(215 days)
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.
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.
This submission is for a medical device (Guiding Catheters) and not an AI/ML powered device, so most of the requested information (related to AI/ML studies, ground truth, expert consensus, etc.) is not applicable. However, I can extract the relevant information regarding acceptance criteria and performance testing for this device.
Here's the summary of the acceptance criteria and the study for the Guiding Catheters:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Test | Reported Device Performance |
|---|---|
| Tensile Strength | Adequate at hub-to-shaft and tip-to-shaft joints. |
| Shaft Wall Strength | Acceptable at pressures of 500 psi. |
| Biocompatibility | Non-toxic, non-irritating, non-pyrogenic, and blood compatible. |
| Sterile Shelf Life | Two years. |
| Technological Characteristics | Similar to predicate devices (injection molded luer hubs, kink protection sheaths, thermoplastic catheter shafts with embedded braided stainless steel wire, radiopaque tips, similar lumen diameters, similar curve styles, optional side holes). |
| Packaging and Sterilization | Individually packaged in Tyvek/Mylar, sterilized by ethylene oxide gas. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document states that "The 6 Fr and 8 Fr guiding catheters of each manufacturer were tested." This implies at least two sizes of the applicant's device (6 Fr and 8 Fr) and two sizes of the predicate device (6 Fr and 8 Fr) were used for testing. The exact number of individual units tested within each size is not specified.
- Data Provenance: This was an in vitro performance testing and biocompatibility testing. The data originates from laboratory testing conducted by the manufacturer, Biocompatibles Cardiovascular Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the submission pertains to a medical device's physical and biological properties rather than an AI/ML algorithm requiring expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for a physical device's performance testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable as the submission pertains to a medical device and not an AI/ML system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the submission pertains to a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on established engineering and biological standards for catheter functionality and safety. This includes:
* Engineering Standards: Bench testing for tensile strength and shaft wall strength.
* Biocompatibility Standards: Established tests for toxicity, irritation, pyrogenicity, and blood compatibility, likely performed according to ISO standards or similar guidelines.
* Comparison to Predicate Device: The predicate devices (Cordis Corporation 6 Fr and 8 Fr Brite Tip® Guiding Catheters) serve as a de facto "ground truth" or benchmark for technological characteristics.
8. The sample size for the training set
This is not applicable as the submission pertains to a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as the submission pertains to a physical medical device.
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510(K) Summary
FEB 12 1997
| Submitter's Name: | Biocompatibles Cardiovascular Inc.(formerly Atlantis Catheter Company)1049 Kiel CourtSunnyvale, CA 94089Tel. (408)-747-0200 |
|---|---|
| FDA Registration No.: | 2951413 |
| Contact Person: | Mr. James WoodChief Engineer |
| 510(k) Summary Date: | July 10, 1996 |
| Device Names: | 6 Fr Guiding Catheter with Phosphorylcholine ("PC")Polymer Coating7 Fr Guiding Catheter with PC Polymer Coating8 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 CatheterCordis 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.
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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.
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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.
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§ 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).