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Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery

Page Type
Product Code
Definition
Designed to provide counter-pressure to the perianal region during vaginal childbirth to help reduce the likelihood of Cesarean delivery
Physical State
External device that provides counter pressure to peri-anal region
Technical Method
Provide counter-pressure to the perianal region during vaginal childbirth
Target Area
Perianal region
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
884.5210
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.5210 Pressure wedge for the reduction of cesarean delivery

§ 884.5210 Pressure wedge for the reduction of cesarean delivery.

(a) Identification. A pressure wedge for the reduction of cesarean delivery is a prescription device that provides external mechanical support to the perianal region during the labor and vaginal delivery process. External mechanical support of the perianal region is intended to help reduce the occurrence of cesarean delivery.

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

(1) The patient contacting materials must be evaluated to be biocompatible.

(2) Nonclinical performance data must demonstrate that the device will not break when subjected to the forces it will be exposed to during labor.

(3) Performance data must validate the sterility of the device.

(4) Performance data must support the shelf life of the device by demonstrating continued sterility and package integrity over the labeled shelf life.

(5) Clinical performance data must be provided that characterizes the rate of skin/tissue trauma.

(6) The labeling must include:

(i) Specific instructions regarding the proper placement and use of the device.

(ii) A shelf life.

[82 FR 61448, Dec. 28, 2017]

Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery

Page Type
Product Code
Definition
Designed to provide counter-pressure to the perianal region during vaginal childbirth to help reduce the likelihood of Cesarean delivery
Physical State
External device that provides counter pressure to peri-anal region
Technical Method
Provide counter-pressure to the perianal region during vaginal childbirth
Target Area
Perianal region
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
884.5210
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.5210 Pressure wedge for the reduction of cesarean delivery

§ 884.5210 Pressure wedge for the reduction of cesarean delivery.

(a) Identification. A pressure wedge for the reduction of cesarean delivery is a prescription device that provides external mechanical support to the perianal region during the labor and vaginal delivery process. External mechanical support of the perianal region is intended to help reduce the occurrence of cesarean delivery.

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

(1) The patient contacting materials must be evaluated to be biocompatible.

(2) Nonclinical performance data must demonstrate that the device will not break when subjected to the forces it will be exposed to during labor.

(3) Performance data must validate the sterility of the device.

(4) Performance data must support the shelf life of the device by demonstrating continued sterility and package integrity over the labeled shelf life.

(5) Clinical performance data must be provided that characterizes the rate of skin/tissue trauma.

(6) The labeling must include:

(i) Specific instructions regarding the proper placement and use of the device.

(ii) A shelf life.

[82 FR 61448, Dec. 28, 2017]