(263 days)
The indication for use of this device must be restricted to colon cleansing when medically indicated, such as before radiological or endoscopic examination.
This device is not a kit. This device is an instrument for hydrotherapy of the colon. It introduces filtered water at a confortable temperature into the large intestine. It is an automatic system for filling and emptying water into and out of the colon and thus cleansing the colon of its contents when medically indicated such as before radiological or endoscopic examination. It is hygienic, painless and odorless. The instrument has an automatic pressure safety system; automatic disinfection; a system for collection of samples for analysis; remote and frontal panel control; a counter for the number of liters of water used; a three-way faucet; flow regulator; thermostatic mixer and an automatic temperature safety feature. It contains disposable components for use only once in the therapy
The provided document is a 510(k) Premarket Notification summary for the TRANSCOM Colon Hydrotherapy Model HC-2000. It focuses on demonstrating substantial equivalence to already marketed predicate devices rather than providing detailed acceptance criteria and a study proving performance against those criteria in the context of a new, quantifiable performance claim.
Here's a breakdown based on the request:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not define specific "acceptance criteria" in terms of measurable performance thresholds. Instead, it relies on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. The table provided (pages 2-3) compares various parameters of the TRANSCOM device with three predicate devices.
Table: Comparative Technological Characteristics (as a proxy for acceptance and performance based on equivalence)
| Parameter | TRANSCOM (Reported Performance) | Predicate Devices (Baseline/Acceptable Performance) |
|---|---|---|
| Water Source | Household/Commercial | Household/Commercial (Specialty Health, Clearwater, Dotolo Research) |
| Water Flow (Pressure) | Yes | Yes (All Predicates) |
| Water Flow Control Valve | Yes | Yes (All Predicates) |
| Drainage System (Gravity) | Yes | Yes (All Predicates) |
| Closed System Water | Yes | Yes (All Predicates) |
| Drainage | Yes | Yes (All Predicates) |
| Mixing Valve (Grohemix) | Yes | Yes (All Predicates) |
| Powers Hydroguard | N/A (Difference noted in text: Transcom uses a syringe, predicates use gravity flow or pump. This implies a different mechanism but must be functionally equivalent for therapy.) | Yes (Specialty Health, Clearwater, Dotolo Research) |
| Fittings (Brass/Stainless) | Yes | Yes (All Predicates) |
| Cabinet Composition (Stainless Steel/Sheet Metal) | N/A (Implied: Stainless Steel, as other options are N/A for Transcom) | Stainless Steel / Sheet Metal (Varies by predicate; for example, Specialty Health has both, Transcom only Stainless Steel appears to be listed) |
| Sink & Faucet | N/A (Difference noted in text: Clearwater needs a sink/faucet, Transcom is plumbed) | N/A (Specialty Health, Dotolo Research). Yes for Clearwater as part of Major Separate System Components. |
| Cabinet Design | Wall-Mount | Wall-Mount (Specialty Health, Dotolo Research), Portable (on-wheels) (Clearwater) |
| Weight | 132.3 lbs. | Approx 40 lbs. (Specialty Health, Dotolo Research), 70 lbs. (Clearwater) |
| Physical Dimensions | 1020 x 720 x 270 CM | 20" w x 7" d x 20" h (Specialty Health, Dotolo Research), 19" w x 16" d x 41" h (Clearwater) |
| Sanitation System | None (as listed under "Sanitation System" property, but listed as "Sanitation System" component below) | None (All Predicates - under "Sanitation System" property). Yes (All Predicates - under "Major Separate System Components"). This appears to be an inconsistency in the table for "Sanitation System" property. |
| Pumps | (Implied: Not applicable as it uses a syringe) | (Clearwater uses a pump. Others gravity flow.) |
| Mode of Operation | Continuous Water Flow, Gravity Flow Drainage, Manual Operation | Continuous Water Flow, Gravity Flow Drainage, Manual Operation (All Predicates) |
| Major Separate System Components | Mixing Valve, Pressure Regulator, Water Manifold System, Relief Valve System, Monitoring System (Temp. Pressure), Viewing Assembly, Sanitation System, Lighting Assembly, Drainage Assembly, None (last "None" likely for Sink & Faucet difference) | Mixing Valve, Pressure Regulator, Water Manifold System, Relief Valve System, Monitoring System (Temp. Pressure), Viewing Assembly, Sanitation System, Lighting Assembly, Drainage Assembly, None (Specialty Health, Dotolo Research). For Clearwater: includes Sink & Faucet. |
| Intended Usage | Colonic Irrigator | Colonic Irrigator (All Predicates) |
| Monitoring Systems (Water Temperature/Pressure) | Yes | Yes (All Predicates) |
| View Tube Assembly (Fluid Discharge Path) | Yes | Yes (All Predicates) |
| Fluid Pathway | Disinfected, and disposable except the view tube assembly which must be cleaned & sterilized prior to each procedure | Disinfected, and disposable except the view tube assembly which must be cleaned & sterilized prior to each procedure (All Predicates) |
| Specimen Collection | Yes | Yes (Specialty Health, Dotolo Research), No (Clearwater) |
| Regulators (Water Pressure) | Norgren, Yes | Norgren, Yes (All Predicates) |
| Relief Valve (Water Pressure) | Norgren, Yes | Norgren, Yes (All Predicates) |
| Over Pressure Relief System | Yes | Yes (All Predicates) |
| Systems Check Valves | Yes | Yes (All Predicates) |
| Sanitation System (overall) | Yes | Yes (All Predicates) |
| Syringe/Pump | Yes (Syringe) | Gravity Flow System (Specialty Health, Dotolo Research), Yes (Pump for Clearwater) |
| Gauges (Water Temperature/Pressure) | Yes | Yes (All Predicates) |
| Electrical Requirements | 110/120 VAC 50/60 Hz service, power outlet to be grounded and polarized and GFI, Yes | 110/120 VAC 50/60 Hz service, power outlet to be grounded and polarized and GFI, Yes (All Predicates) |
| View Tube Assembly Rack Lighting | Yes | Yes (All Predicates) |
2. Sample size used for the test set and the data provenance
The document explicitly states:
- "Substantial equivalence is not based on an assessment of non-clinical performance data." (page 5, Section 7)
- "Substantial equivalence is not based on an assessment of clinical performance data." (page 5, Section 8)
Therefore, no test set was used as no particular performance study was conducted to prove the device met acceptance criteria beyond demonstrating similar technological characteristics and intended use to predicate devices already on the market. There is no information on data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no test set or clinical/non-clinical performance data was used in the assessment for substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no test set or performance evaluation requiring ground truth adjudication was conducted.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device (colonic irrigation system), not an AI-assisted diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no specific performance evaluation requiring ground truth was conducted. The ground for equivalence is the functional and technological similarity to legally marketed predicate devices.
8. The sample size for the training set
Not applicable, as this is a medical device for hydrotherapy, not a machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable, as this is a medical device for hydrotherapy, not a machine learning algorithm.
§ 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.