(59 days)
Not Found
No
The 510(k) summary describes a physical implantable venous access device and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML for data processing, analysis, or decision-making. The performance studies focus on physical and material properties and compatibility.
Yes
The device is described as an implantable venous access device used for the administration of fluids (e.g., chemotherapy, analgesics), nutritional therapy, and blood products, and for blood specimen withdrawal. These functions are therapeutic as they are involved in the treatment, management, or diagnosis of conditions.
No
The device is an implantable venous access device used for administering fluids, chemotherapy, analgesics, nutritional therapy, blood products, and for blood specimen withdrawal. It does not perform any diagnostic function.
No
The device description clearly details a physical, implantable medical device (subcutaneous implantable venous access device) with various hardware components (reservoir, septum, catheter, etc.). There is no mention of software being the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for administering fluids and withdrawing blood specimens from the central venous system. It also mentions power injection of contrast media. These are all procedures performed on the patient's body, not on samples outside the body for diagnostic purposes.
- Device Description: The description details an implantable venous access device with a reservoir, septum, and catheter. This is consistent with a device used for direct access to the circulatory system, not for analyzing samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status. The device facilitates the collection of blood specimens, but it doesn't perform any diagnostic testing on those specimens itself.
In summary, the NMI Port II is a medical device used for therapeutic and procedural purposes (administering substances, withdrawing blood, injecting contrast), not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The NMI Port II with and without PASV Valve Technology is 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 is indicated for power injection of contrast media. The maximum recommended infusion rate is 5 ml/sec with a 19G or 20G noncoring power injectable needle or 2 ml/sec with a 22G non-coring power injectable needle.
Product codes (comma separated list FDA assigned to the subject device)
LJT
Device Description
The NMI Port II with and without PASV Valve Technology is 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.
NMI Port II is available in plastic or titanium single lumen and valved or non-valved 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 catheter shaft incorporates Endexo polymer for improved resistance to thrombus accumulation and/or formation on the catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance evaluation of the NMI Port II included testing conducting 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 10555-1:2009, Sterile, Single Use Intravascular Catheters - Part 1: General Requirements
- EN ISO 10555-3:1997 COR 2002, Sterile, Single Use Intravascular Catheters -- Part 3: . Central Venous Catheters
- . Biocompatibility per ISO 10993-1
The proposed NMI Port II successfully passed relevant testing per the above Guidance, standards, and pre-established acceptance criteria, including:
- . Internal Product Specification Requirements
- Power Injection .
- t Valve Integrity
- Catheter Compatibility with Procedural Aid Devices .
- Port Septum Testing .
- Chemical / Vesicant Compatibility .
- . Thromboresistance
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) Summary for the NMI Port II
Date prepared: 07-June-2013
AUG 0 8 2013
A. Sponsor
Navilyst Medical, Inc 26 Forest Street Marlborough, MA 01752
B. Contact
Brandon M. Brackett Specialist, Global Regulatory Affairs 508-658-7984
OR
Lorraine M. Hanley Vice President, Global Regulatory Affairs 508-494-1129
C. Device Name
Trade Name: Common/Usual name: Classification Name:
Classification Panel:
NMI Port II
Implanted Port Catheter, Subcutaneous. Implanted, Intravascular Infusion Port and Catheter 21CFR§880.5965, Class II General Hospital
D. Predicate Device(s)
Trade Name: Common/Usual name: Classification Name:
Classification Panel:
Premarket Notification:
Trade Name: Common/Usual name: Classification Name:
Classification Panel:
Premarket Notification:
NMI Port
Implanted Port Catheter, Subcutaneous, Implanted, Intravascular Infusion Port and Catheter
21CFR§880.5965, Class II General Hospital
NMI PICC III
Peripherally Inserted Central Catheter (PICC) Short and Long-Term Intravascular Catheter
21CFR§880.5970, Class II General Hospital
1
E. Device Description
The NMI Port II with and without PASV Valve Technology is 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.
NMI Port II is available in plastic or titanium single lumen and valved or non-valved 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 catheter shaft incorporates Endexo polymer for improved resistance to thrombus accumulation and/or formation on the catheter.
F. Indication for Use
The NMI Port II with and without PASV Valve Technology is 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 is indicated for power injection of contrast media. The maximum recommended infusion rate is 5 ml/sec with a 19G or 20G noncoring 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 device has similar materials, design and components and technological characteristics as predicate devices. 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; 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.
2
H. Performance Data
The performance evaluation of the NMI Port II included testing conducting 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 10555-1:2009, Sterile, Single Use Intravascular Catheters - Part 1: General Requirements
- EN ISO 10555-3:1997 COR 2002, Sterile, Single Use Intravascular Catheters -- Part 3: . Central Venous Catheters
- . Biocompatibility per ISO 10993-1
The proposed NMI Port II successfully passed relevant testing per the above Guidance, standards, and pre-established acceptance criteria, including:
- . Internal Product Specification Requirements
- Power Injection .
- t Valve Integrity
- Catheter Compatibility with Procedural Aid Devices .
- Port Septum Testing .
- Chemical / Vesicant Compatibility .
- . Thromboresistance
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.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three legs and a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
August 08, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MIJ 20993-0002
Navilyst Medical, Incorporated C/O Mr. Brandon M. Brackett Specialist, Global Regulatory Affairs 26 Forest Street Marlborough, MA 01752
Re: K131694
Trade/Device Name: NMI Port II Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutancous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: June 7, 2013 Received: June 12, 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 docs 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.
4
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 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fdagov/MedicalDevices/Resourcesfor You/Industrvidefault.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/Safetv/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 yours,
Kwame O. Ulmer -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
5
Indications for Use
×131694 510(k) Number (if Known):
Device Name: NMI Port II
Indications for Use:
The NMI Port II with and without PASV Valve Technology is 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 is indicated for power injection of contrast media. The maximum recommended infusion rate is 5 ml/sec with a 19G or 20G noncoring power injectable needle or 2 ml/sec with a 22G non-coring power injectable needle.
| Prescription Use |
|---|
| (21 CFR 801 Subpart D) |
ズ 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)
Richard C. Chapman 2013.08.07 17:01:31 -04'00'
(Division Sign-Off) (Division Sign-On)
Division of Anesthestology, General Hospital Division of Ancolnocionology, Dental Devices
510(k) Number;
4-2