(393 days)
Not Found
No
The document describes a device that uses ultrasonic energy for wound therapy and debridement. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The description focuses on the physical mechanism of action (ultrasonic energy) and its application.
Yes
The device is described as an "Ultrasonic Wound Therapy System" that "promotes wound healing" and performs functions like debridement, debridement, and irrigation to achieve this goal. These are therapeutic actions.
No
The device is intended and described for wound therapy, including debridement and cleansing, to promote healing, which are therapeutic rather than diagnostic actions.
No
The device description clearly outlines hardware components including a generator, conductive cable, hand held converter, and probe/Qurette, which deliver ultrasonic energy. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device that applies ultrasonic energy directly to a wound on a patient's body for therapeutic purposes (wound debridement, cleansing, promoting healing). This is a direct treatment of the patient.
- Device Description: The description details a system that generates and delivers ultrasonic energy to a hand-held probe for application to the wound. It describes a physical intervention on the patient's tissue.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide information about a patient's health status. IVDs are designed to perform tests on samples in vitro.
The device is a therapeutic device used for wound management, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
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.
The AR1000 Series and its variants produce and deliver low frequency ultrasound used to promote wound healing via:
- 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 of debris, . exudates, fragments, bacteria, slough, fibrin, excised or fragmented tissue, and other matter.
IRRIGATION (LAVAGE) FLUID
- Irrigation fluid may be sterile de-ionized water, sterile saline solution, other . approved wound therapy or debridement solution.
The AR1000 Series and its variants produce and deliver low frequency ultrasound used to promote wound healing by:
- Preparing the wound bed for graft or other subsequent procedures using contact . and or non-contact techniques to achieve wound debridement.
Product codes (comma separated list FDA assigned to the subject device)
LFL, NRB
Device Description
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.
Specifications:
Generator Power Source: 85 -260V~ (VAC), 2.5A, 50/60Hz
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.
0
MAY 1 6 2014
510(k) Summary (K131096)
In accordance with the requirements of 21 CFR 807.92, Arobella Medical is submitting the following 510(k) summary for the AR1000 Ultrasonic Wound Therapy System and its variants. (Reference previous 510(k) K062544)
807.92(a)(1)
Submitter Information
Arobella Medical LLC 5929 Baker Road, Suite 470 Minnetonka, MN 55345 Main: (952) 345-6840 Fax: (952) 345-6841
Contact Person: Matthew Berscheid Director of Quality and Regulatory Affairs Office: (952) 288-2801 Fax: (952) 345-6841 Cell (612) 998-7416
Date: May 16, 2014
807.92(a)(2)
Trade Names: AR1000/B Ultrasonic Wound Therapy System, AR1000/B Qoustic Wound Therapy System™ (QWTS), or Qoustic Choice Wound Therapy System Common Name: Ultrasonic Wound Therapy System Classification Name(s): Ultrasonic Surgical Instrument; Wound Cleaner, Ultrasound Product Classification: Class II or in the alternate Unclassified Product Code: LFL
807.92(a)(3)
Predicate Device(s)
| Arobella Medical, LLC | AR1000 Ultrasonic Wound Therapy System | K062544 |
|---|---|---|
| Misonix, Inc | SonicOne Ultrasonic Wound Debridement System | K112782 |
| Celleration | Celleration Mist Therapy System | K122246 |
| Soring Gmbh | SONOCA 180 / 185 Wound Care System | K072904 |
1
807.92(a)(4)
Device Description
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
Section 005 510(k) Summary
Page 005-2 of 005-13
2
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.
Specifications:
| Generator Power Source | 85 -260V~ (VAC), 2.5A, 50/60Hz |
|---|---|
| Converter Power Output |