(110 days)
The CS-Pro MED is intended to provide acoustic shock waves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule but without bone exposure. The CS-Pro MED is indicated for adults (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care.
The CS-Pro MED is a handheld, battery-operated device that produces high-pressure focused acoustic shock waves. It is designed to provide healthcare professionals with an effective and easy-to-use device for administering focused Extracorporeal Shock Wave Therapy (ESWT) treatment. The CS-Pro MED is battery-powered and utilizes an array of piezocomposite transducers to create acoustic shock waves. The device delivers a drive signal to the piezocomposite transducers to create pressure pulses that propagate through the elastomeric standoffs and into the patient's tissue. Each pressure pulse is calibrated to arrive simultaneously at the focal point. The device includes a touch-sensitive display that indicates useful information and allows the operator to adjust the energy level, set the number of shock wave pulses, and adjust the pulse repetition frequency. The CS-Pro MED includes five standoffs of varying sizes to control the depth at which the therapy is focused, allowing the physician to target a specific tissue depth based on the treatment protocol.
The provided FDA 510(k) clearance letter for the CS-Pro MED does not include any information about the acceptance criteria or a study that proves the device meets specific performance acceptance criteria related to its clinical effectiveness.
The document discusses performance in terms of:
- Electrical Safety, Electromagnetic Compatibility, and Biocompatibility: These are engineering and safety standards, not clinical performance metrics. The document states "meets applicable biocompatibility requirements" and "Electrical Safety testing in accordance with IEC 60601-1," etc. which indicates compliance with these technical standards.
- Bench Testing: This includes "Characterization of acoustic" per IEC 61846 and "Nonclinical verification and validation testing... demonstrated that the CS-Pro MED meets the design specifications and is safe and effective for its intended use." This refers to physical and technical performance (e.g., how the shock waves are generated and characterized), not clinical efficacy.
- Substantial Equivalence: The primary focus of the 510(k) summary is to demonstrate substantial equivalence to a predicate device (DuoLith SD1 with C-ACTOR, K202112) based on similarities in indications for use, technological characteristics, and mechanism of action. Differences are argued to "not raise any new questions of safety or effectiveness."
Crucially, the "Clinical Information" section explicitly states "Not applicable. Bench and performance testing support the conclusion of substantial equivalence in this submission." This means no clinical study data (such as a multi-reader, multi-case study, or a standalone algorithm performance study) was submitted or evaluated for the substantial equivalence determination for clinical efficacy.
Therefore, I cannot fulfill your request for the specific acceptance criteria for clinical performance and the details of a study proving the device meets those criteria, as this information is not present in the provided 510(k) clearance letter. The clearance is based on substantial equivalence to a predicate device and engineering/safety performance, not a demonstration of clinical efficacy through specific performance metrics outlined in a clinical study.
§ 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.