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 central venous pressure monitoring 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 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.

The NMI PICC III with PASV Vale 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.

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.

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

The Navilyst Medical PICC Maximal Barrier Nursing Kit is a medical device that combines a Peripherally Inserted Central Catheter (PICC) with procedural aides and maximal barrier precaution devices. The 510(k) premarket notification K131038 states that the device's performance evaluation was conducted based on a risk analysis and included testing in accordance with national/international standards and FDA guidance documents.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Tests Conducted	Reported Device Performance
Biocompatibility	AAMI/ANSI/ISO 10993-7 (Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals)	"Successful results" demonstrating safe use and substantial equivalence to predicate devices.
Packaging Integrity	AAMI/ANSI/ISO 11607-1 (Packaging for terminally sterilized medical devices-Part 1: Requirements for materials, sterile barrier systems, and packaging systems)	"Successful results" demonstrating safe use and substantial equivalence to predicate devices.
	AAMI/ANSI/ISO 11607-2 (Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes)	"Successful results" demonstrating safe use and substantial equivalence to predicate devices.
Sterilization	EO Sterilization Testing	"Successful results" demonstrating safe use and substantial equivalence to predicate devices.
Overall Safety & Performance	(Implicitly, compliance with FDA guidance documents for changes to existing devices, convenience kits, and bundling)	The device met "pre-determined acceptance criteria applicable to the safe use of the devices," leading to a determination of "substantially equivalent to the predicate NMI PICCs."

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for the packaging standards testing or EO sterilization testing. It mentions that "All packaging is manufactured from packaging materials that are well characterized and commonly used in the medical industry." However, it does not specify the number of units tested.

The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. The studies were conducted by Navilyst Medical.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the document. The performance evaluation relied on standardized testing, not expert-based ground truth for the device's main components. The "maximal barrier precaution devices" are based on recommendations from the Center of Disease Control and Prevention (CDC), implying general clinical best practices rather than specific expert review of test outcomes.

4. Adjudication Method for the Test Set:

An adjudication method (such as 2+1 or 3+1) is not mentioned in the document. The testing described (packaging, sterilization) typically relies on objective measurements against established standards, rather than subjective expert review requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of results, which is not applicable to the PICC Maximal Barrier Nursing Kit, whose performance is primarily evaluated through physical and biological property testing.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This question is not applicable as the PICC Maximal Barrier Nursing Kit is a physical medical device, not an algorithm or AI system. Its performance relates to its physical characteristics, sterility, and packaging integrity, not software performance.

7. The Type of Ground Truth Used:

The ground truth used for this device's evaluation was primarily established by national/international standards and recognized FDA guidance documents. For example, ISO 10993-7 sets acceptance limits for ethylene oxide residuals, and ISO 11607 outlines requirements for packaging systems. The "successful results" indicate that the device met these objective, pre-defined criteria.

8. The Sample Size for the Training Set:

This question is not applicable as there is no "training set" for this device. The device is not based on a learning algorithm that requires training data.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable as there is no training set for this device.

Summary

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K131038

510(k) Premarket Notification PICC Maximal Barrier Nursing Kit

MAY 9 2013

Navilyst
Medical

26 Forest Street Marlborough. MA 01752 Tel 508,658.7990

www.navilystmedical.com

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

Date prepared: 11 April 2013

A. Sponsor Navilyst Medical, Inc. 26 Forest Street

Marlborough, MA 01752

B. Contact

Marion W. Gordon Sr. Project Manager Global Regulatory Affairs Phone: 508-658-7942

C. Device Name

Trade Name: Common/Usual name: Classification Name:

Classification Panel:

D. Predicate Device

Common/Usual name: Classification Name:

Premarket Notification

Lorraine M. Hanley Vice President Global Regulatory Affairs Phone: 508-494-1129

PICC Maximal Barrier Nursing Kits Peripherally Inserted Central Catheter (PICC) Catheter, Intravascular Therapeutic, short and longterm greater than 30 days 21 CFR §880.5970, Class II General Hospital Device Panel

Peripherally Inserted Central Catheter (PICC) Catheter, Intravascular Therapeutic, short and longterm greater than 30 days 21 CFR §880.5970, Class II K122882, K121089, K111906, K093366, K091261, K070002

E. Device Description

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F. Intended Uses

· PICC Maximal Sterile Barrier Kit with NMI HPICC III

NON-VALVED VERSION

· PICC Maximal Sterile Barrier Kit with NMI PICC III

NON-VALVED VERSION

Maximum Power Injection Flow Rate:

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 .

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, 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 with PASV® Valve Technology:

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· PICC Maximal Sterile Barrier Kit with NMI PICC II; or with NMI PICC; or with BSC PICC:

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

Similarities

The proposed PICC Maximal Barrier Nursing Kit contains one of the identified predicate PICCs 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 packaging configuration differs from the predicate PICC kit packaging in order to contain a selection of procedural aides used in PICC placement including those identified as maximal barrier precaution devices. All packaging is manufactured from packaging materials that are well characterized and commonly used in the medical industry.

H. Performance

. 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 was conducted based upon a risk analysis and included testing conducted in accordance with the following national/international standards and FDA guidance documents:
. A AMI/ANSI/ISO 10993-7 Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals (2008)
AAMI/ANSI/ISO 11607-1 Packaging for terminally sterilized medical devices-Part 1: ◆ Requirements for materials, sterile barrier systems, and packaging systems (2006)
. A AMI/ANSI/ISO 11607-2 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes (2006)
Deciding When to Submit a 510(k) for a Change to an Existing Device, 10 January 1997 .
Convenience Kits, Interim Regulatory Guidance: 20 May 1997 �
Sterilized Convenience Kits for Clinical and Surgical Use: 7 January 2002 .
Bundling Multiple Devices or Multiple Indications in a Single Submission: 22 June 2007 ●

Safety and Performance Testing l.

Tests:

The successful results of the following key tests demonstrate that the proposed PICC Maximal Barrier Nursing Kit has met the pre-determined acceptance criteria applicable to the safe use of the devices.

Packaging Standards Testing
EO Sterilization Testing

J. Conclusion

Results of testing according to recognized standards and in consideration to the responses posed in FDA's Guidance on the CDRH Premarket Notification Review Program, 510(k) Decision Making Tree, the proposed PICC Maximal Barrier Nursing Kit is determined to be substantially equivalent to the predicate NMI PICCs.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The text is in all caps and appears to be in a sans-serif font.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

May 9, 2013

Ms. Marion W. Gordon Senior Project Manager Navilyst Medical, Incorporated 26 Forest Street MARLBOROUGH, MA 01752

Re: K131038

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: April 11, 2013 Received: April 17, 2013

Dear Ms. Gordon:

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 - Ms. Gordon

Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat 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 (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" (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/ReportalProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely vours.

Image /page/4/Picture/8 description: The image contains a handwritten note with the word "for" at the top left. The note also includes the words "with" and what appears to be a name or word that is difficult to decipher due to the handwriting style. There are also some decorative swirls and lines around the text, adding a personal touch to the note.

Anthony D. Watson, B.S., M.S., M.B.A. 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):

Device Name:

PICC Maximal Barrier Nursing Kit

with NMI PICC III

Indications for Use:

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:

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 .

VALVED VERSION

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 .

Prescription Use (21 CFR 801 Subpart D) 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)

Kathleen E. Fitzgerald 200 Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

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

Indications for Use

510(k) Number (if Known):

Device Name:

PICC Maximal Barrier Nursing Kit

NMI HPICC III with i

Indications for Use:

NON-VALVED VERSION

Prescription Use (21 CFR 801 Subpart D) × 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)

Kathle 300.100.1-1=0010093027. Fitzger

(Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices

510(k) Number: K131038

4-2

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510(k) Premarket Notification PICC Maximal Barrier Nursing Kit

Indications for Use

510(k) Number (if Known):

Device Name:

PICC Maximal Barrier Nursing Kit

K131038

Xcela® Hybrid PICC with PASV® Valve Technology with

Indications for Use:

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.

Prescription Use (21 CFR 801 Subpart D)

区 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)

Image /page/7/Picture/14 description: The image shows the letters FDA in a stylized, outlined font. The letters are interconnected and have a three-dimensional appearance due to the multiple outlines. The overall design is simple and recognizable, likely representing the Food and Drug Administration.

Richard C. Chapman 2013.05.07 12:39:02 -04'00'

(Division Sign-Off) (Division Sign-Cor)
Division of Anesthesiology. General Hospital Division of Anesian Devices

510(k) Number: K131038

{8}------------------------------------------------

510(k) Premarket Notification PICC Maximal Barrier Nursing Kit

Indications for Use

510(k) Number (if Known):
Device Name:	PICC Maximal Barrier Nursing Kitwith NMI PICC IIOr
	PICC Maximal Barrier Nursing Kitwith NMI PICCOr
	PICC Maximal Barrier Nursing Kitwith BSC PICC

Indications for Use:

Prescription Use (21 CFR 801 Subpart D) ಸ 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)

Kathleen E
Fitzgerald

Digitally signed by Kathleen E. Fitzgerald
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People,
0.9.2342.19200300.100.1.1-0010093027,
cn=Kathleen E. Fitzgerald
Date: 2013.05.09 15:27:31 -04'00'

(Division Sign-Off) (Division of Anesthesiology, General Hospital Intection Control, Dental Devices

510(k) Number:

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.”