(121 days)
The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillator leads.
The Delivery Catheter is a single-use percutaneous catheter intended to introduce various types of catheters and pacing or defibrillator leads. The Delivery Catheter is packaged with a dilator for introduction into the vasculature. Proximally, the Delivery Catheter is equipped with a hemostatic valve, and the distal soft, rounded, radiopaque tip facilitates imaging under fluoroscopy. The Delivery Catheter is designed to be slittable, thereby allowing its removal after device placement. A variety of curves and lengths are available to accommodate various anatomies and different lead locations. The Delivery Catheter has an inner diameter of 6.5F, an outer diameter of 8F, and the dilator is compatible with a 0.035" guidewire
This document is a 510(k) summary for a medical device called "Delivery Catheter". This type of document is typically used for medical devices that are being cleared for marketing by demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness de novo. Therefore, it focuses on comparing the new device to existing ones and confirming that it performs as intended, rather than establishing new acceptance criteria and conducting studies to meet those.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state quantitative "acceptance criteria" in the format typically seen for a new medical device's performance study. Instead, it describes various tests performed and states that the device "passed" these tests or "meets intended product specifications." The "reported device performance" is a qualitative statement of success in meeting these testing criteria.
| Test / Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 | Passed |
| Bench testing (dimensional evaluation, tensile testing, etc.) | Meet intended product specifications | Confirmed to meet intended product specifications |
| Simulated Use testing | Perform as intended in a simulated environment | Confirmed to perform as intended in a simulated environment |
| In Vivo Testing | Perform as intended in an in vivo model | Confirmed to perform as intended in an in vivo model |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not provide any specific sample sizes for the test sets used in the biocompatibility, bench testing, simulated use testing, or in vivo testing.
The data provenance (country of origin, retrospective/prospective) is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable or not provided. For this type of submission (510(k) for a delivery catheter), the "ground truth" isn't typically established by expert consensus on diagnoses or interpretations of images, but rather by objective physical and biological measurements during performance testing. The document does not mention any experts involved in reviewing test results in a "ground truth" capacity.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable or not provided. Adjudication methods are typically used in clinical studies where interpretation of data (e.g., medical images, patient outcomes) by multiple experts is required to establish a gold standard. The tests mentioned (biocompatibility, bench, simulated use, in vivo) involve objective measurements or observations of the device's physical and biological behavior, not expert interpretation.
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:
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned and is not applicable to this type of device submission. MRMC studies are typically for AI/imaging devices where the performance of human readers, with and without AI assistance, is evaluated using a set of cases. This device is a physical delivery catheter.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
A standalone algorithm performance study is not applicable as this is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the performance tests mentioned (biocompatibility, bench, simulated use, in vivo), the "ground truth" would be established by:
- Biocompatibility: Standardized tests for cytotoxity, sensitization, irritation, material-mediated pyrogenicity, according to ISO 10993-1. The "ground truth" is adherence to the scientific principles and pass/fail criteria of these established international standards.
- Bench testing: Engineering specifications and objective measurements (e.g., dimensional tolerances, tensile strength, material properties). The "ground truth" is whether the measured values fall within the predefined acceptable ranges of the product specifications.
- Simulated Use testing: Observation of the device's functional performance in a simulated environment (e.g., successful navigation, deployment, or removal without failure). The "ground truth" is direct observation of successful operation per design intent.
- In Vivo testing: Observation of the device's functional performance and interaction with biological tissue in an animal model (e.g., successful delivery, absence of adverse tissue reaction beyond expected). The "ground truth" is direct observation of satisfactory performance in a living system.
8. The sample size for the training set:
This information is not applicable and not provided. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable and not provided. This is not an AI/ML device that requires a training set.
§ 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).