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510(k) Data Aggregation
(97 days)
FLA
The NxStage Express Fluid Warmer and Express Fluid Warmer Disposable Set are accessories to the NxStage System One Cycler used to warm dialysate prior to administration.
The NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm dialysate prior to administration. The Express Fluid Warmer is for use with the NxStage System One only and is not used to warm blood or blood products. The Express Fluid Warmer consists of an electro-mechanical warming unit and a single-use disposable.
The provided text describes a 510(k) submission for a medical device, the NxStage Express Fluid Warmer. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific acceptance criteria and detailed performance reporting in the same way a de novo device might.
Based on the provided document, here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in a quantitative manner with corresponding performance results. Instead, it demonstrates substantial equivalence to a predicate device (NxStage Travel Warmer) through a comparison of technological characteristics and non-clinical performance testing. The "reported device performance" is essentially the determination that it functions similarly to the predicate.
| Parameter | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (as stated) |
|---|---|---|
| Indications for Use | Same as predicate | The NxStage Express Fluid Warmer and Express Fluid Warmer Disposable Set are accessories to the NxStage System One Cycler used to warm dialysate prior to administration. |
| Heating Method | Same as predicate | Same (as predicate: One Aluminum plate heated by electrical resistance) |
| Fluid Temperatures | Same as predicate | Same (as predicate: 31°C – 38°C Adjustable) |
| Temperature Control | Same as predicate | Same (as predicate: Thermistors) |
| Alarm Logic (Upper limit) | Same as predicate (alarms at 41°C) | Same (as predicate: Alarms activate when temperature reaches 41°C) |
| Alarm Logic (Lower Limit) | N/A (same as predicate) | N/A |
| Alarms | Same as predicate (Audible and Visual) | Same (as predicate: Audible and Visual) |
| Secondary Safety Mechanism | Same as predicate | Same (as predicate: Hardware safety circuit cuts the power to the heater if the fluid temperature is ≥ 41°C for more than 5 seconds) |
| Fluid Flow Rates | Same as predicate (0 - 200 ml/min) | Same (as predicate: 0 - 200 ml/min) |
| Control System | Same as predicate (Microcontroller) | Same (as predicate: Microcontroller) |
| Voltage | 110-240 VAC | 100-120/230 VAC Auto ranging (Minor difference, deemed equivalent) |
| Power | Same as predicate (400 VA) | Same (as predicate: 400 VA) |
| Frequency | Same as predicate (50/60 Hz) | Same (as predicate: 50/60 Hz) |
| Mounting Method | Same as predicate (Top Mount with IV pole support) | Same (as predicate: Top Mount with IV pole support) |
| Dimensions | Same as predicate (13"W X 10"L X 1 ½"H) | Same (as predicate: 13"W X 10"L X 1 ½"H) |
| Material | Same as predicate (PVC, ABS) | Same (as predicate: PVC, ABS) |
| Fluid warming Method | Same as predicate | Same (as predicate: 5L Dialysate Bag with connectors to MLA and therapy fluid outlet line) |
| Method of air removal | Same as predicate | Same (as predicate: Air entrapment in bag – release not required due to large bag capacity) |
| Priming Volume | Same as predicate (100 ml) | Same (as predicate: 100 ml) |
| Method of Sterilization | Same as predicate (Gamma SAL 10^-6) | Same (as predicate: Gamma SAL 10^-6) |
| Pyrogenicity | Same as predicate (Non-pyrogenic) | Same (as predicate: Non-pyrogenic) |
| Packaging | Same as predicate (Packaged in polyethylene bags) | Same (as predicate: Packaged in polyethylene bags) |
| Single/Multiple Use | Same as predicate (Single Use only) | Same (as predicate: Single Use only) |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a numerical sample size for "test sets" in the context of clinical data. It states, "Performance, verification and validation testing was conducted to characterize performance of the proposed NxStage Express Fluid Warmer to provide a basis of comparison to the predicate device." These would be bench tests.
- Data Provenance: The testing described is "Non-Clinical Test/Performance Testing - Bench." This indicates that the data is from laboratory (bench) experiments, not human or animal subjects, and is neither retrospective nor prospective in a clinical sense. The location of the manufacturer is given as Lawrence, MA, USA, so presumably, the bench testing was conducted there or at an approved facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable to this submission. The device is a fluid warmer, and the evaluation is based on engineering and performance specifications demonstrable through bench testing, not expert interpretation of diagnostic images or clinical outcomes.
4. Adjudication method for the test set:
- This information is not applicable to this submission, as it relates to expert consensus for ground truth establishment, which is not relevant for this type of device and study.
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:
- This information is not applicable to this submission. The device is a medical accessory (fluid warmer), not an AI-powered diagnostic tool, so MRMC studies are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This information is not applicable to this submission. The device is not an algorithm or AI system.
7. The type of ground truth used:
- The "ground truth" for this device's evaluation is its measured physical performance and functional characteristics (e.g., temperature range, alarm activation, flow rates) as compared to the established specifications of the predicate device. This would be based on engineering specifications and direct measurements from bench testing.
8. The sample size for the training set:
- This information is not applicable to this submission. The device does not employ machine learning or AI that requires a "training set."
9. How the ground truth for the training set was established:
- This information is not applicable to this submission, as there is no training set for this device.
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