(26 days)
The Texan LONGhorn™ Foreign Body Retrieval Device is intended for use as a tool to retrieve and manipulate foreign bodies from distal peripheral vessels of the cardiovascular system.
The Texan LONGhorn™ is comprised of the following:
- A nitinol wire formed into a loop. The wire is secured distally to the catheter body; the proximal wire end is attached to a shaft that functions as a push-rod, and passes through a catheter. The "loop" portion of the wire has a platinum core for enhanced radiopacity.
- An inner member accepting an 0.018" guidewire. The proximal end of the inner carrier extends out the side port of a Y-connector allowing for the physician to manipulate the guidewire thru the device.
- An outer member. The proximal end is connected to a hemostasis Y-connector, having a side port and Tuohy-Borst connector on the central port for securing the hypotube.
- the Tuohy-Borst connector allows the physician to secure the loop size once it is deployed to the desired diameter
- the side port of the Y-connector allows access to the guidewire-dedicated lumen and the T-connector to allow for contrast injection and flushing
The loop is activated by moving the red capped knob and handle axially. The device should be manipulated in such a way that the loop can surround the foreign body. To capture the foreign body, the user shall slowly tighten the loop around the foreign body by retracting the red capped knob proximally while the device is held stationary in position. Once the loop is tightened around the foreign body, the handle and shaft shall be locked by rotating the hemeostasis valve connected to the proximal end of the handle clockwise. Retrieval of the foreign body is performed by slowly withdrawing the Texan LONGhorn™ TX30120060 and the foreign body as a unit into the sheath.
The provided document is a 510(k) summary for the Texan LONGhorn™ Foreign Body Retrieval Device, seeking substantial equivalence to a predicate device. It contains information about the device description, intended use, technological characteristics, and a non-clinical performance test. However, it does not provide the detailed acceptance criteria and study results in the format requested.
Specifically, the document states:
"The Texan LONGhorn™ Foreign Body Retrieval Device has successfully passed all functional and safety testing requirements to ensure substantial equivalence to the predicate device. The testing is described below:
- Tensile to verify design meets minimum tensile strength requirements at all joints, as 프 defined in product specification.
- Animal Study to evaluate the safety and efficacy of a proposed device, and evaluate . operational characteristics of the device with respect to utilization of a predicate device."
This is a high-level summary and lacks the specific details required to populate the requested table and answer many of the questions.
Therefore, many of the requested details cannot be extracted from the provided text.
Here is what can be inferred or stated as unavailable based on the provided text:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Tensile Strength | "meets minimum tensile strength requirements at all joints, as defined in product specification." (Specific values and criteria not provided) |
| Safety and Efficacy (Animal Study) | "evaluate the safety and efficacy of a proposed device, and evaluate operational characteristics of the device with respect to utilization of a predicate device." (Specific metrics and results not provided) |
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not specified. The document mentions an "Animal Study," but the number of animals or specific foreign body retrieval instances is not provided.
- Data provenance: Prospective (as it's an animal study conducted for regulatory submission). Country of origin is not specified, but the submission is to the US FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not specified.
- Qualifications of experts: Not specified. Given it's an animal study for a medical device, it would likely involve veterinary professionals and/or device engineers, but no details are provided.
4. Adjudication method for the test set:
- Not specified.
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, a MRMC comparative effectiveness study was not done. This device is a mechanical foreign body retrieval device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device does not involve an algorithm.
7. The type of ground truth used:
- For the tensile test, the ground truth would be the pre-defined product specifications for tensile strength.
- For the animal study, the ground truth would be the observed safety outcomes (e.g., absence of perforation, embolization, or other adverse events) and successful retrieval/manipulation of foreign bodies in the animal model, observed directly by the investigators.
8. The sample size for the training set:
- Not applicable. This device is a mechanical device, not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable as there is no training set for this type of device.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).