(215 days)
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Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a guiding catheter, with no mention of AI or ML technology.
No
The device is a guiding catheter used to aid in the placement of other devices (like guide wires, balloon dilatation catheters) for diagnosis and therapy, rather than directly providing a therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the guiding catheters are indicated to aid in "peripheral and coronary artery transcatheter diagnosis and therapy," directly indicating its role in diagnostic procedures.
No
The device description clearly details a physical catheter with specific dimensions, materials (thermoplastic, stainless steel, radiopaque thermoplastic), and manufacturing processes (extrusion, heat welding, injection molding). It also mentions packaging and sterilization methods, all indicative of a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to "aid the percutaneous placement of guide wires, balloon dilatation catheters, and other devices required for peripheral and coronary artery transcatheter diagnosis and therapy." This describes a device used within the body for interventional procedures.
- Device Description: The description details a physical catheter with a shaft, hub, tip, and coatings, designed for insertion into blood vessels.
- Anatomical Site: The specified anatomical site is "peripheral and coronary artery," which are locations within the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests outside the body on samples taken from the body. This device is used inside the body to facilitate medical procedures.
N/A
Intended Use / Indications for Use
The Guiding Catheters with PC Polymer Coating are indicated to aid the percutaneous placement of guide wires, balloon dilatation catheters, and other devices required for peripheral and coronary artery transcatheter diagnosis and therapy. The guiding catheters are not intended for use in the cerebral vasculature.
Product codes
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Device Description
The 6 Fr, 7 Fr, and 8 Fr Guiding Catheters with PC Polymer Coating have shaft nominal outside diameters of 0.079", 0.092", and 0.104" with nominal inside diameters of 0.064", 0.075", and 0.087", respectively. The guiding catheters are available in lengths of 65 cm, 85 cm, 100 cm, and 110 cm. Distal side holes and different curve styles are available. The inner and outer surfaces of the guiding catheter are coated with a hydrophilic polymer. The catheter hub is disk shaped and injection molded onto the shaft. The shaft is an extruded thermoplastic with an embedded stainless steel braided wire extending from the hub to the radiopaque tip. A hub-to-shaft kink protector is included. The tip is made of a low durometer radiopaque thermoplastic and is heat welded to the end of the catheter shaft. The guiding catheters are packaged in Tyvek/Mylar heat sealed sterilization pouches and gas sterilized by ethylene oxide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and coronary artery vasculature; not intended for use in the cerebral vasculature.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
In vitro performance testing was conducted to determine the safety and effectiveness of the BCP guiding catheters in comparison to the predicate devices. The 6 Fr and 8 Fr guiding catheters of each manufacturer were tested. The PC-coated guiding catheters were found to have adequate tensile strength at the hub-to-shaft and tip-to-shaft joints. Additional tests demonstrated acceptable shaft wall strength at pressures of 500 psi. The biocompatibility of the BCP guiding catheter was tested and the results showed the device to be non-toxic, non-irritating, non-pyrogenic, and blood compatible. The BCP guiding catheters are biocompatible for short term use in the vascular system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Cordis Corporation 6 Fr Brite Tip® Guiding Catheter, Cordis Corporation 8 Fr Brite Tip® Guiding 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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
510(K) Summary
FEB 12 1997
| Submitter's Name: | Biocompatibles Cardiovascular Inc.
(formerly Atlantis Catheter Company)
1049 Kiel Court
Sunnyvale, CA 94089
Tel. (408)-747-0200 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Registration No.: | 2951413 |
| Contact Person: | Mr. James Wood
Chief Engineer |
| 510(k) Summary Date: | July 10, 1996 |
| Device Names: | 6 Fr Guiding Catheter with Phosphorylcholine ("PC")
Polymer Coating
7 Fr Guiding Catheter with PC Polymer Coating
8 Fr Guiding Catheter with PC Polymer Coating |
| Common Name: | Guiding Catheter |
| Classification Name: | Percutaneous Catheter (21 CFR 870.1250) |
| Predicate Devices: | Cordis Corporation 6 Fr Brite Tip® Guiding Catheter
Cordis Corporation 8 Fr Brite Tip® Guiding Catheter |
Device Description:
The 6 Fr, 7 Fr, and 8 Fr Guiding Catheters with PC Polymer Coating have shaft nominal outside diameters of 0.079", 0.092", and 0.104" with nominal inside diameters of 0.064", 0.075", and 0.087", respectively. The guiding catheters are available in lengths of 65 cm, 85 cm, 100 cm, and 110 cm. Distal side holes and different curve styles are available. The inner and outer surfaces of the guiding catheter are coated with a hydrophilic polymer. The catheter hub is disk shaped and injection molded onto the shaft. The shaft is an extruded thermoplastic with an embedded stainless steel braided wire extending from the hub to the radiopaque tip. A hub-to-shaft kink protector is included. The tip is made of a low durometer radiopaque thermoplastic and is heat welded to the end of the catheter shaft. The guiding catheters are packaged in Tyvek/Mylar heat sealed sterilization pouches and gas sterilized by ethylene oxide.
000049
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1
Intended Use:
The Guiding Catheters with PC Polymer Coating are indicated to aid the percutaneous placement of guide wires, balloon dilatation catheters, and other devices required for peripheral and coronary artery transcatheter diagnosis and therapy. The guiding catheters are not intended for use in the cerebral vasculature.
Comparison of Technological Characteristics:
The Guiding Catheters with PC Polymer Coating have similar technological characteristics as the predicate devices. The respective guiding catheters have injection molded luer hubs designed to allow device torqueing, kink protection sheaths, thermoplastic catheter shafts with embedded braided stainless steel wire, and have radiopaque tips. Guiding catheter lumen diameters are similar for each size catheter. Curve styles of the guiding catheters with PC polymer coating are similar to those marketed for the predicate devices. Both guiding catheters are available with optional side holes. The predicate guiding catheters have an inner 0.0015" Teflon liner and are not coated on the outside. The lumen and outside wall of the BCP guiding catheters are coated with PC polymer. Predicate device tips are solvent bonded to the catheter shafts; the BCP catheter tips are heat welded to the shafts.
Packaging and Sterilization
The BCP and predicate guiding catheters are individually packaged in a Tyvek/Mylar heat sealed gas sterilization pouches and sterilized by ethylene oxide gas. The sterile shelf life of the BCP guiding catheters is two years; the shelf life of the predicate devices is three years.
Safety and Effectiveness:
In vitro performance testing was conducted to determine the safety and effectiveness of the BCP guiding catheters in comparison to the predicate devices. The 6 Fr and 8 Fr guiding catheters of each manufacturer were tested. The PC-coated guiding catheters were found to have adequate tensile strength at the hub-to-shaft and tip-to-shaft joints. Additional tests demonstrated acceptable shaft wall strength at pressures of 500 psi. The biocompatibility of the BCP guiding catheter was tested and the results showed the device to be non-toxic, non-irritating, non-pyrogenic, and blood compatible. The BCP guiding catheters are biocompatible for short term use in the vascular system.
000050
2
Based on the indications for use, design and construction, and results of the bench and biocompatibility testing, the BCP Guiding Catheters with PC Polymer Coating are equivalent to the predicate device.
000051
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