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510(k) Data Aggregation
(130 days)
The PH Band is a compression device used to assist hemostasis of the radial artery after a transradial procedure.
The PH Band, herein referred to as the "Device," is an compression device consisting of a wrist band (also referred to as the "band"), a syringe, and two finger cots. The Device is used to assist in the hemostasis of the radial artery after a transradial percutaneous procedure.
The Device is similar to the predicate device but differs in that it has been designed to be used in conjunction with an ultrasound doppler system utilizing a flat doppler probe. The PH Band may be used to achieve patent hemostasis when used with the recommended Doppler technology. Located on the Radial Artery Compression Band of the Device is an Access Site Visualization Window used to visualize the hemostasis of the access site. An ultrasound doppler probe is placed immediately distal to the access site and under the Doppler Probe Harnessing band portion of the PH Band. The probe can be viewed and aligned within the access site window. When used with the Doppler probe, the device not only gains hemostasis but allows the physician to confirm patency and confirms antegrade blood flow distal to the access site compression bladder via the ultrasound doppler probe. Use of the doppler system helps guide the physician in applying the appropriate amount of pressure to achieve patent hemostasis and avoid over-compression of the radial artery during wound closure.
This document, K201695, is a 510(k) premarket notification for a medical device called the "PH Band," a compression device used to assist hemostasis of the radial artery after a transradial procedure. The FDA has determined the device is substantially equivalent to a legally marketed predicate device (Medtronic Vascular TRAcelet Compression Device, K162027).
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes several non-clinical bench tests performed on the PH Band. While it lists the types of tests, it does not provide specific numerical acceptance criteria or quantitative performance results for each test. Instead, it states that the device "met all required specifications and performs as intended" and that the "collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the PH Band meet the established specifications necessary for consistent performance during its intended use."
Here's a table summarizing the tests, noting the absence of specific criteria/results in this document:
| Test Name | Acceptance Criteria (as reported in document) | Reported Device Performance (as reported in document) |
|---|---|---|
| Nonclinical Bench Testing | Met all required specifications | Designed to meet established specifications necessary for consistent performance during its intended use. Does not raise new or different questions of safety or effectiveness compared to the predicate device. |
| Visual Inspection | (Not explicitly stated, implied to meet quality standards) | (Implied to have passed, as part of overall nonclinical testing success) |
| Dot Detection Test | (Not explicitly stated, implied to meet quality standards) | (Implied to have passed) |
| Doppler Compatibility | (Not explicitly stated, implied to ensure proper function with Doppler) | Designed for use with an ultrasound Doppler system and flat Doppler probe. Secondary strap incorporated to hold the Doppler probe in place. Functionality is implied to be acceptable. |
| Bladder Leak Test | (Not explicitly stated, implied to ensure bladder integrity) | (Implied to have passed) |
| Pressure Decay Test | (Not explicitly stated, implied to ensure pressure retention) | (Implied to have passed) |
| Velcro Peel/Shear Strength Test | (Not explicitly stated, implied to ensure secure fastening) | (Implied to have passed) |
| Luer Valve/Tubing Tensile Test | (Not explicitly stated, implied to ensure structural integrity) | (Implied to have passed) |
| Sterilization Validation | Sterility Assurance Level of 10⁻⁶ (for Radiation Electron Beam, ISO 11137-1:2006 +A1:2013 and EN ISO 11137-1:2015) | Met the Sterility Assurance Level of 10⁻⁶. Demonstrated that the difference in sterilization method does not raise different questions of safety or effectiveness. |
| Biocompatibility Testing | Performed in accordance with ISO 10993-1. | Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, and Material Mediated Pyrogenicity testing were performed and implied to have passed, demonstrating no different questions of safety or effectiveness. |
| Transit Testing | (Not explicitly stated, implied to ensure device integrity during transport) | (Implied to have passed) |
| Shelf Life Validation | (Not explicitly stated, implied to ensure device integrity over its shelf life) | (Implied to have passed) |
| Bladder Burst Testing | (Not explicitly stated, implied to ensure bladder can withstand anticipated pressures) | (Implied to have passed) |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that clinical data was not required to demonstrate substantial equivalence (Page 8, [807.92(b)(2)] Clinical Testing Summary). Therefore, there is no "test set" in the context of human subjects or clinical data mentioned in this document. The testing described is entirely non-clinical bench testing. The data provenance is internal testing performed by Medical Ingenuities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable, as no clinical test set or human-derived ground truth was established for this submission. The ground truth for bench testing is derived from engineering specifications and industry standards.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring expert adjudication was used.
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:
Not applicable. This device is a physical compression band, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
For the non-clinical bench testing, the ground truth used would be engineering specifications, industry standards (e.g., ISO standards for biocompatibility and sterilization), and design requirements established by the manufacturer. These are derived from established scientific and engineering principles.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical device and 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 no training set was used.
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