(374 days)
These devices are replacement accessories for the original manufacturer's fetal monitor transducers and are intended to monitor and chart Fetal Heart Rate and maternal uterine activity.
These devices are replacement accessories for the original manufacturer's fetal monitor transducers and are intended to obtain signals to monitor and chart Fetal Heart Rate and maternal uterine activity on a fetal monitor.
Cetro America, Inc. Transducers for Ultrasonic and Tocodynamometer fetal monitoring will be used as replacements for similar transducers manufactured by Corometrics (currently GE), Hewlett Packard Medical (currently Phillips Medical) and Advanced Medical Systems (currently Spacelabs Medical) and their respective fetal monitors. The ultrasound transducer is used to detect Fetal Heart Rate (FHR) using the ultrasound Doppler shift technology. Ultrasound transducers operate in a pulsed Doppler mode with around a 33% Duty Cycle. The Tocodynamometer transducer uses a strain gauge to detect uterine contraction frequency and duration during labor.
The provided text is a 510(k) summary for Cetro America, Inc.'s Transducers for Ultrasonic and Tocodynamometer fetal monitoring. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.
However, the document does not describe a study involving detailed acceptance criteria and reported device performance metrics in the way that would typically be associated with AI/ML device validation. This is a clearance for replacement medical transducers based on substantial equivalence to existing devices, not a study evaluating an AI algorithm's performance.
Therefore, many of the requested categories (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission.
Here's a breakdown of what can be extracted and what is not present:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by demonstrating substantial equivalence to predicate devices and conformity to consensus performance standards. The "reported device performance" is not quantified with specific metrics like sensitivity, specificity, or AUC, but rather by stating that "Bench testing demonstrates that the devices perform as intended."
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use (Ultrasound) | To detect, measure and record fetal heart rate and the duration and frequency of uterine contractions during labor. | "Same" as predicate devices (Corometrics 174 & 145, HP 1356, AMS IM-76 & IM-77). Implicitly, the device successfully detects, measures, and records FHR and uterine contractions as intended. |
| Intended Use (Toco) | To detect, measure and record uterine pressure to determine timing of contractions. | "Same" as predicate devices. Implicitly, the device successfully detects, measures, and records uterine pressure as intended. |
| Target Patient Population | Gravid patients, particularly during labor. | "Same" as predicate devices. |
| Anatomical sites | Ultrasound on abdomen aimed at fetal heartbeat; Toco on abdomen at top of uterus. | "Same" as predicate devices. |
| FHR Range | As per monitor system specifications. | "Same" as predicate devices. Implicitly, it operates within the same FHR range as the monitors it's compatible with. |
| Uterine Activity Range | As per monitor system specifications. | "Same" as predicate devices. Implicitly, it operates within the same uterine activity range as the monitors it's compatible with. |
| Patient Use/Reuse | Reusable. | "Same" as predicate devices. |
| Sterility | Non-sterile. | "Same" as predicate devices. |
| Patient Attachment | Attaches with elastic belts strapped to the patient. | "Same" as predicate devices. |
| Cable Length | Eight feet. | "Same" as predicate devices. |
| Accessories | Transducer belts and Ultrasonic Gel. | "Same" as predicate devices. |
| Connector Design | Color-coded and designed to fit appropriate monitoring system. | "Same" as predicate devices. |
| Acoustic Output (Ultrasound) |
§ 884.2740 Perinatal monitoring system and accessories.
(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).