NMI PICC IV

K140266 · Navilyst Medical, Inc. · LJS · Mar 5, 2014 · General Hospital

Device Facts

• Record ID: K140266
• Device Name: NMI PICC IV
• Applicant: Navilyst Medical, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Mar 5, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NMI PICC IV is indicated for short- or long-term peripheral access 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 PICC IV is a peripherally inserted central catheter (PICC) for central venous access. Device facilitates fluid/medication/nutrient delivery, blood sampling, pressure monitoring, and power injection of contrast media. Available in single and multi-lumen configurations (3F to 6F diameters). Used in clinical settings by healthcare professionals. Operates via standard catheter insertion techniques. Power injection capability supports flow rates up to 6 mL/sec and pressures up to 325 psi. Benefits include reliable central venous access for various therapeutic needs.

Clinical Evidence

Bench testing only. Performance evaluation conducted per EN ISO 10555-1:2009 and EN ISO 10555-3:1997. Testing included gravity flow rate and priming volume assessments.

Technological Characteristics

Intravascular catheter; single and multi-lumen configurations; 3F to 6F diameters; 55cm length; rated for power injection up to 325 psi and 6 mL/sec flow rate. Materials and design identical to predicate. Sterile, single-use. Complies with EN ISO 10555-1 and EN ISO 10555-3.

Indications for Use

Indicated for patients requiring short- or long-term peripheral access to the central venous system for IV therapy, 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

• NMI PICC III (K133264)
• NMI PICC III (K131942)

Submission Summary (Full Text)

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1/140266

MAR - 5 2014

# 510(K) SUMMARY FOR THE NMI PICC IV

| | | | Date prepared: 04-March-2014 |
|----|-------------------------------------------------------------------------------------------------------------------|----|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| A. | Sponsor<br>Navilyst Medical, Inc<br>26 Forest Street<br>Marlborough, MA 01752 | | |
| | B. Contact | | |
| | Brandon Brackett<br>Specialist, Global Regulatory Affairs<br>508-658-7984<br>[e-mail] | OR | Wanda Carpinella<br>Director, Global Regulatory Affairs<br>508-658-7929<br>[e-mail] |
| C. | Device Name<br>Trade Name:<br>Common/Usual name:<br>Classification Name:<br>Classification Panel: | | NMI PICC IV<br>Peripherally Inserted Central Catheter (PICC)<br>Percutaneous, implanted, long-term intravascular<br>catheter<br>21CFR§880.5970, Class II<br>General Hospital |
| D. | Predicate Device<br>Common/Usual name:<br>Classification Name:<br>Classification Panel:<br>Premarket Notification | | Peripherally Inserted Central Catheter (PICC)<br>Percutaneous, implanted, long-term intravascular<br>catheter<br>21CFR&880.5970, Class II<br>General Hospital<br>K 133264, K 131942 (NMI PICC III) |

#### E. Device Description

## Intended Use

The NMI PICC IV is indicated for short- or long-term peripheral access 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.

| Maximum Power Injection Flow Rate | |
|-----------------------------------|------------|
| Description . | Flow Rate |
| 3F Single Lumen - 55cm length | 1 mL/sec |
| 4F Single Lumen - 55cm length | 3.5 mL/sec |
| 5F Single Lumen - 55cm length | 5 mL/sec |
| 5F Dual Lumen - 55 cm length | 4 mL/sec |
| 6F Dual Lumen - 55cm length | 5 mL/sec |
| 6F Triple Lumen - 55cm length | 6 mL/sec |

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### F. Summary of Similarities and Differences in Technological Characteristics and Performance

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

Both the proposed and predicate devices are, in brief,

- · intended for short- or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, for central venous pressure monitoring and power injection of contrast media.
- · available in single and multi-lumen configurations in a wide range of sizes from 3F to 6 F outside catheter diameter;
- · rated for maximum power injector settings up to 325 psi
- · rated for maximum power injection flow rate up to 6 ml/second based on model; and
- · available kitted with a range of procedural accessories for user convenience and,
- · demonstrate resistance to blood components (platelet and thrombus) accumulation.

### G. Performance Data

The NMI PICC IV is substantially equivalent to Navilyst predicate devices based on comparison of technological characteristics and the results of non-clinical tests which included the performance evaluation conducted in accordance with the following FDA guidance documents, international standards, and testing which included:

- EN ISO 10555-1:2009, Sterile, Single use intravascular catheters Part 1: General . Requirements
- EN ISO 10555-3:1997 Corrigendum 1:2002, 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"
- . Gravity Flow Rate
- Priming Volume .

### H. Conclusion

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

March 5, 2014

Navilyst Medical, Incorporation Mr. Brandon Brackett Specialist, Global Regulatory Affairs 26 Forest Street Marlborough, MA 01752

Re: K140266

Trade/Device Name: NMI PICC IV Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: January 31, 2014 Received: February 3, 2014

Dear Mr. Brackett:

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.

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Page 2 - Mr. Brackett

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

Sincerelv vours.

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Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

for

Enclosure

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Navilyst Medical, Inc. NMI PICC IV, Special 510(k) 31-January-2014

### INDICATIONS FOR USE STATEMENT

510(k) Number (if Known):

K140266

Device Name: NMI PICC IV

Indications for Use:

The NMI PICC IV is indicated for short- or long-term peripheral access 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.

| Maximum Power Injection Flow Rate | |
|-----------------------------------|------------|
| Description | Flow Rate |
| 3F Single Lumen - 55cm length | 1 mL/sec |
| 4F Single Lumen - 55cm length | 3.5 mL/sec |
| 5F Single Lumen - 55cm length | 5 mL/sec |
| 5F Dual Lumen - 55 cm length | 4 mL/sec |
| 6F Dual Lumen - 55cm length | 5 mL/sec |
| 6F Triple Lumen - 55cm length | 6 mL/sec |

Prescription Use (21 CFR 801 Subpart D) ਲ 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)

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Digitally.signed by Richard C. Chapman Date: 2014.03.04 13:09:50 -05'00'

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