(57 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 a sterile single use disposable tubing set. 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. The pump provides an adjustable flow-rate from 0 - 45 ml/min at 45 psi. 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. The tubing set will mate with a standard bottle of sterile water or saline and is provided sterile. A portion of the tubing set is placed in the peristaltic pump for flow creation.
The provided text does not contain detailed information about specific acceptance criteria or a comprehensive study report with quantitative performance data for the SpyGlass Irrigation System.
The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive performance study details as might be found in a full clinical trial report or engineering validation document.
Here's what can be extracted and what is missing based on your template:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use | "To provide irrigation during endoscopic surgical procedures" (Matched to predicate) |
| System Components | Matched to predicate |
| Flow rate adjustments | Matched to predicate |
| Min/max Pressures | Matched to predicate |
| Pump Type | Matched to predicate |
Missing: Specific numerical values for flow rate ranges, pressure ranges, or other quantifiable performance metrics are not detailed in this summary. The acceptance criteria essentially appear to be "substantially equivalent to the predicate device" in these identified characteristics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing. The document only states "Performance Testing: Information presumed to demonstrate that the Spyglass Irrigation would perform as intended." It does not describe any specific test set, sample size, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Missing. No information on expert involvement or ground truth establishment is provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing. No information on adjudication methods is provided.
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 an irrigation system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a hardware irrigation system, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Missing. The concept of "ground truth" as typically applied to AI or diagnostic studies is not directly applicable or discussed for this irrigation hardware device. Performance would likely be evaluated against engineering specifications and predicate device performance.
8. The sample size for the training set
Missing. No training set is mentioned as this is a hardware device, not a machine learning model.
9. How the ground truth for the training set was established
Not Applicable. See point 8.
Summary of the Study (Based on the Provided Text):
The document submitted for the SpyGlass Irrigation System (K063700) is a 510(k) summary. The primary "study" or justification presented is a comparison of technological characteristics to demonstrate substantial equivalence to predicate devices (Endogator Endoscopy Irrigation Pump - K060962, K031773).
The comparison covered:
- Intended Use
- System Components
- Flow rate adjustments
- Minimum/maximum Pressures
- Pump Type
The statement "Performance Testing: Information presumed to demonstrate that the Spyglass Irrigation would perform as intended" indicates that some internal testing was conducted, but the details of this testing (e.g., methodology, results, data, sample sizes, specific acceptance criteria beyond "performs as intended") are not included in this public 510(k) summary. The FDA's letter confirms that based on the information provided, the device was found substantially equivalent to predicate devices.
§ 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.