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510(k) Data Aggregation
(250 days)
The Water Bottle Cap irrigation system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump
The EndoChoice water bottle cap irrigation system is designed to supply sterile water when used in conjunction with an irrigation pump.
This submission describes the EndoChoice Water bottle cap irrigation system, a device designed to supply sterile water during GI endoscopic procedures when used with an irrigation pump. The submission focuses on demonstrating substantial equivalence to a predicate device, the Byrne Medical, Inc. EndoGator System (K092429).
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list numerical acceptance criteria. Instead, it frames the performance in terms of "equivalent performance" to the predicate device.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Water flow rate | Demonstrated equivalent performance compared to the predicate device. |
| Device leakage | Demonstrated equivalent performance compared to the predicate device. |
| Durability (up to 24 hours use) | Tested to ensure effective function. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the test set. It mentions "Performance Data: using a simulated setup" but doesn't quantify the number of devices or trials.
- Data Provenance: The testing was conducted by EndoChoice, Inc. and is retrospective, based on simulated setups to compare directly with the predicate device. The country of origin for the data is implicitly the USA, where EndoChoice, Inc. is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
No experts were used to establish ground truth in the traditional sense. The performance evaluation was based on engineering tests (water flow rate, leakage, durability) rather than clinical readings or expert consensus on medical images.
4. Adjudication Method for the Test Set
No adjudication method was used, as the performance evaluation was based on objective engineering measurements against the predicate device, not subjective interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is an irrigation system accessory, not an AI diagnostic tool requiring human reader performance analysis.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the performance evaluation described (water flow rate, leakage, durability testing) can be considered a standalone assessment of the device's physical and functional characteristics. It does not involve human interaction or interpretation in its primary performance assessment.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is essentially the performance of the legally marketed predicate device (Byrne Medical, Inc. EndoGator System), against which the new device demonstrated equivalence in specific engineering parameters (water flow rate, leakage). Additionally, durability was assessed against a 24-hour use timeframe.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical accessory and does not involve AI or machine learning algorithms that require a "training set" in the computational sense. The "training" in this context would be the design and manufacturing processes guided by engineering principles.
9. How the Ground Truth for the Training Set was Established
Not applicable, for the same reasons as point 8.
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