(186 days)
The BladderManager® PC1 5000(+) is intended to project ultrasound energy through r he bladenwanager of the non-pregnant in order to obtain an image of the bladder that is used to determine bladder volume non-invasively. This capability is provided in 2 fundamental modes; 1) hand held probe, aimed by user to obtain reading and 2) Automatically monitor bladder volume via a garment-held probe on non-mobile, supine patient. Patients and/or caregivers are alerted visually and/or audibly when the bladder volume exceeds a pre-programmed threshold.
The BladderManager PCI 5000 is a portable, battery powered ultrasound instrument designed for a patient to non-invasively monitor his or her bladder volume on an intermittent basis.
Here's an analysis of the provided text regarding the BladderManager® Personal Care Instrument PCI 5000:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Primary Goal: Substantial equivalence to predicate device (BladderManager PCI 5000, K955840) for intended use and technological characteristics. This encompasses: | The study data and analyses demonstrated that "the BladderManager PCI 5000 used to measure bladder volume in autoscan mode is substantially equivalent to the BladderManager PCI 5000 used in manual mode." This directly addresses the substantial equivalence for the new autoscan feature to the previously cleared manual mode. |
| 1. Ability to non-invasively monitor bladder volume (manual mode, as per predicate). | The device in manual mode is the predicate, and its performance is established. The study implicitly confirms the new autoscan mode performs equivalently. |
| 2. Ability of new "autoscan mode" to track bladder filling and emptying. | The clinical study was performed "to assess the capability of the BladderManager PCI 5000 to automatically track the bladder filling and emptying in a supine adult." The stated conclusion is that the autoscan mode is substantially equivalent to the manual mode, implying successful tracking. |
| 3. Ability of new "autoscan mode" to alarm at a specific bladder volume. | The study explicitly aimed "to alarm at a specific bladder volume." The conclusion states, "The study also showed that the device can accurately alarm at a preset volume to allow the patient or caregiver time to manage the urological needs of the patient." |
| 4. Safety profile equivalent to predicate device. | The submission states: "All safety testing reported in the previous model BladderManager PCI 5000 510(k) submission is applicable." And "the differences are minor and do not raise new questions of safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 40 subjects.
- Data Provenance: The study was conducted at "two sites." The document does not specify the country of origin of the data, but given the US regulatory context (FDA), it's highly probable the study was conducted in the United States.
- Retrospective or Prospective: This was a prospective clinical study, as it "was performed to assess the capability of the BladderManager PCI 5000 to automatically track the bladder filling and emptying." Subjects were enrolled and data was collected specifically for the purpose of this evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number of experts or their qualifications for establishing ground truth. The "ground truth" for directly comparing bladder volume measurements appears to be derived from the device itself (manual mode readings and voided volume measurement). The post-void residual volume was "manually measured and recorded," implying a clinical measurement rather than an expert consensus on interpreting images.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set in the traditional sense of multiple reviewers resolving discrepancies. The comparison was statistical: "bladder volume measured in autoscan mode was compared to volume measured in the manual mode, and to voided volume." The "post void residual volume was then manually measured and recorded." This suggests direct comparison of objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The study compared different measurement modes of the same device (autoscan vs. manual) and against a physical measurement (voided volume, post-void residual volume). It did not evaluate human readers' improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a way, the evaluation of the "autoscan mode" can be considered a standalone performance assessment of the algorithmic feature. While a human sets the device and observes the alarm, the autoscan function itself is an automated process without continuous human intervention during the measurement cycles. The comparison of autoscan volume to manual mode volume (which is also a device measurement) and voided volume directly assesses the accuracy of the automated function.
7. The Type of Ground Truth Used
The ground truth used was a combination of:
- Reference Device Measurement: Bladder volume measured in "manual mode" of the BladderManager PCI 5000 (which is itself the predicate device and considered reliable).
- Physical Measurement/Outcomes Data: "Voided volume" (measured into a graduated receptacle) and "post void residual volume" (manually measured). These are objective physiological measurements.
8. The Sample Size for the Training Set
The document does not provide any information about a training set size. This device is an ultrasound instrument (hardware) with a minor software update. It's likely that developmental testing and calibration of the algorithms within the device (even for the manual mode) happened internally, but explicit "training set" data, as understood in modern AI/machine learning contexts, is not described in this 1998 submission.
9. How the Ground Truth for the Training Set Was Established
As no training set is described, there is no information on how its ground truth was established.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.