(271 days)
VASCU-SHEATH II® II INTRODUCERS ARE INTENDED TO OBTAIN CENTRAL VENTRAL VENOUS CHIPEL CATHETER INSERTION INTO THE CENTRAL VENOUS SYSTEM.
The Medcomp Vascu-Sheath® II is a two-part single use device used to obtain vascular access and facilitate intravascular catheter insertion. The Medcomp Vascu-Sheath® II consists of a peel-able introducer sheath and vessel dilator. The dilator is comprised of a cylindrical tube with a hub; the sheath is also a cvlindrical tube with a hub. The dilator extends beyond the sheath to provide a zero tolerance clearance between sheath and dilator. The device is available in three dilator lengths, 5cm, 10cm and 13.5cm and a range of French sizes from 5F thru 7F for the 5 and 10cm lengths and 5F thru 18F for the 10cm length. The sheath and dilator when used in conjunction with an introducer needle and guidewire provide a means to obtain a percutaneous opening to the vascular system to facilitate the insertion of a catheter. After removing the dilator a catheter can then be placed through the sheath. Breaking the sheaths hub and peeling the sheath away from the catheter then allows the sheath to be removed. The dilator is composed of a High Density Polyethylene with Barium Sulfate in the dilator for visibility under fluoroscopy by the attending physician during insertion. The sheath is composed of PTFE to provide a smooth, consistent peel.
The provided 510(k) summary for the Medcomp Vascu-Sheath® II describes an introducer set, not an AI/ML medical device. Therefore, many of the requested elements for describing studies proving a device meets acceptance criteria, particularly those related to algorithms, AI performance, ground truth, and human reader studies, are not applicable.
However, I can extract the relevant information regarding acceptance criteria and the type of study conducted for this specific device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by equivalence claim) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (K993191, K022513) in: | In Vitro performance data for the Medcomp Vascu-Sheath® II, including peel force, demonstrates that this device is substantially equivalent to the legally marketed device. |
| - Intended Use | - Intended Use: "to obtain central venous access to facilitate catheter insertion into the central venous system." (Matches predicate) |
| - Design | - Design: Two-part, single-use device (peel-able introducer sheath and vessel dilator) with specific materials (HDPE with Barium Sulfate for dilator, PTFE for sheath). Available in 5F-18F sizes and 5cm, 10cm, 13.5cm lengths. |
| - Material Type | - Material Type: Polyethylene, Barium Sulfate, PTFE (Components listed match those typically used in such devices, implicitly equivalent to predicate). |
| - Performance (e.g., peel force, ease of insertion, patency) | - Performance: "In Vitro performance data... including peel force, demonstrates that this device is substantially equivalent." |
| - Method of Sterilization | - Method of Sterilization: Implicitly equivalent to predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The submission states "In Vitro performance data," which implies testing of units, but the number of units tested is not provided.
- Data Provenance: The data is "In Vitro," meaning it was conducted in a lab setting, not on human subjects. No information on country of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not Applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires expert ground truth for classification or diagnosis. Performance was evaluated against engineering specifications and comparison to predicate device characteristics.
4. Adjudication Method for the Test Set
- Not Applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This is not an AI/ML diagnostic device, so MRMC studies are not relevant. Clinical studies were explicitly "not deemed necessary."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm. Benchtop "In Vitro performance data" was conducted for the physical device.
7. The Type of Ground Truth Used
- Engineering Specifications and Predicate Equivalence: The "ground truth" (or basis for acceptance) was the ability of the device to meet specified performance criteria (e.g., peel force) and to demonstrate substantial equivalence in design, materials, and intended use as compared to the legally marketed predicate devices.
8. The Sample Size for the Training Set
- Not Applicable. This device uses traditional materials and manufacturing, not AI/ML, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not Applicable. See point 8.
§ 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).