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Fluid Jet Removal System

Page Type
Product Code
Definition
The system is used for removal of prostate tissue with a fluid jet.
Physical State
The system consists of a hand piece through which the fluid exits, and may have a conformal planning unit (CPU), which is used in treatment planning.
Technical Method
The system is a personalized image-guided tissue removal system that uses a high-velocity fluid jet to resect and remove a predetermined volume of tissue.
Target Area
Prostate.
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.4350
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.4350 Fluid jet system for prostate tissue removal

§ 876.4350 Fluid jet system for prostate tissue removal.

(a) Identification. A fluid jet system for prostate tissue removal is a prescription device intended for the resection and removal of prostatic tissue for the treatment of benign prostatic hyperplasia. The device cuts tissue by using a pressurized jet of fluid delivered to the prostatic urethra. The device is able to image the treatment area, or pairs with an imaging modality, to monitor treatment progress.

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

(1) Clinical performance testing must evaluate the following:

(i) All adverse events associated with the device, and

(ii) Improvement in lower urinary tract symptoms (LUTS).

(2) Physician training must be provided that includes:

(i) Information on key aspects and use of the device, and

(ii) Information on how to override or stop resection.

(3) Animal testing must demonstrate that the device resects targeted tissue in a controlled manner without injury to adjacent non-target tissues.

(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) Measurement of targeting accuracy and reproducibility of high velocity fluid jet, and

(ii) High pressure fluid jet verification testing at target and non-target tissues.

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

(6) The patient-contacting elements of the device must be demonstrated to be biocompatible.

(7) Performance data must demonstrate the electrical safety and electromagnetic compatibility of the device.

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

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

(10) Performance data must validate the instructions for reprocessing and reliability of reusable components.

(11) Labeling must include the following:

(i) A section that summarizes the clinical testing results, including the adverse event profile and improvement in LUTS;

(ii) A shelf life for single use components;

(iii) A use life for reusable components; and

(iv) Reprocessing instructions for reusable components.

[83 FR 27897, June 15, 2018]

Fluid Jet Removal System

Page Type
Product Code
Definition
The system is used for removal of prostate tissue with a fluid jet.
Physical State
The system consists of a hand piece through which the fluid exits, and may have a conformal planning unit (CPU), which is used in treatment planning.
Technical Method
The system is a personalized image-guided tissue removal system that uses a high-velocity fluid jet to resect and remove a predetermined volume of tissue.
Target Area
Prostate.
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.4350
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.4350 Fluid jet system for prostate tissue removal

§ 876.4350 Fluid jet system for prostate tissue removal.

(a) Identification. A fluid jet system for prostate tissue removal is a prescription device intended for the resection and removal of prostatic tissue for the treatment of benign prostatic hyperplasia. The device cuts tissue by using a pressurized jet of fluid delivered to the prostatic urethra. The device is able to image the treatment area, or pairs with an imaging modality, to monitor treatment progress.

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

(1) Clinical performance testing must evaluate the following:

(i) All adverse events associated with the device, and

(ii) Improvement in lower urinary tract symptoms (LUTS).

(2) Physician training must be provided that includes:

(i) Information on key aspects and use of the device, and

(ii) Information on how to override or stop resection.

(3) Animal testing must demonstrate that the device resects targeted tissue in a controlled manner without injury to adjacent non-target tissues.

(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) Measurement of targeting accuracy and reproducibility of high velocity fluid jet, and

(ii) High pressure fluid jet verification testing at target and non-target tissues.

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

(6) The patient-contacting elements of the device must be demonstrated to be biocompatible.

(7) Performance data must demonstrate the electrical safety and electromagnetic compatibility of the device.

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

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

(10) Performance data must validate the instructions for reprocessing and reliability of reusable components.

(11) Labeling must include the following:

(i) A section that summarizes the clinical testing results, including the adverse event profile and improvement in LUTS;

(ii) A shelf life for single use components;

(iii) A use life for reusable components; and

(iv) Reprocessing instructions for reusable components.

[83 FR 27897, June 15, 2018]