(251 days)
The Gambro WRO 300 Water Purification Unit is intended to be used as a dialysis accessory to produce water through reverse osmosis for one hemodialysis equipment.
The WRO 300 can be connected to hemodialysis equipment used both in hospitals and in home environments, in conjunction with appropriate pre and post treatment units, as a part of a water treatment system designed to meet current AAMI and Federal (U.S.) standards.
The Gambro WRO 300 H Water Purification Unit is intended to be used as a dialysis accessory to produce water through reverse osmosis for one hemodialysis equipment.
The WRO 300 H can be connected to hemodialysis equipment used both in hospitals and in home environments, in conjunction with appropriate pre and post treatment units, as a part of a water treatment system designed to meet current AAMI and Federal (U.S.) standards.
The Gambro WRO 300 and WRO 300 H Water Purification Units are dialysis accessories that produce water through reverse osmosis for one hemodialysis equipment.
They are both designed to maintain the low microbiological level in their flow path by the use of regular disinfection as a regular maintenance. Both WRO 300 and WRO 300 H Water Purification Units are designed with chemical disinfection capability. The WRO 300 H Water Purification Unit is also designed with heat disinfection capability.
WRO 300 or WRO 300 H Water Purification Unit is intended for use in conjunction with one dialysis machine, provided that the input flow and pressure demands correspond to the output of the WRO 300 or WRO 300 H Water Purification Unit.
WRO 300 and WRO 300 H Water Purification Units utilize the Reverse Osmosis Principle. A high pressure pump forces the water through the RO membrane. The product water is further distributed to the dialysis machine.
Reverse osmosis (RO) is a membrane process that is the most widely used technique for purification of water for dialysis. When the feed water is in contact with the semipermeable membrane (the most vital part of the system) and a high pressure is applied, water will flow through the membrane to the product water side. Most of the other constituents (dissolved salts, particles, bacteria and pyrogens) will remain on the feed water side of the membrane and be flushed to drain as reject water. The membrane material used for the WRO 300 and WRO 300 H Water Purification Units are Polyamide Thin-Film Composite.
An acceptable quality of the feed water is required. The feed water is usually pretreated with such as active carbon filters, softener, and particle filters before it is supplied to the WRO 300 or WRO 300 H Water Purification Unit. Depending on the local water quality and regulations different pretreament equipment may be required.
Gambro WRO 300 and WRO 300 H Water Purification units contain the same software package (version P4.2) which is intended for controlling water production and disinfection / clanning of the flow path of the WRO.
The software also supports Heat Disinfection in the WRO 300 H Water Purification Unit.
The provided text describes the WRO 300 and WRO 300 H Water Purification Units by Gambro Renal Products, Inc. and their substantial equivalence to a predicate device for use in hemodialysis.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria are derived from the performance specifications compared to the predicate device and relevant standards. The reported device performance indicates that both the WRO 300 and WRO 300 H meet these criteria.
| Acceptance Criteria | Reported Device Performance (WRO 300 & WRO 300 H) |
|---|---|
| Feed Water Supply: | |
| Input | Min. 3.0 l/min required |
| Pressure | 0.15 to 0.8 MPa during operation |
| Temperature | +5 to +30°C |
| Hardness | recommendation 96% |
| Rejection rates: Bacteria and endotoxin | >99% |
| Drain requirements: | |
| Operation | 1.2 ±0.1 l/min |
| Peak flow (rinse) | 3.0 l/min |
| Reverse osmosis membrane: | |
| Material | Polyamide, thin film composite |
| Configuration | Spiral wound |
| pH-tolerance | 2-11 |
| Disinfection and cleaning: | |
| Chemical disinfection | Chemical disinfection supported |
| Heat disinfection (WRO 300 H only) | Heat disinfection supported, no effect on safety or membrane performance |
| Ambient Temperature | +10 to +40 °C |
| Electrical safety | Compliant with IEC 60601-1 |
| Electromagnetic compatibility | Compliant with IEC 60601-1-2 |
| Biocompatibility | Compliant with ISO 10993-5, ANSI/AAMI RD62, ISO/FDIS 13959, European Pharmacopoeia 5th ed. |
| Software validation | Software version P4.2 validated |
| Membrane life expectancy | Meets requirements |
| User interface/control system | Meets requirements |
| Physical ergonomics | Meets requirements |
| Maintenance and reliability | Meets requirements |
| Heat disinfection procedure (WRO 300 H) | Coolest spot in flow path at least 80°C, with 5 log reduction for all positions |
| Microbial retention by RO membrane | Evaluated and meets requirements |
Study Information:
The provided text describes a non-clinical performance data assessment to establish substantial equivalence with a predicate device (Gambro WRO 300 Water Purification System, K042797). It explicitly states that clinical performance data is "Not applicable for this submission." This indicates that no human trials or studies were conducted for this submission.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify sample sizes for the non-clinical tests. It refers to "testing results of the R.O. Membrane," implying a physical testing of the device and its components.
- Data provenance: The testing was performed internally by the manufacturer (Gambro Renal Products, Inc.) and by "external independent personnel." The country of origin for the testing data is not explicitly stated, but the submitter's address is in Lakewood, Colorado, USA. The nature of the testing (verification and validation of software, and functional/performance/safety requirements) suggests prospective testing conducted specifically for this submission, rather than retrospective data analysis from previous use.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document states that the assessment was performed by "internal and external independent personnel with the appropriate skills." It does not specify the number of experts or their specific qualifications (e.g., years of experience, specific certifications).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not describe an adjudication method as it pertains to expert reviews of interpretations for a test set. The nature of the evaluation involves technical testing against established standards and specifications, not subjective interpretation requiring adjudication.
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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:
- No MRMC comparative effectiveness study was done. This device is a water purification unit, not an imaging or diagnostic AI device that would involve human readers or AI assistance in interpretation. The submission explicitly states "Assessment of clinical performance data: Not applicable for this submission."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable in the context of a water purification unit. The device itself performs the function (water purification) autonomously once set up. The "software package (version P4.2)" controls water production and disinfection/cleaning. The software's performance was verified and validated, which could be considered a form of standalone testing of the algorithm's functional correctness for its intended purpose. However, it's not "algorithm only" in the sense of a diagnostic AI without human input to the diagnostic process.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is established by technical specifications, functional requirements, and compliance with international standards. For example, for water quality, the ground truth is defined by specific rejection rates (e.g., >96% for total dissolved salts, >99% for bacteria and endotoxin) and physical parameters (e.g., output flow, pressure, temperature). For safety, the ground truth is compliance with electrical safety and EMC standards. For the heat disinfection on the WRO 300 H, the ground truth includes a minimum temperature of 80°C and a 5 log reduction for all positions.
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The sample size for the training set:
- This document describes a non-clinical assessment for a physical device, not an AI/ML model for which a "training set" in the traditional sense would apply. Therefore, no training set sample size is mentioned or relevant.
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How the ground truth for the training set was established:
- As there is no training set mentioned, this question is not applicable. The ground truth for the device's performance is established through adherence to engineering specifications, performance tests, and compliance with recognized industry standards.
§ 876.5665 Water purification system for hemodialysis.
(a)
Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.(b)
Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.