NMI Port, NMI Port II
Device Facts
| Record ID | K153228 |
|---|---|
| Device Name | NMI Port, NMI Port II |
| Applicant | Navilyst Medical, Inc. |
| Product Code | LJT · General Hospital |
| Decision Date | Dec 4, 2015 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 880.5965 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications 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.
Device Story
Subcutaneous implantable venous access device consisting of a reservoir and catheter; provides long-term central venous access. Clinician accesses reservoir via non-coring Huber needle through self-sealing silicone septum. Available in plastic or titanium, single lumen, valved (PASV) or non-valved configurations. Catheter shaft incorporates Endexo polymer to reduce thrombus formation. Radiopaque CT mark identifies power injectability. Used in clinical settings for fluid administration, blood withdrawal, and power injection of contrast media. Benefits include reliable long-term venous access and reduced risk of thrombus accumulation.
Clinical Evidence
Bench testing only. Performance evaluation included power injection and burst testing, aspiration strength (open and closed-ended), CT ink durability, port body height, and port body break strength. All tests met pre-established acceptance criteria per FDA guidance and EN ISO 10555-1:2013 and EN ISO 10555-3:2013 standards.
Technological Characteristics
Subcutaneous port with silicone septum and radiopaque catheter. Materials include plastic or titanium port body and Endexo polymer-coated catheter. Features PASV (Pressure Activated Safety Valve) technology. Dimensions: port body height 1.29 +/- 0.21 cm. Catheter diameter 6F or 8F. Power injection rated up to 300 psi and 5 ml/sec. Sterilization method not specified.
Indications for Use
Indicated for patients requiring long-term central venous access for fluid administration (hydration, chemotherapy, analgesics, nutrition, blood products) and blood specimen withdrawal. NMI Port II indicated for power injection of contrast media when used with compatible non-coring power injectable needles.
Regulatory Classification
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.
Special Controls
*Classification.* Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.
Predicate Devices
Submission Summary (Full Text)
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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.
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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
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### Indications for Use
510(k) Number (if known) K153228
Device Name NMI Port and NMI Port II
#### Indications for Use (Describe)
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.
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)
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# 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
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.
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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:
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| Test | Acceptance Criteria | Samples<br>Tested | Results of<br>Verification |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Power<br>Injection<br>and Burst | Port assembly must<br>withstand 15 power<br>injection cycles without<br>any failures (leaking,<br>fracturing and bursting)<br>with an 11.8cp fluid at<br>300 psi maximum<br>pressure setting and a 5<br>mL/sec flow rate setting<br>for a 19 or 20 ga infusion<br>set, and a 2 mL/sec flow<br>rate setting for a 22 g<br>infusion set.<br><br>The port must then have a<br>static burst strength of 50<br>psi minimum. Record<br>burst strength. | Three lots<br>of 15 each<br>(45 total). | All samples tested met<br>the acceptance criteria.<br>Average static burst<br>pressures were 138.7,<br>148.8 and 149.2 psi. |
| Aspiration<br>Strength -<br>Open<br>Ended | Port must be able to be<br>aspirated (no occlusions<br>or wall collapses<br>preventing aspiration)<br>using a 10 mL syringe on<br>an open ended catheter<br>without leaking or<br>bursting post 4 hour<br>conditioning at 37°C +/-<br>2ºC. Record as<br>PASS/FAIL | Three lots<br>of 75 each<br>(225<br>total). | All samples tested met<br>the acceptance criteria. |
| Aspiration<br>Strength -<br>Closed<br>Ended | No leaks during<br>aspiration with a 10 mL<br>syringe for 15 seconds<br>(leak = ingress of air<br>bubbles to the syringe)<br>post 4 hour conditioning<br>at 37°C +/- 2°C without<br>leaking or bursting on an<br>occluded catheter.<br>Record as PASS/FAIL | Three lots<br>of 75 each<br>(225<br>total). | All samples tested met<br>the acceptance criteria. |
| CT Ink<br>Durability | CT printing shall not<br>flake or chip off.<br>Additional requirements<br>soaking port in saline at<br>body temperature for 24<br>hours and perform and<br>alcohol rub. Record as<br>PASS/FAIL | Three lots<br>of 75 each<br>(225<br>total). | All samples tested met<br>the acceptance criteria |
| Port body<br>height | 1.29 +/- 0.21 cm | Three lots<br>of 75 each<br>(225<br>total). | All samples tested met<br>the acceptance criteria |
| Port Body<br>Break<br>Strength | Must not break at less<br>than 636 lb force. Record<br>as PASS/FAIL | Three lots<br>of 75 each<br>(225<br>total). | All samples tested met<br>the acceptance criteria |
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#### 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.
