21 CFR 892.5720 — Prostate Immobilizer Rectal Balloon
Radiology (RA) · Subpart F—Therapeutic Devices · § 892.5720
Identification
A rectal balloon for prostate immobilization is a single use, inflatable, non-powered positioning device placed in the rectum to immobilize the prostate in patients undergoing radiation therapy. The device is intended to be used during all the phases of radiation therapy, including treatment planning, image verification, and radiotherapy delivery.
Classification Rationale
Class II (special controls). The special controls for this device are:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| PCT | Prostate Immobilizer Rectal Balloon | 2 | 5 | 3rd Party |
Special Controls
PCT — Prostate Immobilizer Rectal Balloon
In addition to the general controls of the FD&C Act, the Prostate Immobilization Rectal Balloon is subject to the following special controls: - 1) The premarket notification submission must include methodology and results of the following non-clinical and clinical performance testing: - Biocompatibility testing of the final finished device; i) - ii) If provided sterile, sterilization validation; - iii) If not provided sterile, bioburden testing of the final finished device; - iv) Shelf life and expiration date validation; and - v) Performance testing, including, but not limited to: - A) Venting mechanism (if device has a vent mechanism); - B) Safety mechanism(s) to prevent advancement beyond its intended safe placement; and - C) Structural integrity testing (e.g., tensile strength, balloon leakage and burst strength). - 2) Labeling that includes: - i) Appropriate warnings and contraindications, including, but not limited to the following statements: - A ) "Do not transport the patient with the rectal balloon inserted. The balloon should be removed prior to transport."; - B) "Failure to perform the standard imaging position verification protocol may cause the device to not perform as intended." ; - C) "Reduce the rectal balloon fill volume if the patient experiences discomfort due to the rectal balloon inflation."; and - D) "Do not apply excessive pressure/force on the shaft or tubing of the rectal balloon."; - ii) Adequate instructions for use on the proper insertion procedure, positioning, and inflation of the rectal balloon; - iii) Whether the device is sterile or non-sterile; and, - iv) An expiration date.
De Novo Order DEN130036
PCT — Prostate Immobilizer Rectal Balloon
*Classification.* Class II (special controls). The special controls for this device are:(1) The premarket notification submission must include methodology and results of the following non-clinical and clinical performance testing: (i) Biocompatibility testing of the final finished device; (ii) If provided sterile, sterilization validation; (iii) If not provided sterile, bioburden testing of the final finished device; (iv) Shelf life and expiration date validation; and (v) Performance testing including but not limited to: (A) Venting mechanism (if device has a vent mechanism); (B) Safety mechanism(s) to prevent advancement beyond its intended safe placement; and (C) Structural integrity testing ( *e.g.,* tensile strength, balloon leakage and burst strength).(2) Labeling that includes: (i) Appropriate warnings and contraindications, including, but not limited to the following statements: (A) “Do not transport the patient with the rectal balloon inserted. The balloon should be removed prior to transport.”; (B) “Failure to perform the standard imaging position verification protocol may cause the device to not perform as intended.”; (C) “Reduce the rectal balloon fill volume if the patient experiences discomfort due to the rectal balloon inflation.”; and (D) “Do not apply excessive pressure/force on the shaft or tubing of the rectal balloon.” (ii) Adequate instructions for use on the proper insertion procedure, positioning, and inflation of the rectal balloon; (iii) Whether the device is sterile or non-sterile; and (iv) An expiration date.
eCFR
PCT — Prostate Immobilizer Rectal Balloon
(1) The premarket notification submission must include methodology and results of the following non-clinical and clinical performance testing: (i) Biocompatibility testing of the final finished device; (ii) If provided sterile, sterilization validation; (iii) If not provided sterile, bioburden testing of the final finished device; (iv) Shelf life and expiration date validation; and (v) Performance testing including but not limited to: (A) Venting mechanism (if device has a vent mechanism); (B) Safety mechanism(s) to prevent advancement beyond its intended safe placement; and (C) Structural integrity testing ( *e.g.,* tensile strength, balloon leakage and burst strength).(2) Labeling that includes: (i) Appropriate warnings and contraindications, including, but not limited to the following statements: (A) “Do not transport the patient with the rectal balloon inserted. The balloon should be removed prior to transport.”; (B) “Failure to perform the standard imaging position verification protocol may cause the device to not perform as intended.”; (C) “Reduce the rectal balloon fill volume if the patient experiences discomfort due to the rectal balloon inflation.”; and (D) “Do not apply excessive pressure/force on the shaft or tubing of the rectal balloon.” (ii) Adequate instructions for use on the proper insertion procedure, positioning, and inflation of the rectal balloon; (iii) Whether the device is sterile or non-sterile; and (iv) An expiration date.
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