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510(k) Data Aggregation
(15 days)
ENDO GATOR SYSTEM
The Endo Gator Irrigation Tubing is intended as sterile, disposable water bottle tubing with cap and back-flow device that supplies sterile water to irrigation pumps and cauterizing units.
The Endo Gator Cartridge is intended as a replacement cartidge for irrigation pumps or cauterizing units for use with the Endo Gator disposable water bottle tubing and cap.
The Auxiliary Water-port tubing for the Olympus Endoscopes is intended as a replacement for the existing water-port tubing make by Olympus for the 160 Series of Endoscopes.
The Byrne Medical Endo Gator System consists of the following assemblies:
- 100125 Endo Gator Irrigation Tubing A sterile, disposable water bottle A tubing with cap and back-flow device which supplies sterile water to irrigation pump or cauterizing units. Works only with the Endo Gator Cartridge.
- 100110 Endo Gator Cartridge Replacement cartridge for imgation pump(s) A or cauterizing units. The cartridge hub is designed to seat the Endo Gator Tubing and replace the existing cartridge from the pump manufacturer.
- 2 100115 Auxiliary Water-port Tubing for Olympus Scopes A sterile, disposable water irrigation tubing that replaces the existing water-port tubing made by Olympus for the 160 Series of scopes.
The Endo Gator System tubing sets are sold as a sterile, single patient use devices. It is packaged in a Chevron-style sterile barrier pouch with product label affixed to the clear side of the package. The Endo Gator Cartridge is reusable and is sold not sterile.
The provided text is a 510(k) summary for the "Endo Gator System" by Byrne Medical, Inc. It describes the device, its intended use, and a comparison to predicate devices, along with some test data. However, the document does NOT contain a formal study that proves the device meets specific acceptance criteria in the way a clinical trial or a performance study for an AI/diagnostic device would.
The "Study" section below is based on the "Test Data" provided, which is limited to bench testing. The document does not describe a clinical study, a multi-reader multi-case study, or a standalone performance study with human subjects or radiologists.
Here's the information extracted and formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated or Inferred) | Reported Device Performance |
|---|---|
| Flow Rate | |
| Minimum pump setting: ≥ 155 ml/min | 155 ml/min |
| Maximum pump setting: ≥ 650 ml/min | 650 ml/min |
| Measurement error: ± 4% | Achieved ± 4% |
| Pressure Tolerance | |
| Withstand pressure up to 10 PSI without leakage or any other failure | Tested to 10 PSI without leaking or any other failure. |
| (Note: Pump manufacturer's stated maximum is 4.4 PSI) | (Device exceeds manufacturer's max pressure) |
| Sterility | Supplied sterile |
| Single Patient Use | Sold as single patient use |
| Appropriate Materials for Application | Made of appropriate materials |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for each test (flow, pressure). The "Endo Gator System" (tubing sets and cartridge) was used in the bench tests, but the number of units tested is not provided.
- Data Provenance: Retrospective bench testing. No country of origin for data is specified, but the manufacturer is based in the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth was established through physical measurements (flow rate, pressure integrity) in a laboratory/bench testing setting, not through expert interpretation of data.
4. Adjudication method for the test set
Not applicable. The tests involved physical device performance measurements, not interpretative assessments requiring adjudication.
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
No. An MRMC comparative effectiveness study was not performed. This device is an accessory (tubing and cartridge) for endoscopes and irrigation pumps, not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Yes, in a sense, bench testing represents a standalone performance evaluation of the physical device components. The tests focused on the device's ability to maintain flow and pressure independently of human interaction beyond setup. However, it's not an "algorithm only" study as no algorithm is mentioned.
7. The type of ground truth used
For the bench tests described:
- Flow Rate: Measured actual water flow over time.
- Pressure Testing: Observation of leakage or failure at specified pressures.
8. The sample size for the training set
Not applicable. This device is a physical medical accessory, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
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