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510(k) Data Aggregation
(100 days)
REDSENSE-ALARM UNIT AND SENSOR
The Redsense device is intended to monitor for potential blood loss from the hemodialysis access site in hemodialysis patients undergoing continuous hemodialysis treatment up to 8 hours in the clinical settings. The device includes a blood sensor incorporated into an adhesive sensor patch. The sensor monitors potential blood leakage from the venous needle puncture site via an infrared light and will alarm if blood leakage is detected via absorption onto the device's sensor patch.
Redsense is a system for monitoring the vein needle during hemodialysis. Redsense consists of an alarm unit and optical sensor incorporated into an adhesive patch. The patch with the sensor is placed over the vein needle and detects any blood that drips onto the patch if the needle has been accidentally pulled out or if there is leakage during dialysis. If blood loss is detected, the device will alarm.
The provided text describes a 510(k) premarket notification for the Redsense Alarm Unit for Clinical Use, Model RA-1-RA001C. The submission's purpose is to expand the intended use of the device for up to 8 hours of clinical use, compared to the previously cleared 5 hours.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria (e.g., specific sensitivity, specificity, or false alarm rates) or numerical performance metrics for the device. Instead, the "Summary of Testing" broadly states that "Test results met the requirements of the standards used for testing."
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Device fulfills requirement specifications for up to 8 hours clinical use. | "Verification testing has been performed to verify that the Redsense device fulfills the Requirement Specifications and can be used for up to 8 hours in a clinical setting." |
| Audible and visual alarm capabilities meet requirements. | "Additional tests of the audible and visual capability of the alarm have been performed. Test results met the requirements of the standards used for testing." |
| Device is safe and effective for its intended use (up to 8 hours clinical use, potential blood loss detection). | "Verification testing showed the Redsense device to be safe and effective for its intended use." (This is a conclusion drawn from the testing, not a direct performance metric). The FDA's substantial equivalence determination implies that current performance is at least equivalent to the predicate device for this expanded use. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply refers to "Verification testing."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not provide any information regarding the number of experts, their qualifications, or how ground truth was established for the test set.
4. Adjudication Method for the Test Set:
No information is provided about any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, the document does not mention an MRMC comparative effectiveness study, nor does it discuss the effect size of human readers improving with AI vs. without AI assistance. The Redsense device is described as a standalone alarm system, not an AI-assisted diagnostic tool for humans.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the device described is a standalone alarm unit. The description of its function ("will alarm if blood leakage is detected via absorption onto the device's sensor patch") indicates it operates independently to detect blood loss and trigger an alarm without requiring human interpretation of its internal detection mechanism. The verification testing would have assessed this standalone performance.
7. The Type of Ground Truth Used:
The document does not explicitly state the type of ground truth used for the verification testing. Given the nature of the device (detecting blood leakage), it's highly probable that the ground truth would involve simulated or actual blood leakage events under controlled conditions, with the "true positive" of blood presence verified through direct observation or precise measurement. It is unlikely to be pathology, expert consensus in the diagnostic sense, or outcomes data for this type of device function.
8. The Sample Size for the Training Set:
The document does not refer to a "training set" or "training data." This is consistent with the device being a hardware-based sensor and alarm system, rather than a machine learning or AI algorithm that typically requires a training phase. The "verification testing" described is for demonstrating the device's functional performance against specifications.
9. How the Ground Truth for the Training Set Was Established:
As no training set is mentioned, there is no information on how its ground truth would have been established.
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