(29 days)
The VASOBandTM is a compression device to assist patent hemostasis of the radial artery after a transradial procedure.
The VASOBand™ Vascular Compression Device is an external compression device to promote patent radial artery hemostasis after a transradial procedure. The VASOBand™ Vascular Compression Device is an external compression device used on a human arm and provides a means for a healthcare professional to apply external compression proximal to and/or over a catheterization puncture site for the purpose of assisting post-procedure patent hemostasis at a target vessel's puncture site. Each device is a single-use, sterile, individually pouched inflatable band. The VASOBand™ Vascular Compression Device is available in two different lengths. The strap measures approximately 26 cm or 29 cm in length and is composed of biocompatible multiple-layer PVC film and PVC tubing, and valves made of biocompatible thermoplastics. Hook and loop materials are used to secure the strap in position. Only the biocompatible thermoplastic film comes into contact with broken skin. The user can control the compression applied by the device by introducing or removing air in a bladder of the device.
The provided text describes a 510(k) premarket notification for the VASOBand™ Vascular Compression Device. This submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel performance against specific acceptance criteria in the context of a new AI-based diagnostic or imaging device.
Therefore, the requested information regarding acceptance criteria for device performance, clinical study details for proving the device meets these criteria (like sample size for test sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, training set details), is not directly applicable to this document.
This document describes a device used for physical compression (a vascular clamp), not an AI/software device that generates diagnostic outputs requiring detailed performance metrics such as sensitivity, specificity, or AUC based on a test set and ground truth established by experts.
However, I can extract and structure the information that is present in the document which relates to performance and equivalence:
Acceptance Criteria and Device Performance (in the context of demonstrating substantial equivalence to a predicate device):
The "acceptance criteria" here are implicitly related to demonstrating that changes made from the predicate device do not adversely affect safety or effectiveness, and that the device performs "as well as" the predicate. The performance evaluation is primarily focused on bench testing for material and manufacturing changes, and leveraging publicly available clinical data from an independent study for the indication of patent hemostasis.
1. Table of Acceptance Criteria (as implied by testing) and Reported Device Performance:
| Implied Acceptance Criteria (via Testing Performed) | Reported Device Performance |
|---|---|
| Bench Testing: | Result: |
| Fastener peel force meets specified criteria | Pass |
| Fastener slippage meets specified criteria | Pass |
| Biocompatibility: Cytotoxicity (ISO Elution Method) meets specified criteria | Pass |
| Biocompatibility: Guinea Pig Skin Sensitization (ISO) meets specified criteria | Pass |
| Biocompatibility: Intracutaneous Irritation (ISO) meets specified criteria | Pass |
| Biocompatibility: Material-Mediated Pyrogen (USP Rabbit) meets specified criteria | Pass |
| Biocompatibility: Acute Systemic Toxicity (ISO) meets specified criteria | Pass |
| Clinical Performance: | Result: |
| Ability to assist patent hemostasis of radial artery post-transradial procedure | Met all specified criteria (leveraged from publicly available clinical data) |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set (Clinical Data): The document references a clinical study (NCT04002791) listed on www.clinicaltrials.gov and a publication: "Patel G. Shah S. Patel BA. Patel TM. Randomized Comparison of Isolated Radial Artery ComPrEssioN Versus Radial and Ipsilateral Ulnar Artery Compression in Achieving Radial Artery Patency: The OPEN-Radial Trial, 2020, J Invasive Cardiol 32(9):Epub".
- Sample Size: Not specified in this 510(k) summary document. It states "Clinical performance data is leveraged from publicly available information of a clinical trial conducted by an independent sponsor investigator." To find the sample size, one would need to refer to the referenced NCT04002791 study or the associated publication.
- Data Provenance: The document does not explicitly state the country of origin. It leverages an independent clinical trial, implying it's prospective, but the specific design (retrospective/prospective) and location would be detailed in the referenced clinical trial documentation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable in the context of this device and 510(k) submission. The clinical data referenced is for demonstrating the device's function (assisting hemostasis), not for validating an AI algorithm's diagnostic accuracy against expert-established ground truth. The "ground truth" for a hemostasis device would be the actual state of hemostasis, determined clinically.
4. Adjudication Method for the Test Set:
- Not applicable as this is not an AI diagnostic algorithm requiring expert adjudication of outputs.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This type of study is typically performed for AI-assisted diagnostic tools to show how AI assistance impacts human reader performance. This device is a physical compression device, not an imaging or diagnostic AI tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This isn't an algorithm. The "performance" relates to its physical function as a medical device.
7. The Type of Ground Truth Used:
- For the clinical performance, the ground truth would inherently be clinical outcomes data related to patent hemostasis of the radial artery, as determined by the clinical trial methods. This is not "expert consensus" or "pathology" in the sense of an image-based diagnosis.
8. The Sample Size for the Training Set:
- Not applicable. This device does not involve machine learning or a "training set."
9. How the Ground Truth for the Training Set was Established:
- Not applicable. This device does not involve machine learning or a "training set."
Summary of what the document does provide regarding "proof" and "acceptance":
The core of this 510(k) submission is to demonstrate substantial equivalence to an existing predicate device (VASOBand™ K190318). The "proof" relies on:
- Bench Testing: To show that the material and manufacturing changes (specifically to the hook and loop fasteners and their attachment) do not negatively impact the device's fundamental function. All these tests passed.
- Comparison of Technological Characteristics: Highlighting similarities with the predicate device and asserting that the few differences (fastener materials, welding, slightly modified Indications for Use to include "patent hemostasis") do not raise new questions of safety or effectiveness.
- Leveraging Existing Clinical Data: Rather than conducting a new clinical trial for this specific 510(k) submission, the applicant refers to publicly available clinical trial data (OPEN-Radial Trial, NCT04002791) to support the device's ability to assist patent hemostasis. The document states that the VASOBand™ Vascular Compression Device "met all specified criteria" based on this leveraged data.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).