(143 days)
The OrthoGold 100™ is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 years and older). The OrthoGold 100 is indicated for use in conjunction with standard of care burn treatment(s).
The OrthoGold 100™ is a pulsed acoustic wave device. It includes an electrically powered generator to generate transient compressed air that rapidly expands to create the acoustic waves, which in turn are propagated through a water-filled coupling membrane attached to the hand-held applicator. The hand-held applicator reflects the acoustic waves towards the treatment area through a silicone membrane and ultrasound transmission gel.
The provided document describes the FDA 510(k) clearance for the OrthoGold 100 device, an extracorporeal shock wave device. The information details the device's indications for use, a comparison to a predicate device, and performance data including non-clinical, animal, and clinical studies.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly demonstrated through the clinical study's primary endpoint, which showed a statistically significant improvement in the time to epithelialization. The safety was also assessed by monitoring adverse events.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Efficacy: Show significant reduction in wound healing time for superficial partial thickness second-degree burns. | Efficacy Met: Mean time to ≥95% epithelialization was significantly shorter for the ESWT group (9.6 ± 1.7 days) vs. control (12.5 ± 2.2 days), with p |
§ 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.