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Hemorrhoid Prevention Pressure Wedge

Page Type
Product Code
Definition
Provides a counter-pressure to the anus during vaginal delivery. Intended to prevent the occurrence of and/or stop the progression of hemorrhoids associated with vaginal delivery.
Physical State
Items include: rigid base with cushioning pad and two lateral straps and two adhesive pads that are applied to the buttocks
Technical Method
Uses a rigid base with cushioning pad applied to the anus held in place by two adhesive strips attached to the buttocks, to provide a counter-pressure to the anus during vaginal delivery
Target Area
Anus, hemorrhoids
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
884.5200
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.5200 Hemorrhoid prevention pressure wedge

§ 884.5200 Hemorrhoid prevention pressure wedge.

(a) Identification. A hemorrhoid prevention pressure wedge provides mechanical support to the perianal region during the labor and delivery process. External mechanical support of the perianal region is intended to help prevent the occurrence of external hemorrhoids associated with vaginal childbirth.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. The special controls for this device are:

(1) The sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter.

(2) The labeling must include specific instructions regarding the proper placement and use of the device.

(3) The device must be demonstrated to be biocompatible.

(4) Mechanical bench testing of material strength must demonstrate that the device will withstand forces encountered during use.

(5) Safety and effectiveness data must demonstrate that the device prevents hemorrhoids in women undergoing spontaneous vaginal delivery, in addition to general controls.

[76 FR 21238, Apr. 15, 2011, as amended at 84 FR 71816, Dec. 30, 2019]

Hemorrhoid Prevention Pressure Wedge

Page Type
Product Code
Definition
Provides a counter-pressure to the anus during vaginal delivery. Intended to prevent the occurrence of and/or stop the progression of hemorrhoids associated with vaginal delivery.
Physical State
Items include: rigid base with cushioning pad and two lateral straps and two adhesive pads that are applied to the buttocks
Technical Method
Uses a rigid base with cushioning pad applied to the anus held in place by two adhesive strips attached to the buttocks, to provide a counter-pressure to the anus during vaginal delivery
Target Area
Anus, hemorrhoids
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
884.5200
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.5200 Hemorrhoid prevention pressure wedge

§ 884.5200 Hemorrhoid prevention pressure wedge.

(a) Identification. A hemorrhoid prevention pressure wedge provides mechanical support to the perianal region during the labor and delivery process. External mechanical support of the perianal region is intended to help prevent the occurrence of external hemorrhoids associated with vaginal childbirth.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. The special controls for this device are:

(1) The sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter.

(2) The labeling must include specific instructions regarding the proper placement and use of the device.

(3) The device must be demonstrated to be biocompatible.

(4) Mechanical bench testing of material strength must demonstrate that the device will withstand forces encountered during use.

(5) Safety and effectiveness data must demonstrate that the device prevents hemorrhoids in women undergoing spontaneous vaginal delivery, in addition to general controls.

[76 FR 21238, Apr. 15, 2011, as amended at 84 FR 71816, Dec. 30, 2019]