(154 days)
, L-Cath PICC and midline, One-Cath PICC and midline, Arrow PICC, SoloPICC and midline, Per-Q-Cath PICC, V-Cath PICC and midline, SiL-Cath PICC and midline catheters
Not Found
No
The document describes a standard medical device (PICC and midline catheters) and does not mention any AI or ML components in its description, intended use, or performance studies.
No
The device is a catheter used for venous access or intravenous therapy, which are methods of delivering substances to the body or accessing the bloodstream, not directly treating a disease or condition itself.
No
The device description clearly states its purpose as "Peripherally inserted central venous (PICC) and midline catheters placed for venous access or prolonged intravenous therapy," which are therapeutic rather than diagnostic functions.
No
The device description clearly describes physical catheters and associated components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Peripherally inserted central venous (PICC) and midline catheters placed for venous access or prolonged intravenous therapy." This describes a device used for delivering substances into the body, not for examining specimens from the body to provide diagnostic information.
- Device Description: The description details a catheter used for venous access and therapy delivery, focusing on its physical characteristics and insertion method. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no mention of providing diagnostic information based on such analysis.
Therefore, this device falls under the category of a medical device used for therapeutic or access purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes
FOZ
Device Description
Peripherally inserted central venous (PICC) and midline catheters placed for venous access or prolonged intravenous therapy. Method of insertion is through an introducer sheath. The optimal catheter tip location for the PICC catheter is in the superior vena cava of the heart. The recommended tip location for the midline catheter is below the shoulder, at the level of the axilla. The products will be available in single and dual lumen confiqurations; with and without a flushable guidewire; and as sterile individual units or in insertion kits containing the components used for insertion of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
superior vena cava of the heart, axilla
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
The JJMI Polyurethane PICC and midline catheters have passed all tests for safety and effectiveness (i.e., biocompatibility, sterility and device performance). The testing and conclusions are summarized below.
| Test | Conclusion |
|---|---|
| Flow rate | Passed |
| Tensile strength of body | Passed |
| Tensile strength of catheter to hub | Passed |
| Catheter stiffness | Passed |
| Catheter elongation | Passed |
| Leakage at hub joint | Passed |
| Burst pressure (positive pressure) | Passed |
| Catheter collapse (negative pressure) | Passed |
| Biocompatibility per ISO 10993 | Passed |
| Sterilization | Passed |
Key Metrics
Not Found
Predicate Device(s)
L-Cath PICC and midline, One-Cath PICC and midline, Arrow PICC, SoloPICC and midline, Per-Q-Cath PICC, V-Cath PICC and midline, and SiL-Cath PICC and midline catheters.
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
iK964556
pril 16, 1997
Summary of Safety and Effectiveness Information for JJMI Polyurethane PICC and Midline Catheters
- Classification Name: Percutaneous Intravascular Catheter 80 FOZ 1. Common Name: Peripherally Inserted Central Venous Catheter (PICC) and Midline catheter Proprietary Name: None has been designated at this time
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- Establishment Registration Number: 2938241
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- Establishment Name/Address: Menlo Care, Inc. Johnson & Johnson Medical, Inc. 1350 Willow Road Suite 202 Menlo Park, CA 94025
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- Classification: Class II
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- Substantially Equivalent Devices: L-Cath PICC and midline, One-Cath PICC and midline, Arrow PICC, SoloPICC and midline, Per-Q-Cath PICC, V-Cath PICC and midline, and SiL-Cath PICC and midline catheters.
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- Description and Device Function: Peripherally inserted central venous (PICC) and midline catheters placed for venous access or prolonged intravenous therapy. Method of insertion is through an introducer sheath. The optimal catheter tip location for the PICC catheter is in the superior vena cava of the heart. The recommended tip location for the midline catheter is below the shoulder, at the level of the axilla. The products will be available in single and dual lumen confiqurations; with and without a flushable guidewire; and as sterile individual units or in insertion kits containing the components used for insertion of the device.
- Performance Standards: No performance standards have been 7. established by the FDA for this type of device.
1
- Packaging and Sterilization: These devices will be packaged in pouches 8. and will be sterile and pyrogen-free. Insertion kits will be sterilized as well. Non-pyrogenicity will be established for each production lot by the LAL procedure.
- Tests/Studies with Conclusions: The JJMI Polyurethane PICC and 9. midline catheters have passed all tests for safety and effectiveness (i.e., biocompatibility, sterility and device performance). The testing and conclusions are summarized below.
| Test | Conclusion |
|---|---|
| Flow rate | Passed |
| Tensile strength of body | Passed |
| Tensile strength of catheter to hub | Passed |
| Catheter stiffness | Passed |
| Catheter elongation | Passed |
| Leakage at hub joint | Passed |
| Burst pressure (positive pressure) | Passed |
| Catheter collapse (negative pressure) | Passed |
| Biocompatibility per ISO 10993 | Passed |
| Sterilization | Passed |