(160 days)
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No
The summary describes a mechanical device (catheter introducer sheath with a needle safety system) and makes no mention of AI, ML, image processing, or any data-driven analytical capabilities.
No
The device is described as an introducer sheath and needle safety system used for percutaneous access to introduce catheters and guidewires. Its primary function is to facilitate the insertion of other devices and prevent needle stick injuries, rather than to treat a specific medical condition itself.
No
This device is designed for "percutaneous access for the introduction of catheters and guidewires" and to "reduce needle sticks injuries." Its function is interventional, not diagnostic.
No
The device description clearly states it is a "Catheter Introducer Sheath with PROTECTIV* 2000 Needle Safety System," which are physical medical 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 is for "percutaneous access for the introduction of catheters and guidewires." This describes a procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The description focuses on the physical components and safety features of the introducer sheath and needle system, not on reagents, calibrators, or other components typically associated with in vitro testing.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a tool used in a medical procedure, not for analyzing biological samples.
N/A
Intended Use / Indications for Use
The CENTERMARK * Catheter Introducer Sheath with PROTECTIV* 2000 Needle Safety System is designed for percutaneous access for the introduction of catheters and guidewires. The PROTECTIV* 2000 Needle Safety System is designed to reduce needle sticks injuries.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The introducer sheath portion of the system is the same product that is currently marketed by JJMI.
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)
The Safety system has passed all tests for safety and effectiveness (i.e. biocompatability, sterility and system performance).
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.
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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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§ 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
JAN - 7 1997
July 24, 1996
510(k) Summary of Safety and Effectiveness
CENTERMARK* Catheter Introducer Sheath \With PROTECTIV* 2000 Needle Safety System
The CENTERMARK * Catheter Introducer Sheath with PROTECTIV* 2000 Needle Safety System is designed for percutaneous access for the introduction of catheters and guidewires. The PROTECTIV* 2000 Needle Safety System is designed to reduce needle sticks injuries.
The introducer sheath portion of the system is the same product that is currently marketed by JJMI. The Safety system has passed all tests for safety and effectiveness (i.e. biocompatability, sterility and system performance).