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.

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.

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.

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.

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

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.

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 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).

AI/ML Overview

This document describes a 510(k) premarket notification for "PICC Maximal Barrier Nursing Kits" by Navilyst Medical, Inc. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device.

The document primarily focuses on a packaging change for the kit and vendor changes for several kit accessories. It does not detail new device performance, clinical studies for efficacy, or the development of an AI/ML model. Therefore, many of your requested points regarding acceptance criteria, study details for device performance (beyond packaging integrity), expert adjudication, AI/ML impact, and ground truth establishment are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance / Supporting Information
Packaging Integrity and Sterility (New Packaging Configuration)	The performance evaluation was conducted in accordance with: - 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 document states "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." (Specific test results or quantitative performance metrics for packaging integrity are not provided in this summary but are implied to meet the standards.)
Equivalence to Predicate Device (Overall)	"The proposed PICC indications for use, technological characteristics, materials and operating principles are identical." "The performance evaluation... is the result of design verification and validation activities, and risk assessment." "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."

Acceptance Criteria

Reported Device Performance / Supporting Information

Packaging Integrity and Sterility (New Packaging Configuration)

The performance evaluation was conducted in accordance with: - 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 document states "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." (Specific test results or quantitative performance metrics for packaging integrity are not provided in this summary but are implied to meet the standards.)

Equivalence to Predicate Device (Overall)

"The proposed PICC indications for use, technological characteristics, materials and operating principles are identical." "The performance evaluation... is the result of design verification and validation activities, and risk assessment." "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."

2. Sample size used for the test set and the data provenance

Not applicable. This submission is for packaging and accessory vendor changes, not a new device requiring a clinical test set with patient data. The "test set" here refers to samples of the new packaging and components subjected to engineering and packaging validation tests. Specific sample sizes for these engineering tests are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This pertains to a packaging and component change, not a diagnostic or AI device requiring expert-established ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This pertains to a packaging and component change, not a diagnostic or AI device requiring adjudication of results.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. There is no mention of AI or machine learning in this submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. There is no mention of AI or machine learning in this submission.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. For this submission, "ground truth" relates to the compliance of the new packaging and components with established engineering and regulatory standards (e.g., sterility, seal integrity, material compatibility).

8. The sample size for the training set

Not applicable. There is no mention of AI or machine learning, and therefore no training set.

9. How the ground truth for the training set was established

Not applicable. There is no mention of AI or machine learning, and therefore no training set or ground truth for it.

Summary of Device and Changes:

The device, "PICC Maximal Barrier Nursing Kits," includes various PICC catheter types (BioFlo Hybrid, BioFlo, Xcela Hybrid, Xcela) packaged with procedural aides and maximal barrier precautions. The "indications for use, technological characteristics, materials and operating principles are identical" to the predicate device. The only "differences" are a packaging change (outer tray with Tyvek lid replaced with a Tyvek/Nylon Pouch) and changes in vendors for "several kit accessories." The entire submission focuses on demonstrating that these changes do not alter the substantial equivalence to the predicate device, primarily through performance testing of the new packaging configuration against recognized international standards.

Summary

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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 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

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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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

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

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

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

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*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

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.

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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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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: 508-658-7986

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

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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

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

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. 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:

· 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.

Regulation Number and Section

§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.

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