(64 days)
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No
The device description and performance studies focus on the physical properties and mechanical performance of the catheter, with no mention of AI or ML.
No
The device aids in the delivery of therapeutic agents but is not a therapeutic agent itself.
No
The device is described as assisting in the delivery of diagnostic agents, not performing the diagnosis itself. It is a tool for accessing vasculature, not for analyzing data or making a diagnosis.
No
The device description clearly describes a physical catheter with specific material properties (Hydrolene™ coating, graded shaft stiffness) and physical components (single lumen, tip markers). The performance studies also focus on bench testing of physical characteristics and biocompatibility, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist in the delivery of diagnostic agents such as contrast media and therapeutic agents such as occlusion coils into the peripheral, coronary, and neuro vasculature." This describes a device used in vivo (within the body) for delivering substances or devices.
- Device Description: The description details a physical catheter designed for navigating blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information about a patient's health.
IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose diseases or other conditions. This device is a delivery tool used directly within the patient's circulatory system.
N/A
Intended Use / Indications for Use
TurboTRACKERs are intended to assist in the delivery of diagnostic agents such as contrast media and therapeutic agents such as occlusion coils into the peripheral, coronary, and neuro vasculature.
Product codes
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Device Description
TurboTRACKERs are single lumen devices designed to aid the physician in the access of distal vasculature when used with a guiding catheter and steerable guidewire. Graded shaft stiffness ranging from a highly flexible tip to a semi-rigid proximal section aids the physician in tracking over the selectively placed guidewire. TurboTRACKERs are externally coated with Hydrolene™, a hydrophilic surface that reduces friction during manipulation. TurboTRACKERs are available in one and two tip marker versions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
peripheral, coronary, and neuro vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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
Bench testing (Tensile Test, Tip Flexibility Test, Static Pressure Strength Test, Post Steam Shaping Outer Diameter Hydrophilic Coating Durability Test, Forces Required to Deliver Occlusion Coils Test, Flow Rate Test, Forces Required to Withdraw the Catheter Through a Guiding Catheter Test, Tip Buckling Test, Coefficient of Friction Test .O.D., Minimum Bend Radius Test, and Steam Shaping Shrinkage Test) and biocompatibility testing were performed. The results support the substantial equivalence claims of the TurboTRACKER for its intended use.
Key Metrics
Not Found
Predicate Device(s)
Target Therapeutics' Hydrophilic Tracker Infusion Catheter
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for Target Therapeutics. The logo consists of a black circle with a horizontal line through the middle on the left side, and the word "TARGET" in large, bold, black letters on the right side. Below the word "TARGET" is the word "THERAPEUTICS" in smaller, bold, black letters.
510(K) SUMMARY OF SAFETY AND EFFECTIVENES
MAY - 2 1996
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 Manager, Regulatory Affairs Target Therapeutics, Inc. 47201 Lakeview Blvd. Fremont, CA 94538-6530
DEVICE NAME: TurboTRACKER; Class II
DEVICE DESCRIPTION:
22.23
TurboTRACKERs are single lumen devices designed to aid the physician in the access of distal vasculature when used with a guiding catheter and steerable guidewire. Graded shaft stiffness ranging from a highly flexible tip to a semi-rigid proximal section aids the physician in tracking over the selectively placed guidewire. TurboTRACKERs are externally coated with Hydrolene™, a hydrophilic surface that reduces friction during manipulation. TurboTRACKERs are available in one and two tip marker versions.
INDICATIONS FOR USE:
TurboTRACKERs are intended to assist in the delivery of diagnostic agents such as contrast media and therapeutic agents such as occlusion coils into the peripheral, coronary, and neuro vasculature.
PREDICATE DEVICE:
Target Therapeutics' Hydrophilic Tracker Infusion Catheter
1
TESTING in SUPPORT of SUBSTANTIAL EOUIVALENCE DETERMINATION:
The results of bench testing (Tensile Test, Tip Flexibility Test, Static Pressure Strength Test, Post Steam Shaping Outer Diameter Hydrophilic Coating Durability Test, Forces Required to Deliver Occlusion Coils Test, Flow Rate Test, Forces Required to Withdraw the Catheter Through a Guiding Catheter Test, Tip Buckling Test, Coefficient of Friction Test . O.D., Minimum Bend Radius Test, and Steam Shaping Shrinkage Test) and biocompatibility testing support the substantial equivalence claims of the TurboTRACKER for its intended use in the peripheral, coronary, and neuro vasculature. Results of these tests, in conjunction with the substantial equivalence claims as outlined in the premarket notification, effectively demonstrate the TurboTRACKER's substantial equivalence to the predicate device.
SUBSTANTIAL EQUIVALENCE CONCLUSIONS:
Substantial equivalence is based on the fact that the TurboTRACKER has the same intended use and similar technological characteristics as the predicate device. In instances where the technological characteristics are different, it has been demonstrated that there are no new questions raised regarding safety or efficacy of the TurboTRACKER. Therefore, it can be concluded that the TurboTRACKER is substantially equivalent to the predicate device.