(34 days)
Not Found
No
The summary describes a standard intravascular catheter with no mention of AI or ML capabilities, image processing, or data analysis features typically associated with such technologies. The focus is on material, design, and performance characteristics related to fluid delivery and blood sampling.
Yes
The device is used for intravenous therapy, including the administration of fluids, medications, and nutrients, which are all therapeutic interventions for a patient's health.
No
The device is a peripherally inserted central catheter (PICC) indicated for administering fluids, medications, nutrients, sampling blood, and injecting contrast media. It is not described as analyzing data to diagnose a condition.
No
The device description clearly indicates it is an intravascular catheter, which is a physical medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for direct access to the central venous system for administering fluids, medications, nutrients, sampling blood, and power injection of contrast media. These are all procedures performed in vivo (within the living body).
- Device Description: The description reinforces its use as an intravascular catheter for accessing the central venous system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the living body) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are typically used to analyze samples like blood, urine, or tissue in a laboratory setting to provide diagnostic information. This device is a medical device used for direct patient care and access to the circulatory system.
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.
The NMI HPICC 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, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring.
Product codes
LJS
Device Description
The proposed device has identical materials, design, components and technological characteristics as the predicate intravascular catheters.
Both the proposed and predicate devices are, in brief,
- . intended for short- or 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 sized from 3 to 6 . FR 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, .
- available kitted with a range of procedural accessories for user convenience; and .
- demonstrative of enhanced resistance to blood component (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 and NMI HPICC III are substantially equivalent to predicate devices based on comparison of technological characteristics and the results of non-clinical tests which included biocompatibility testing conducted in accordance with ISO-10933-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
26-June-2013
JUle: 3.1-2018
510(k) Summary for the NMI PICC III and NMI HPICC III
Date prepared: 26-June-2013
A. SPONSOR
Navilyst Medical, Inc 26 Forest Street Marlborough, MA 01752
B. CONTACT
Brandon M. Brackett Specialist, Global Regulatory Affairs Tel: 508-658-7984 Fax: 508-658-7976 E-mail: brandon.brackett@navilyst.com
Lorraine M. Hanley Vice President of Global Regulatory Affairs Tel: 508-658-7945 Fax: 508-658-7976 E-mail: lorraine.hanley@navilyst.com
C. DEVICE NAME
| Trade Name: | NMI PICC III and NMI HPICC III |
|---|---|
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | Short and Long-Term Intravascular Catheter |
| 21 CFR §880.5970, Class III | |
| Classification Panel: | General Hospital |
D. PREDICATE DEVICE
| Trade Name: | NMI PICC III and NMI HPICC III |
|---|---|
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | Short and Long-Term Intravascular Catheter |
| 21 CFR §880.5970, Class II | |
| Classification Panel: | General Hospital |
| Premarket Notification(s): | K121089, K122882 |
1
E. DEVICE DESCRIPTION
INTENDED USE(S):
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 |
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 |
The NMI HPICC 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, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the NMI HPICC III is 6 mL/sec.
2
F. SUMMARY OF SIMILARITIES AND DIFFERENCES IN TECHNOLOGICAL CHARACTERISTICS AND PERFORMANCE
The proposed device has identical materials, design, components and technological characteristics as the predicate intravascular catheters.
Both the proposed and predicate devices are, in brief,
- . intended for short- or 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 sized from 3 to 6 . FR 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, .
- available kitted with a range of procedural accessories for user convenience; and .
- demonstrative of enhanced resistance to blood component (platelet and thrombus) . accumulation.
G. PERFORMANCE DATA
The NMI PICC III and NMI HPICC III are substantially equivalent to predicate devices based on comparison of technological characteristics and the results of non-clinical tests which included biocompatibility testing conducted in accordance with ISO-10933-1.
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.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Subce Spring, MD 20993-0002
July 31, 2013
Navilyst Medical. Incorporated Mr. Brandon Brackett Specialist. Global Regulatory Affairs 26 Forest Street MARLBOROUGH MA 01752
Re: K131942
Trade/Device Name: NMI PICC III and NMI HPICC III Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: June 26. 2013 Received: July 2, 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 does not evaluate information related to contract liability warranties. We remind you, however, that device fabeling 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 - Mr. Brackett
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 yours,
Mary S. Runner -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
Navilyst Medical, Inc.
26-Junc-2013
INDICATIONS FOR USE
510(K) NUMBER (IF KNOWN): _ | 31942
DEVICE NAME: NMI PICC III and NMI HPICC III
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.
| 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 |
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. and the same of the same of the same of the same of the same of the same
| 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 |
The NMI HPICC 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, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the NMI HPICC III is 6 mL/sec.
Division Sign-Off) :Division of Anesthesiology, General Hospital nfection Control, Dental Devices
| Prescription Use (21 CFR 801 Subpart D) | \u2611 And/Or |
|---|---|
| ----------------------------------------- | ----------------------------------------------------------------------- |
| 10(k) Number: | K131942 |
|---|---|
| --------------- | --------- |
| AND/OR Over-The-Counter Use: (21 CFR 801 Subpart C) | \u25a1 |
|---|---|
| ----------------------------------------------------- | -------- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Richard C. Chapman | 4-2 |
|---|---|
| 2013.07.30 15:44:42 | |
| -04'00' |