(163 days)
The Water Lily The is indicated for colon cleansing when medically indicated, such as before radiological or endoscopic examination.
The Water Lily 10 is a professional colon hydrotherapy system for use when medically indicated. It introduces filtered water at a comfortable temperature into the large intestine, thus cleansing the colon of its contents. Water temperature is controlled by means of a mixing valve; flow is controlled by one switch operated by the user. The system is manually sanitized prior to each use with a suitable broad spectrum disinfectant (not included). The system includes disposable tubing and a sterile, disposable rectal nozzle intended for single use only (ConMed Corporation K050992).
The provided document describes the K094022 510(k) submission for the Water Lily™ Colon Hydrotherapy System. This device is a colonic irrigation system and its acceptance criteria and the study proving it meets them are detailed primarily through a comparison to a predicate device, the Angel of Water™ Colon Hydrotherapy System (K003720), and non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
This device is cleared based on demonstrating substantial equivalence to a predicate device. The acceptance criteria are implicitly met by showing similar technical characteristics and performance to the predicate. The "reported device performance" below refers to the results of non-clinical testing for specific safety parameters.
| Acceptance Criteria (Inferred from Predicate Equivalence and Safety Tests) | Reported Device Performance (Water Lily™) |
|---|---|
| Intended Use | Colon cleansing when medically indicated, such as before radiological or endoscopic examination. |
| Target Population | Same as predicate |
| Design | Same principles of operation as predicate |
| Performance | Similar to predicate |
| Materials Used | Similar to predicate (e.g., single-use sterile disposable nozzle, ConMed K050992) |
| Where Used | Similar to predicate |
| Patient Control | Yes |
| Temperature Range | 99°-103° F |
| Temperature cannot rise above 103° F (safety mechanism) | Yes. When water temperature reaches 104°F, an audible alarm sounds, and a solenoid valve closes water flow to the client. The therapist then cools the system to 104°F and resets the unit. |
| Water flow controlled by mixing valve | Yes |
| Filtration: Ultraviolet | Yes |
| Filtration: Carbon Filtration | Yes |
| Pressure inside patient's colon will not exceed 2 psi (safety mechanism) | Formula for PSI: 2.5 Ft drop = 1.075 psi. Confirmed by 0-3 psi gage. |
| Electrical Safety - UV filtration system | Approved by UL and CSA |
| Electrical Safety - Controller-thermocouple and solenoid valve | Approved by UL and CSA |
2. Sample size used for the test set and the data provenance
The document does not detail a "test set" in the traditional sense involving human subjects or clinical data for evaluating the device's performance against the acceptance criteria. Instead, the evaluation is based on:
- Non-clinical bench testing: This was used to verify specific safety parameters (pressure, temperature shutdown, electrical safety). There is no "sample size" indicated for these tests, as they are typically performed on a limited number of manufactured units to confirm design specifications.
- Comparison to a predicate device: The Water Lily™ was compared to the Angel of Water™ (K003720) based on shared technical characteristics. This is a design and functional comparison, not a data-driven clinical comparison.
- Data provenance: Not applicable in the context of clinical trials as no clinical trials were performed. The testing described is bench testing.
Therefore, there is no explicit sample size for a "test set" or data provenance information (country of origin, retrospective/prospective) because the submission focuses on substantial equivalence through design and non-clinical engineering verification rather than clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device's clearance is based on substantial equivalence to a predicate device and non-clinical bench testing. There was no "ground truth" derived from expert consensus for a test set as would be found in a clinical study for diagnostic accuracy or efficacy.
4. Adjudication method for the test set
Not applicable. As no clinical "test set" was described requiring expert assessment or ground truth establishment, no adjudication method was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
No. The document does not mention any clinical studies, including MRMC comparative effectiveness studies, demonstrating how human readers (or users in this context) improve with or without AI assistance. This device is a physical medical device, not an AI-driven diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This device is a colon hydrotherapy system and does not involve any algorithms or AI, thus rendering "standalone performance" (in the context of AI) irrelevant.
7. The type of ground truth used
Not applicable in the sense of clinical "ground truth." For the non-clinical tests, the "ground truth" equates to engineering specifications and safety standards (e.g., pressure not exceeding 2 psi, temperature shutdown at 104°F, UL/CSA electrical safety approvals). The primary ground for clearance is substantial equivalence to the legally marketed predicate device.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
§ 876.5220 Colonic irrigation system.
(a)
Identification. A colonic irrigation system is a device intended to instill water into the colon through a nozzle inserted into the rectum to cleanse (evacuate) the contents of the lower colon. The system is designed to allow evacuation of the contents of the colon during the administration of the colonic irrigation. The device consists of a container for fluid connected to the nozzle via tubing and includes a system which enables the pressure, temperature, or flow of water through the nozzle to be controlled. The device may include a console-type toilet and necessary fittings to allow the device to be connected to water and sewer pipes. The device may use electrical power to heat the water. The device does not include the enema kit (§ 876.5210).(b)
Classification. (1) Class II (performance standards) when the device is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.(2) Class III (premarket approval) when the device is intended for other uses, including colon cleansing routinely for general well being.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any colonic irrigation system described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a colonic irrigation system described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other colonic irrigation system shall have an approved PMA in effect before being placed in commercial distribution.