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High Intensity Ultrasound System For Prostate Tissue Ablation

Page Type
Product Code
Definition
Prostate tissue ablation
Physical State
The system consists of a console, a probe with therapy transducer(s), and single use accessories.
Technical Method
Uses high intensity ultrasound to heat target tissue within the prostate gland, causing coagulation necrosis of that tissue.
Target Area
The prostate gland
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.4340
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.4340 High intensity ultrasound system for prostate tissue ablation

§ 876.4340 High intensity ultrasound system for prostate tissue ablation.

(a) Identification. A high intensity ultrasound system for prostate tissue ablation is a prescription device that transmits high intensity therapeutic ultrasound energy into the prostate to thermally ablate a defined, targeted volume of tissue, performed under imaging guidance. This classification does not include devices that are intended for the treatment of any specific prostate disease and does not include devices that are intended to ablate non-prostatic tissues/organs.

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

(1) 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) Characterization of acoustic pressure and power output at clinically relevant levels;

(ii) Measurement of targeting accuracy and reproducibility of high intensity ultrasound output;

(iii) Ultrasound-induced heating verification testing at target and non-target tissues;

(iv) Electrical safety testing; and

(v) Electromagnetic compatibility testing.

(2) Software verification, validation, and hazard analysis must be performed.

(3) The elements of the device that may contact the patient's mucosal tissue must be demonstrated to be biocompatible.

(4) Performance data must demonstrate the sterility of the device components that contact the patient's mucosal tissue.

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

(6) Performance data must support the instructions for reprocessing all reusable components.

(7) In vivo testing must demonstrate that the device thermally ablates targeted tissue in a controlled manner without thermal injury to adjacent, non-target tissues.

(8) Clinical testing must document the adverse event profile, provide evidence of prostatic ablation, and demonstrate that the device performs as intended under anticipated conditions of use.

(9) Training must be provided so that upon completion of the training program, the physician can:

(i) Use all safety features of the device;

(ii) Accurately target the high intensity ultrasound energy within the desired region of the prostate; and

(iii) Perform the ablation procedure in a manner that minimizes damage to non-target tissues.

(10) Labeling must include:

(i) A section that summarizes the clinical testing results, including the adverse event profile and evidence of prostate ablation achieved; and

(ii) An expiration date or shelf life for single use components.

[82 FR 45727, Oct. 2, 2017]

High Intensity Ultrasound System For Prostate Tissue Ablation

Page Type
Product Code
Definition
Prostate tissue ablation
Physical State
The system consists of a console, a probe with therapy transducer(s), and single use accessories.
Technical Method
Uses high intensity ultrasound to heat target tissue within the prostate gland, causing coagulation necrosis of that tissue.
Target Area
The prostate gland
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.4340
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.4340 High intensity ultrasound system for prostate tissue ablation

§ 876.4340 High intensity ultrasound system for prostate tissue ablation.

(a) Identification. A high intensity ultrasound system for prostate tissue ablation is a prescription device that transmits high intensity therapeutic ultrasound energy into the prostate to thermally ablate a defined, targeted volume of tissue, performed under imaging guidance. This classification does not include devices that are intended for the treatment of any specific prostate disease and does not include devices that are intended to ablate non-prostatic tissues/organs.

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

(1) 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) Characterization of acoustic pressure and power output at clinically relevant levels;

(ii) Measurement of targeting accuracy and reproducibility of high intensity ultrasound output;

(iii) Ultrasound-induced heating verification testing at target and non-target tissues;

(iv) Electrical safety testing; and

(v) Electromagnetic compatibility testing.

(2) Software verification, validation, and hazard analysis must be performed.

(3) The elements of the device that may contact the patient's mucosal tissue must be demonstrated to be biocompatible.

(4) Performance data must demonstrate the sterility of the device components that contact the patient's mucosal tissue.

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

(6) Performance data must support the instructions for reprocessing all reusable components.

(7) In vivo testing must demonstrate that the device thermally ablates targeted tissue in a controlled manner without thermal injury to adjacent, non-target tissues.

(8) Clinical testing must document the adverse event profile, provide evidence of prostatic ablation, and demonstrate that the device performs as intended under anticipated conditions of use.

(9) Training must be provided so that upon completion of the training program, the physician can:

(i) Use all safety features of the device;

(ii) Accurately target the high intensity ultrasound energy within the desired region of the prostate; and

(iii) Perform the ablation procedure in a manner that minimizes damage to non-target tissues.

(10) Labeling must include:

(i) A section that summarizes the clinical testing results, including the adverse event profile and evidence of prostate ablation achieved; and

(ii) An expiration date or shelf life for single use components.

[82 FR 45727, Oct. 2, 2017]