(28 days)
INVU by Nuvo™ is a maternal-fetal mon-invasively measures and displays fetal heart rate (FHR), maternal heart rate (MHR) and Uterine Activity (UA).
The INVU Sensor Band™ acquires the fetal heart electrocardiogram and maternal heart electrocardiogram signals from abdominal surface electrodes and the fetal phonocardiogram and the maternal phonocardiogram signals from surface acoustic sensors. The FHR, MHR and UA tracings are derived from these signals and presented.
INVU by Nuvo™ is indicated for use by pregnant women who are in their 32nd week of gestation (or later), with a singleton pregnancy.
The INVU by Nuvo™ maternal-fetal monitor is intended for use by healthcare professionals in health care facilities and by the patient in the patient's home, on the order of a physician.
The INVU by Nuvo™ is indicated for antepartum fetal surveillance (i.e. non-stress testing).
This system does not prevent the onset of preterm labor nor will it prevent the occurrence of preterm birth.
INVU by Nuvo™ is a non-invasive medical device that acquires and displays vital signs of the pregnant woman and her fetus. It measures and processes signals picked up on the abdominal surface using highly sensitive sensors, special electronic circuitry, and processing software. Two types of sensors pick up the signals: ECG-like sensors that pick-up bio-potential signals, and acoustic sensors. The bio-potential (ECG-like) sensors pick up the fECG (of the fetus), the mECG signals (of the pregnant woman) and the acoustic sensors measure the sounds from the pregnant woman's abdomen (PCG -phonocardiogram and fPCG - fetal PCG). The FHR, MHR, and UA tracings are derived from these signals and presented.
INVU by Nuvo™ is an integrated platform that uses a signal acquisition tool to provide input related to fetal heart rate (FHR), maternal heart rate (MHR), to two separate software applications, one for the patient (INVU App) and one for the physician (INVU-Pro application), which also provides uterine activity (UA) tracings. Sensors are incorporated in a belt that is worn on the abdomen of the pregnant woman, where it acquires both biopotential and acoustic signals. The signals are processed at a cloudserver level. The sensors are attached to the pregnant woman's abdomen by a belt (INVU by Nuvo™ sensory band). An integrated electronic module receives, processes and transmits the measured data to algorithmic modules at cloud servers, where the inputs from the sensors are processed, merged, and sent to the INVU by Nuvo™ (patient) application to display the average FHR and average MHR after a 30 minute (minimum) monitoring session and to the INVU by Nuvo™ Pro (physician) application to display the complete FHR, MHR, and uterine activity data from a monitoring session. A monitoring session can only be scheduled by a health care provider.
The purpose of this special 510(k) is to implement several minor improvements to straps, buckles and LED used in the device. There have also been several minor changes to the software.
The provided text describes a Special 510(k) submission (K221046) for the INVU by Nuvo™ maternal-fetal monitor, which is an updated version of a previously cleared device (K210025). The focus of this submission is on minor improvements to straps, buckles, LED, and software, rather than significant changes to the core functionality or algorithms. As such, the performance data presented is primarily focused on demonstrating that these minor changes do not negatively impact safety and effectiveness and that the device remains substantially equivalent to its predicate.
Therefore, the acceptance criteria and study details provided in the document are not structured in a way that directly addresses the comprehensive set of questions about device performance in terms of accuracy or efficacy against a ground truth, as would be expected for a de novo device or a submission with significant algorithmic changes.
Here's a breakdown of the information available based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative "acceptance criteria" for clinical performance (e.g., FHR accuracy, UA detection sensitivity/specificity) or report specific device performance metrics against such criteria in the way you might expect from a comprehensive clinical validation study. Instead, the performance data focuses on demonstrating that the modifications to the device (straps, buckles, LED, software) do not compromise the safety and effectiveness relative to the predicate device.
The study listed in the document for performance evaluation include:
| Acceptance Criteria (Implied) | Reported Device Performance (Demonstrated by Testing) |
|---|---|
| Biocompatibility: Device components in contact with the patient are biocompatible. | Passed: Biocompatibility testing (cytotoxicity, irritation, sensitization) per ISO 10993-1. |
| Software: Software changes maintain safety and effectiveness and comply with regulations. | Passed: Software documentation and validation per 2017 guidance document "Deciding When to Submit a 510(k) for a Software Change to an Existing Device". |
| Mechanical Performance: Straps and buckles have adequate mechanical integrity. | Passed: Functional testing (mechanical functionality and tensile strength testing) of straps and buckles. |
| Electrical Performance (Snapping Feature): Continued electrical performance of the sensor snapping feature. | Passed: Electrical resistance testing to demonstrate continued electrical performance of the snapping feature. |
| Electrical Performance (LED): Continued electrical performance of the LED light. | Passed: Electrical testing (bio-potential frequency response and charge mode testing) to demonstrate continued electrical performance of the LED light. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not mention specific sample sizes for test sets related to human subjects or patient data. The performance data described are related to engineering and software validation tests for the modifications, not a clinical trial on a large patient cohort. Therefore, details like country of origin or retrospective/prospective nature of data for clinical performance are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The listed tests (biocompatibility, software validation, mechanical, electrical) do not typically involve experts establishing clinical ground truth for diagnostic accuracy in the way a clinical study would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. The performance data pertains to technical verification and validation of device changes, not the adjudication of clinical outcomes or interpretations by multiple experts.
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
There is no indication that an MRMC comparative effectiveness study was conducted or that the device involves "AI assistance" in a way that would alter human reader performance. The device is described as measuring and displaying FHR, MHR, and UA, with signals processed at a cloud server level, but the submission focuses on hardware and minor software changes rather than new AI algorithms for interpretation or augmentation of human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the device as a "maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), maternal heart rate (MHR) and Uterine Activity (UA)." While signals are processed at a "cloud server level," the submission's focus on hardware and minor software changes to an existing device means that a standalone algorithm performance study, distinct from overall device function, is not described or required for this particular 510(k). The device presents tracings that healthcare professionals use for "antepartum fetal surveillance (i.e. non-stress testing)."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given that the listed performance data relates to engineering and software validation of device modifications, rather than clinical efficacy studies, there is no mention of clinical ground truth (like expert consensus, pathology, or outcomes data) in the context of device performance reporting for this submission. The "ground truth" for the tests performed would be established by standard engineering and testing protocols related to biocompatibility, mechanical properties, and electrical performance.
8. The sample size for the training set
This information is not provided. The document doesn’t mention a training set, as the evaluation focuses on verifying hardware and minor software modifications to an already cleared device, rather than the development or re-training of a new diagnostic algorithm.
9. How the ground truth for the training set was established
This information is not provided, as there is no mention of a training set or its associated ground truth in the context of this 510(k) submission.
§ 884.2730 Home uterine activity monitor.
(a)
Identification. A home uterine activity monitor (HUAM) is an electronic system for at home antepartum measurement of uterine contractions. The HUAM system comprises a tocotransducer and an at-home recorder. This device is intended for use in women with a previous preterm delivery to aid in the detection of preterm labor.(b)
Classification. Class II (special controls); guidance document (Class II Special Controls Guidance for Home Uterine Activity Monitors).