(90 days)
Not Found
No
The device description focuses on the physical characteristics and materials of the catheter, and the performance studies evaluate standard engineering properties and biocompatibility. There is no mention of AI, ML, image processing, or data sets for training or testing algorithms.
No
The device is described as an infusion catheter used to facilitate access and infuse diagnostic agents or other therapeutics, not to provide a therapeutic effect itself.
No
The device is an infusion catheter, indicated for facilitating access and controlled, regional infusion of diagnostic agents. While it uses diagnostic agents, the device itself is not performing diagnosis. It's an interventional tool for delivering substances.
No
The device description clearly details a physical catheter, stylet, and mandrel, which are hardware components. It is not solely software.
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 for facilitating access through vasculature and for the controlled, regional infusion of diagnostic agents (like contrast media) and a specific therapeutic agent (Berenstein Liquid Coil -10). This is an in vivo application, meaning it's used within the living body.
- Device Description: The description details a catheter designed for insertion into blood vessels, with features like shaft stiffness, a luer fitting for accessories, and a hydrophilic coating for manipulation within the vessel. These are characteristics of a device used directly on a patient.
- 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.) outside of the body. IVDs are designed for testing these types of samples to provide information about a person's health.
The device is an infusion catheter used for delivering substances directly into the patient's vasculature, which is a medical device used for treatment and diagnosis within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Spinnaker is indicated for use in facilitating access through distal, tortuous vasculature, and may be used for the controlled, regional infusion of diagnostic agents, such as contrast media and Target Therapeutics' Berenstein Liquid Coil -10 in the peripheral and neuro vasculature. It is not intended for use in the coronary vasculature.
The Spinnaker Infusion Catheter in Contraindicated for use with any other occlusion oils.
Note: Compatibility testing has been conducted with the Berenstein Liquid Coil -10 only.
Product codes
Not Found
Device Description
Spinnaker Infusion Catheter is a single lumen device with a graded shaft stiffness, ranging from a highly flexible tip to a semi-rigid proximal section that allows ease of advancement by the physician. A lure fitting located on the catherer hub is used for the attachment of accessories. Spinnaker is manufactured with HYDROLENE®, a hydrophilic surface coating that reduces friction during manipulation in the vessel.
The Spinnaker Infusion Catheter will be made available as a system consisting of a Spinnaker Infusion Catheter, a stylet with a torque device attached, and a steam shaping mandrel.
SPINNAKER with HYDROLENE Infusion Catheter (SPINNAKER) is a single lumen device designed to aid the physician in accessing distal vasculature when used with a guiding catheter. Graded shaft stiffness ranging from a highly flexible tip to a semi-rigid proximal section allows ease of advancement by the physician. A luer fitting located on the catheter hub is used for the attachment of accessories. A radiopaque tip and body facilitate fluoroscopic visualization. SPINNAKER is manufactured with HYDROLENE, a hydrophilic surface that reduces friction during manipulation in the vessel. The stylet accompanying the SPINNAKER is used to increase rigidity of the distal section during introduction into the guiding catheter. The steam shaping mandrel packaged with the SPINNAKER is used when the physician desires to shape the catheter's distal end.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic visualization
Anatomical Site
peripheral and neuro vasculature. It is not intended for use in the coronary 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
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)
Substantial equivalence is based on the fact that the Spinnaker has similar technological characteristics and intended use as the predicate devices. The results of performance testing (flow rates, tip flexibility, tensile, static rupture, and coefficient of friction) and Biocompatibility testing support the claim of substantial equivalence to the predicate device. Results of the performance and Biocompatibility testing in conjunction with the substantial equivalence claims as outlined in this premarket notification, effectively demonstrate that the Spinnaker is substantially equivalent to the predicate devices.
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.
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
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/3 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '965188'. The numbers are written in a clear, legible style, with consistent spacing between them.
MAR 24 1997
Image /page/0/Picture/5 description: The image shows the logo for Target Therapeutics. The logo consists of a black circle on the left, followed by the word "TARGET" in large, bold, black letters. Below "TARGET" is the word "THERAPEUTICS" in smaller, bold, black letters. A horizontal line connects the circle to the word "TARGET".
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
CONTACT PERSON:
Laraine Pangelina Sr. Manager, Regulatory Affairs Target Therapeutics, Inc. 47201 Lakeview Blvd. Fremont, CA 94538-6530
DEVICE NAME:
SPINNAKER™ Infusion Catheter, Class II
DEVICE DESCRIPTION:
Spinnaker Infusion Catheter is a single lumen device with a graded shaft stiffness, ranging from a highly flexible tip to a semi-rigid proximal section that allows ease of advancement by the physician. A lure fitting located on the catherer hub is used for the attachment of accessories. Spinnaker is manufactured with HYDROLENE®, a hydrophilic surface coating that reduces friction during manipulation in the vessel.
The Spinnaker Infusion Catheter will be made available as a system consisting of a Spinnaker Infusion Catheter, a stylet with a torque device attached, and a steam shaping mandrel.
INDICATIONS FOR USE:
The Spinnaker is indicated for use in facilitating access through distal, tortuous vasculature, and may be used for the controlled, regional infusion of diagnostic agents, such as contrast media and Target Therapeutics' Berenstein Liquid Coil -10 in the peripheral and neuro vasculature. It is not intended for use in the coronary vasculature.
The Spinnaker Infusion Catheter in Contraindicated for use with any other occlusion oils.
Note: Compatibility testing has been conducted with the Berenstein Liquid Coil -10 only.
PREDICATE DEVICE: Balt Magic Infusion Catheter, K923368 Zephyr Infusion Catheter, K921247
TESTING in SUPPORT of SUBSTANTIAL ROUTVALRNCE DETERMINATION:
Substantial equivalence is based on the fact that the Spinnaker has similar technological characteristics and intended use as the predicate devices. The results of performance testing (flow rates, tip flexibility, tensile, static rupture, and coefficient of friction) and Biocompatibility testing support the claim of substantial equivalence to the predicate device. Results of the performance and Biocompatibility testing in conjunction with the substantial equivalence claims as outlined in this premarket notification, effectively demonstrate that the Spinnaker is substantially equivalent to the predicate devices.
1
0003
DEVICE DESCRIPTION
SPINNAKER with HYDROLENE Infusion Catheter (SPINNAKER) is a single lumen device designed to aid the physician in accessing distal vasculature when used with a guiding catheter. Graded shaft stiffness ranging from a highly flexible tip to a semi-rigid proximal section allows ease of advancement by the physician. A luer fitting located on the catheter hub is used for the attachment of accessories. A radiopaque tip and body facilitate fluoroscopic visualization. SPINNAKER is manufactured with HYDROLENE, a hydrophilic surface that reduces friction during manipulation in the vessel. The stylet accompanying the SPINNAKER is used to increase rigidity of the distal section during introduction into the guiding catheter. The steam shaping mandrel packaged with the SPINNAKER is used when the physician desires to shape the catheter's distal end.
INTENDED USE
The Spinnaker is indicated for use in facilitating access through distal, tortuous vasculature, and may be used for the controlled, regional infusion of diagnostic agents, such as contrast media and Target Therapeutics' Berenstein Liquid Coil -10 in the peripheral and neuro vasculature. It is not intended for use in the coronary vasculature.
The Spinnaker Infusion Catheter in Contraindicated for use with any other occlusion oils.
Note: Compatibility testing has been conducted with the Berenstein Liquid Coil -10 only.
| SPINNAKER
Catalog No. | SPINNAKER Catheter Lengths (cm) | | | | Approximate Flow Rates at
100 psi (690 kPa)
(cc/sec) | | | |
|--------------------------|---------------------------------|------------------------|---------------------------|-------------------------|------------------------------------------------------------|-------|--------------------------|--------------------------|
| | Proxi.
Section
(cm) | Mid
Section
(cm) | Distal
Section
(cm) | Total
Length
(cm) | Dead
Space
Volume
(cc) | Water | 60%
Ionic
Contrast | 76%
Ionic
Contrast |
| 191601 | 30 | 20 | 10 | 60 | .17 | .75 | .23 | .11 |
Table 1 SPINNAKER Infusion Catheter
POTENTIAL COMPLICATIONS
191020
Potential complications include, but are not limited to: hematoma at the site of entry, vessel perforation, emboli, hemorthage, ischemia, vasospasm, neurological deficits including stroke and death.