(64 days)
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.
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.
This 510(k) summary does not contain the information required to complete the requested table and answer many of the questions. This document describes a medical device (TurboTRACKER) and its substantial equivalence to a predicate device, focusing on bench and biocompatibility testing rather than a clinical study evaluating diagnostic or therapeutic accuracy against specific acceptance criteria.
Here's what can be inferred and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified for clinical performance. The document mainly focuses on engineering and biocompatibility criteria. | 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. This implies the device met internal specifications for these performance attributes, but the specific numerical criteria and results are not provided. |
2. Sample size used for the test set and the data provenance:
- Not Applicable / Not provided. The "testing" referred to is bench testing and biocompatibility testing, not a clinical study on a human "test set" in the context of diagnostic or therapeutic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not provided. This information is relevant for studies validating diagnostic or therapeutic accuracy with expert ground truth, which is not described here.
4. Adjudication method for the test set:
- Not Applicable / Not provided.
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:
- No, this was not done. This document pertains to a medical device (catheter) and its physical/biological properties, not an AI or imaging-based diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this was not done. This is not relevant to the type of device described.
7. The type of ground truth used:
- Not Applicable / Not provided. For the bench testing, the "ground truth" would be the engineering specifications and established test methods used to evaluate the device's physical properties. For biocompatibility, it would be established toxicological and biological safety standards.
8. The sample size for the training set:
- Not Applicable / Not provided. This document describes a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established:
- Not Applicable / Not provided.
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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
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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.
§ 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).