(28 days)
Not Found
No
The summary describes a physical medical device (a PICC catheter) and its performance characteristics. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The performance studies focus on physical properties and flow rates, not algorithmic performance.
No.
The device is for accessing the central venous system for intravenous therapy, including administration of fluids, medications, and nutrients, as well as blood sampling and pressure monitoring, but it does not directly treat a disease or condition itself.
No
The device is a peripherally inserted central catheter (PICC) used for intravenous therapy, blood sampling, and pressure monitoring. While blood sampling and pressure monitoring can provide data used in diagnosis, the device itself does not perform analysis or interpretation of that data to make a diagnosis.
No
The device description clearly states it is a Peripherally Inserted Central Catheter (PICC), which is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The NMI PICC III is a catheter designed to be inserted into the body to provide access to the central venous system for administering fluids, medications, and nutrients, as well as for blood sampling and pressure monitoring. It is a device used in vivo (within the body), not in vitro (outside the body).
- Intended Use: The intended use clearly describes its function as a means of accessing the central venous system for therapeutic and monitoring purposes, not for performing diagnostic tests on samples.
The information provided about the device's function, intended use, and description all point to it being a medical device used for direct patient care, not an in vitro diagnostic test.
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.
Product codes (comma separated list FDA assigned to the subject device)
LJS
Device Description
The proposed device incorporates identical materials, design, components and technological characteristics as the predicate intravascular catheters.
In brief, both the proposed and predicate devices are:
- . 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 sized from 4F to 6F . outside catheter diameter;
- . rated for maximum power injector settings up to 325 psi;
- rated for maximum power injection flow rate up to 5 ml/second based on model; .
- available kitted with a range of procedural accessories for user convenience; and, .
- . demonstrate resistance to blood components (platelet and thrombus) accumulation.
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 is substantially equivalent to Navilyst predicate devices based on comparison of technological characteristics and the results of non-clinical tests which included the performance evaluation 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"
- Gravity Flow Rate o
- Priming Volume .
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.
K131942 (NMI PICC III and NMI HPICC 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
K133264
Navilyst Medical, Inc.
Re: NMI PICC III, Special 510(k)
510(K) SUMMARY FOR THE NMI PICC III
Date prepared: 22-October 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
Wanda Carpinella Director, Global Regulatory Affairs 508-658-7929
C. Device Name
Trade Name Common/Usual name: Classification Name:
Classification Panel:
D. Predicate Device
Common/Usual name:
Classification Name
Classification Panel: Premarket Notification
E. Device Description
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.
| Maximum Power Injection Flow Rate | |
|---|---|
| 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 |
NOV 20 2013
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)
Percutaneous, Implanted, Long-Term Intravascular Catheter 21CFR§880.5970, Class II General Hospital K131942 (NMI PICC III and NMI HPICC III)
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1
F. Summary of Similarities and Differences in Technological Characteristics and Performance
The proposed device incorporates identical materials, design, components and technological characteristics as the predicate intravascular catheters.
In brief, both the proposed and predicate devices are:
- . 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 sized from 4F to 6F . outside catheter diameter;
- . rated for maximum power injector settings up to 325 psi;
- rated for maximum power injection flow rate up to 5 ml/second based on model; .
- 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 is substantially equivalent to Navilyst predicate devices based on comparison of technological characteristics and the results of non-clinical tests which included the performance evaluation 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"
- Gravity Flow Rate o
- Priming Volume .
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.
2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 20, 2013
Navilyst Medical, Incorporated Mr. Brandon M. Brackett Specialist, Globel Regulatory Affairs 26 Forest Street MARLBOROUGH MA 01752
Re: K133264
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: October 22, 2013 Received: October 23, 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: CDRFI 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.
3
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 (OS) 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/Resourcesfor You/Industry/default,htm.
Sincerely yours.
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for
Erin Keith 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133264
Device Name NMI PICC III
Indications for Use (Describe)
The NMI PICC III is indicated for short- or long-term peripheral access to the central venous 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 4F Single Lumen - 55cm length 3.5 mL/sec SF Single Lumen - 55cm length 5 mL/sec 5F Dual Lumen - 55 cm length 4 mL/sec 6F Dual Lumen - 55cm length 5 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
. " " Start Status " " Martin For For USE ONLY - Status" (1992) " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " ్నార్లు ప్రాం Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Digitally signed by Richard C. Chapman Date: 2013.11.19 15:41:37 -05'00'
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.