(121 days)
This device is intended to measure/ display collected urine volume. It detects fill level and temperature.
iBag™ is a urine management system that includes bladder and temperature measurement for catheterized patients who desire to be fully mobile. · iBag™ provides accurate, real-time assistive data. It does this through use of a calibrated drainage bag integrated with a Future Path Medical sensor, a base transmitter unit called Wi-Mitter™ for wireless transmission of urine bag fill and bladder temperature information. Once the Wi-Mitter™ is snapped in place, the container is polled and the measurement of fluid level begins and this data is then transmitted to the patient, the care provider (an aid) a family member, or even to the hospital's base station. Data is transmitted via traditional data networking and may be interpreted and displayed on a user's laptop computer, and other types monitors. Since the data from the Wi-Mitter™ is time and date stamped, time of fill level may be automatically calculated, noted and threshold values used for fill level alarming.
Here's an analysis of the provided text to extract information about the acceptance criteria and the study conducted for the iBag™ Urine Management System:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Volume Accuracy | Not explicitly stated as a separate acceptance criteria, but for predicate device "Not stated" | ±5% of the actual fill for 70 – 100% fill level readings. |
| Temperature Accuracy | ± 0.2 °F (for predicate device) | ± 0.2 °F |
| Temperature Range | 50°F to 110°F (10°C to 43.3°C) (for predicate device) | 50 to 110 °F in increments of 0.1 °F |
| Electrical Safety | Electrical Safety per IEC-60601 (for predicate device) | SAME (Implies compliance with IEC 60601-1) |
| Electromagnetic Comp. | N/A (not explicitly stated for predicate) | IEC 60601-1-2 |
| FCC Compliance | N/A (not explicitly stated for predicate) | FCC Compliance Testing |
| RF Dosimetric Asses. | N/A (not explicitly stated for predicate) | RF Dosimetric Assessment Testing |
| Transmitter Range | N/A | Transmitter effective range testing was done |
| User Feedback | N/A | User Feedback Study was done |
| Battery Life | N/A | Battery life computations were done |
| Simulated Use | N/A | Simulated Use Testing was done |
| Leak Testing | N/A | Leak Testing was done |
| Sterility Testing | N/A | Sterility Testing was done |
Note: The predicate device's specifications for volume accuracy and temperature range are used as a proxy for acceptance criteria where the iBag™ device states "SAME" or explicitly meets/exceeds them. For other tests, the text indicates that the testing was "successfully conducted" or that the device meets the respective standard.
2. Sample Size and Data Provenance for the Test Set
- Sample Size for Test Set: The document does not specify the sample sizes for the "Fill level accuracy" or "Temperature measurement accuracy" tests, nor for the "User Feedback Study" or "Simulated Use Testing."
- Data Provenance: The document does not provide details on the country of origin of the data or whether the studies were retrospective or prospective. It only states that "Bench and test laboratory results indicate that the new device is as safe and effective as the predicate device" and lists the tests conducted.
3. Number and Qualifications of Experts for Ground Truth
The document does not provide any information about the number or qualifications of experts used to establish ground truth for any of the tests.
4. Adjudication Method for the Test Set
The document does not specify any adjudication methods for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being done, or any effect size related to human readers improving with or without AI assistance. This device is not an AI-based system.
6. Standalone Performance (Algorithm Only)
The document primarily focuses on the device's mechanical and electronic performance, not on an algorithm's standalone performance. It states that "iBag™ provides accurate, real-time assistive data" and "Software is designed to be used with little or no training," but does not detail an algorithm's standalone performance separate from the hardware.
7. Type of Ground Truth Used
Based on the provided information, the ground truth for volume and temperature accuracy would likely be established through:
- Reference measurements: Using highly accurate, calibrated instruments to measure actual urine volume and temperature.
- Bench testing: Controlled laboratory conditions for precise measurements.
For other tests like electrical safety, EMC, leak testing, and sterility, the ground truth would be defined by the relevant industry standards (e.g., IEC 60601-1, IEC 60601-1-2) and their specific test protocols.
8. Sample Size for the Training Set
No information is provided about a "training set" as this device is not an AI/ML-based system requiring a training phase in the typical sense. The testing described is for performance validation, not algorithm training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for an AI/ML algorithm.
§ 876.5250 Urine collector and accessories.
(a)
Identification. A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:(1) A urine collector and accessories intended to be connected to an indwelling catheter, which includes the urinary drainage collection kit and the closed urine drainage system and drainage bag; and
(2) A urine collector and accessories not intended to be connected to an indwelling catheter, which includes the corrugated rubber sheath, pediatric urine collector, leg bag for external use, urosheath type incontinence device, and the paste-on device for incontinence.
(b)
Classification —(1)Class II (special controls) for a urine collector and accessories intended to be connected to an indwelling catheter. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2)
Class I (general controls). For a urine collector and accessories not intended to be connected to an indwelling catheter, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.