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Fetal Head Elevator

Page Type
Product Code
Definition
To elevate the fetal head and facilitate delivery of the fetus in women requiring a Caesarean Section at full dilation or those requiring a Caesarean Section after a failed instrumental vaginal delivery.
Physical State
Inflatable balloon device that provides pressure to the fetal head.
Technical Method
Provides pressure via an inflatable balloon inserted into the vaginal canal to elevate the fetal head.
Target Area
Vaginal canal.
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
884.4350
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.4350 Fetal head elevator

§ 884.4350 Fetal head elevator.

(a) 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.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The patient-contacting components of the device must be demonstrated to be biocompatible.

(2) Performance data must demonstrate the sterility of patient-contacting components of the device.

(3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.

(4) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Reliability testing of device deployment and retrieval under relevant use conditions must be conducted.

(ii) Testing of the maximum force applied to the fetal head in an anatomic model must be conducted.

(iii) Testing of uniform application of the elevator mechanism on the fetal head must be conducted.

(5) Labeling must include the following:

(i) Contraindication for use in the presence of active genital infection;

(ii) Specific instructions regarding the proper placement and use of the device; and

(iii) A shelf life.

[82 FR 60114, Dec. 19, 2017]

Fetal Head Elevator

Page Type
Product Code
Definition
To elevate the fetal head and facilitate delivery of the fetus in women requiring a Caesarean Section at full dilation or those requiring a Caesarean Section after a failed instrumental vaginal delivery.
Physical State
Inflatable balloon device that provides pressure to the fetal head.
Technical Method
Provides pressure via an inflatable balloon inserted into the vaginal canal to elevate the fetal head.
Target Area
Vaginal canal.
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
884.4350
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.4350 Fetal head elevator

§ 884.4350 Fetal head elevator.

(a) 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.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The patient-contacting components of the device must be demonstrated to be biocompatible.

(2) Performance data must demonstrate the sterility of patient-contacting components of the device.

(3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.

(4) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Reliability testing of device deployment and retrieval under relevant use conditions must be conducted.

(ii) Testing of the maximum force applied to the fetal head in an anatomic model must be conducted.

(iii) Testing of uniform application of the elevator mechanism on the fetal head must be conducted.

(5) Labeling must include the following:

(i) Contraindication for use in the presence of active genital infection;

(ii) Specific instructions regarding the proper placement and use of the device; and

(iii) A shelf life.

[82 FR 60114, Dec. 19, 2017]