(15 days)
The BladderScan® BVI 9400 is intended to project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the bladder and uses that image to calculate the bladder volume and bladder wall mass noninvasively.
Contraindications:
- The BladderScan® BV19400 is contraindicated for fetal use and for use on pregnant patients.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Other (Bladder) Mode of Operation: N
Clinical Application: Abdominal Mode of Operation: P
The Verathon Inc. BladderScan® BVI 9400 Ultrasound System is a portable, battery powered, software controlled ultrasound system used to acquire and display real time B-mode images of the bladder. The system is intended to non invasively monitor bladder volume on an intermittent basis. The system is an effective, low cost, simple to use option for use in a clinical hospital or nursing home setting or for home use under medical supervision.
The Verathon Inc. BladderScan® BVI 9400 Ultrasound System and its integrated 3.0 MHz mechanical sector transducer operate only in B-mode to locate and automatically measure bladder volume. The same transducer is driven at 1.74 MHz to obtain a second harmonic for enhanced bladder wall detection. Bladder volume, patient gender, non optimal directional aiming, battery status, and usage rate indicators are all displayed on the Verathon Inc. BladderScan® BVI 9400 Ultrasound System scanner. The ultrasonic power transmitted the system is not user adjustable. The portable Verathon Inc. BladderScan® BVI 9400 Ultrasound System is applied to the patient's abdomen with a single patient use Sontac® hydrogel pad, manufactured by Verathon Inc. BladderScan® BVI 9400 Ultrasound System. The transducer collects cross-sectional images of the bladder from twelve (12) scan planes. From this information, the Verathon Inc. BladderScan® BVI 9400 Ultrasound System constructs a finite element model of the bladder and automatically computes the volume of urine via volumetric integration.
Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:
Device: Verathon Inc. BladderScan® BVI 9400 Ultrasound System
Intended Use (from the provided text, specifically page 6 and 7):
- To project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the bladder.
- To calculate the bladder volume and bladder wall mass noninvasively.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary focuses primarily on equivalence to a predicate device and safety, rather than explicit numerical acceptance criteria for accuracy against a gold standard in a clinical setting. However, the mention of "accuracy has been demonstrated by comparing CIRS measurements to the measurements of the Verathon Inc. BladderScan® BVI 9400 Ultrasound System" suggests that the implied acceptance criterion is that the device's measurements are consistent with known measurements from a standardized phantom.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Accuracy of Bladder Volume Measurement: Device's bladder volume measurements should be comparable to known volumes (from NIST traceable measurements or standard ultrasound systems). | "Accuracy has been demonstrated by comparing CIRS measurements to the measurements of the Verathon Inc. BladderScan® BVI 9400 Ultrasound System." |
| "These results obtained through the Verathon Inc. BladderScan® BVI 9400 Ultrasound System are compared to the expected results derived from the NIST traceable measurements." | |
| "In addition to these measurements, additional measurements are taken by standard ultrasound systems, such as the Sonosite 180, to compare bladder mass measurements." (While a specific numerical comparison or percentage accuracy is not given, the claim is that accuracy has been demonstrated against these standards.) | |
| Safety: Acoustic measurements should be within pre-amendment limits. | "all acoustic measurements remain within Preamendment limits." |
| Substantial Equivalence: Device is substantially equivalent to predicate device. | "All clinical and non clinical testing of the Verathon Inc. BladderScan® BVI 9400 Ultrasound System indicate that the Verathon Inc. BladderScan® BVI 9400 Ultrasound System is substantially equivalent to the Verathon Inc. BladderScan® BVI 6100 Ultrasound System..." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of phantoms. The text refers to "tissue equivalent phantoms with known dimensions" and "each phantom comes with a certification sheet listing the measurements." It implies the use of one or more BladderScan Phantoms created by CIRS.
- Data Provenance: The 'data' for the test set is derived from phantom measurements. These phantoms were built by Computerized Imaging Reference Systems (CIRS), a vendor known for supplying medical imaging phantoms. The measurements provided by CIRS are NIST traceable. This is a prospective study design as the phantoms were specifically built for testing this device. There is no mention of human subject data for this specific accuracy assessment, rather a phantom study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The ground truth for the test set was established by the NIST traceable measurements provided by CIRS when constructing the phantoms.
- Qualifications of Experts: Not applicable. The ground truth relies on physical measurements and established phantom production standards, not human expert consensus.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "ground truth" (known phantom dimensions/volumes) is inherent in the phantom's construction via NIST traceable measurements. The comparison is between the device's output and these known values, not between human interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, an MRMC study was not done. The study described is a phantom study specifically comparing the device's measurements to known phantom volumes. There is no mention of human readers or AI assistance in this context.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
- Standalone Study: Yes, effectively. The device is designed to automatically compute bladder volume via volumetric integration from collected cross-sectional images. The assessment described (comparing the device's calculation to known phantom volumes) is a standalone performance evaluation of the device's algorithmic capability without human intervention in the measurement process itself.
- The statement "The Verathon Inc. BladderScan® BVI 9400 Ultrasound System constructs a finite element model of the bladder and automatically computes the volume of urine via volumetric integration" supports that this is a standalone measurement.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth used is physical measurements from manufactured phantoms with NIST traceability. The phantoms are designed to mimic bladder and tissue, and their internal volumes and dimensions are known and certified.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not explicitly stated in the provided text. The document describes a performance study for the device, not the development or training of an AI model within the device. The device uses "finite element model" and "volumetric integration," suggesting a rule-based or algorithmic approach rather than a machine learning model that would require a distinct "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable. As mentioned, the document does not describe the development or training of a machine learning model, but rather the performance evaluation of a device using an algorithmic approach. Therefore, there is no "training set" or corresponding ground truth establishment process described for such a set.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.