(161 days)
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No
The summary describes a physical medical device (catheter) and its intended use, without mentioning any software, algorithms, or data processing capabilities that would indicate AI/ML.
No
The device is a peripherally inserted central venous (PICC) and midline catheter used for venous access or prolonged intravenous therapy, which is an access device, not a therapeutic device.
No
Explanation: The device description clearly states its purpose is for venous access or prolonged intravenous therapy, and it describes catheters for drug delivery, not for diagnosing conditions or diseases.
No
The device description clearly describes physical catheters and associated components for insertion, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for 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 in vivo (within the body) for delivering substances or accessing the bloodstream.
- Device Description: The description details a physical catheter inserted into the body, not a reagent, instrument, or system intended for use in the examination of specimens derived from the human body in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
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
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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 configurations; 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
superior vena cava; axilla
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The JJMI Polyurethane PICC and midline catheters have passed all tests for safety and effectiveness (i.e., biocompatibility, sterility and device performance).
Tests and 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 (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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): 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
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
96447
pril 16, 1997
人 湖
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
- Establishment Registration Number: 2938241 2.
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- Establishment Name/Address: Menio Care, Inc. Johnson & Johnson Medical, Inc. 1350 Willow Road Suite 202 Menlo Park, CA 94025
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- Classification: Class II
- Substantially Equivalent Devices: L-Cath PICC and midline, One-Cath ട. PICC and midline, Arrow PICC, SoloPICC and midline, Per-Q-Cath PICC, V-Cath PICC and midline, and SiL-Cath PICC and midline catheters.
- Description and Device Function: Peripherally inserted central venous 6. (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 configurations; 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
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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.
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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 |