(87 days)
THE MEDCOMP Vascu-Sheath® INTRODUCER SETS ARE INDICATED FOR USE IN ORTAINING CENTRAL VENOUS ACCESS TO FACILITATE CATHETER INSERTION OR PLACING PACING LEADS INTO THE CENTRAL VENOUS SYSTEM.
The Medcomp Vascu-Sheath® Introducer Set is a single use device used to obtain vascular access and facilitate catheter insertion. The Medcomp Vascu-Sheath® Introducer Set consists of an introducer sheath and vessel dilator.
The provided text describes a 510(k) premarket notification for the "Medcomp Vascu-Sheath® Introducer Set." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics in the typical sense of a clinical trial for a novel device.
Here's an analysis based on the information provided:
Acceptance Criteria and Device Performance for Medcomp Vascu-Sheath® Introducer Set
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly from Substantial Equivalence Claim) | Reported Device Performance |
|---|---|---|
| Safety | Equivalent to predicate device (K993191 TFX Medical Introducer Assembly) in terms of unintended effects and risks. | Demonstrated in-vitro performance, including peel force, showing substantial equivalence to the legally marketed predicate device. |
| Effectiveness | Equivalent to predicate device (K993191 TFX Medical Introducer Assembly) in achieving intended use: obtaining vascular access and facilitating catheter insertion for central venous access or placing leads. | Demonstrated in-vitro performance, including peel force, showing substantial equivalence to the legally marketed predicate device. |
| Design | Equivalent to predicate device. | Stated as "substantially equivalent ... in terms of design." |
| Material Type | Equivalent to predicate device. | Stated as "substantially equivalent ... in terms of ... material type." |
| Sterilization Method | Equivalent to predicate device. | Stated as "substantially equivalent ... in terms of ... method of sterilization." |
Explanation: In a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating "substantial equivalence" to a predicate device. This means the new device performs at least as safely and effectively as the predicate for its intended use. The performance data presented (in-vitro peel force) is used to support this claim of equivalence. Specific numerical thresholds for acceptance are not detailed in this summary, but rather the performance being "substantially equivalent" to the predicate is the overarching criterion.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "In Vitro performance data," but does not specify the number of units tested.
- Data Provenance: The study was "in-vitro," meaning it was conducted in a lab environment (e.g., bench testing) rather than on human or animal subjects. The country of origin for this data is not specified. It is an in-vitro study, not retrospective or prospective in a clinical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. This study relied on in-vitro testing comparing the device to a predicate, not expert assessment of patient data.
4. Adjudication Method for the Test Set
- Not applicable. There was no human "test set" requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No. An MRMC study was not conducted as this was an in-vitro substantial equivalence assessment, not a clinical effectiveness study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- While this wasn't an "algorithm," the "standalone" concept could loosely apply to the in-vitro testing. The device's physical properties (like peel force) were tested in isolation, directly compared to the predicate device's known performance characteristics, without human judgment involved in interpreting results beyond standard laboratory procedures.
7. The type of ground truth used
- The "ground truth" for this substantial equivalence submission was the established safety and effectiveness profile of the predicate device (K993191 TFX Medical Introducer Assembly), as demonstrated through its legally marketed status. The in-vitro test results for the new device were compared to the performance characteristics expected or known of the predicate device to show equivalence.
8. The sample size for the training set
- Not applicable. This was an in-vitro comparison study, not a machine learning study requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. There was no training set.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).