(68 days)
SCIMED® 5 French EXPO™ Angiographic Catheter, Cordis® Corporation 5 F Infiniti™ Angiographic Catheter
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No
The device description focuses solely on the physical construction and materials of a catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
This device is designed to deliver contrast media for diagnostic imaging (angiography), not to treat a disease or condition.
No
The device is an angiographic catheter designed to deliver contrast media for imaging, not to diagnose. The diagnostic process occurs after the imaging, using the visual information the catheter helps to provide.
No
The device description clearly details the physical components of a catheter, including materials, layers, and construction, indicating it is a hardware device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure." This describes a device used within the body for a medical procedure, not a device used to test samples outside the body (in vitro).
- Device Description: The description details the physical components of a catheter designed for insertion into blood vessels. This aligns with an in-vivo device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
Therefore, the SCIMED IMPULSE Angiographic Catheters are medical devices used in vivo, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The SCIMED IMPULSE Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The 5 French SCIMED IMPULSE Angiographic Catheters will be available in 3 models; 0.045" ID Selective curve styles, 0.047" ID Selective curve styles, and the 0.045" ID Pigtail and Multipurpose curve styles whose tip ID tapers from 0.045" to 0.041" distally. Curve styles will be available with optional side holes.
The shafts of all 3 models utilize common biocompatible materials and consist of the following three layers: 1) The inner layer provides a smooth surface to allow for dye delivery and ease of guide wire movement. The Selective models utilize Pebax® for the inner layer, while the Pigtail and Multipurpose catheters utilize a Polyurethane/Pebax coextrusion, 2) The middle layer is made of braided stainless steel wire that extends from the shaft to the tip to provide torque control, kink resistance and support, and 3) the outer layer, which is also manufactured from Pebax, provides stiffness and curve retention. Radiopaque materials are utilized in the inner shaft, outer shaft and tip to allow visualization of the catheter during the procedure.
The tips of the Selective models are made from polyurethane, while the multipurpose and pigtail tips are composed of Pebax. Both tips are radiopaque to allow visualization during a procedure. The tips are heat fused to the distal end of the shaft.
The catheters utilize a polycarbonate hub and Pebax strain relief. The hub is molded to the proximal end of the catheter shaft. The devices will be provided sterile and are intended for one procedure use only.
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
vascular system
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)
Functional testing consisted of pressure burst, tip bond tensile, hub tensile, dye flow, maximum dye flow, tip coefficient of friction, force transmitted by the catheter tip, device radiopacity, and pigtail straightener peel-away force testing. Biocompatibility and shelf life testing has also been conducted. Test results verified that the 5 F IMPULSE Angiographic Catheters are adequate for their intended use.
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.
SCIMED® 5 French EXPO™ Angiographic Catheter, and Cordis® Corporation 5 F Infiniti™ Angiographic 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
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§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
4-1
51()(k) Notification SCIMED® 5 F Diagnostic Catheter
Section 4
10 1997
(Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990) Prepared April 2, 1996
General Provisions I.
| Submitter's Name
and Address | SCIMED Life Systems, Inc.
One SCIMED Place
Maple Grove, Minnesota 55311 |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Contact Person | Angela Raun
(612) 494-2456 |
| Classification Name | Diagnostic Intravascular Catheters
(21CFR Part 870.1200) |
| Common or Usual Name | Diagnostic Intravascular Catheter |
| Proprietary Name | SCIMED® 5 French IMPULSE™
Angiographic Catheters |
| Name of Predicate Devices | SCIMED® 5 French EXPO™ Angiographic
Catheter, and Cordis® Corporation 5 F
Infiniti™ Angiographic Catheter |
III. Device Description
II.
The 5 French SCIMED IMPULSE Angiographic Catheters will be available in 3 models; 0.045" ID Selective curve styles, 0.047" ID Selective curve styles, and the 0.045" ID Pigtail and Multipurpose curve styles whose tip ID tapers from 0.045" to 0.041" distally. Curve styles will be available with optional side holes.
The shafts of all 3 models utilize common biocompatible materials and consist of the following three layers: 1) The inner layer provides a smooth surface to allow for dye delivery and ease of guide wire movement. The Selective models utilize Pebax® for the inner layer, while the Pigtail and Multipurpose catheters utilize a Polyurethane/Pebax coextrusion, 2) The middle layer is made of braided stainless steel wire that extends from the shaft to the tip to provide torque control, kink resistance and support, and 3) the outer layer, which is also manufactured from Pebax, provides stiffness and curve retention. Radiopaque materials are utilized in the inner shaft, outer shaft and tip to allow visualization of the catheter during the procedure.
1
Section 4
The tips of the Selective models are made from polyurethane, while the multipurpose and pigtail tips are composed of Pebax. Both tips are radiopaque to allow visualization during a procedure. The tips are heat fused to the distal end of the shaft.
The catheters utilize a polycarbonate hub and Pebax strain relief. The hub is molded to the proximal end of the catheter shaft. The devices will be provided sterile and are intended for one procedure use only.
IV. Intended Use
The SCIMED IMPULSE Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.
V. Summary of Technological Characteristics
The 5 French SCIMED IMPULSE Angiographic Catheters are a modification of SCIMED's currently marketed 5 French EXPO Angiographic Catheters. Changes are summarized as follows:
- The ID has been increased in one Selective model to.0.047". .
- The inner shaft material has been changed from Polyurethane/Pebax to ● Pebax in the Selective models.
- Radiopaque loading components have been changed for the inner shaft layer, ● outer shaft layer, strain relief and tip material.
- A UV stabilizer has been added to the primary shaft material of all new ● models.
- The colorants in the primary shaft, inner shaft, catheter tip and strain relief ● have been changed.
- The inner shaft material durometers have been modified on the Selective . models.
- The distal 1" to 5" of the Selective models will decrease in shaft stiffness using transitional stiffness extrusion processing. The proximal end of the shaft will increase in shaft stiffness due to an added annealing process.
- A pigtail straightener is being provided for the pigtail models, which allows ● the pigtail to be introduced into the sheath more easily.
- The braid wire material has been changed to a different grade of stainless . steel and the braiding pattern has been slightly modified.
VI. Non-clinical Test Summary
Functional testing consisted of pressure burst, tip bond tensile, hub tensile, dye flow, maximum dye flow, tip coefficient of friction, force transmitted by the catheter tip, device radiopacity, and pigtail straightener peel-away force testing. Biocompatibility and shelf life testing has also been conducted. Test results verified
2
Section 4
and the same of the same
に
that the 5 F IMPULSE Angiographic Catheters are adequate for their intended use. The 5 F IMPULSE Angiographic Catheters are considered substantially equivalent to angiographic catheters currently marketed by SCIMED and Cordis based on a comparison of intended use, the design and the results of in-vitro testing and evaluation.
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