(56 days)
Not Found
No
The provided text describes a medical device kit containing PICC lines and associated procedural aids. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on packaging and sterilization standards.
No.
The device is a kit containing PICCs (Peripherally Inserted Central Catheters) and procedural aides used for delivering therapies, not performing the therapy itself. Its indicated uses are for "administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media," which enable therapeutic interventions but are not therapeutic actions in and of themselves.
No
The device is a PICC (Peripherally Inserted Central Catheter) and a Midline Catheter, used for administering fluids, medications, nutrients, and for blood sampling or central venous pressure monitoring. These are therapeutic and access devices, not diagnostic ones.
No
The device description clearly states it is a "packaging configuration containing a specified NMI PICC along with (1) procedural aides typically used for PICC placement and (2) maximal barrier precaution devices". This indicates the device is a physical kit containing hardware components (PICC, procedural aides, barrier devices), not software.
Based on the provided information, 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 accessing the central and peripheral venous systems 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 device is described as a kit containing a PICC (Peripherally Inserted Central Catheter) and procedural aides for its placement. A PICC is a medical device inserted into a vein.
- 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 tool for delivering substances into or withdrawing substances from the body.
N/A
Intended Use / Indications for Use
- PICC Maximal Barrier Nursing Kit with BioFlo Hybrid PICC with Endexo Technology and PASV Technology The PICC Maximal Barrier Nursing Kit with BioFlo Hybrid PICC with Endexo Technology and PASV Valve Technology 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, 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.
- PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology
The PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo 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: - 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 6 mL/sec
- PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology and PASV Valve Technology
The PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology and PASV Valve Technology 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, 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
- Maximal Barrier Nursing Kit with BioFlo Midline Catheter
The Maximal Barrier Nursing Kit with BioFlo Midline Catheter is indicated for short term access (
§ 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 shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three human profiles facing right, stacked on top of each other, with flowing lines extending from the bottom profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 3, 2017
Navilyst Medical, Inc. Robin Fuller Sr. Manager, Regulatory Affairs 26 Forest Street Marlborough, Massachusetts 01752
Re: K163452
Trade/Device Name: PICC Maximal Barrier Nursing Kits Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS, PND Dated: December 8, 2016 Received: December 9, 2016
Dear Robin Fuller:
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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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.
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
1
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 devicerelated 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 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting 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) K163452
Device Name PICC Maximal Barrier Nursing Kits
Indications for Use (Describe)
· PICC Maximal Barrier Nursing Kit with BioFlo Hybrid PICC with Endexo Technology and PASV Technology The PICC Maximal Barrier Nursing Kit with BioFlo Hybrid PICC with Endexo Technology and PASV Valve Technology 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, 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.
· PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology
The PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo 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:
- 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 6 mL/sec
*PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology and PASV Valve Technology
The PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology and PASV Valve Technology 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, 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
*Maximal Barrier Nursing Kit with BioFlo Midline Catheter
The Maximal Barrier Nursing Kit with BioFlo Midline Catheter is indicated for short term access ( Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
510(k) Summary for the PICC Maximal Barrier Nursing Kit
Date prepared: 2 February 2017
A. Sponsor
Navilyst Medical, Inc. 26 Forest Street Marlborough, MA 01752
B. Contact
Robin Fuller Sr. Manager Regulatory Affairs Phone: 508-658-7986
C. Device Name
Trade Name: Common Name: Regulation Number:
Regulation Name: Regulatory Class: Product Code:
Classification Panel:
D. Predicate Device
Trade Name: 510(k) Reference:
Common Name: Regulation Number:
Regulation Name:
Regulatory Class: Product Code:
Classification Panel: Premarket Notification PICC Maximal Barrier Nursing Kits Peripherally Inserted Central Catheter (PICC) 21 CFR 880.5970
Percutaneous, implanted, long-term intravascular catheter Class II ris PND General Hospital Device Panel
PICC Maximal Barrier Nursing Kits K142616
Peripherally Inserted Central Catheter (PICC) 21 CFR 880.5970
Percutaneous, implanted, long-term intravascular catheter
Class II LIS PND General Hospital Device Panel K142616
E. Device Description
The PICC Maximal Barrier Nursing Kit is a packaging configuration containing a specified NMI PICC along with (1) procedural aides typically used for PICC placement and (2) maximal barrier precaution devices based upon recommendations of Center of Disease Control and Prevention (CDC).
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F. Intended Uses
-
· PICC Maximal Barrier Nursing Kit with BioFlo Hybrid PICC with Endexo Technology and PASV Technology
The PICC Maximal Barrier Nursing Kit with BioFlo Hybrid PICC with Endexo Technology and 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. 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. -
· PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology
The PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology is indicated for shortor 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:
- 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 - 6 mL/sec
- · PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology and PASV Valve Technology
The PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology and 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 - 6 mL/sec
· Maximal Barrier Nursing Kit with BioFlo Midline Catheter
The Maximal Barrier Nursing Kit with BioFlo Midline Catheter is indicated for short term access (