure Monitoring .
- A AMI/ANSI/ISO 10993-1: 2003, Biological evaluation of medical devices Part 1: Evaluation . and testing

#### I. Conclusion

Based on responses to questions posed in FDA's 510(k) Decision Making Tree, the proposed device is determined to be substantially equivalent to the predicate devices

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.

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

Mr. Nicholas Condakes Regulatory Affairs Manager Navilyst Medical, Incorporated 26 Forest Street Marlborough, Massachusetts 01752

2 2010 SEP

Re: K101326

Trade/Device Name: NMI Intravascular Catheter (IC) Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: August 11, 2010 Received: August 13, 2010

Dear Mr. Condakes:

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 (the 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 Devices mark 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, not evaluate information related to contract liability warranties. We remind you, for rever, 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 affection 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.

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## Page 2- Mr. Condakes

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 to: tegli (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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Wh for.

Anthony D. Watson, B.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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Abbreviated 510(k) NMI IC 07-May-2010

K101326

# Indications for Use

**510(k) Number (if Known):** K101326

Device Name: .

NMI Intravascular Catheter (IC)

## Indications for Use:

The NMI Intravascular Catheter (IC) is indicated for short or long-term vascular access (including peripheral) to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications and nutrients, the sampling of blood, for central venous pressure monitoring, and for power injection of contrast media.

Prescription Use (21 CFR 801 Subpart D)

ని 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)

Richard C. Unger 8/31/10
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K101326