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The hygh-tec drainage II is a fecal management system that is intended for continuous, trans-anal drainage and collection of liquid or semi-liquid stools and to provide access for the administrations. The device is not intended for use on pediatric patients.

The hygh-tec drainage II is a fecal drainage system that is comprised of a stool collection bag, and an inflating syringe. The device is used by healthcare professional heatthcare environment for continuous trans-anal drainage and collection of stools. The stool drainage tool is the patient while a liquid is infused within a specialized port to irigate the rectum. The organic matter then progresses through the drainage tube where it is eventually stored in the collection bag for evaluation or disposal. Along with stool drainage, the hygh-tec drainage II system can be used for the administration that would be prescribed by physicians.

This is a device for fecal management and thus does not include performance studies that would require the information requested for AI/ML devices. As such, most of the fields are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance
Not applicable, as this device does not contain algorithm/AI.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable, as this device does not contain algorithm/AI.

4. Adjudication Method for the Test Set
Not applicable, as this device does not contain algorithm/AI.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable, as this device does not contain algorithm/AI.

6. Standalone (Algorithm Only) Performance Study
Not applicable, as this device does not contain algorithm/AI.

7. Type of Ground Truth Used
Not applicable, as this device does not contain algorithm/AI.

8. Sample Size for the Training Set
Not applicable, as this device does not contain algorithm/AI.

9. How the Ground Truth for the Training Set Was Established
Not applicable, as this device does not contain algorithm/AI.

Summary of Study that Proves the Device Meets Acceptance Criteria:

The device, hygh-tec drainage II, underwent non-clinical testing to demonstrate substantial equivalence to its predicate device. The following tests were performed and all passed:

• ISO 10993-5:2009: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity.
• ISO 10993-10:2021: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.
• ISO 10993-23:2021: Biological evaluation of medical devices – Part 23: Tests for irritation.
• Tensile Strength Testing: This test assessed the material strength of the device.

These tests indicate that the device is biocompatible and structurally sound for its intended use. The 510(k) summary explicitly states that "all tests passed," leading to the conclusion that the device is substantially equivalent and meets the necessary performance and safety requirements. The primary difference between the subject device and the predicate is the material of the drainage tube, changing from PVC to a three-layer extruded tube made of TPU-EVOH-TPU, which was presumably evaluated through these tests.

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