(89 days)
The FeatherLite Aqua™Toco dynamometer is intended for use in conjunction with telemetry systems for standard fetal monitors for the evaluation of external uterine activity during antepartum and intrapartum periods. Is should only be used in a clinical setting. It may be fully submerged in water for water birthing or monitoring in a whirlpool. Caution: FeatherLite Aqua™Toco is not intended for home monitoring of pre-term labor.
Placement over the fundal area of the uterus to the left or right of the midline is suitable for most patients, It is held on the surface of the abdomen using a standard button hole or Velcro™ type belt.
The product is supplied non-sterile and is intended for single use only.
The FeatherLite Aqua™ tocodynamometer (toco) is intended for use in conjunction with telemetry systems for standard fetal monitors for the evaluation of external uterine activity during antepartum and intrapartum periods in a clinical setting. The fetal monitor is not intended for home monitoring or pre-term labor. It can be used in both dry and fully submerged environments It is held in place on the surface of the abdomen using an elastic belt. It is sold non-sterile and is intended for single use only.
The provided text is a 510(k) summary for the FeatherLite Aqua™ Tocodynamometer. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and performance metrics for a novel device. Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of statistical performance metrics, sample sizes, expert qualifications, and ground truth establishment is not available in this document.
However, I can extract information related to the device's intended use and its comparison to predicate devices, which implicitly serves as the "acceptance criteria" for 510(k) clearance – demonstrating substantial equivalence in safety and effectiveness.
Here's a breakdown of the available information and areas where data is not provided:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission, the "acceptance criteria" are implicitly defined by establishing substantial equivalence to the predicate devices. The performance is assessed by comparing characteristics and functionalities. Specific quantitative performance data from a dedicated study demonstrating superiority or meeting predefined statistical thresholds is not presented.
| Implicit "Acceptance Criteria" (based on substantial equivalence to predicate devices) | Reported Device Performance (FeatherLite Aqua™ Toco) |
|---|---|
| Intended Use: For evaluation of external uterine activity during antepartum and intrapartum periods in a clinical setting. | Intended for use in conjunction with telemetry systems for standard fetal monitors for the evaluation of external uterine activity during antepartum and intrapartum periods. Clinical setting only. |
| Environment: Operates in both dry and fully submerged environments (compared to Corometrics 2264). | Can be used in both dry and fully submerged environments. |
| Sensing Principle: Same principle of sensing the change in muscle tone of the uterus. | Uses a flexible nipple and silicone gel to transmit changes in uterine wall muscle tone to a resistive type strain gauge pressure sensor. |
| Material: Housing molded from rigid thermoplastics. | Housing materials are the same (molded from rigid thermoplastics). |
| Attachment: Same attachment methods for abdominal placement. | Held on the surface of the abdomen using an elastic belt. |
| Servicing: Cannot be serviced. | Cannot be serviced. |
| Connectivity: Requires an adaptor to connect to the fetal monitor. | Uses an adaptor to connect the universal connector of the cable to the specific fetal monitor. |
| Filter: Minimizes unwanted noise. | Adapter includes a digital filter to minimize unwanted noise. |
| Gain: Allows for effective monitoring of obese patients (implied function of a toco, enhanced by switch). | Adapter has a switch to allow the user to increase the toco gain for more effective monitoring of obese patients. |
| Usage: Single-use only. | Intended for single use only. |
| Telemetry compatibility: Used with telemetry units when submersible. | Shall ONLY be used with telemetry units. |
2. Sample Size Used for the Test Set and Data Provenance
- Not provided. This document does not detail a clinical study with a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The evidence for substantial equivalence is based on engineering comparisons and design changes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable/Not provided. No specific "ground truth" establishment by experts for a test set is mentioned in the context of this 510(k) summary. The comparison is made against the established performance of predicate devices.
4. Adjudication Method for the Test Set
- Not applicable/Not provided. No clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is not mentioned as part of this 510(k) submission. The device is a physical medical device (tocodynamometer), not an AI/software-based interpretive system that would typically undergo such a study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Implied Ground Truth: The "ground truth" for the FeatherLite Aqua™ Tocodynamometer's substantial equivalence is the performance and safety characteristics of the predicate devices (FeatherLite™ Tocodynamometer under K013477 and Corometrics 2264 under K982651), as recognized by the FDA. The new device demonstrates similar performance characteristics and design for its intended use, with enhancements that do not raise new questions of safety or effectiveness.
8. The Sample Size for the Training Set
- Not applicable/Not provided. As this is a physical medical device comparison, not an AI model, there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable/Not provided. As there is no training set for an AI model, this information is not relevant to this submission.
§ 884.2720 External uterine contraction monitor and accessories.
(a)
Identification. An external uterine contraction monitor (i.e., the tokodynamometer) is a device used to monitor the progress of labor. It measures the duration, frequency, and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen. This generic type of device may include an external pressure transducer, support straps, and other patient and equipment supports.(b)
Classification. Class II (performance standards).