PICC Maximal Barrier Nursing Kit

K142616 · Navilyst Medical, Inc. · LJS · Oct 14, 2014 · General Hospital

Device Facts

• Record ID: K142616
• Device Name: PICC Maximal Barrier Nursing Kit
• Applicant: Navilyst Medical, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Oct 14, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NMI PICC III is indicated for short-term 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 PICC III is 6 mL/sec.

Device Story

PICC Maximal Barrier Nursing Kit provides a peripherally inserted central catheter (PICC) and procedural accessories for catheter placement. Kit includes catheter, procedural aides, and maximal barrier precaution components per CDC recommendations. Device facilitates peripheral access to central venous system for intravenous therapy, blood sampling, and power injection of contrast media. Used in clinical settings by healthcare professionals. Output is venous access; enables administration of fluids/medications/nutrients and monitoring of central venous pressure. Benefits include standardized, sterile placement procedure and reduced infection risk via maximal barrier components.

Clinical Evidence

Bench testing only. No clinical data provided. Performance evaluation focused on packaging validation (tray lid and adhesive) per AAMI/ANSI/ISO 11607-1 and 11607-2 standards.

Technological Characteristics

Kit includes PICC catheter, procedural aides, and maximal barrier components. Packaging validated per AAMI/ANSI/ISO 11607-1 and 11607-2. Catheters feature Endexo technology or PASV valve technology. Power injection capability up to 6 mL/sec depending on lumen configuration.

Indications for Use

Indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including fluid/medication/nutrient administration, blood sampling, central venous pressure monitoring (non-valved lumens), 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 (K131038)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of three faces in profile, stacked on top of each other.

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

OCtober 14, 2014

Navilyst Medical, Incorporated Ms. Wanda Carpinella Director Regulatory Affairs 26 Forest Street Marlborough, MA 01752

Re: K142616

Trade/Device Name: PICC Maximal Barrier Nursing Kit Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, implanted, long-term intravascular catheter. Regulatory Class: II Product Code: LJS Dated: September 15, 2014 Received: September 16, 2014

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.

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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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 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 yours,

Susan Runno DDS, MA

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

Enclosure

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|

**Indications for Use**

| 510(k) Number (if known) | K142616 |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | PICC Maximal Sterile Barrier with NMI PICC III (BioFlo Hybrid PICC with Endexo Technology) |
| Indications for Use (Describe) | The NMI PICC III is indicated for short-term 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 PICC III is 6 mL/sec. |
| Type of Use (Select one or both, as applicable) | |
| | <span> <svg height="12" width="12"> <rect height="12" style="fill:lightgray;stroke-width:1;stroke:rgb(0,0,0)" width="12"></rect> <line style="stroke:rgb(0,0,0);stroke-width:2" x1="0" x2="12" y1="0" y2="12"></line> <line style="stroke:rgb(0,0,0);stroke-width:2" x1="0" x2="12" y1="12" y2="0"></line> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) <span> <svg height="12" width="12"> <rect height="12" style="fill:lightgray;stroke-width:1;stroke:rgb(0,0,0)" width="12"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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:

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Paperwork Reduction Act (PRA) Staff

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*"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."*

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services [phone] EF

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|

| 510(k) Number (if known) | K142616 |
|--------------------------------|-----------------------------------------------------------------------------------------|
| Device Name | PICC Maximal Barrier Nursing Kit with NMI PICC III (BioFlo PICC with Endexo Technology) |
| Indications for Use (Describe) | |

NON-VALVED VERSION

The NMI PICC III 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 cm 6 mL/sec

VALVED VERSION

The NMI PICC III 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.

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

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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]

[e-mail]

[e-mail]

you not conduct or sponsor, and a person is not required to re

"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."

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services [phone] EF

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|-----------------------------------------|--|
| Food and Drug Administration | |

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

# Indications for Use

510(k) Number (if known) K142616

Device Name

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

#### Indications for Use (Describe)

The Xcela Hybrid PICC with PASV 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.

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.

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."

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services [phone] FI

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

| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|

| 510(k) Number (if known) | K142616 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | PICC Maximal Barrier Nursing Kit with NMI PICC II (Xcela PICC with PASV Valve Technology, 3F SL and 6F TL)<br>PICC Maximal Barrier Nursing Kit with NMI PICC II (Xcela PICC with PASV Valve Technology, 4F SL through 6F DL)<br>PICC Maximal Barrier Nursing Kit with BSC PICC (Xcela Power Injectable PICC) |
| Indications for Use (Describe) | 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) | |
|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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."

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services [phone] EF

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Image /page/6/Picture/1 description: The image contains the logo for Navilyst Medical. The logo consists of a graphic element on the left and the company name on the right. The graphic element is a stylized, abstract design with overlapping curved lines in shades of green and yellow. The company name "Navilyst" is written in a sans-serif font in a teal color, with the word "Medical" written in a smaller font size directly below it.

26 Forest Street Marlborough, MA 01752 Tel [phone]

www.navilystmedical.com

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

Or

Gary Barrett

Director Regulatory Affairs

PICC Maximal Barrier Nursing Kits

General Hospital Device Panel

Peripherally Inserted Central Catheter (PICC)

Short and Long-Term Intravascular Catheter 21 CFR §880.5970, Class II, Product Code LJS

Phone: [phone]

Date prepared: 11 September 2014

#### A. Submitter/Sponsor

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

# B. Contact

Wanda Carpinella Director Regulatory Affairs Phone: [phone]

# C. Device Name

Trade Name: Common/Usual name: Classification Name:

Classification Panel:

# D. Predicate Device

Trade Name: PICC Maximal Barrier Nursing Kits Common/Usual Name: Peripherally Inserted Central Catheter (PICC) Classification Name: Short and Long-Term Intravascular Catheter 21 CFR §880.5970, Class II Classification Panel: General Hospital Device Panel Premarket Notification K131038

#### 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).

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The associated accessories include:

# Sterile Kit:

- · Ampule Breaker
- Cannula 1 ¾" Filtered Straw
- · Cap, male, non-vented
- · Cover, Transducer, 4" x 58"
- · CSR Wrap
- Dilator/Sheath, 3-6F x 5 or 7 cm peelable, (sized to PICC)
- · Drape, Full Body
- · Drape, Under arm
- · Drape, Fenestrated
- · Dressing, Tegaderm
- · Chloraprep 3mL clear and orange tint
- · Gauze 4" x 4", 4 ply
- · Gown, Surgical Extra Large
- Guidewire, 0.18" x 45 cm
- · Hairnet, 24" large
- Lidocaine ampule
- · Mask with earloops
- · Needle, echogenic 21G x 1.575" or 2.75" (sized to PICC)
- · Needle, 25G x 5/8"
- Needle, safety 21 G x 2.75"
- · PICC (based on family and size)
- · Scalpel, #11, Safety
- · Scissors, Blunt
- · Sharps container, single
- Skin Protectant Swab Stick
- Statlock Plus Fixed Post (stabilization)
- · Stiffening Stylet 0.014" or 0.016" x 70 cm (size to PICC)
- · Syringe 5cc
- · Tape Measure, 36" Paper
- · Tape, Surgical 3/4" x 24"
- · Tourniquet, 18" x 1"
- · Towel, 14" x 25"
- Tuohy Borst Adapter w/side arm

# Tandem Package (Pouch): Sterile OEM Devices in 'as received' packaging

- · Gloves, Surgeons
- · Pre-Filled Syringes, Saline

# F. Indications For Use

- · PICC Maxi mal Sterile Barrier Kit with NMI HPICC III (BioFlo Hybrid PICC with Endexo Technology)
The NMI HPICC III 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 NMI HPICC III is 6 mL/sec.

- · PICC Maximal Sterile Barrier Kit with NMI PICC III (BioFlo PICC with Endexo Technology)
# NON-VALVED VERSION

The NMI PICC III 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

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## VALVED VERSION

The NMI PICC III 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.

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 Sterile Barrier Kit with Xcela® Hybrid PICC with PASV® Valve Technology:

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 NMI PICC II (Xcela PICC with PASV Valve Technology, 3 Fr single lumen and 6 Fr triple lumen)
Or

PICC Maximal Barrier Nursing Kit with NMI PICC (Xcela PICC with PASV Valve Technology, 4 Fr single lumen through 6 Fr double lumen)

Or

PICC Maximal Barrier Nursing Kit with BSC PICC (Xcela Power Injectable PICC)

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.

#### G. Comparison of Technological Characteristics With the Predicate Device

#### 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 has a new outer tray lid and adhesive as compared to the predicate PICC Maximal Barrier Nursing Kit packaging.

#### H. Performance Data

No performance standards have been established under section 514 of the Food, Drug and Cosmetic Act for these devices. The performance evaluation of the PICC Maximal Barrier Nursing Kit new outer tray lid and adhesive was conducte in accordance with the following national/international standards:

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- 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)

#### I. Conclusion

Based on results of package 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.