PICC Maximal Barrier Nursing Kit

K163452 · Navilyst Medical, Inc. · LJS · Feb 3, 2017 · General Hospital

Device Facts

• Record ID: K163452
• Device Name: PICC Maximal Barrier Nursing Kit
• Applicant: Navilyst Medical, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Feb 3, 2017
• Decision: SESK
• Submission Type: Special
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PICC Maximal Barrier Nursing Kit with BioFlo Hybrid PICC with Endexo Technology and PASV Technology The PICC Maximal Barrier Nursing Kit with BioFlo Hybrid PICC with Endexo Technology and PASV Valve Technology is indicated for short- or long-term peripheral access to the central venous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the NMI HPICC III is 6 mL/sec. PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology The PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology 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. PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology and PASV Valve Technology The PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology and PASV Valve Technology is indicated for short or long-term peripheral access to the central venous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. Maximal Barrier Nursing Kit with BioFlo Midline Catheter The Maximal Barrier Nursing Kit with BioFlo Midline Catheter is indicated for short term access (< 30 days) to the peripheral venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and the sampling of blood and blood products. PICC Maximal Barrier Nursing Kit with Xcela Hybrid PICC with PASV Valve Technology The PICC Maximal Barrier Nursing Kit with Xcela Hybrid PICC with PASV Valve Technology 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, and for power injection of contrast media. Nonvalved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the Xcela Hybrid PICC with PASV Valave Technology is 6 mL/sec. PICC Maximal Barrier Nursing Kit with Xcela PICC with PASV Valve Technology The PICC Maximal Barrier Nursing Kit with Xcela PICC with PASV Valve Technology is indicated for short or longterm 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, and for power injection of contrast media. PICC Maximal Barrier Nursing Kit with Xcela Power Injectable PICC The PICC Maximal Barrier Nursing Kit with Xcela Power Injectable PICC 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, and for power injection of contrast media.

Device Story

Device is a procedural kit containing a Peripherally Inserted Central Catheter (PICC) or Midline catheter and various procedural accessories; intended for use by clinicians in clinical settings for venous access; kit facilitates adherence to CDC maximal barrier precautions during catheter placement; catheter provides venous access for therapy, sampling, and power injection; output is the established venous access path; benefits include standardized, sterile, and compliant procedural setup for catheter insertion.

Clinical Evidence

Bench testing only. Performance evaluation focused on packaging validation per AAMI/ANSI/ISO 11607-1 and 11607-2 standards to ensure sterile barrier integrity.

Technological Characteristics

Kit includes PICC/Midline catheter and procedural accessories. Packaging: Tyvek/Nylon pouch. Sterilization: Terminally sterilized. Standards: AAMI/ANSI/ISO 11607-1, AAMI/ANSI/ISO 11607-2.

Indications for Use

Indicated for patients requiring short- or long-term peripheral access to the central venous system (or peripheral venous system for Midline catheters <30 days) 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

• PICC Maximal Barrier Nursing Kits (K142616)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three human profiles facing right, stacked on top of each other, with flowing lines extending from the bottom profile.

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

February 3, 2017

Navilyst Medical, Inc. Robin Fuller Sr. Manager, Regulatory Affairs 26 Forest Street Marlborough, Massachusetts 01752

Re: K163452

Trade/Device Name: PICC Maximal Barrier Nursing Kits Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS, PND Dated: December 8, 2016 Received: December 9, 2016

Dear Robin Fuller:

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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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

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

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely,

# Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## Indications for Use

510(k) Number (if known) K163452

Device Name PICC Maximal Barrier Nursing Kits

#### Indications for Use (Describe)

· PICC Maximal Barrier Nursing Kit with BioFlo Hybrid PICC with Endexo Technology and PASV Technology The PICC Maximal Barrier Nursing Kit with BioFlo Hybrid PICC with Endexo Technology and PASV Valve Technology is indicated for short- or long-term peripheral access to the central venous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the NMI HPICC III is 6 mL/sec.

· PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology

The PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology 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:

- 3F Single Lumen/55 cm 1 mL/sec
- · 4F Single Lumen/55 cm 3.5 mL/sec
- 5F Single Lumen/55 cm 5 mL/sec
- 5F Dual Lumen/55 cm 4 mL/sec
- 6F Dual Lumen/55 cm 5 mL/sec
- · 6F Triple Lumen/55 6 mL/sec

*PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology and PASV Valve Technology

The PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology and PASV Valve Technology is indicated for short or long-term peripheral access to the central venous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media.

Maximum Power Injection Flow Rate:

- * 3F Single Lumen/55 cm 1 mL/sec
- * 4F Single Lumen/55 cm 3.5 mL/sec
- * 5F Single Lumen/55 cm 5 mL/sec
- * 5F Dual Lumen/55 cm 4 mL/sec
- * 6F Dual Lumen/55 cm 5 mL/sec
- * 6F Triple Lumen/55 cm 6 mL/sec

*Maximal Barrier Nursing Kit with BioFlo Midline Catheter

The Maximal Barrier Nursing Kit with BioFlo Midline Catheter is indicated for short term access (< 30 days) to the peripheral venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and the sampling of blood and blood products. Maximum Power Injection Flow Rates:

- * 3F Single Lumen, 20 cm: 2 mL/sec
- * 4F Single Lumen, 20 cm: 6 mL/sec
- * 5F Single Lumen, 20 cam: 6 mL/sec

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

*PICC Maximal Barrier Nursing Kit with Xcela Hybrid PICC with PASV Valve Technology

The PICC Maximal Barrier Nursing Kit with Xcela Hybrid PICC with PASV Valve Technology 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, and for power injection of contrast media. Nonvalved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the Xcela Hybrid PICC with PASV Valave Technology is 6 mL/sec.

*PICC Maximal Barrier Nursing Kit with Xcela PICC with PASV Valve Technology

The PICC Maximal Barrier Nursing Kit with Xcela PICC with PASV Valve Technology is indicated for short or longterm 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, and for power injection of contrast media.

*PICC Maximal Barrier Nursing Kit with Xcela Power Injectable PICC

The PICC Maximal Barrier Nursing Kit with Xcela Power Injectable PICC 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, and for power injection of contrast media.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{5}------------------------------------------------

#### 510(k) Summary for the PICC Maximal Barrier Nursing Kit

Date prepared: 2 February 2017

#### A. Sponsor

Navilyst Medical, Inc. 26 Forest Street Marlborough, MA 01752

#### B. Contact

Robin Fuller Sr. Manager Regulatory Affairs Phone: [phone]

#### C. Device Name

Trade Name: Common Name: Regulation Number:

Regulation Name: Regulatory Class: Product Code:

Classification Panel:

#### D. Predicate Device

Trade Name: 510(k) Reference:

Common Name: Regulation Number:

Regulation Name:

Regulatory Class: Product Code:

Classification Panel: Premarket Notification PICC Maximal Barrier Nursing Kits Peripherally Inserted Central Catheter (PICC) 21 CFR 880.5970

Percutaneous, implanted, long-term intravascular catheter Class II ris PND General Hospital Device Panel

PICC Maximal Barrier Nursing Kits K142616

Peripherally Inserted Central Catheter (PICC) 21 CFR 880.5970

Percutaneous, implanted, long-term intravascular catheter

Class II LIS PND General Hospital Device Panel K142616

#### E. Device Description

The PICC Maximal Barrier Nursing Kit is a packaging configuration containing a specified NMI PICC along with (1) procedural aides typically used for PICC placement and (2) maximal barrier precaution devices based upon recommendations of Center of Disease Control and Prevention (CDC).

{6}------------------------------------------------

#### F. Intended Uses

- · PICC Maximal Barrier Nursing Kit with BioFlo Hybrid PICC with Endexo Technology and PASV Technology
The PICC Maximal Barrier Nursing Kit with BioFlo Hybrid PICC with Endexo Technology and PASV Valve Technology 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, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the NMI HPICC III is 6 mL/sec.

- · PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology
The PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology is indicated for shortor 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:

- 3F Single Lumen/55 cm 1 mL/sec
- 4F Single Lumen/55 cm 3.5 mL/sec ●
- 5F Single Lumen/55 cm 5 mL/sec ●
- 5F Dual Lumen/55 cm 4 mL/sec ●
- . 6F Dual Lumen/55 cm 5 mL/sec
- 6F Triple Lumen/55 - 6 mL/sec
- · PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology and PASV Valve Technology

The PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology and PASV Valve Technology 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, and for power injection of contrast media.

Maximum Power Injection Flow Rate:

- 3F Single Lumen/55 cm 1 mL/sec ●
- . 4F Single Lumen/55 cm 3.5 mL/sec
- 5F Single Lumen/55 cm 5 mL/sec ●
- 5F Dual Lumen/55 cm 4 mL/sec ●
- 6F Dual Lumen/55 cm 5 mL/sec
- . 6F Triple Lumen/55 - 6 mL/sec

· Maximal Barrier Nursing Kit with BioFlo Midline Catheter

The Maximal Barrier Nursing Kit with BioFlo Midline Catheter is indicated for short term access (< 30 days) to the peripheral venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and the sampling of blood and blood products. Maximum Power Injection Flow Rates:

- . 3F Single Lumen, 20cm: 2 mL/sec

{7}------------------------------------------------

- . 4F Single Lumen, 20cm: 6 mL/sec
- 5F Single Lumen, 20cm: 6 mL/sec ●
- 5F Dual Lumen, 20cm: 6 mL/sec ●
- · PICC Maximal Barrier Nursing Kit with Xcela® Hybrid PICC with PASV® Valve Technology:

The PICC Maximal Barrier Nursing Kit with Xcela Hybrid PICC with PASV Valve Technology 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, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the Xcela Hybrid PICC with PASV Valve Technology is 6 mL/sec

- · PICC Maximal Barrier Nursing Kit with Xcela PICC with PASV Valve Technology:
The Xcela PICC with PASV Valve Technology 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, and for power injection of contrast media.

- · PICC Maximal Barrier Nursing Kit with Xcela Power Injectable PICC:
The PICC Maximal Barrier Nursing Kit with Xcela Power Injectable PICC is indicated for short or longterm 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, and for power injection of contrast media.

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

#### Similarities

The proposed PICC Maximal Barrier Nursing Kit contains a PICC catheter packaged with a variety of procedural aide componentry typically used during PICC placement. The proposed PICC indications for use, technological characteristics, materials and operating principles are identical.

#### Differences

The proposed PICC Maximal Barrier Nursing Kit will have a packaging change. The current outer tray with Tyvek lid will be replaced with a Tyvek/Nylon Pouch. The vendor of several kit accessories will be changed.

#### H. Performance

The performance evaluation of the PICC Maximal Barrier Nursing Kit new packaging configuration was conducted in accordance with the following national/international standards:

- AAMI/ANSI/ISO 11607-1 Packaging for terminally sterilized medical devices-Part 1: Requirements ● for materials, sterile barrier systems, and packaging systems (2006)
- . AAMI/ANSI/ISO 11607-2 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes (2006)

The testing listed in this summary is the result of design verification and validation activities, and risk assessment.

#### I. Conclusion

Based on results of packaging testing performed according to recognized standards, the proposed PICC Maximal Barrier Nursing Kit is determined to be substantially equivalent to the predicate PICC Maximal Barrier Nursing Kit.