(43 days)
The TR Band™ is a compression device to assist hemostasis of the radial artery after a transradial procedure.
The TR Band is a tourniquet style device consisting of a plastic belt with hook and loop adjustable fastener on each end, two compression balloons, and an injection port. The device also contains a TR Band Inflator and an Air Volume Regulator.
The TR Band is placed around the patient's wrist and the hook and loop strap is connected. Once the introducer sheath is removed from the patient's wrist, pressure is applied to the patient's access site by inflating the compression balloons of the TR Band. Both compression balloons are filled at the same time while air is being introduced through the air injection port.
The balloons are inflated when air is injected into the air injection port by the TR Band Inflator. The TR Band inflator is a specially designed syringe for use only with the TR Band. A valve on the air injection port assures that the air remains within the compression balloons. The volume of air can be reduced or increased by use of the TR Band Inflator or the TR Band Air Volume Regulator. The TR Band Air Volume Regulator is an accessory device. The TR Band Air Volume Regulator is a smaller syringe (5 ml) compared to the TR Band Inflator (20ml syringe). This allows the physician to make fine adjustments to the pressure in the TR Band.
With the two compression balloons (large and small) the pressure is applied for efficient compression for haemostasis. The belt also has a support plate over the two compression balloons to assure that the balloons and belt conform to the contour of the wrist. The belt and compression balloons are made of clear plastic which allows the physician to view the access site during the haemostasis process.
The TR Band is for single use only.
Here's an analysis of the provided text regarding the TR Band™:
Acceptance Criteria and Device Performance Study for TR Band™
The provided 510(k) summary for the TR Band™ does not explicitly state specific quantitative acceptance criteria (e.g., success rates, failure rates, or specific performance metrics) for device functionality or clinical outcomes. Instead, the primary "acceptance criterion" articulated is substantial equivalence to a predicate device. The study described focuses on demonstrating this equivalence through bench testing.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the provided document, the "acceptance criteria" are implied by the regulatory standard of substantial equivalence, and the "reported device performance" is a general statement of equivalence rather than specific numerical results.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device in performance. | "The performance of the TR Band is substantially equivalent to the performance of the predicate device." |
| Biological Safety (Biocompatibility) | Blood contacting materials found to be biocompatible, tested per ISO 10993. |
| Sterility Assurance Level (SAL) | Sterilization validated to provide an SAL of 10-6 per ANSI / AAMI / ISO 11135-1994. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that equivalence was shown through bench testing. It does not specify a "test set" in the context of patient data. Therefore:
- Sample size for the test set: Not applicable, as this was bench testing, not a clinical study on a patient population.
- Data provenance: Not applicable. The testing was conducted in a laboratory/bench setting, not on human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The study was bench testing for substantial equivalence, not a clinical study requiring expert consensus on ground truth.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. The document focuses on device performance equivalence through bench testing, not human reader performance with or without AI assistance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. The TR Band™ is a physical medical device (tourniquet), not an AI algorithm. Therefore, a standalone performance study in the context of AI is irrelevant.
7. Type of Ground Truth Used
For the performance aspect, the "ground truth" was essentially the performance characteristics of the predicate device as measured through comparative bench testing. The device's performance was evaluated against the established performance of the legally marketed predicate device to demonstrate substantial equivalence.
For biological safety, the ground truth was based on the ISO 10993 biocompatibility testing standards.
For sterility, the ground truth was based on ANSI / AAMI / ISO 11135-1994 sterilization validation standards.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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).