(159 days)
Not Found
No
The summary describes a physical medical device (sheath introducer) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device can be used for the introduction of devices for therapeutic procedures, but the device itself is a "sheath introducer," which is an access device, not a therapeutic device. It facilitates therapy but does not provide therapy.
No
Explanation: The device is described as a sheath introducer used for percutaneous introduction of other devices, not for actively diagnosing conditions itself. Its "Intended Use" states it is used for introducing devices for "diagnostic and therapeutic procedures," implying that the diagnostic function is performed by other devices introduced through it, not by the sheath introducer itself.
No
The device description clearly states it is a "wire-reinforced flexible tube with an integral side port/hemostasis valve," which are physical hardware components.
Based on the provided information, the Bipore AccuFlex™ Percutaneous Sheath Introducer is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "percutaneous introduction of various devices into arteries and/or veins for diagnostic and therapeutic procedures." This describes a device used within the body for accessing blood vessels, not a device used to test samples outside the body (which is the definition of an IVD).
- Device Description: The description of a "wire-reinforced flexible tube with an integral side port/hemostasis valve" aligns with a medical device used for vascular access, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, this device falls under the category of a medical device used for interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Bipore AccuFlex™ Percutanous Sheath Introducer is designed to be used for the percutaneous introductionn of various devices into arteries and/or veins for diagnostic and therapeutic procedures.
Product codes
Not Found
Device Description
The Bipore AccuFlex™ Percutaneous Sheath Introducer is a wire-reinforced flexible tube with an integral side port/hemostasis valve at the proximal end.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arteries and/or veins
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)
Not Found
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
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
K9664814
MAY - T 1997 SUMMARY OF SAFETY AND EFFECTIVENESS BIPORE ACCUFLEX™ PERCUTANEOUS SHEATH INTRODUCER November 26, 1996
| Trade Name: | Bipore AccuFlex™ Percutaneous Sheath Introducer |
|---|---|
| Manufacturer: | Bipore, Inc. |
| 31 Industrial Parkway | |
| Northvale, NJ 07647 | |
| Tel: (201) 767-1993 Fax: (201) 767-0435 | |
| Device Generic Name: | Sheath Introducer |
| Classification: | Class II, Performance Standards |
| Predicate Device: | Arrow Super Arrow-Flex™ Percutaneous Sheath Introducer |
| 510(k): K924607 | |
| Description of Device: | The Bipore AccuFlex™ Percutaneous Sheath Introducer is a wire- |
| reinforced flexible tube with an integral side port/hemostasis valve | |
| at the proximal end. | |
| Indications for Use: | The Bipore AccuFlex™ Percutanous Sheath Introducer is designed |
| to be used for the percutaneous introductionn of various devices | |
| into arteries and/or veins for diagnostic and therapeutic procedures. | |
| Safety and Peformance: | Information concerning adverse health effects for this type of |
| product is presented here and in the Instructions for Use. | |
| Generally, the potential complications for devices of this type are: | |
| Vessel wall perforation Bacteremia | |
| Pleural and mediastinal injuries Septicemia | |
| Air embolism Thrombosis | |
| Thoracic duct laceration Nerve damage | |
| Inadvertant vessel puncture Hematoma formation | |
| Hemorrhage Dysrythmias | |
| Conclusion: | Based on the indications for use, technological characteristics, and |
| mechanical tests the Bipore AccuFlex™ Percutaneous Sheath | |
| Introducer is safe and effective for its intended use. |