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510(k) Data Aggregation
(205 days)
AQUA CLEANSE
THIS DEVICE IS INTENDED FOR COLON CLEANSING WHEN MEDICALLY INDICATED. SUCH AS BEFORE RADIOLOGICAL OR ENDOSCOPIC EXAMINATION.
The proposed device "Aqua Cleanse" is for colon cleansing when medically indicated such as before radiological or endoscopic examination. It introduces water at a comfortable temperature into the large intestine. It fills and empties water into and out of the colon thus cleansing it of its contents. The device is equipped with a pressure regulated safety system; a self-contained cleaning system, and flow regulator. lt is used with the accessory, disposable rectal speculum kits.
The associated disposable kit is intended to introduce water into the colon through a speculum inserted into the rectum to assist with the evacuation of the contents of the lower colon. This is a single-use only kit.
The provided document is a 510(k) premarket notification for the "Aqua Cleanse" colonic irrigation system. As such, it does not contain the acceptance criteria or results from a study proving device performance in the manner typically associated with clinical trials of diagnostic or therapeutic devices.
Instead, this document focuses on demonstrating substantial equivalence to a predicate device (HC-1 Classic, K131852) through non-clinical testing and comparison of technological characteristics.
Therefore, many of the requested sections about clinical study design (sample size, ground truth, expert adjudication, MRMC studies) are not applicable to this submission.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Bench Test Results) |
|---|---|---|
| Pressure Safety | Maintain pressure within safe limits for a colonic irrigation system. | "Proved safety": Accurate pressure range. |
| Temperature Safety | Maintain temperature within a safe and comfortable range for colon cleansing. | "Proved safety": Accurate temperature range. |
| Electrical Safety | Compliance with relevant electrical safety standards. | "Correct operation": Compliant. |
| Leak Resistance | No leaks during operation. | "Correct operation": Leak resistant. |
| Functionality | Introduction, filling, and emptying of water into and out of the colon for cleansing. | "Correct operation": Per intended use. |
| Colon Hydrotherapy Treatment | Perform treatment in accordance with device performance specifications. | "Correct operation": Per specifications. |
Note: The document states that "Bench test results proved safety and effectiveness when testing for accurate pressure and temperature range." The specific numerical acceptance criteria (e.g., pressure range, temperature range) are not explicitly detailed in the summary provided.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The document refers to "bench testing," which typically involves testing a limited number of manufactured units or prototypes to verify engineering specifications, not a clinical "test set" of patients.
- Data Provenance: Not applicable. The data comes from the manufacturer's internal bench testing. No country of origin for clinical data is relevant as no clinical data was used.
- Retrospective/Prospective: Not applicable, as no clinical study was performed.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. Ground truth as typically understood for clinical studies (e.g., disease diagnosis) was not established for this non-clinical bench testing. The "ground truth" here would be adherence to engineering specifications and safety standards.
4. Adjudication Method for the Test Set
- Not applicable, as no clinical test set requiring expert adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No animal or clinical testing was performed on the proposed device."
- Effect Size: Not applicable, as no such study was conducted.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This device is a physical medical device (colonic irrigation system), not an AI algorithm. Its performance is evaluated through bench testing of its mechanical and electrical functions, not algorithmic accuracy.
7. Type of Ground Truth Used
- For the bench testing, the "ground truth" was adherence to established engineering and safety specifications, and proper mechanical/electrical function.
- For the accessory kits, material biocompatibility was assessed against ANSI/AAMI/ISO 10993-5 standards by Nelson Laboratories ("certified to ANSI/AAMI/ISO 10993-5").
8. Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of a physical device like this. The device is not based on a machine learning algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this device.
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