(197 days)
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No
The device description and performance studies focus on material properties and basic functional tests, with no mention of AI or ML.
No
The device description indicates it is a catheter, which is used for accessing the body for various medical purposes, but it does not inherently provide a therapeutic effect itself. The "Summary of Performance Studies" focuses on physical characteristics and comparison to a predicate catheter, not on a therapeutic outcome.
No
A midline catheter is used for administering fluids or medications, not for diagnosing medical conditions. The device description and performance studies focus on physical characteristics and safety, not diagnostic capabilities.
No
The device description clearly states it is a physical catheter made of polyurethane material, available in different configurations and lengths, and can be inserted with or without a placement wire. This indicates a hardware medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- No mention of in vitro testing: The description focuses on a catheter designed for insertion into a patient's body. IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to diagnose conditions.
- Device type: A peripherally inserted midline catheter is a medical device used for delivering fluids or medications directly into a vein. This is an in vivo application, not in vitro.
- Performance studies: The performance studies described (flow rate, priming volume, flex modulus, burst pressure, tensile strength, biocompatibility) are all related to the physical and biological properties of the catheter itself, not to the analysis of biological specimens.
Therefore, the Arrow Peripherally Inserted Midline Catheter is a medical device, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Arrow Peripherally Inserted Midline Catheter is made of polyurethane material that is similar to our existing PIC catheters. The midline catheter will be available in both single and double lumen configurations, several trimmable and non-trimmable lengths, and the option of inserting with or without a placement wire.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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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)
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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.
Menlo Care Landmark Catheter
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.
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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).
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§ 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
MAR - 4 1997
510(k) Summary - K963257
The Arrow Peripherally Inserted Midline Catheter is made of polyurethane material that is similar to our existing PIC catheters. The midline catheter will be available in both single and double lumen configurations, several trimmable and non-trimmable lengths, and the option of inserting with or without a placement wire.
The device has comparable technological characteristics to several predicate devices. For the purposes of this submission, the Arrow Midline Catheter is compared to the Menlo Care Landmark Catheter in terms of the following nonclinical test results:
- Flow rate test ●
- . Priming volume test
- Flex modulus test .
- Burst pressure test .
- · Tensile strength test
The device also meets all biocompatability requirements.
96113