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510(k) Data Aggregation
(51 days)
UNIVERSAL IRRIGATION SOLUTION HYBRID
The Universal Irrigation Solution Hybrid™ (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water and to supply air (via an air pump) or CO2 (via aCO2 pump) along with sterile water during GI endoscopic procedures when used in conjunction with an irrigation pump or cautery unit.
The Universal Irrigation Solution Hybrid™ (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water and to supply air (via an air pump) or CO2 (via aCO2 pump) along with sterile water during GI endoscopic procedures when used in conjunction with an irrigation pump or cautery unit. It is a disposable, sterile device.
Acceptance Criteria and Study for Byrne Medical, Inc., Universal Irrigation Solution Hybrid™
This document analyzes the provided information regarding the Byrne Medical, Inc., Universal Irrigation Solution Hybrid™ to extract the acceptance criteria and details of the study supporting its substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text describes a comparison to two predicate devices rather than explicit acceptance criteria in the traditional sense (e.g., specific thresholds for accuracy, sensitivity, or specificity). Instead, the performance of the Universal Irrigation Solution Hybrid™ is deemed acceptable if it meets or exceeds the performance of the predicate devices for each function.
| Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (Hybrid™) |
|---|---|---|
| Irrigation | Meets or exceeds the performance of the predicate device (100130 EndoGator® with 100115 Auxiliary Water Jet Connector). | Meets or exceeds the performance of the predicate device for irrigation, providing an effective means of achieving irrigation in GI endoscopic procedures. |
| Insufflation | Insufflation air flow rate comparable to that when using the predicate device (100145 SmartCap). Delivers enough air for insufflation in the time typically used for insufflation. | Insufflation air flow rate is comparable to that of the 100145 SmartCap. The system will deliver enough air for insufflation in the time typically used for insufflation, making it an effective means of achieving insufflation in GI endoscopic procedures. |
| Lens Rinsing | Provides a quicker delivery of a blast of water than the predicate device (100145 SmartCap) and maintains a sufficient flow of water to rinse debris from the lens. | Provides a quicker delivery of a blast of water than the predicate 100145 SmartCap device and maintains a sufficient flow of water to rinse debris from the lens, making it an effective means of achieving lens rinsing in GI endoscopic procedures. |
2. Sample Size for Test Set and Data Provenance
The provided text does not explicitly state the sample size used for the comparative testing. It refers to "comparative testing" and "data results generated" but does not quantify the number of tests, devices, or procedures involved.
The data provenance is also not specified. The document does not indicate the country of origin of the data or whether the study was retrospective or prospective. It appears to be an internal performance evaluation for the 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth
The provided text does not mention the use of experts to establish ground truth for the test set. The study focuses on direct performance comparisons against predicate devices rather than expert interpretation of results.
4. Adjudication Method
The provided text does not describe an adjudication method. Since the study appears to be a direct performance comparison, there is no indication of expert review or consensus building for results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The provided information details a technical comparison of device performance against predicates, not a study involving human readers' performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance
The device described is a medical instrument (tubing and accessories for irrigation/insufflation during endoscopy), not an algorithm or AI system. Therefore, a standalone (algorithm only) performance study is not applicable and was not conducted. The study assesses the physical performance of the device itself.
7. Type of Ground Truth Used
The "ground truth" for this type of device comparison is based on the objective performance characteristics of the predicate devices. The new device's performance (e.g., flow rate, delivery speed) is measured and compared directly to the established performance of the legally marketed predicate devices. This represents a form of empirical performance data from the predicate devices.
8. Sample Size for Training Set
This question is not applicable as the device is not an AI/ML algorithm that requires a training set. The study concerns the physical performance of a medical device.
9. How Ground Truth for Training Set was Established
This question is not applicable as the device is not an AI/ML algorithm that requires a training set.
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