Identifiers
- 510(k) Number
- K253021 FDA 510(k)
- FDA Product Code
- HGM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.2740 FDA 510(k)
- Regulation Number
- 884.2740 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ANNE Maternal is a System, Monitoring, Perinatal, designed for continuous maternal-fetal monitoring during pregnancy and labor. It provides real-time physiological data to assess fetal well-being, maternal vital signs, and uterine activity, supporting clinical decision-making in obstetric care. The device integrates wireless sensors to deliver comprehensive monitoring without physical constraints on the patient.
Supplied as a non-sterile, reusable system, the ANNE Maternal is intended for use in obstetric settings and is classified under FDA 510(k) clearance (K253021). It operates within Class II regulatory standards (884.2740) and is MRI-safe for specified imaging environments. The system requires proper calibration, storage in a clean, dry environment, and adherence to manufacturer guidelines to ensure accurate performance and patient safety.
Frequently asked questions
What is the ANNE Maternal used for?
The ANNE Maternal is designed for continuous monitoring of maternal and fetal physiology during pregnancy and labor. It provides real-time data on fetal well-being, maternal vital signs, and uterine activity, enabling clinicians to make informed decisions in obstetric care. The wireless sensors eliminate physical constraints on the patient, ensuring comfort and ease of use.
Is the ANNE Maternal sterile or reusable?
The ANNE Maternal is supplied as a non-sterile, reusable system. Since it is intended for use in multiple patients, proper cleaning and maintenance between uses are essential to ensure hygiene and accurate performance. Follow the manufacturer’s guidelines for disinfection and storage to maintain functionality and patient safety.
How should the ANNE Maternal be stored?
The device requires storage in a clean, dry environment to prevent damage and ensure accurate readings. Avoid exposure to extreme temperatures, moisture, or direct sunlight. Proper calibration and adherence to manufacturer instructions are also critical for optimal performance and reliability in clinical settings.
Can the ANNE Maternal be used in an MRI environment?
Yes, the ANNE Maternal is MRI-safe for specified imaging environments. However, always verify compatibility with the specific MRI machine and follow the manufacturer’s guidelines to avoid interference or safety risks. Ensure sensors and components are positioned correctly to prevent signal distortion or damage during imaging.
What regulatory clearance does the ANNE Maternal hold?
The ANNE Maternal holds FDA 510(k) clearance under the classification of System, Monitoring, Perinatal, with the clearance number K253021. It is classified under FDA’s Class II regulatory standards (884.2740) and is intended for use in obstetric settings as a non-invasive monitoring solution for maternal-fetal health.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Clinical Care - Sibel Health, Inc., Sibel Health Receives FDA-Clearance for ANNE® Maternal, a Comprehensive ..., Home - Sibel Health, Inc., FDA clears Sibel Health's ANNE Maternal wireless system
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253021 | Class II | Active |
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Manufacturer
- Manufacturer
- Sibel Health Inc.
- FDA Applicant
- Sibel Health, Inc.
Sources (1)
- FDA 510(k) K253021 24 fields · synced Oct 1, 2026