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 Valve Technology is indicated for short- or long-term 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 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. Non-valved lumens are indicated for central venous pressure monitoring.

Device Description

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

Both the proposed and predicate devices are, in brief,

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

AI/ML Overview

The provided text describes a 510(k) summary for medical devices (PICC lines) and focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against acceptance criteria in the context of an AI/ML device.

Therefore, many of the requested categories for AI/ML device studies cannot be answered from the provided document.

Here's an analysis based on the information available:

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly state "acceptance criteria" in the traditional sense for a new software or AI/ML device performance study. Instead, it focuses on demonstrating substantial equivalence to predicate devices. The "performance" is primarily described by the predicate device's characteristics and the non-clinical tests confirming the similarity of the new device.

Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance (NMI PICC III and NMI HPICC III)
Intended Use: Short- or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, CVP monitoring (for some models), and power injection of contrast media.	Meets this intended use.
Material, Design, Components, Technological Characteristics: Identical to predicate intravascular catheters.	Confirmed to be identical.
Available Configurations: Single and multi-lumen in 3-6FR.	Available in single and multi-lumen configurations in a wide range of sizes from 3 to 6 FR.
Maximum Power Injector Settings: Up to 325 psi.	Rated for maximum power injector settings up to 325 psi.
Maximum Power Injection Flow Rate: Up to 6 ml/second (model dependent).	Rated for maximum power injection flow rate up to 6 ml/second based on model (detailed in tables).
Procedural Accessories: Kitted with a range of accessories.	Available kitted with a range of procedural accessories.
Resistance to Blood Component Accumulation: Enhanced resistance to platelet and thrombus accumulation.	Demonstrative of enhanced resistance to blood component (platelet and thrombus) accumulation.
Biocompatibility: In accordance with ISO-10933-1.	Biocompatibility testing conducted in accordance with ISO-10933-1.

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

Sample Size: Not applicable in the context of human data validation or an AI/ML model test set. The "testing" referred to is non-clinical bench testing (biocompatibility, mechanical properties) of the physical device.
Data Provenance: Not applicable. The "study" is a non-clinical evaluation of the physical device's characteristics and materials.

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

Not applicable. There is no mention of human experts establishing ground truth for a test set in this document, as it pertains to a physical medical device.

4. Adjudication method for the test set:

Not applicable. There is no test set or human adjudication described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. This document describes the substantial equivalence of a physical medical device (PICC lines), not an AI/ML system.

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

Not applicable. This is not an algorithm or AI/ML device.

7. The type of ground truth used:

Not applicable. The "ground truth" for this medical device's performance is based on established engineering principles, material science, and performance standards for intravascular catheters, as demonstrated through non-clinical testing.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Summary

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26-June-2013

JUle: 3.1-2018

510(k) Summary for the NMI PICC III and NMI HPICC III

Date prepared: 26-June-2013

A. SPONSOR

Navilyst Medical, Inc 26 Forest Street Marlborough, MA 01752

B. CONTACT

Brandon M. Brackett Specialist, Global Regulatory Affairs Tel: 508-658-7984 Fax: 508-658-7976 E-mail: brandon.brackett@navilyst.com

Lorraine M. Hanley Vice President of Global Regulatory Affairs Tel: 508-658-7945 Fax: 508-658-7976 E-mail: lorraine.hanley@navilyst.com

C. DEVICE NAME

Trade Name:	NMI PICC III and NMI HPICC III
Common/Usual Name:	Peripherally Inserted Central Catheter (PICC)
Classification Name:	Short and Long-Term Intravascular Catheter21 CFR §880.5970, Class III
Classification Panel:	General Hospital

D. PREDICATE DEVICE

Trade Name:	NMI PICC III and NMI HPICC III
Common/Usual Name:	Peripherally Inserted Central Catheter (PICC)
Classification Name:	Short and Long-Term Intravascular Catheter21 CFR §880.5970, Class II
Classification Panel:	General Hospital
Premarket Notification(s):	K121089, K122882

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E. DEVICE DESCRIPTION

INTENDED USE(S):

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

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

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F. SUMMARY OF SIMILARITIES AND DIFFERENCES IN TECHNOLOGICAL CHARACTERISTICS AND PERFORMANCE

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

Both the proposed and predicate devices are, in brief,

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

G. PERFORMANCE DATA

The NMI PICC III and NMI HPICC III are substantially equivalent to predicate devices based on comparison of technological characteristics and the results of non-clinical tests which included biocompatibility testing conducted in accordance with ISO-10933-1.

H. CONCLUSION

The results of the non-clinical testing and a comparison of similarities and differences demonstrate that the proposed and predicate devices are substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

Public Health Service

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

July 31, 2013

Navilyst Medical. Incorporated Mr. Brandon Brackett Specialist. Global Regulatory Affairs 26 Forest Street MARLBOROUGH MA 01752

Re: K131942

Trade/Device Name: NMI PICC III and NMI HPICC III Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: June 26. 2013 Received: July 2, 2013

Dear Mr. Brackett:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28. 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device fabeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Brackett

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (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/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Kwame Ulmer M.S. Acting Division 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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Navilyst Medical, Inc.

26-Junc-2013

INDICATIONS FOR USE

510(K) NUMBER (IF KNOWN): _ | 31942

DEVICE NAME: NMI PICC III and NMI HPICC III

INDICATIONS FOR USE:

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

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

Division Sign-Off) :Division of Anesthesiology, General Hospital nfection Control, Dental Devices

Prescription Use (21 CFR 801 Subpart D)	\u2611 And/Or
-----------------------------------------	-----------------------------------------------------------------------

10(k) Number:	K131942
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AND/OR Over-The-Counter Use: (21 CFR 801 Subpart C)	\u25a1
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Richard C. Chapman	4-2
2013.07.30 15:44:42
-04'00'

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.”