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Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia

Page Type
Product Code
Definition
The device comprises one or more objects placed in a blood vessel to permanently obstruct blood flow to the prostate to treat benign prostatic hyperplasia (BPH).
Physical State
Beads in suspension
Technical Method
A catheter is threaded from femoral artery to the prostatic artery and beads are injected until stasis in flow is achieved.
Target Area
Prostate
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.5550
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.5550 Prostatic artery embolization device

§ 876.5550 Prostatic artery embolization device.

(a) Identification. A prostatic artery embolization device is an intravascular implant intended to occlude the prostatic arteries to prevent blood flow to the targeted area of the prostate, resulting in a reduction of lower urinary tract symptoms related to benign prostatic hyperplasia. This does not include cyanoacrylates and other embolic agents which act by in situ polymerization or precipitation, or embolization devices used in neurovascular applications (see 21 CFR 882.5950).

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

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

(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Evaluation of suitability for injection through catheters intended for use in embolization; and

(ii) Evaluation of the size distribution of the device.

(3) Performance data must support the sterility and pyrogenicity of the device.

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

(5) Clinical data must evaluate post-embolization damage due to non-target embolization under anticipated use conditions.

(6) The labeling must include:

(i) Specific instructions on safe device preparation and use;

(ii) The device shelf life;

(iii) Data regarding urinary retention; and

(iv) Data regarding post-prostatic artery embolization syndrome.

[82 FR 52651, Nov. 14, 2017]

Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia

Page Type
Product Code
Definition
The device comprises one or more objects placed in a blood vessel to permanently obstruct blood flow to the prostate to treat benign prostatic hyperplasia (BPH).
Physical State
Beads in suspension
Technical Method
A catheter is threaded from femoral artery to the prostatic artery and beads are injected until stasis in flow is achieved.
Target Area
Prostate
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.5550
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.5550 Prostatic artery embolization device

§ 876.5550 Prostatic artery embolization device.

(a) Identification. A prostatic artery embolization device is an intravascular implant intended to occlude the prostatic arteries to prevent blood flow to the targeted area of the prostate, resulting in a reduction of lower urinary tract symptoms related to benign prostatic hyperplasia. This does not include cyanoacrylates and other embolic agents which act by in situ polymerization or precipitation, or embolization devices used in neurovascular applications (see 21 CFR 882.5950).

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

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

(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Evaluation of suitability for injection through catheters intended for use in embolization; and

(ii) Evaluation of the size distribution of the device.

(3) Performance data must support the sterility and pyrogenicity of the device.

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

(5) Clinical data must evaluate post-embolization damage due to non-target embolization under anticipated use conditions.

(6) The labeling must include:

(i) Specific instructions on safe device preparation and use;

(ii) The device shelf life;

(iii) Data regarding urinary retention; and

(iv) Data regarding post-prostatic artery embolization syndrome.

[82 FR 52651, Nov. 14, 2017]