(135 days)
No
The 510(k) summary describes a physical catheter device and its performance characteristics. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is a peripherally inserted central catheter (PICC) used to administer fluids, medications, and nutrients, sample blood, and monitor central venous pressure, all of which are considered therapeutic interventions.
No.
The device is a catheter used for intravenous therapy, blood sampling, and pressure monitoring. While it assists in obtaining samples for diagnosis and allows for monitoring, it does not itself perform any diagnostic function (e.g., analyze data or interpret results to identify a disease).
No
The device description clearly outlines a physical catheter with various hardware components (flexible radiopaque catheters, suture wing, extension tubes, luer lock adapters, etc.). It is a hardware medical device.
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 accessing the central venous system for administering fluids, medications, nutrients, sampling blood, monitoring central venous pressure, and power injecting contrast media. These are all procedures performed in vivo (within the living body).
- Device Description: The description details a catheter designed for insertion into the body.
- Performance Studies: The performance studies focus on aspects like luer connection strength, power injection capabilities, valve integrity, biocompatibility, and thrombus reduction in vivo (in an ovine model). These are all relevant to a device used within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease.
Therefore, the NMI PICC III is an in vivo medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 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.
Product codes
LJS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computerized Tomography (CT) scans and Magnetic Resonance Imaging (MRIs)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K070002, K101326, K091261, K093366, K083763
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
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,
1
E. 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.
F. Intended Use
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.
| 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 |
2
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.
3
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.
4
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
5
Indications for Use
510(k) Number (if Known):
6121089
Device Name:
NMI PICC III
Indications for Use:
NON-VALVED VERSION
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.
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
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.
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: