(77 days)
To provide irrigation during endoscopic surgical procedures
Spyglass is an irrigation system for Endoscopy. This system is a peristaltic pump for delivering sterile water or saline through an endoscope (or catheter) for rinsing substances such as blood or bile from the procedural site. It is intended for open and endoscopic procedures. The system is compromised of a pump, foot pedal, and power cord. The connection of the pumping unit to the foot pedal and fluid supply provides the user with a system capable of producing a broad range of pressures. This is based on a variable motor RPM. The motor is controlled by the use of a potentiometer and control dial. An electrically activated foot pedal controls the, running or stopping of the pump motor. The footswitch provide continuous flow when pressed.
Here's an analysis of the provided text regarding the Spyglass Irrigation System's acceptance criteria and study, structured to address your specific points:
The provided 510(k) summary for the Spyglass Irrigation System offers very little detail regarding specific acceptance criteria or a comprehensive study demonstrating direct performance against those criteria. It primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific criteria (e.g., flow rate accuracy, pressure range, sterility, safety features, durability, ease of use with endoscope) | Not explicitly stated. The document broadly mentions "perform as intended" and "demonstrate substantial equivalence." |
| Predicate Device Performance Reference | Implicitly, the device performance is deemed acceptable if it matches or is comparable to the predicate device in terms of: |
- Intended Use
- System Components
- Flow rate adjustments
- Min/max flow rate
- Min/max Pressures
- Pump Type |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not mentioned. The document only states "Bench testing was performed." It doesn't specify if this involved multiple devices, repeated trials, or a representative sample.
- Data Provenance: Not mentioned. Given the nature of a 510(k) submission and "bench testing," it's highly likely to be internal R&D data from the manufacturer (Medical Scientific Corporation) in the USA. It is prospective testing, as it's for premarket notification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable/Not mentioned. The testing described is "bench testing," which typically involves objective measurements by engineers or technicians against specifications, rather than expert judgment for ground truth.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving interpretation of data (e.g., medical images) by multiple experts. The described testing is bench testing, which doesn't involve this type of adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The document focuses on technical bench testing and comparison to a predicate device, not on assessing human reader improvement with or without AI assistance. The device is an irrigation pump, not an AI-assisted diagnostic tool.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Yes, in a sense, a standalone evaluation was performed through "bench testing." This type of testing assesses the device's technical specifications and functionality independent of direct human operational variables beyond standard use. However, it's not an "algorithm only" study as the device is mechanical/electronic, not AI-driven.
7. Type of Ground Truth Used
- Bench Test Specifications/Predicate Device Data: The ground truth for the bench testing would be the pre-defined technical specifications for flow rate, pressure, and operational parameters, often benchmarked against the predicate device's known performance characteristics.
8. Sample Size for the Training Set
- Not applicable/Not mentioned. The Spyglass Irrigation System is a medical device, not an AI/machine learning algorithm, so it doesn't have a "training set" in the conventional sense of data used to train a model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there's no training set for this type of device, no ground truth needed to be established for it.
Summary of Study limitations based on the provided text:
The provided document (a 510(k) summary) is very high-level and intentionally brief. It aims to demonstrate substantial equivalence, not to provide a detailed report of all validation testing. Key information regarding specific performance metrics, the methodology of the "bench testing," sample sizes, and detailed acceptance criteria are omitted for brevity in this public summary. Such details would be present in the full 510(k) submission, which is not publicly available in this format.
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.