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 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 NMI PICC III are flexible radiopaque catheters with suture wing for catheter securement, extension tubes(s) which connect to proximally located luer lock adapter(s) with and without a pressure activated safety valve (PASV), available in single lumen and multi-lumen configurations and a reverse tapered shaft to aid in staunching bleeding at the insertion site.

The lumens are differentiated by proximally located colored extension tube clamps and/or colored luer adaptors, which identify lumen size, if the lumen is rated for power injection the maximum power injection flow rates, and "NO CT" for non-power injectable lumens.

All NMI PICC III models have been designed with the option of being used with power injectors for the administration of contrast media for imaging studies such as Computerized Tomography (CT) scans and Magnetic Resonance Imaging (MRIs). Models with at least one non-valved lumen are also indicated for central venous pressure monitoring. All catheters are available packaged with a variety of procedural accessories as a convenience to suit specific clinician preference that meet of the PICC placement practice at their institution and in standard kit configurations.

Endexo technology has been shown to be effective in reducing thrombus accumulation. Reduction of thrombus accumulation was evaluated using in vitro and in vivo models. Preclinical in vitro and in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.

AI/ML Overview

The acceptance criteria for the NMI PICC III device and the studies that demonstrate its performance are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary primarily focuses on establishing substantial equivalence to predicate devices and demonstrating compliance with relevant standards through various tests. The 'acceptance criteria' are implicitly defined by successful completion of these tests, which ensure the device meets specified functional and safety requirements. The reported device performance is generally qualitative (e.g., successful passed testing) rather than specific numerical metrics, with the exception of maximum power injection flow rates.

Acceptance Criteria (Implied by successful testing) & Reported Device Performance

Acceptance Criteria (Study Type)	Reported Device Performance and Remarks
Material & Design Equivalence	Outcome: Device has similar materials, design, and components to predicate devices.
Compliance with EN ISO 10555-1:2009	Outcome: Successfully passed requirements for sterile, single-use intravascular catheters.
Compliance with EN ISO 10555-3:1997 Corrigendum 1:2002	Outcome: Successfully passed requirements for central venous catheters.
Compliance with FDA Guidance (March 16, 1995)	Outcome: Successfully passed all applicable requirements outlined in the "Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters."
Biocompatibility (ISO 10993-1)	Outcome: Successfully passed biocompatibility requirements.
Internal Product Specification Requirements	Outcome: Successfully passed all internal product specifications.
Luer Connection / Strength	Outcome: Successfully passed testing for Luer connection integrity and strength.
Power Injection Performance	Outcome: The device is rated for maximum power injector settings up to 325 psi. Specific maximum power injection flow rates are:- Non-Valved: 4F SL 3.5 mL/s, 5F SL 5 mL/s, 5F DL 4 mL/s, 6F DL 5 mL/s- Valved (PASV): 3F SL 1 mL/s, 4F SL 3.5 mL/s, 5F SL 5 mL/s, 5F DL 4 mL/s, 6F DL 5 mL/s, 6F TL 6 mL/s. All models achieved intended flow rates.
Valve Integrity	Outcome: Successfully passed testing for valve integrity.
Catheter Interface Compatibility	Outcome: Successfully passed testing for compatibility with various interfaces.
Central Venous Pressure Monitoring	Outcome: Models with at least one non-valved lumen successfully demonstrated capability for central venous pressure monitoring.
Chemical / Vesicant Compatibility	Outcome: Successfully passed testing for compatibility with various chemicals/vesicants.
In-Vitro Thrombus Reduction	Outcome: Demonstrated enhanced resistance to blood component (platelet and thrombus) accumulation compared to commonly used PICCs. This was quantified via 2-hour blood loop testing.
In Vivo Thromboresistance Study	Outcome: Demonstrated enhanced resistance to blood component accumulation compared to a heparin-based thromboresistant control catheter over 14 and 31 days.

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

Test Set Sample Size: The document does not specify the exact sample sizes (number of devices or animal subjects) used for each individual test (e.g., Luer connection strength, power injection, in-vitro blood loop, in-vivo ovine study). It only states that the testing was "successfully passed."
Data Provenance: The studies are described as preclinical ("in vitro and in vivo models") and conducted by the sponsor (Navilyst Medical, Inc.) to support the 510(k) submission. The in-vivo study used an "ovine model," indicating animal testing. The country of origin for the data is not specified beyond being generated by the sponsor for a US FDA submission. The studies are prospective in design for the purpose of evaluating the device's performance against pre-defined criteria.

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

For the technical and performance tests (e.g., Luer connection, power injection, valve integrity, chemical compatibility), the "ground truth" is established by the specified engineering standards (ISO, FDA guidance) and internal product specifications. These usually involve objective measurements and calibrated equipment, rather than expert human interpretation.
For the in-vitro and in-vivo thrombus reduction studies, the "ground truth" would be the measured thrombus accumulation. The document does not mention the involvement of external experts to establish this ground truth; it is assumed to be determined by the study investigators. No specific number or qualifications of experts are mentioned for establishing ground truth for any of the performance studies.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (like 2+1 or 3+1 consensus) for the test sets. The performance evaluation relies on objective measurements against established standards and internal specifications, along with direct quantitative or comparative outcomes from in-vitro and in-vivo studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The device is a medical catheter, not an imaging AI diagnostic tool that would typically involve human readers interpreting images. The studies conducted are focused on the physical and biological performance of the catheter itself.

6. Standalone Performance Study (Algorithm Only)

Not applicable. The NMI PICC III is a physical medical device (catheter), not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only without human-in-the loop performance)" does not apply.

7. Type of Ground Truth Used

The ground truth for the performance studies is based on:

Objective Measurements: For tests like Luer connection strength, power injection flow rates, and central venous pressure monitoring capabilities, the ground truth is obtained through direct instrumental measurements.
Compliance with Standards: Meeting the requirements of international standards (EN ISO 10555-1, EN ISO 10555-3, ISO 10993-1) and FDA guidance documents.
In-vitro Quantifiable Data: For thrombus reduction, the ground truth is based on quantitative measurements of thrombus accumulation in in-vitro blood loop models.
In-vivo Observational Data: For thromboresistance, the ground truth is derived from observations and measurements in an ovine animal model over specified indwelling times.

8. Sample Size for the Training Set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or artificial intelligence. The device's design and manufacturing processes are developed through engineering and material science principles, not through data-driven training sets.

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

Not applicable, as there is no "training set" for this physical medical device.

Summary

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K 12.089

510(K) SUMMARY

AUG 2 3 2012

Date prepared: July 24, 2012

A. Sponsor

Navilyst Medical, Inc 26 Forest Street Marlborough, MA 01752

B. Contact

Lorraine M. Hanley Vice President, Global Regulatory Affairs 508-658-7945 Lorraine.Hanley@Navilyst.com

C. Device Name

Trade Name:

Common/Usual name:

Classification Name:

Classification Panel:

D. Predicate Device(s)

Common/Usual name: Classification Name:

Premarket Notification(s):

NMI PICC III

Peripherally Inserted Central Catheter (PICC) Short and Long-Term Intravascular Catheter 21CFR§880.5970, Class II

General Hospital

Peripherally Inserted Central Catheter (PICC) Short and Long-Term Intravascular Catheter

21CFR§880.5970, Class II K070002, K101326, K091261, K093366,

K083763

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E. Device Description

F. Intended Use

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

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

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

Both the NMI proposed and predicate devices are,

· in brief, intended for short and 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 sizes from 3 to 6 Fr outside diameter.
· rated for maximum power injector settings up to 325 psi with maximum power injection flow rate up to 6 ml/second based on model, and
· available kitted with a range of procedural accessories for user convenience.

When compared to currently marketed PICCS, the proposed NMI PICC III has demonstrated enhanced resistance to blood component (platelet and thrombus) accumulation.

H. Performance Data

The performance evaluation of the NMI PICC III included testing conducted in accordance with the following FDA guidance document and international standards:

EN ISO 10555-1:2009, Sterile, Single use intravascular catheters Part 1: General . Requirements
EN ISO 10555-3:1997 Corrigendum 1:2002, Sterile, Single-Use Intravascular Catheters Part . 3: Central Venous Catheters
FDA's "Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-. Term Intravascular Catheters dated March 16, 1995"
Biocompatibility per ISO 10993-1. .

The proposed NMI PICC III successfully passed testing including:

Internal Product Specification Requirements .
. Luer Connection / Strength
Power Injection .
Valve Integrity .
Catheter Interface Compatibility .
Central Venous Pressure Monitoring .
Chemical / Vesicant Compatibility .
In-Vitro 2 hour blood loop thrombus reduction testing to quantify the relative thrombogenic . potential of the NMI PICC III in comparison to commonly used PICC's.
In Vivo study evaluating the thromboresistance of the NMI PICC III compared to a heparin-based . thromboresistant control catheter during both 14 and 31 day indwelling times in an ovine model.

I. Conclusion

Results of testing according to recognized standards, and in-vitro and in-vivo testing, and in consideration of the responses to questions posed in FDA's 510(k) Decision Making Tree, the proposed device is determined to be substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.

Public Health Service

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

AUG 2 3 2012

Navilyst Medical, Inc. C/O Lorraine M. Hanley VP Global Regulatory Affairs 26 Forest Street Marlborough, Massachusetts 01752

Re: K121089

Trade/Device Name: NMI PICC III Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, implanted, long-term intravascular catheter Regulatory Class: II. Product Code: LJS Dated: July 24, 2012 Received: July 25, 2012

Dear Ms. Hanley:

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. Hanley

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm_for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

For

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if Known):

6121089

Device Name:

NMI PICC III

Indications for Use:

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/5 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 cm - 6 mL/sec

Prescription Use

ಸಿ And/Or AND/OR Over-The-Counter Use:

(21 CFR 801 Subpart D)

(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)

Ald (loge 8/22/12
(Division Sign-Off)

General Hospita

510(k) Number:

K121089

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.”