The NMI Port and NMI Port II with and without PASV Valve Technology are indicated for patients who require longterm access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal. When used with a power injectable needle, the NMI Port II are indicated for power injection of contrast media. The maximum recommended infusion rate is 5 ml/sec with a 19G or 20G non-coring power injectable needle or 2 ml/sec with a 22G non-coring power injectable needle.

Device Description

The NMI Port and NMI Port II with and without PASV Valve Technology are a subcutaneous implantable venous access device with one reservoir and is designed for optional power injection of contrast media, CECT. The ports are designed to be accessed using a non-coring Huber needle introduced through the skin into the self-sealing silicone septum covering the reservoir. The NMI Port and NMI Port II are available in plastic or titanium single lumen and valved or nonvalved configurations. The ports are available with either silicone filled or non-filled suture fixation holes. Ports with non-filled suture fixation holes are generally utilized based on clinical need to anchor the port to the subcutaneous tissue; whereas ports with filled suture holes, designed to prevent tissue in-growth to the suture holes, are generally utilized when not anchoring the port to the subcutaneous tissue. If needed, filled suture holes are accessed through the silicone. All port configurations have a radiopaque identifier (CT mark) to identify the port as power injectable. The radiopaque catheter has graduated marks at 1 centimeter intervals and can be cut to the desired length by the clinician. Ports are provided with a variety of procedural accessories. The NMI Port II catheter shaft incorporates Endexo polymer for improved resistance to thrombus accumulation and/or formation on the catheter.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, specifically, the NMI Port and NMI Port II, which are subcutaneous implantable venous access devices. The purpose of this type of submission is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than to prove its clinical effectiveness in AI-assisted diagnosis.

Therefore, the information typically requested for AI/ML device studies (such as MRMC studies, expert qualifications, ground truth establishment for training sets, etc.) is not applicable to this document. This document focuses on the physical and performance characteristics of an implantable medical device.

However, I can extract the acceptance criteria and performance data related to the device's physical and functional properties based on the provided text.

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

Test	Acceptance Criteria	Reported Device Performance
Power Injection and Burst	Port assembly must withstand 15 power injection cycles without any failures (leaking, fracturing and bursting) with an 11.8cp fluid at 300 psi maximum pressure setting and a 5 mL/sec flow rate setting for a 19 or 20 ga infusion set, and a 2 mL/sec flow rate setting for a 22 g infusion set. The port must then have a static burst strength of 50 psi minimum. Record burst strength.	All samples tested met the acceptance criteria. Average static burst pressures were 138.7, 148.8 and 149.2 psi.
Aspiration Strength - Open Ended	Port must be able to be aspirated (no occlusions or wall collapses preventing aspiration) using a 10 mL syringe on an open ended catheter without leaking or bursting post 4 hour conditioning at 37°C +/- 2ºC. Record as PASS/FAIL.	All samples tested met the acceptance criteria.
Aspiration Strength - Closed Ended	No leaks during aspiration with a 10 mL syringe for 15 seconds (leak = ingress of air bubbles to the syringe) post 4 hour conditioning at 37°C +/- 2°C without leaking or bursting on an occluded catheter. Record as PASS/FAIL.	All samples tested met the acceptance criteria.
CT Ink Durability	CT printing shall not flake or chip off. Additional requirements: soaking port in saline at body temperature for 24 hours and perform an alcohol rub. Record as PASS/FAIL.	All samples tested met the acceptance criteria.
Port body height	1.29 +/- 0.21 cm	All samples tested met the acceptance criteria (implying measurements were within the specified range, though specific measurements are not provided beyond 'met criteria').
Port Body Break Strength	Must not break at less than 636 lb force. Record as PASS/FAIL.	All samples tested met the acceptance criteria.

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

Power Injection and Burst Test: 3 lots of 15 each (45 total).
Aspiration Strength - Open Ended Test: 3 lots of 75 each (225 total).
Aspiration Strength - Closed Ended Test: 3 lots of 75 each (225 total).
CT Ink Durability Test: 3 lots of 75 each (225 total).
Port body height Test: 3 lots of 75 each (225 total).
Port Body Break Strength Test: 3 lots of 75 each (225 total).

Data Provenance: The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective clinical data. However, given this is an engineering and material performance test for a 510(k) submission, the "data" refers to physical measurements and tests conducted on manufactured device samples, not patient data. These are likely prospective tests conducted on new production lots.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This document does not describe the use of human experts to establish "ground truth" for a test set in the context of diagnostic performance. The tests are engineering and material performance assessments, likely conducted by qualified testing personnel or automated equipment, following established international standards (EN ISO 10555-1:2013, EN ISO 10555-3:2013) and FDA guidance.

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

Not applicable. This is not a study involving human interpretation or adjudication of diagnostic images or clinical outcomes.

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. This document is for an implantable medical device (infusion port), not an AI/ML diagnostic software.

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

Not applicable. This document is for an implantable medical device, not an AI algorithm.

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

The "ground truth" in this context refers to the defined physical and functional specifications and performance standards established for the device. These are objective measurements (e.g., burst pressure, freedom from leaks, physical dimensions, breaking force) and visual inspections (e.g., no flaking/chipping of ink). The "truth" is determined by whether the device's performance meets these pre-established quantitative and qualitative acceptance criteria. It's based on engineering principles and regulatory standards.

8. The sample size for the training set:

Not applicable. There is no AI/ML model training discussed in this document.

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

Not applicable. There is no AI/ML model training discussed in this document.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

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

December 4, 2015

Navilyst Medical, Inc. Robin Fuller Sr. Manager, Regulatory Affairs 26 Forest Street Marlborough, Massachusetts 01752

Re: K153228

Trade/Device Name: NMI Port and NMI Port II Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: November 4, 2015 Received: November 6, 2015

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. 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.

{1}------------------------------------------------

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 of medical devicerelated 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 (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 yours,

Tina Kiang -S

for 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K153228

Device Name NMI Port and NMI Port II

Indications for Use (Describe)

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 PRAStaff(@fda.hhs.gov

"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."

{3}------------------------------------------------

510(k) Summary for the NMI Port and NMI Port II

K153228

Date prepared: 19-November-2015

A. Sponsor

Navilyst Medical, Inc 26 Forest Street Marlborough, MA 01752

B. Contact

Robin Fuller Sr.Manager, Regulatory Affairs 508-658-7986

C. Device Name

Trade Name:	NMI Port and NMI Port II
Common/Usual name:	Implanted port catheter
Classification Name:	Implanted port catheter, subcutaneous, implanted, intravascular infusion port and catheter

21CFR§880.5965, Class II Classification Panel: ProCode:

D. Predicate Device(s)

Trade Name: Common/Usual name: Classification Name:

General Hospital LJT

NMI Port and NMI Port II Implanted port catheter Implanted port catheter, subcutaneous, implanted, intravascular infusion port and catheter

21CFR§880.5965, Class II
Classification Panel:	General Hospital
ProCode:	LJT
Predicate 510(k)s:	K122767, K131694

E. Device Description

{4}------------------------------------------------

The NMI Port and NMI Port II are available in plastic or titanium single lumen and valved or nonvalved configurations. The ports are available with either silicone filled or non-filled suture fixation holes. Ports with non-filled suture fixation holes are generally utilized based on clinical need to anchor the port to the subcutaneous tissue; whereas ports with filled suture holes, designed to prevent tissue in-growth to the suture holes, are generally utilized when not anchoring the port to the subcutaneous tissue. If needed, filled suture holes are accessed through the silicone. All port configurations have a radiopaque identifier (CT mark) to identify the port as power injectable. The radiopaque catheter has graduated marks at 1 centimeter intervals and can be cut to the desired length by the clinician. Ports are provided with a variety of procedural accessories.

The NMI Port II catheter shaft incorporates Endexo polymer for improved resistance to thrombus accumulation and/or formation on the catheter.

F. Indication for Use

The NMI Port and NMI Port II with and without PASV Valve Technology are indicated for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.

When used with a power injectable needle, the NMI Port II are indicated for power injection of contrast media. The maximum recommended infusion rate is 5 ml/sec with a 19G or 20G non-coring power injectable needle or 2 ml/sec with a 22G non-coring power injectable needle.

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

The proposed NMI Port and NMI Port II devices have identical materials, design and components and technological characteristics as predicate devices with the only difference being that the plastic port body ultrasonic welding process will be brought in-house to Navilyst Medical's manufacturing facility from the current outside contract manufacturer. Both the NMI Port II and predicate ports are, in brief, intended for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products; available in single lumen configurations; with and without PASV Valve Technology (Pressure Activated Safety Valve); plastic or titanium port body available with either a 6F or 8F outside diameter catheter; rated for maximum power injector settings up to 300 psi with maximum power injection flow rate up to 5 ml/second based on model; and available kitted with a variety of procedural accessories.

H. Performance Data

A risk analysis and necessary verification and validation activities to demonstrate that the design outputs of the modified device met the design input requirements were completed. The performance evaluation of the NMI Port and NMI Port II included testing conducted in accordance with the following FDA guidance documents and international standards:

. FDA's "Guidance on 510(k) Submissions for Implanted Infusion Ports dated October 1990.
. EN ISO 10555-1:2013, Sterile, Single Use Intravascular Catheters - Part 1: General Requirements
. EN ISO 10555-3:2013, Sterile, Single Use Intravascular Catheters – Part 3: Central Venous Catheters

The proposed NMI Port and NMI Port II successfully passed relevant testing per the above Guidance. standards, and pre-established acceptance criteria, including:

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

Test	Acceptance Criteria	SamplesTested	Results ofVerification
PowerInjectionand Burst	Port assembly mustwithstand 15 powerinjection cycles withoutany failures (leaking,fracturing and bursting)with an 11.8cp fluid at300 psi maximumpressure setting and a 5mL/sec flow rate settingfor a 19 or 20 ga infusionset, and a 2 mL/sec flowrate setting for a 22 ginfusion set.The port must then have astatic burst strength of 50psi minimum. Recordburst strength.	Three lotsof 15 each(45 total).	All samples tested metthe acceptance criteria.Average static burstpressures were 138.7,148.8 and 149.2 psi.
AspirationStrength -OpenEnded	Port must be able to beaspirated (no occlusionsor wall collapsespreventing aspiration)using a 10 mL syringe onan open ended catheterwithout leaking orbursting post 4 hourconditioning at 37°C +/-2ºC. Record asPASS/FAIL	Three lotsof 75 each(225total).	All samples tested metthe acceptance criteria.
AspirationStrength -ClosedEnded	No leaks duringaspiration with a 10 mLsyringe for 15 seconds(leak = ingress of airbubbles to the syringe)post 4 hour conditioningat 37°C +/- 2°C withoutleaking or bursting on anoccluded catheter.Record as PASS/FAIL	Three lotsof 75 each(225total).	All samples tested metthe acceptance criteria.
CT InkDurability	CT printing shall notflake or chip off.Additional requirementssoaking port in saline atbody temperature for 24hours and perform andalcohol rub. Record asPASS/FAIL	Three lotsof 75 each(225total).	All samples tested metthe acceptance criteria
Port bodyheight	1.29 +/- 0.21 cm	Three lotsof 75 each(225total).	All samples tested metthe acceptance criteria
Port BodyBreakStrength	Must not break at lessthan 636 lb force. Recordas PASS/FAIL	Three lotsof 75 each(225total).	All samples tested metthe acceptance criteria

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

I. Conclusion

Based on successful results of testing and on 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.

Regulation Number and Section

§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.

(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.