(604 days)
The Bio Fluff System is intended for colon cleansing to remove fecal residues when medically indicated, such as before radiological or endoscopic examination.
The Bio Fluff System is intended to instill water through a disposable speculum into the colon. Intestinal Cleansing is carried out by inserting water in the patient's rectum at controlled temperature and pressure through the disposable specula. This action allows the cleaning of the lower tract of the colon. The Bio Fluff System comprises:
- different models of the Bio Fluff device:
- HT model, for professional use,
- HTP model, portable version of HT model,
- associated components:
- disposable HT specula for both Bio Fluff model HT and Bio Fluff model HTP.
The provided document is a 510(k) summary for the Bio Fluff System, a colonic irrigation system. Unlike submissions for AI/ML-based medical devices, which typically describe acceptance criteria based on metrics like sensitivity, specificity, or accuracy derived from clinical performance studies, this document focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and biocompatibility.
Therefore, this document does not contain the specific information requested regarding acceptance criteria related to AI/ML device performance, such as:
- A table of acceptance criteria and reported device performance based on AI/ML metrics.
- Sample sizes used for test sets in the context of AI/ML performance evaluation.
- Number of experts and their qualifications for ground truth establishment for AI/ML data.
- Adjudication methods for AI/ML test sets.
- Multi-reader multi-case (MRMC) comparative effectiveness studies for AI assistance.
- Standalone (algorithm-only) performance evaluations relevant to AI/ML.
- Specific types of ground truth (e.g., pathology, outcomes data) for AI/ML algorithm training or testing.
- Sample sizes for training sets of AI/ML algorithms.
- Methods for establishing ground truth for training sets of AI/ML algorithms.
Instead, the document focuses on:
- Biocompatibility Testing:
- Acceptance Criteria (Implied): Compliance with ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization), and ISO 10993-10 (Irritation).
- Reported Performance: "The devices do not arise any issues of biocompatibility for their intended use." This indicates the tests were passed.
- Bench Tests:
- Acceptance Criteria (Implied): Correct operation for Pressure Safety, Flow Control, Temperature Safety, and Leak Resistance.
- Reported Performance: "Functional testing showed correct operation of the Bio Fluff System as per its intended use." This indicates the tests were passed.
The core of the submission is a comparison to a predicate device (Aqua Cleanse, K150381) to establish substantial equivalence based on:
- Indications for Use: Substantially equivalent.
- Classification, Product Code, Intended User, Insertion Point, Antibacterial Filters, Flow Regulator, Temperature Gauge, Timer, Outgoing Waste Material Observation, Circuit Cleaning System, Biocompatibility: All deemed substantially equivalent or same.
- Temperature Safety, Flow Control, Pressure Control: Deemed substantially equivalent despite minor technical differences.
- Electrical Components and Performance Test (Electrical Safety): Not present in the subject device, which the submission argues does not affect safety or effectiveness, thus still leading to substantial equivalence.
In summary, this document describes the acceptance criteria and study findings for a traditional medical device (colonic irrigation system) based on non-clinical testing and comparison to a predicate device, not an AI/ML-based medical device. Therefore, it cannot provide the detailed information requested about AI/ML device validation.
§ 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.