AS 1000 ULTRASOUND WOUND THERAPY SYSTEM

{0}------------------------------------------------ K 091038 l Page 1/8 # 510(k) Summary The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a). ### 807.92(a)(1) # Submitter Information JUN 19 2009 I Eliaz Babaev 5929 Baker Road, Suite 470 Minnetonka, MN 55345 Phone: (952) 345-6846 Fax: (952) 345-6841 Contact Person: Eliaz Babaev Date: April 1, 2009 807.92(a)(2) | Trade Name: | AS1000 Ultrasonic Wound Therapy System | |-------------------------|----------------------------------------| | Common Name: | Ultrasonic Wound Therapy System | | Classification Name(s): | Wound Cleaner,<br>Ultrasound | | Classification Number: | NRB | 807.92(a)(3) # Predicate Device(s) | Celleration | Celleration Mist Therapy System | K050129 | |-----------------------|----------------------------------------|---------| | Arobella Medical, LLC | AR1000 Ultrasonic Wound Therapy System | K062544 | | DeRoyal | Jetox-ND | Class I | | Smith & Nephew | VersaJet Hydrosurgery System | K060782 | 807.92(a)(4) # Device Description The AS1000 Ultrasonic Wound Therapy System promotes wound healing through the ultrasonic lavage of wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue) and cleansing irrigation & maintenance debridement of the removal of debris, exudates, fragments, bacteria, and other matter through the use of low-frequency, low-intensity, nonthermal non-contact ultrasonic energy and oxygenated fluid irrigation. {1}------------------------------------------------ K091038 Page 2/8 This is accomplished by the non-contact, non-thermal application of a fine oxygenated fluid stream spray to the wound bed whereby ultrasound energy is transmitted via the stream from the applicator tip to the wound tissue. Non-contact ultrasound provides cellular stimulation, increased blood flow, and reduced bioburden with much less pain or thermal-effect than competing direct contact ultrasound devices. The AS1000 uses continuous ultrasonic energy to oxygenate the fluid (typically sterile saline) into a solution stream and couple the delivery of ultrasonic energy via the stream to the treatment site. The level of airborne ultrasound energy generated by the device, its spatial characteristics, and the potential exposure to unwanted acoustic energy is substantially equivalent between the AS1000 device and the predicate Celleration MIST device since both have the same size diameter (10mm) oscillating surface generating the ultrasonic energy transmitted thru their respective streams. In addition, since both the AS1000 device and the predicate Celleration i MIST device are intended to treat tissue at the same distance and same pattern, the level of ultrasound energy transmitted to the patient and the effects of the applicator from the wound is substantially equivalent. As the AS1000 device and the predicates (Celleration MIST device and Arobella AR1000 device) are all derived from classic Langevin transducer designs, the variability in the field from device is expected to be substantially equivalent, and all AS1000 devices are tested and verified to perform within the reported parameters to maintain safety and efficacy The converter has a transducer horn that is made from titanium alloy (TI-6AL-4V). The applicator and tip are made from titanium alloy (TI-6AL-4V), like the probes for Celleration MIST and Arobella AR1000 predicated devices, and the other indirect patient-contact materials are stainless steel (both AIS) Type 300 & 17-4PH series), anodized aluminum alloy (6061), nylon, polyurethane, and silicone tubing. No latex is used in this device, including any potential patientcontact areas, and testing has revealed no negative reactions to the materials used in this device. Specifications: Generator Power Source 115VAC. 2.5A. 50/60Hz Converter Power Output Amplitude Frequency Weight Generator: ~16.5 Ibs <140 watts 0um ~ 80um 35kHz (+3kHz) Approximate Dimensions System 18" D x 14" W x 8" H Handheld Applicator: ~1.5lbs 2 {2}------------------------------------------------ K091038 Page 3/8 3 Storage Temperature Operating Temperature -20 to 50° C at a maximum relative humidity of 90% (non-condensing) 0 to 40° at a maximum relative humidity of 90% (non-condensing) ## 807.92(a)(5) ## Intended Use(s) Promotes wound healing through lavage of wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue) and maintenance debridement for the removal of debris, exudates, fragments, bacteria and other matter. ### 807.92(a)(6) # Technological Characteristics (see tables on following pages) {3}------------------------------------------------ ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… | COMPARISON<br>TABLE | Indications For<br>Use | 510(k) or PMA<br>Submission /<br>CFR Citation | Primary Device<br>Agent | Agent Delivery | | Agent<br>Mechanism | Treatment<br>Variable | Treatment<br>Setting | Pre Use<br>Sterilization | Material(s) In<br>Patient Contact | Post Use<br>Disposition | |--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|----------------------------------------------------|----------------------------------------------------------|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------| | Arobella Medical AS1000<br>Ultrasonic Wound Therapy<br>System | Promotes wound healing<br>through lavage of wound tissue<br>(acute and chronic wounds,<br>burns, diseased or necrotic<br>tissue) and maintanance<br>debridement for the removal of<br>debris, exudates, fragments,<br>bacteria, and other matter. | Pending Submission | Low-Intensity Low-Frequency<br>Ultrasound (35kHz) | Oxygenated Irrigant (e.g.<br>Saline) & Non-Contact Probe | Arobella Medical AS1000<br>Ultrasonic Wound Therapy<br>System | Ultrasound lavage spray for<br>cleansing irrigation of wound<br>bed over course of treatment | Applicator shape/positioning,<br>frequency and duration of<br>treatments; irrigant flow rate | Hospital, clinic, in-home, or<br>Intraoperative settings | Probe - Autoclave or Steam<br>Sterilize; Shield - Single-Use<br>Packaged Disposable | Probe (Horn & Tip) - Ti-6Al-4V | Probe - Reusable, Single<br>Patient Use Post-Sterilization,<br>User-Sterilizable; Shield -<br>Cleanable, Single Patient Use | | Celleration<br>(www.celleration.com) Mist<br>Therapy System | Promotes wound healing<br>through wound cleansing and<br>maintenance debridement<br>by the removal of yellow<br>slough, fibrin, tissue<br>exudates<br>and bacteria | K032378 / K050129 | Low-Intensity Low-Frequency<br>Ultrasound (40kHz) | Atomized Saline Irrigant &<br>Non-Contact Probe | Celleration<br>(www.celleration.com) Mist<br>Therapy System | Ultrasound wound cleansing<br>and maintenance<br>debridement | Applicator positioning,<br>frequency and duration of<br>treatments: Mist flow rate | Hospital, clinic, or in-home<br>settings | Probe - Cleaned/Disinfected;<br>Applicator - Sterile Single-<br>Use Packaged Disposable | Probe - Ti-6Al-4V<br>Applicator - Polymer Resin | Probe(s) - Reusable, User-<br>Cleanable;<br>Applicator - Disposable,<br>Single Patient Use | | DeRoyal (TAVTECH Ltd.)<br>(www.deroyal.com; alt<br>www.tav-tech.com) JetOx-<br>ND System | Cleansing and<br>debridement of wounds such<br>as pressure ulcers, diabetic<br>and venous ulcers, burns,<br>traumatic wounds, difficult-to-<br>heal tissue, and post-surgery<br>wounds. | Exempt<br>(880.5475 Jet Lavage) | Focused Irrigant Stream<br>Mixed With Oxygen | Atomized Oxygenated<br>Saline Irrigant | DeRoyal (TAVTECH Ltd.)<br>(www.deroyal.com; alt<br>www.tav-tech.com) JetOx-<br>ND System | Wound lavage cleansing and<br>debridement | Applicator positioning,<br>frequency and duration of<br>treatments; irrigant flow rate | Hospital, clinic, or in-home<br>settings | Applicator - Sterile Single-<br>Use Packaged Disposable | Tubing - Elastomer Resin<br>Applicator - Polymer Resin | Applicator & Tubing -<br>Disposable, Single Patient<br>Use | | Arobella Medical<br>(www.arobella.com) AR1000<br>(Qoustic) Wound Therapy<br>System | Selective dissection &<br>fragmentation of tissue, wound<br>debridement (acute and chronic<br>wounds, burns, diseased or<br>necrotic tissue), and cleansing<br>irrigation of the site for the<br>removal of debris, exudates,<br>fragments, and other matter. | K062544 | High-Intensity Low-Frequency<br>Ultrasound (35kHz) | Saline Irrigation & Contact<br>Probe | Arobella Medical AR1000<br>Ultrasonic Wound Therapy<br>System | Ultrasound for selective tissue<br>dissection and fragmentation<br>and irrigation of wound bed<br>over course of treatment | Applicator size/positioning/<br>contact-surface, frequency and<br>duration of treatments;<br>irrigation flowrate | Hospital, clinic, in-home, or<br>intraoperative settings | Probe - Autoclave or Steam<br>Sterilize; Shroud - Sterile<br>Single-Use Packaged<br>Disposable | Probe (Horn & Tip) - Ti-6Al-4V | Probe - Reusable, Single<br>Patient Use Post-Sterilization,<br>User-Sterilizable | | Smith & Nephew<br>(wound.smith-nephew.com/<br>us/Home.asp) VersaJet<br>Hydrosurgery System | Wound debridement, soft<br>tissue debridement, and<br>cleansing of surgical site and<br>burns | K991383 / K011612 /<br>K060782 | Pressurized Fluid Stream &<br>Evacuation | Saline Irrigation Jet / Suction<br>Nozzle | Smith & Nephew<br>(wound.smith-nephew.com/<br>us/Home.asp) VersaJet<br>Hydrosurgery System | Pressurized stream and<br>evacuation cuts, ablates, and<br>removes tissue and foreign<br>matter and surgically resects/<br>removes material | Applicator positioning,<br>frequency and duration of<br>treatments: flow and<br>evacuation rate | Hospital, clinic, or<br>Intraoperative settings | Probe/Pump - Sterile Single-<br>Use Packaged Disposable | Probe - AISI Type 300?<br>Disposable Pump Housing -<br>Polymer Resin | Probe/Pump - Disposable,<br>Single Patient Use Only | K091038 Page 4/8 4 {4}------------------------------------------------ · : . : ... .. .. . : 1 | | Arobella Medical AS1000<br>Ultrasonic Wound Therapy<br>System | Celleration<br>(www.celleration.com) Mist<br>Therapy System | DeRoyal (TAVTECH Ltd.)<br>(www.deroyal.com; alt<br>www.tav-tech.com) JetOx-<br>ND System | Arobella Medical AR1000<br>Ultrasonic Wound Therapy<br>System | Smith & Nephew<br>(wound.smith-nephew.com/<br>us/Home.asp) VersaJet<br>Hydrosurgery System | |-------------------------|---------------------------------------------------------------|-------------------------------------------------------------|------------------------------------------------------------------------------------------|---------------------------------------------------------------|--------------------------------------------------------------------------------------------| | Ultrasound<br>Intensity | Variable 10%~100%<br>$(0.1-0.5 W/cm^2)$ | Preset based on wound size<br>$(0.1-0.5 W/cm^2)$ | No ultrasound effect | Variable 10%~100%<br>$(0.1-2.0 W/cm^2)$ | No ultrasound effect | | Operational<br>Modes | Continuous or pulsed<br>ultrasound | Continuous ultrasound | Continuous flowstream | Continuous or pulsed<br>ultrasound | Continuous flowstream | | Coupling<br>Interface | Sterile oxygenated-fluid<br>(saline) stream | Sterile saline mist | Sterile oxygenated-fluid<br>(saline) stream | Sterile saline stream | Sterile saline stream | | Aerosolization | Minimal | Minimal | Minimal | Minimal | Minimal | | Fluid Splatter | Yes | Yes | Yes | Yes | Yes | | User Controls | Foot Pedal & Panel Buttons<br>(Oxygen & Fluid Valving) | Button & Fluid Valving On<br>Applicator Body | Oxygen & Fluid Valving | Foot Pedal & Panel Buttons<br>(Fluid Valving) | Panel Buttons (Fluid Valving) | | Treatment Time | Varies on wound size<br>(1-5 minutes) | Varies on wound size<br>(3-20 cm) | Varies on wound size<br>(3-10 minutes) | 1-5 minutes | 1-5 minutes | | Treatment<br>Distance | 5~15 mm | 5-15 mm | 10-25 mm | Contact with applicator probe | Contact with cutting stream | | Treatment<br>Pattern | Mesh (Top-Bottom, Left-Right) | Mesh (Top-Bottom,<br>Left-Right) | Mesh (Top-Bottom,<br>Left-Right) | Depends on tissue<br>selected for removal | Depends on tissue<br>selected for removal | | Debridement | Maintenance | Maintenance | Maintenance | Selective / Volumetric Ablation | Precision cutting | . - 5 . K09 1038 Page 5/e . {5}------------------------------------------------ K091038 Page 4/8 807.92(b) # Safety and Effectiveness The AS1000 Ultrasound Wound Therapy System is substantially equivalent to the Celleration MIST system and the Arobella AR1000 Ultrasonic Wound Therapy System as well as the DeRoyal JetOx ND and Smith+Nephew VersaJet. ### 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; typical treatment regimen is approximately two (2) weeks or more, depending on the size and nature/condition of the treated area as well as other subject dependent factors, but may be prescribed for more frequent use and/or for a shorter or longer treatment regimen duration on the order of a physician. This device also compares with the predicates, as follows: 1. Controlled ultrasonic delivery of oxygenated-fluid irrigation, primarily recommended for use with 0.9% sterile saline solution and filtered oxygen, to lavage the wound tissue (e.g. acute and chronic wounds, burns, diseased or necrotic tissue), like the Celleration predicate ultrasonic wound cleanser though with the addition of oxygenated-irrigant and like the DeRoyal JetOx predicate jet lavage with the additional of ultrasound. 2. Maintenance debridement of the site for the removal of loose fragments, debris, exudate, bacteria, and other matter, like the Celleration predicate ultrasonic wound cleanser though with the addition of oxygenated-irrigant and like the DeRoyal JetOx predicate jet lavage with the additional of ultrasound. 3. Ultrasonic separation/debridement of tissue through the use of the applicator and tip, either parallel to the wound bed surface for shallow separation of tissue layers, like the predicate Smith+Nephew hydrosurgical device, or normal to the wound bed for non-contact cavitational ablation of the unwanted tissue. like the Arobella AR1000 predicate selective, contact debridement device but instead with low-intensity, non-contact ultrasonic energy and like the low-intensity, low-frequency Celleration predicate ultrasonic wound cleanser though with the addition of oxygenated-irrigant. 4. As a result, the AS1000 promotes wound or tissue healing, like the Celleration predicate ultrasonic wound cleanser though with the addition of oxygenated-irrigant. There is significant clinical literature (see list of Example References Cited in the Technical Device Description) as precedence to support the use of therapeutic ultrasound to demonstrate the different aspects and characteristics associated with or required for the promotion of wound healing (e.g. stimulation of blood flow, fibrin promulgation, macrophage stimulation/bacteria destruction, and so forth). {6}------------------------------------------------ K091038. Page 7/8 In addition, the 2008 CPT codebook provides a Class III for this treatment modality as 0183T -Low frequency, non-contact, non-thermal ultrasound, including topical application(s) when performed, wound assessment, and instruction(s) for ongoing care, per day. The Instructions For Use (IFU) for more specific examples of the applicator's use, and the entire system is compact in size such that in can be used at a primary care provider's office (on an out-patient basis), clinic, specialized treatment center (i.e. burn center), or hospital, like all of the predicate devices. ### 2.0 Safety ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ The AS1000 system consists of an ultrasonic power supply (hereto after referred to as a generator), an ultrasonic converter hand piece (or just converter), an applicator & tip, a saline supply reservoir & conduit tubing, a oxygen supply reservoir & conduit tubing, and, optionally, a waste chamber for material removed by aspiration. This establishes substantial equivalence to the Celleration predicate ultrasonic wound cleanser and Arobella AR1000 predicate selective, contact debridement device. The option to aspirate establishes substantial equivalence to the Smith+Nephew VersaJet and the DeRoyal JetOx HDC (though not listed in the comparison table, the JetOx HDC is essentially the JetOx ND with the addition of aspiration). 2.1 Electrical Safety & Electromagnetic Compatibility Like 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 Like 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 2.3 Biocompatibility Like 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 {7}------------------------------------------------ K091038 Page 8/8. 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 AS1000 system is preferred to be 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, valving (for saline flow control), and connector (for attachment to the converter). Alternately, the AS1000 can also be used with other FDA-approved irrigants. This is comparable 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 applicator, tips, shroud, optional aspiration port, et al) keep the product without deterioration and without a specific level of sterility stipulated, like all the predicate devices. Those accessories used specifically for treatment (e.g. applicator, tip, shroud, etc) are to be sterilized prior to use to minimize the risk of microbial contamination, like the predicate Arobella AR1000 selective, contact debridement device. In addition, the packaging system will be subjected to the appropriate testing (as applicable) to ensure the device and the accessories arrive in usable and functioning condition for use. like the predicate devices. As the device and the accessories are durable goods with little or no notable deterioration, the shelf life is at the very least as long as the product lifecycle, barring storage, transportation, and/or use under extremes of environmental conditions (e.g. temperature, humidity, moisture, etc). ### 2.5 Reprocessing This device is virtually identical from an infection control perspective to the Arobella AR1000 wound debridement device for which we have previously validated the reprocessing instructions. The instructions for reprocessing (i.e. cleaning and sterilizing) the device from the IFU are identical to the predicate Arobella AR1000 which have already been validated. {8}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. Public Health Service JUN 19 2009 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Arobella Medical, LLC % Eliaz Babaev 5929 Baker Road, Suite 470 Minnetonka, Minnesota 55345 Re: K091038 Trade/Device Name: AS1000 Ultrasonic Wound Therapy System Regulation Number: 21 CFR 878.4410 Regulation Name: Low energy ultrasound wound cleaner Regulatory Class: II Product Code: NRB, FQH Dated: April 1, 2009 Received: April 13, 2009 Dear Eliaz Babev: We have reviewed your 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. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {9}------------------------------------------------ Page 2 - Eliaz Babaev 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Mark N. Molkersen Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {10}------------------------------------------------ # Indications for Use 510(k) Number (if known): KC91038 Device Name: AS1000 Ultrasonic Wound Therapy System Indications for Use: Promotes wound healing through lavage of wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue) and maintenance debridement for the removal of debris, exudates, fragments, bacteria and other matter. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Daniel Keane for MXM (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K091038