(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: <140 watts (Similar to K062544) Amplitude: 0um ~ 75um (0% to 100% power level) (Similar to K062544) Frequency: 35kHz (±3kHz) (Similar to K062544; predicates range from 22.5kHz to 40kHz) Weight: Generator: ~12.5 lbs; Handheld Converter: ~1.0 lbs (Similar to K062544) Dimensions: System 15" D x 12" W x 6" H; Handheld Converter: 9" x 1.3" diameter (Similar to K062544) Storage Temperature: -20 to +50° C at max RH 90% Operating Temperature: 0 to +40° C at max RH 90% (Similar to K062544) |
Note: For 510(k) submissions demonstrating substantial equivalence, the "study" is often a comparison to legally marketed predicate devices and compliance with relevant performance standards, rather than a de novo clinical trial with specific performance targets for a novel device. The document explicitly states: "There have been no changes to the AR1000 Ultrasonic Wound Therapy System cleared under 510(k) K062544 as a result of the proposed labeling changes. This 510(k) submission supports an expansion of the device's Indications For Use... The expansion of the device's Indications For Use... do not raise any new issues of safety or effectiveness."
2. Sample Size Used for the Test Set and the Data Provenance
The document does not describe a "test set" in the context of diagnostic performance or a clinical study for this 510(k) submission. This submission is for an expanded indication for use of an existing device by demonstrating substantial equivalence to predicates and compliance with standards.
The text mentions "expanded patient results and laboratory findings" that support the expanded Indications For Use (page 10, section 10.0 Safety and Effectiveness). However, it does not specify the sample size, country of origin, or whether this data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This 510(k) submission does not detail a study involving expert-established ground truth for a test set in the way a diagnostic or AI device might. The "expanded patient results and laboratory findings" are not further described in terms of expert review or ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. As there is no described test set with expert-established ground truth, no adjudication method is mentioned.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. The AR1000 is an ultrasonic wound therapy system, not an AI-assisted diagnostic or imaging device used by human readers for interpretation. Therefore, a MRMC comparative effectiveness study involving AI assistance for human readers is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) Was Done
Not applicable. This device is an ultrasonic therapy system, not an algorithm. Its operation inherently involves a human operator (physician) in the loop and is not a standalone algorithm.
7. The Type of Ground Truth Used
The document mentions "expanded patient results and laboratory findings" (page 10) as support for the expanded indications. However, it does not elaborate on the specific type of ground truth used within these findings (e.g., pathology, clinical outcomes, etc.) or how it was established. Given the nature of a wound therapy system, clinical outcomes like wound healing rates, reduction in non-viable tissue, or absence of infection would likely be relevant, but specific details are not provided in this summary.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/machine learning device that requires a training set with established ground truth.
{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 | <140 watts |
| Amplitude (adjustable) | 0um ~ 75um (0% to 100% power level) |
| Frequency | 35kHz (±3kHz) |
| Weight | Generator: ~12.5 lbsHandheld Converter: ~1.0 lbs |
| Approximate Dimensionsinches Height | System 15 inches Deep x 12 inches Wide x 6 |
| diameter | Handheld Converter: 9 inches x 1.3 inches |
| Storage Temperature90% | -20 to +50° C at a maximum relative humidity of(non-condensing) |
| Operating Temperature | 0 to +40° C at a maximum relative humidity of 90%(non-condensing) |
{3}------------------------------------------------
807 92(a)(5)
Intended Use(s)
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.
Patient population is patients of any age with one or more wounds. Patient population may also exhibit diabetes mellitus (DM).
The AR1000 Series and its variants is intended for Prescription use.
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.
Patient population is patients of any age with one or more wounds. Patient population may also exhibit diabetes mellitus (DM).
The AR1000 Series and its variants is intended for Prescription use.
{4}------------------------------------------------
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.
Patient population is patients of any age with one or more wounds. Patient population may also exhibit diabetes mellitus (DM).
The AR1000 Series and its variants is intended for Prescription use.
Section 005 510(k) Summary
{5}------------------------------------------------
807.92(Δ)δ)
There have been no changes to the AR1000 Ultrasonic Wound Therapy System deared under 510K) K062644 a a
result title proposed dibeling changes.
The following Tabl
The following Tables illustrate similarities and differences between the submitted AR1000 Ultrasonic Wound Therapy
System and the predicate devices.
ection 005_510(k) Summar
{6}------------------------------------------------
....... ﺎﻟﻠﻐﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ L ifi F .
Innia t T ---C 141 T.
| Device | 510(k) | Indicationsfor UseperindicatedUS FDA510(k) | Arobella AR1000 (ProposedK131096) | Arobella AR1000 | Misonix SonicOne | Celleration Mist | |
|---|---|---|---|---|---|---|---|
| Table 1: Comparison of Technical Characteristics Table - Specified Indications For Use with Identified Predicates | The AR1000 Series and itsvariants produce and deliver lowfrequency ultrasound used topromote wound healing via:• Selective and non-selectivedissection and fragmentation ofsoft and or hard tissue;• Surgical, excisional or sharp-edge wound debridement(acute and chronic wounds,burns) for the removal ofnonviable tissue including butnot limited to diseased tissue,necrotic tissue, slough andeschar, fibrin, tissue exudates,bacteria and other matter. | Selective dissectionand fragmentation oftissue, wounddebridement (acuteand chronic wounds,burns, diseased ornecrotic tissue), andcleansing irrigation ofthe site for the removalof debris, exudates,fragments, and othermatter. | The Misonix SonicOne isindicated for use in thedebridement of wounds,such as, but not limitedto: burn wounds, diabeticulcers, bedsores andvaginal ulcers, soft tissuedebridement andcleansing of the surgicalsite in applications inwhich, in the physician'sjudgment would requirethe use of an ultrasonicaspirator with sharpdebridement. | The MIST Therapysystem produces a lowenergyultrasound generatedmist used to promotewound healing throughwound cleansing andmaintenancedebridement by theremoval of yellowslough, fibrin, tissueexudates and bacteria. |
Page 005-7 of 005-13
.
Section 005_510(k) Summar
{7}------------------------------------------------
| Device | 510(k) | Indicationsfor UseperindicatedUS FDA510(k) | Arobella AR1000 (ProposedK131096) | ArobellaAR1000K062544 | Misonix SonicOne | K112782 | Celleration Mist | K122246 | Soring Sonoca | K072904 |
|---|---|---|---|---|---|---|---|---|---|---|
| The AR1000 Series and itsvariants produce and deliverlow frequency ultrasoundused to promote woundhealing via: | Selectivedissection andfragmentationof tissue,wounddebridement(acute andchronicwounds, burns,diseased ornecrotic tissue),and cleansingirrigation of thesite for theremoval ofdebris,exudates,fragments, andother matter. | The MisonixSonicOne isindicated for use inthe debridement ofwounds, such as,but not limited to:burn wounds,diabetic ulcers,bedsores andvaginal ulcers, softtissue debridementand cleansing ofthe surgical site inapplications inwhich, in thephysician'sjudgment wouldrequire the use ofan ultrasonicaspirator with sharpdebridement. | The MISTTherapysystemproduces a lowenergyultrasoundgenerated mistused topromote woundhealing throughwoundcleansing andmaintenancedebridement bythe removal ofyellow slough,fibrin, tissueexudates andbacteria. | The SONOCA 180/ 185 Wound Caresystem is aninstrumentintended forselectedultrasounddissection andfragmentation oftissue, wounddebridement(acute and chronicwounds, burns,diseased ornecrotic tissue)and cleansingirrigation of the sitefor removal ofdebris, exudates,fragments, andother matter. | ||||||
| • Site cleansing irrigationand lavage of wound tissue(acute and chronicwounds, burns, diseasedor necrotic tissue);• Contact and non-contactmaintenance debridementfor the removal of debris,exudates, fragments,bacteria, slough, fibrin,excised or fragmentedtissue, and other matter.IRRIGATION (LAVAGE)FLUID• Irrigation fluid may besterile de-ionized water,sterile saline solution, otherapproved wound therapyor debridement solution. |
·
Section 005_510(k) Summar
{8}------------------------------------------------
Table 3: Comparison of Technical Characteristics Table -- Specified Indications For Use with Identified Predicates
| Device | 510(k) | Indications for Use per indicated US FDA 510(k) | Arobella AR1000 (Proposed K131096) | Arobella AR1000K062544 | Misonix SonicOneK112782 | Celleration MistK122246 | Soring SonocaK072904 |
|---|---|---|---|---|---|---|---|
| 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. | Selective dissection and fragmentation of tissue, wound debridement (acute and chronic wounds, burns, diseased or necrotic tissue), and cleansing irrigation of the site for the removal of debris, exudates, fragments, and other matter. | The Misonix SonicOne is indicated for use in the debridement of wounds, such as, but not limited to: burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement. | The MIST Therapy system produces a low energy ultrasound generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates and bacteria. | The SONOCA 180 / 185 Wound Care system is an instrument intended for selected ultrasound dissection and fragmentation of tissue, wound debridement (acute and chronic wounds, burns, diseased or necrotic tissue) and cleansing irrigation of the site for removal of debris, exudates, fragments, and other matter. |
Page 005-9 of 005-13
Section 005_510(k) Summar
{9}------------------------------------------------
Table 4: Comparison of Technical Characteristics Table continued
| Device | Arobella AR1000 | Arobella AR1000 | Misonix SonicOne | Celleration Mist | Soring Sonoca |
|---|---|---|---|---|---|
| 510(k) number | This submissionK131096 | K062544 | K112782 | K122246 | K072904 |
| Device Agent | High IntensityUltrasound andirrigation 35KHz | High IntensityUltrasound andirrigation 35KHz | High IntensityUltrasound 22.5KHz | High IntensityUltrasound40KHz | High IntensityUltrasound40KHz |
| Agent Delivery | Irrigation, atomizedirrigation, contact, andnon-contact probe | Irrigation, atomizedirrigation, contact, andnon-contact probe | Contact probe | Atomized irrigantand Non-contactprobe | Contact probe |
| Agent Mechanism | Ultrasound forselective tissuedissection,fragmentation, andirrigation of wound bedover course oftreatment | Ultrasound forselective tissuedissection,fragmentation, andirrigation of wound bedover course oftreatment | General cavitation(thermal agitationand fragmentation)of wounds andtissue | Ultrasoundwound cleansingand maintenancedebridement | Generalcavitation(thermal agitationandfragmentation) ofwounds andtissue |
| Treatment Variable | Applicator size,positioning, contactsurface, frequencyand duration oftreatments, irrigationflow rate | Applicator size,positioning, contactsurface, frequencyand duration oftreatments, irrigationflow rate | Applicator size,positioning,frequency andduration oftreatments | Applicatorpositioning,frequency andduration oftreatments, Mistflow rate | Applicator size,positioning,frequency andduration oftreatments |
| Treatment Setting | Hospital, clinic, in-home, or intra-operative settings | Hospital, clinic, in-home, or intra-operative settings | Hospital, clinic, in-home, or intra-operative settings | Hospital, clinic,or in-homesettings | Intra-operativesettings |
Page 005-10 of 005-13
Section 005_510(k) Summar
{10}------------------------------------------------
807.92(b)
Safety and Effectiveness
There have been no changes to the AR1000 Ultrasonic Wound Therapy System cleared under 510(k) K062544 as a result of the proposed labeling changes.
This 510(k) submission supports an expansion of the device's Indications For Use. with respect to K062544, to incorporate expanded patient results and laboratory findings.
The expansion of the device's Indications For Use, with respect to K062544, do not raise any new issues of safety or effectiveness.
For safety and effectiveness purposes the AR1000 Ultrasound Wound Therapy System and its variants is substantially equivalent to the previously cleared AR1000 Ultrasound Wound Therapy System (K062544), the Misonix SonicOne (K112782) system, Celleration MIST (K122246) system, the Soring Sonoca (K072904) systems, and the Ethicon (K002906) system.
1.0 Efficacy
This device, like the predicates, is directed for single (1) treatment, and total recommended treatments shall be no more than three (3) times per week or as directed on the order of the physician. A typical treatment regimen is approximately two (2) weeks or more, depending on the size and nature and or condition of the treated area as well as other subject dependent factors, but may be prescribed for more or less frequent use and or for shorter or longer treatment regimen durations on the order of a physician.
This device also compares with the predicates, as follows:
1.1. Controlled ultrasonic delivery with 0.9% sterile saline solution, or other approved medium, to lavage the wound tissue (e.g. acute and chronic wounds, burns, diseased or necrotic tissue), like the Arobella AR1000 (K062544) system and the Celleration (K122246) predicate ultrasonic wound system.
1.2. Maintenance debridement of the treatment site for the removal of loose fragments, debris, exudate, bacteria, and other matter, like Arobella AR1000 (K062544) system, the Misonix SonicOne (K112782) system, the Celleration (K122246) system, and the Soring Sonoca (K072904) predicate ultrasonic wound system.
Section 005 510(k) Summary
Page 005-11 of 005-13
{11}------------------------------------------------
1.3. Ultrasonic selective dissection and debridement of tissue through the use of the probe (aka Qurette), including parallel to the wound bed surface for shallow separation of tissue lavers, like the predicate Arobella AR1000 (K062544) system and the Misonix SonicOne (K112782) system.
2.0 Safety
The AR1000 Ultrasonic Wound Therapy System and its variants consists of an ultrasonic power supply (hereto after referred to as a generator), an ultrasonic converter hand piece (or just converter), and distal end probe tip (Qurette), a liquid supply reservoir and delivery tubing. Substantial equivalence has been previously established between the AR1000 Ultrasonic Wound Therapy System (K062544) and the Celleration Mist, and the Misonix SonicOne predicate ultrasonic wound cleanser devices as outlined under K062544.
2.1 Electrical Safety & Electromagnetic Compatibility
Similar to the relevant predicates, this device complies with the following standards:
· IEC 60601-1 Medical electrical equipment, Part 1: General requirements for basic safety and essential performance
· UL 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety
• IEC 60601-1-2 Medical electrical equipment, Part 1-2: Electromagnetic compatibility
- Requirements and tests
· IEC 60601-1-4 Medical electrical equipment, Part 1-4: Programmable electrical medical svstems
· FCC Part 18 - EMC Requirements
2.2 Ultrasonic Safety
Similar to the relevant predicates, this device complies with the following standards:
- · 21 CFR 1050.10 Ultrasonic therapy products
- · IEC 61847 Ultrasonics Surgical systems Measurement and declaration of the basic output characteristics
Section 005 510(k) Summary
{12}------------------------------------------------
2.3 Biocompatibility
Similar to the relevant predicates, this device was tested for and complies with the standard ISO 10993-1:2003 - Biological evaluation of medical devices, Part 1: Evaluation and testing and its relevant annexes (based on nature and duration of patient contact). All testing was conducted in compliance to 21 CFR. Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies.
The AR1000 system is routinely used with 0.9% sterile saline solution, which is widely available for purchase from medical suppliers in bottle or bag form and is to be supplied by the user, as well as the tubing and the valve (for saline flow control). In the alternate, the AR1000 can also be used with other appropriate sterile mediums and US FDA-approved irrigation liquids. This is substantially equivalent to all of the predicate devices and irrigation solutions.
2.4 Transportation/Storage
Packaging systems for the non-sterile device and for the non-sterile accessories of the device (e.g. the converter, tips, shroud, et al) keep the product without deterioration and without a specific level of sterility stipulated, as do the predicate devices. Those accessories used specifically for treatment (e.g. converter, tip, shroud, etc) are to be sterilized prior to use to minimize the risk of microbial contamination, as established with the AR1000 K062544 device clearance.
As the device and the accessories are durable goods with little or no notable deterioration, the shelf life is the product lifecycle, barring storage or transportation damage, and/or use under extremes of environmental conditions (e.g. temperature, humidity, moisture, etc).
2.5 Reprocessing
The AR1000 system, as well as the AR1000 ultrasonic converter hand piece, is the wound debridement device cleared under K062544 for which reprocessing instructions have been previously validated and cleared.
The variant AR1000 ultrasonic converter hand piece allows for steam sterilization (autoclave) in addition to the previously cleared and validated reprocessing methodology. This variant may therefore be reprocessed by steam sterilization (autoclave), as well as the previously cleared and validated reprocessing methodology.
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Image /page/13/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. The logo is presented in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 16, 2014
Arobella Medical LLC Matthew Berscheid Director of Quality and Regulatory Affairs 5929 Baker Road, Suite 470 Minnetonka, MN 55345
Re: K131096
Trade/Device Name: AR1000 Ultrasonic Wound Therapy System Regulation Number: 21 CFR 878.4410 Regulatory Class: Class II Product Code: NRB Dated: April 03, 2014 Received: April 04, 2014
Dear Mr. Berscheid:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Matthew Berscheid
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
Binita Ashar, MD, MBA, FACS for Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
cc: DMC 510(k) Staff Division D.O.
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Indications for Use
510(k) Number (if known): K131096
Device Name: AR1000 Series Ultrasonic Wound Therapy System
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.
Patient population is patients of any age with one or more wounds. Patient population may also exhibit diabetes mellitus (DM).
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jiyoung Dang -S
Division Sign-Off Office of Device Evaluation
510(k) K131096
Page 1 of 3
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Indications for Use
510(k) Number (if known): K131096
Device Name: AR1000 Series Ultrasonic Wound Therapy System
Indications For Use:
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.
Patient population is patients of any age with one or more wounds. Patient population may also exhibit diabetes mellitus (DM).
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jiyoung Dang -S
Division Sign-Off Office of Device Evaluation
510(k)__K131096
Page 2 of 3
{17}------------------------------------------------
Indications for Use
510(k) Number (if known): K131096
Device Name: AR1000 Series Ultrasonic Wound Therapy System
Indications For Use:
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.
Patient population is patients of any age with one or more wounds. Patient population may also exhibit diabetes mellitus (DM).
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jiyoung Dang -S
Division Sign-Off Office of Device Evaluation
510(k)K131096_
Page 3 of 3
§ 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.