(393 days)
The AR1000 Series and its variants produce and deliver low frequency ultrasound used to promote wound healing via:
- Selective and non-selective dissection and fragmentation of soft and or hard tissue;
- Surgical, excisional or sharp-edge wound debridement (acute and chronic wounds, burns) for the removal of nonviable tissue including but not limited to diseased tissue, necrotic tissue, slough and eschar, fibrin, tissue exudates, bacteria and other matter.
- Site cleansing irrigation and lavage of wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue);
- Contact and or non-contact maintenance debridement for the removal ofdebris, exudates, fragments, bacteria, slough, fibrin, excised or fragmented tissue, and other matter.
- Preparing the wound bed for graft or other subsequent procedures using contact and or non-contact techniques to achieve wound debridement.
The AR1000 Ultrasonic Wound Therapy System and its variants use ultrasonic energy from a generator delivered by a conductive cable to a hand held converter through the converter's distal end probe and liquid coupling medium: to perform wound therapy; to perform ultrasonic surgical, excisional, and or sharp-edge selective dissection procedures; with the intended end result to promote healing. The AR1000 Ultrasonic Wound Therapy System generator utilizes commonly available wall outlet power (85 -260VAC, 50/60Hz) to produce the ultrasonic signal. A conductive cable connects the generator to the hand held converter. The hand held converter converts the signal into ultrasonic mechanical displacement in the distal end probe or Qurette. The ultrasonic mechanical displacement energy is applied to the treatment site by the distal end probe or Qurette through direct contact or noncontact techniques. The ultrasonic mechanical displacement energy is also transmitted as ultrasonic energy to the treatment site via the liquid coupling medium. The AR1000 Ultrasonic Wound Therapy System distal end probe or Qurette is used with contact or non-contact modes to achieve intended wound therapy modalities to promote wound healing. This is achieved through the use of the low-frequency, controlled-intensity, ultrasonic energy to perform ultrasonic dissection and fragmentation of tissues, debridement of wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue), and surgical, excisional or sharp-edge incisions. The AR1000 Ultrasonic Wound Therapy System distal end probe or Qurette is used with contact or non-contact modes to achieve wound therapy and promotes wound healing through the ultrasonic dissection and fragmentation of tissues, debridement of wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue) through the use of the low-frequency, controlled-intensity, non-thermal ultrasonic energy. The AR1000 Ultrasonic Wound Therapy System ultrasonic energy, via the liquid coupling medium to the treatment site, promotes wound healing through the lavage of wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue) and cleansing irrigation of the site for the removal of debris, exudates, fragments, bacteria, and other matter. The AR1000 Ultrasonic Wound Therapy System uses continuous ultrasonic energy to propel the liquid medium (e.g. sterile saline, or other appropriate US FDA cleared medium) into a solution stream and couples the delivery of ultrasonic energy to the treatment site. This is accomplished by the ultrasonic energy application to the treatment site where the ultrasonic energy is transmitted via the converter probe (Qurette) and also coupled via the liquid medium to the treatment site. The converter has a transducer horn that is made from titanium alloy (TI-6AL-4V). The converter probe Qurette tips are made from titanium alloy (TI-6AL-4V). No latex is used in this device, including any potential patient-contact areas, and testing has revealed no negative reactions to the materials used in this device.
This 510(k) summary is for a device, the AR1000 Ultrasonic Wound Therapy System, which is substantially equivalent to previously cleared predicate devices. Therefore, the information provided focuses on demonstrating substantial equivalence rather than presenting an independent study with defined acceptance criteria and device performance metrics in the typical sense of a novel device.
The "acceptance criteria" here are established by compliance with recognized standards and demonstration of substantial equivalence to predicate devices, particularly regarding safety and effectiveness. The "study" proving this is primarily a compilation of comparative analyses against these predicates and adherence to safety standards.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission for substantial equivalence with an expanded indication for use, the "acceptance criteria" are implicitly met by demonstrating that the device is as safe and effective as the predicate devices, and that the expanded indications do not raise new safety or effectiveness concerns. The performance is therefore characterized by its equivalence to these predicates and compliance with relevant standards.
| Acceptance Criterion (Implicit) | Reported Device Performance (Demonstrated by Substantial Equivalence and Compliance) |
|---|---|
| Expanded Indications for Use (demonstrate safety and effectiveness for new uses without raising new issues) | The AR1000 Series and its variants produce and deliver low frequency ultrasound for: |
- Selective and non-selective dissection and fragmentation of soft and/or hard tissue.
- Surgical, excisional or sharp-edge wound debridement (acute and chronic wounds, burns) for removal of nonviable tissue.
- Site cleansing irrigation and lavage of wound tissue.
- Contact and/or non-contact maintenance debridement for removal of debris, exudates, fragments, bacteria, slough, fibrin, excised/fragmented tissue.
- Preparing the wound bed for graft or other subsequent procedures.
These expanded indications are supported by expanded patient results and laboratory findings, and comparably meet the performance characteristics of the predicate devices for analogous indications (Arobella AR1000 K062544, Misonix SonicOne K112782, Celleration Mist K122246, Soring Sonoca K072904). |
| Controlled Ultrasonic Delivery and Lavage (comparable to predicates) | Delivers controlled ultrasonic energy with 0.9% sterile saline solution (or other approved medium) to lavage wound tissue (acute and chronic wounds, burns, diseased/necrotic tissue), similar to Arobella AR1000 (K062544) and Celleration (K122246). |
| Maintenance Debridement (comparable to predicates) | Performs maintenance debridement for removing loose fragments, debris, exudate, bacteria, and other matter, similar to Arobella AR1000 (K062544), Misonix SonicOne (K112782), Celleration (K122246), and Soring Sonoca (K072904). |
| Ultrasonic Selective Dissection and Debridement (comparable to predicates) | Enables ultrasonic selective dissection and debridement of tissue using the probe (Qurette), including shallow separation of tissue layers, similar to predicate Arobella AR1000 (K062544) and Misonix SonicOne (K112782). |
| Electrical Safety & Electromagnetic Compatibility (compliance with standards) | Complies with IEC 60601-1, UL 60601-1, IEC 60601-1-2, IEC 60601-1-4, and FCC Part 18. |
| Ultrasonic Safety (compliance with standards) | Complies with 21 CFR 1050.10 and IEC 61847. |
| Biocompatibility (compliance with standards) | Tested for and complies with ISO 10993-1:2003 and relevant annexes (based on nature and duration of patient contact). All testing conducted under 21 CFR Part 58 Good Laboratory Practice. |
| Reprocessing (validated methodology for sterilization) | Reprocessing instructions for the AR1000 system and converter hand piece (K062544) have been previously validated and cleared. The variant converter hand piece allows for steam sterilization (autoclave) in addition to previously cleared methods. |
| Technical Specifications (Generator Power Source, Converter Power Output, Amplitude, Frequency, Weight, Dimensions, Storage/Operating Temperature) (comparable to K062544 and predicate devices where applicable for safety/effectiveness) | Generator Power Source: 85-260V~ (VAC), 2.5A, 50/60Hz (Similar to K062544)
Converter Power Output:
§ 878.4410 Low energy ultrasound wound cleaner.
(a)
Identification. A low energy ultrasound wound cleaner is a device that uses ultrasound energy to vaporize a solution and generate a mist that is used for the cleaning and maintenance debridement of wounds. Low levels of ultrasound energy may be carried to the wound by the saline mist.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner.” See § 878.1(e) for the availability of this guidance document.