(232 days)
Not Found
No
The summary describes a physical implantable device (venous access port) and its intended use and performance testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
This device is used for the administration of fluids, including but not limited to chemotherapy and nutritional therapy, and blood products, which are therapeutic interventions.
No
The device is an implantable venous access device used for administering fluids, chemotherapy, and withdrawing blood specimens. It is designed to provide access to the central venous system, not to diagnose medical conditions.
No
The device description clearly details a physical, implantable medical device (subcutaneous implantable venous access devices with one reservoir) made of plastic or titanium, with physical components like a septum, catheter, and suture fixation holes. It also mentions physical testing and performance studies related to these hardware components.
Based on the provided information, 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 is a device used in the body for therapeutic and diagnostic sample collection purposes, not a device used on a sample outside the body to diagnose a condition.
- Device Description: The description details an implantable venous access device, which is a physical device inserted into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any process that would be performed in vitro (outside the living organism) for diagnostic purposes.
The device is a medical device used for accessing the central venous system for various clinical procedures.
N/A
Intended Use / Indications for Use
The NMI Ports 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 Ports 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.
Product codes (comma separated list FDA assigned to the subject device)
LJT
Device Description
The NMI Ports are subcutaneous implantable venous access devices with one reservoir and are 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 Ports are 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) as a power injectable port. 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.
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 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, FDA's "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheter dated March 16, 1995., Biocompatibility per ISO 10993-1. The proposed NMI Port successfully passed relevant testing per the above Guidance and standards including: Internal Product Specification Requirements, Power Injection, Valve Integrity, Port Septum Testing, Chemical/Vesicant Compatibility.
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.
K030083, K031844, K032008, K032375, K032600, K071993, K072481 and K073210
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
APR 3 0 2013
510(k) Summary for the NMI Port
Date prepared: 07 -Sep -2012
A. Sponsor
Navilyst Medical, Inc 26 Forest Street Marlborough, MA 01752
B. Contact
Lorraine M. Hanley Vice President, Global Regulatory Affairs 508-494-1129
Or
Wanda M. Carpinella Director, Global Regulatory Affairs 508-658-7929
C. Device Name
Trade Name: Common/Usual name: Classification Name:
Classification Panel:
D. Predicate Device(s)
Common/Usual name:
Classification Name:
Classification Panel: Premarket Notification(s):
NMI Port
Implanted Port Catheter, Subcutaneous, Implanted, Intravascular Infusion Port and Catheter
21CFR§880.5965, Class II General Hospital
Peripherally Inserted Central Catheter (PICC)
Short and Long-Term Intravascular Catheter
21CFR§880.5965, Class II K030083, K031844, K032008, K032375, K032600, K071993, K072481 and K073210
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E. Device Description
The NMI Ports are subcutaneous implantable venous access devices with one reservoir and are 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 Ports are 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) as a power injectable port. 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.
F. Intended Use
The NMI Ports 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 Ports 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 device has similar materials, design and components and technological characteristics as predicate port catheters. Both the NMI Ports and predicate devices are, in brieff, 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 and 6 or 8 F outside catheter diameter, 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 range of procedural accessories.
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H. Performance Data
The performance evaluation of the NMI Port 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
- . FDA's "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheter dated March 16, 1995.
- Biocompatibility per ISO 10993-1 .
The proposed NMI Port successfully passed relevant testing per the above Guidance and standards including:
- . Internal Product Specification Requirements
- . Power Injection
- Valve Integrity
- Port Septum Testing .
- Chemical/Vesicant Compatibility .
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-00002
April 30, 2013
Ms. Lorraine M. Hanley Vice President Global Regulatory Affairs Navilyst Medical, Incorporated 26 Forest Street MARLBOROUGH MA 01752
Re: K122767
Trade/Device Name: NMI Port Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: March 22, 2013 Received: March 25, 2013
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. Iisting 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 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 vours.
Vor
Seth
urohitus.
Anthony D. Watson, B.S., M.S., M.B.A. 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
510(k) Number (if Known):
Device Name: NMI Port
Indications for Use:
The NMI Ports 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 Ports are 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) ಸ 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
2013.04.29 15:22:45
-04'00' |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| | (Division Sign-Off)
Division of Anesthesiology General Hospital
Infection Control, Dental Devices | |
| 510(k) Number: | K122767 | |
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