(27 days)
Not Found
No
The device description explicitly states the only difference from the predicate is the ink used on the catheter shaft, and there are no mentions of AI, ML, or related concepts.
No
The device is a peripherally inserted central catheter (PICC) used to access the central venous system for various medical purposes, such as administering fluids and medications, sampling blood, and monitoring central venous pressure. While it is used in the context of therapy, it is a tool for delivering or monitoring rather than providing therapy itself.
No
The device is a peripherally inserted central catheter (PICC) used for administering fluids and medications, and for blood sampling. It does not analyze patient data or provide a diagnosis.
No
The device description and performance studies clearly indicate this is a physical intravascular catheter, not a software-only device.
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 used for accessing the central venous system for administering fluids, medications, nutrients, sampling blood, monitoring central venous pressure, and power injection of contrast media. These are all procedures performed in vivo (within the body).
- Device Description: The description refers to an "intravascular catheter," which is a device inserted into blood vessels.
- Anatomical Site: The anatomical site is the "central venous system," which is part of the circulatory system within the body.
- Performance Studies: The performance studies focus on the physical and biological characteristics of the catheter for its intended use within the body, referencing standards related to intravascular catheters and biological evaluation of medical devices.
IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device is used within the body for therapeutic and diagnostic procedures performed directly on the patient.
N/A
Intended Use / Indications for Use
The NMI PICC II and NMI PICCIV are indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administrations 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 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 IV 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 (comma separated list FDA assigned to the subject device)
LJS
Device Description
Not Found
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 NMI PICC III and NMI PICC IV are substantially equivalent to Navilyst predicate devices based on comparison of technological characteristics and the results of non-clinical tests which included the performance evaluation and biocompatibility testing conducted in accordance with the following FDA guidance documents, international standards, and testing which included:
- 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"
- FDA Blue Book Guidance G95-1 "Use of International Standard ISO 10993-1. ● "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"
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.
K140266 (NMI PICC IV), K131942 (NMI PICC III)
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
§ 880.5970 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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other, creating a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 19, 2015
Navilyst Medical Inc. Ms. Wanda Carpinella Director, Regulatory Affairs 26 Forest Street Marlborough, Maine 01752
Re: K150448
Trade/Device Name: NMI PICC III and NMI PICC IV Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, implanted, long-term intravascular catheter Regulatory Class: II Product Code: LJS Dated: February 18, 2015 Received: February 20, 2015
Dear Ms. Carpinella:
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 (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 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/Resourcesfor You/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 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 vours.
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) K150448
Device Name NMI PICC III and NMI PICC IV
Indications for Use (Describe)
The NMI PICC II and NMI PICCIV are indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administrations and nutrients, the sampling of blood, for central venous pressure monitoring and for power injection of contrast media. Maximum Power Iniection 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 |
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, for central venous pressure monitoring and for power injection of contrast media. Maximum Power Injection Flow Rate
| Description |
|---|
| 3F Single Lumen - 55cm Length |
| 4F Single Lumen - 55cm Length |
| 5F Single Lumen - 55cm Length |
| 5F Dual Lumen - 55cm Length |
| 6F Dual Lumen - 55cm Length |
| 6F Triple Lumen - 55cm Length |
Flow Rate 1 mL/sec 3.5 mL/sec 5 mL/sec 4 mL/sec 5 mL/sec 6 mL/sec
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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3
510(K) SUMMARY FOR THE NMI PICC III AND NMI PICC IV
510(K) #: K150448
Date prepared: February 18, 2015
A. Sponsor Navilyst Medical, Inc 26 Forest Street Marlborough, MA 01752
B. Contact
| Wanda Carpinella
Director, Regulatory Affairs
508-658-7929 | OR | Gary Barrett
Vice President, Regulatory Affairs
508-658-7940 |
|------------------------------------------------------------------|----|------------------------------------------------------------------------|
| C. Device Name | | |
| Trade Name: | | NMI PICC III and NMI PICC IV |
| Common/Usual name: | | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | | Short and Long-Term Intravascular Catheter
21CFR§880.5970, Class II |
| Classification Panel: | | General Hospital |
| D. Predicate Device | | |
| Common/Usual name: | | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | | Short and Long-Term Intravascular Catheter
21CFR§880.5970, Class II |
| Classification Panel: | | General Hospital |
| Premarket Notification | | K140266 (NMI PICC IV), K131942 (NMI PICC III) |
| E. Device Description | | |
Intended Use
The NMI PICC IV 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 | ||
|---|---|---|
| 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 – 55 cm length | 4 mL/sec | |
| 6F Dual Lumen – 55cm length | 5 mL/sec | |
| 6F Triple Lumen – 55cm length | 6 mL/sec |
4
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 |
F. Summary of Similarities and Differences in Technological Characteristics and Performance
The proposed device has similar design, components and technological characteristics as the predicate intravascular catheters; the only difference between the predicate and proposed devices is the type of ink used on the markings of the catheter shaft. Biocompatibility testing per ISO 10993-1 demonstrates that the new ink on the proposed device does not affect safety and/or effectiveness.
Similarities between the proposed and predicate devices include:
- intended for short- or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, for central venous pressure monitoring and power injection of contrast media.
- available in single and multi-lumen configurations in a wide range of sizes from 3F to 6 F outside catheter diameter;
- · rated for maximum power injector settings up to 325 psi
- rated for 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 and,
- · demonstrate resistance to blood components (platelet and thrombus) accumulation.
G. Performance Data
The NMI PICC III and NMI PICC IV are substantially equivalent to Navilyst predicate devices based on comparison of technological characteristics and the results of non-clinical tests which included the performance evaluation and biocompatibility testing conducted in accordance with the following FDA guidance documents, international standards, and testing which included:
- . 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"
- FDA Blue Book Guidance G95-1 "Use of International Standard ISO 10993-1. ● "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"
H. Conclusion
The results of the non-clinical testing and a comparison of similarities and differences demonstrate that the proposed and predicate devices are substantially equivalent.