(29 days)
The VASOBand™ is a compression device to assist hemostasis of the radial artery 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 hemostasis at a target vessel's puncture site. Each device is a single-use, sterile, individually pouched inflatable band. The VASOBand™ 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 material is 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.
This document is a 510(k) summary for the VASOBand™ Vascular Compression Device. The purpose of a 510(k) summary is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process generally relies on non-clinical performance data rather than extensive clinical studies with human participants. Therefore, the information provided below will be based on the type of data typically found in a 510(k) submission for a device of this nature.
The device being cleared is the VASOBand™ Vascular Compression Device.
1. A table of acceptance criteria and the reported device performance
The provided document lists performance data that was submitted to support substantial equivalence. It states that "The VASOBand™ Vascular Compression Device met all specified criteria." However, it does not explicitly state the specific acceptance criteria or the quantitative reported device performance for each test. It only lists the types of tests conducted.
Based on the information provided, a table would look like this, with the understanding that the specific numerical acceptance criteria and performance are not detailed in this public summary. They would typically be in the full 510(k) submission.
| Acceptance Criterion (Type of Test) | Reported Device Performance |
|---|---|
| Band clarity | Met specified criteria |
| Check valve actuations | Met specified criteria |
| Bladder inflation/deflation cycles | Met specified criteria |
| Band deployment time | Met specified criteria |
| Bladder inflation/deflation time | Met specified criteria |
| Bladder inflated height | Met specified criteria |
| Bladder integrity (2h compressive force) | Met specified criteria |
| Bladder integrity (underwater air leak) | Met specified criteria |
| Bladder integrity (simulated use testing) | Met specified criteria |
| Tubing/check valve tensile strength | Met specified criteria |
| Fastener tensile strength | Met specified criteria |
| Fastener slippage | Met specified criteria |
| Cytotoxicity Study (ISO Elution Method) | Met specified criteria |
| ISO Guinea Pig Skin Sensitization Study | Met specified criteria |
| ISO Intracutaneous Irritation Study | Met specified criteria |
| USP Rabbit Material-Mediated Pyrogen Study | Met specified criteria |
| ISO Acute Systemic Toxicity Study | Met specified criteria |
| Endotoxin (LAL) Study | Met specified criteria |
| Shelf Life Testing | Met specified criteria |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each test. For devices like this, the sample size for non-clinical performance and biocompatibility testing is typically determined by industry standards (e.g., ISO, ASTM) and statistical rationale to ensure representative results.
The data provenance is described as "performance data provided in support of the substantial equivalence" by the manufacturer, VASOInnovations, Inc. This is non-clinical, in-vitro, and bench testing, as well as biocompatibility studies (which may involve animal testing as indicated for pyrogen and sensitization studies). The country of origin for the data generation is not explicitly stated, but it would have been conducted by or for VASOInnovations, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is generally not applicable to a 510(k) submission for a physical device like a vascular compression band. The "ground truth" for the performance tests listed are objective, measurable physical and chemical properties and biological responses (e.g., tensile strength, air leak, cytotoxicity). These are assessed against pre-defined engineering specifications and relevant ISO/USP standards, not by expert consensus in a clinical setting.
4. Adjudication method for the test set
Not applicable. As described above, the "test set" here refers to the physical device samples undergoing engineering and biological safety tests, not clinical data requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No. An MRMC comparative effectiveness study is typically relevant for diagnostic imaging AI algorithms or similar technologies where human readers interpret medical images or data. The VASOBand™ is a physical medical device (a vascular compression band), and its substantial equivalence is demonstrated through non-clinical performance and safety testing, not human reader studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used
The "ground truth" for the numerous performance data points (e.g., tensile strength, bladder integrity, biocompatibility) are established through objective measurements against predetermined scientific and engineering specifications, and relevant international standards (e.g., ISO, USP). For biocompatibility, this involves specific lab tests following protocols to assess cytotoxicity, irritation, sensitization, pyrogenicity, and systemic toxicity.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this device.
§ 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).