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Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

Page Type
Product Code
Definition
Treatment of diabetic foot ulcers
Physical State
The device generally has a console with a handheld applicator attachment. The device has touch tone/display screen or other mechanical buttons for user interactions.
Technical Method
The shock waves can be generated using electrostatic spark discharge (spark gap), electromagnetically repelled membranes, or piezoelectric crystal arrays, and focused onto the patient with a specially designed reflector, dish, or acoustic lens. The shock waves are created inside a liquid medium within the device, and are transferred to the patient's body using an appropriate acoustic interface.
Target Area
The device generally targets foot skin including the dermis, the epidermis, and underlying soft tissue.
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4685
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4685 Extracorporeal shock wave device for treatment of chronic wounds

§ 878.4685 Extracorporeal shock wave device for treatment of chronic wounds.

(a) Identification. An extracorporeal shock wave device for treatment of chronic wounds is a prescription device that focuses acoustic shock waves onto the dermal tissue. The shock waves are generated inside the device and transferred to the body using an acoustic interface.

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

(1) Non-clinical performance testing must be conducted to demonstrate that the system produces anticipated and reproducible acoustic pressure shock waves.

(2) The patient-contacting components of the device must be demonstrated to be biocompatible.

(3) Performance data must demonstrate that the reusable components of the device can be reprocessed for subsequent use.

(4) Performance data must be provided to demonstrate the electromagnetic compatibility and electrical safety of the device.

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

(6) Performance data must support the use life of the system by demonstrating continued system functionality over the labeled use life.

(7) Physician labeling must include:

(i) Information on how the device operates and the typical course of treatment;

(ii) A detailed summary of the device's technical parameters;

(iii) Validated methods and instructions for reprocessing of any reusable components; and

(iv) Instructions for preventing hearing loss by use of hearing protection.

(8) Patient labeling must include:

(i) Relevant contraindications, warnings, precautions, adverse effects, and complications;

(ii) Information on how the device operates and the typical course of treatment;

(iii) The probable risks and benefits associated with the use of the device;

(iv) Post-procedure care instructions; and

(v) Alternative treatments.

[83 FR 9699, Mar. 7, 2018]

Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

Page Type
Product Code
Definition
Treatment of diabetic foot ulcers
Physical State
The device generally has a console with a handheld applicator attachment. The device has touch tone/display screen or other mechanical buttons for user interactions.
Technical Method
The shock waves can be generated using electrostatic spark discharge (spark gap), electromagnetically repelled membranes, or piezoelectric crystal arrays, and focused onto the patient with a specially designed reflector, dish, or acoustic lens. The shock waves are created inside a liquid medium within the device, and are transferred to the patient's body using an appropriate acoustic interface.
Target Area
The device generally targets foot skin including the dermis, the epidermis, and underlying soft tissue.
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4685
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4685 Extracorporeal shock wave device for treatment of chronic wounds

§ 878.4685 Extracorporeal shock wave device for treatment of chronic wounds.

(a) Identification. An extracorporeal shock wave device for treatment of chronic wounds is a prescription device that focuses acoustic shock waves onto the dermal tissue. The shock waves are generated inside the device and transferred to the body using an acoustic interface.

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

(1) Non-clinical performance testing must be conducted to demonstrate that the system produces anticipated and reproducible acoustic pressure shock waves.

(2) The patient-contacting components of the device must be demonstrated to be biocompatible.

(3) Performance data must demonstrate that the reusable components of the device can be reprocessed for subsequent use.

(4) Performance data must be provided to demonstrate the electromagnetic compatibility and electrical safety of the device.

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

(6) Performance data must support the use life of the system by demonstrating continued system functionality over the labeled use life.

(7) Physician labeling must include:

(i) Information on how the device operates and the typical course of treatment;

(ii) A detailed summary of the device's technical parameters;

(iii) Validated methods and instructions for reprocessing of any reusable components; and

(iv) Instructions for preventing hearing loss by use of hearing protection.

(8) Patient labeling must include:

(i) Relevant contraindications, warnings, precautions, adverse effects, and complications;

(ii) Information on how the device operates and the typical course of treatment;

(iii) The probable risks and benefits associated with the use of the device;

(iv) Post-procedure care instructions; and

(v) Alternative treatments.

[83 FR 9699, Mar. 7, 2018]