Identification. A fetal head elevator is a prescription device consisting of a mechanism that elevates the fetal head to facilitate delivery during a Caesarean section.
Classification. Class II (special controls). The special controls for this device are:
The patient-contacting components of the device must be demonstrated to be biocompatible.
Performance data must demonstrate the sterility of patient-contacting components of the device.
Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
Reliability testing of device deployment and retrieval under relevant use conditions must be conducted.
Testing of the maximum force applied to the fetal head in an anatomic model must be conducted.
Testing of uniform application of the elevator mechanism on the fetal head must be conducted.
Labeling must include the following:
Contraindication for use in the presence of active genital infection;
Specific instructions regarding the proper placement and use of the device; and
A shelf life.
Copyright ©2024 LegalFix. All rights reserved. LegalFix is not a law firm, is not licensed to practice law, and does not provide legal advice, services, or representation. The information on this website is an overview of the legal insurance products you can purchase—or that may be provided by your employer as an employee benefit or by your credit union or other membership group as a membership benefit.
LegalFix provides its members with access to legal services through a network of provider law firms. LegalFix, its corporate entity, and its officers, directors, employees, agents, and contractors do not provide legal advice, services, or representation—directly or indirectly.
The articles and information on the site are not legal advice and should not be relied upon—they are for information purposes only. You should become a LegalFix member to get legal services from one of our provider law firms.
You should not disclose confidential or potentially incriminating information to LegalFix—you should only communicate such information to your provider law firm.
The benefits and legal services described in the LegalFix legal plans are not always available in all states or with all plans. See the legal plan Benefit Overview and the more comprehensive legal plan contract during checkout for coverage details in your state.
Use of this website, the purchase of legal insurance products, and access to the LegalFix network of provider law firms are subject to the LegalFix Terms of Service and Privacy Policy.
