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.

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. 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.

AI/ML Overview

The provided 510(k) summary for the AS1000 Ultrasonic Wound Therapy System does not contain specific acceptance criteria or a dedicated study proving the device meets particular numerical performance targets. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, safety standards compliance, and intended use.

Therefore, many of the requested sections (e.g., specific performance values, sample sizes for test sets, number of experts for ground truth, MRMC study, training set details) cannot be extracted directly from this document. The document describes the basis for equivalence rather than presenting a performance study with detailed acceptance criteria and results against those criteria.

However, I can extract information related to safety and the general approach to demonstrating effectiveness through equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit numerical acceptance criteria for performance are not stated in this 510(k) summary. The "acceptance criteria" are implied to be substantial equivalence to predicate devices in terms of intended use, technological characteristics, and safety.

Feature/Aspect	Acceptance Criteria (Implied)	Reported Device Performance/Characteristics
Intended Use	Substantially equivalent to predicate devices for promoting wound healing through lavage and debridement.	"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." This is explicitly stated to be comparable to the predicates.
Technological Characteristics	Substantially equivalent to predicate devices (Celleration MIST, Arobella AR1000, DeRoyal JetOx ND, Smith & Nephew VersaJet) in key features like agent, delivery, mechanism, treatment variables, and physical specifications.	AS1000: Low-Intensity Low-Frequency Ultrasound (35kHz), Oxygenated Irrigant (e.g. Saline) & Non-Contact Probe, Ultrasound lavage spray for cleansing, variable intensity (0.1-0.5 W/cm2), continuous or pulsed modes, 5-15mm treatment distance. Compared to predicates: Similar ultrasound frequency, non-contact delivery, similar intensity range, uses oxygenated irrigant (distinguishing it from some predicates but combining features from others), similar treatment distance to Celleration MIST. Explicitly states "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."
Safety - Electrical & EMC	Compliance with relevant international and national electrical safety and electromagnetic compatibility standards.	Complies with: IEC 60601-1, UL 60601-1, IEC 60601-1-2, IEC 60601-1-4, FCC Part 18.
Safety - Ultrasonic	Compliance with relevant ultrasonic safety standards.	Complies with: 21 CFR 1050.10, IEC 61847.
Safety - Biocompatibility	Compliance with biological evaluation standards for medical devices based on patient contact.	Complies with: ISO 10993-1:2003 and relevant annexes. Testing conducted in compliance with 21 CFR, Part 58 (GLP).
Reprocessing	Reprocessing instructions are validated and comparable to predicate devices.	Instructions for reprocessing (cleaning and sterilizing) are "identical to the predicate Arobella AR1000 which have already been validated."

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a test set or clinical study with a specified sample size.
The "data provenance" for performance is based on the substantial equivalence argument to existing, legally marketed predicate devices, and a general reference to clinical literature supporting the use of therapeutic ultrasound for wound healing. It does not refer to new clinical data generated specifically for the AS1000.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable, as no specific test set requiring expert-established ground truth is described.

4. Adjudication Method for the Test Set

Not applicable, as no specific test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study is not mentioned or described in this 510(k) summary. The submission focuses on device equivalence, not a comparison of human reader effectiveness with or without AI assistance, as this is not an AI-based diagnostic device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not applicable, as this is a physical medical device, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" implicitly used is the established safety and efficacy profile of the predicate devices and the general scientific understanding of ultrasound therapy for wound healing, as supported by referenced (though not detailed) clinical literature. There is no specific, newly generated ground truth data for the AS1000 in this submission.

8. The Sample Size for the Training Set

Not applicable, as this is a physical medical device, not an AI/Machine Learning algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is a physical medical device.

Summary

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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

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,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

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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

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K091038 Page 3/8

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)

807.92(a)(6)

Technological Characteristics

(see tables on following pages)

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………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

COMPARISONTABLE	Indications ForUse	510(k) or PMASubmission /CFR Citation	Primary DeviceAgent	Agent Delivery		AgentMechanism	TreatmentVariable	TreatmentSetting	Pre UseSterilization	Material(s) InPatient Contact	Post UseDisposition
Arobella Medical AS1000Ultrasonic Wound TherapySystem	Promotes wound healingthrough lavage of wound tissue(acute and chronic wounds,burns, diseased or necrotictissue) and maintanancedebridement for the removal ofdebris, exudates, fragments,bacteria, and other matter.	Pending Submission	Low-Intensity Low-FrequencyUltrasound (35kHz)	Oxygenated Irrigant (e.g.Saline) & Non-Contact Probe	Arobella Medical AS1000Ultrasonic Wound TherapySystem	Ultrasound lavage spray forcleansing irrigation of woundbed over course of treatment	Applicator shape/positioning,frequency and duration oftreatments; irrigant flow rate	Hospital, clinic, in-home, orIntraoperative settings	Probe - Autoclave or SteamSterilize; Shield - Single-UsePackaged Disposable	Probe (Horn & Tip) - Ti-6Al-4V	Probe - Reusable, SinglePatient Use Post-Sterilization,User-Sterilizable; Shield -Cleanable, Single Patient Use
Celleration(www.celleration.com) MistTherapy System	Promotes wound healingthrough wound cleansing andmaintenance debridementby the removal of yellowslough, fibrin, tissueexudatesand bacteria	K032378 / K050129	Low-Intensity Low-FrequencyUltrasound (40kHz)	Atomized Saline Irrigant &Non-Contact Probe	Celleration(www.celleration.com) MistTherapy System	Ultrasound wound cleansingand maintenancedebridement	Applicator positioning,frequency and duration oftreatments: Mist flow rate	Hospital, clinic, or in-homesettings	Probe - Cleaned/Disinfected;Applicator - Sterile Single-Use Packaged Disposable	Probe - Ti-6Al-4VApplicator - Polymer Resin	Probe(s) - Reusable, User-Cleanable;Applicator - Disposable,Single Patient Use
DeRoyal (TAVTECH Ltd.)(www.deroyal.com; altwww.tav-tech.com) JetOx-ND System	Cleansing anddebridement of wounds suchas pressure ulcers, diabeticand venous ulcers, burns,traumatic wounds, difficult-to-heal tissue, and post-surgerywounds.	Exempt(880.5475 Jet Lavage)	Focused Irrigant StreamMixed With Oxygen	Atomized OxygenatedSaline Irrigant	DeRoyal (TAVTECH Ltd.)(www.deroyal.com; altwww.tav-tech.com) JetOx-ND System	Wound lavage cleansing anddebridement	Applicator positioning,frequency and duration oftreatments; irrigant flow rate	Hospital, clinic, or in-homesettings	Applicator - Sterile Single-Use Packaged Disposable	Tubing - Elastomer ResinApplicator - Polymer Resin	Applicator & Tubing -Disposable, Single PatientUse
Arobella Medical(www.arobella.com) AR1000(Qoustic) Wound TherapySystem	Selective dissection &fragmentation of tissue, wounddebridement (acute and chronicwounds, burns, diseased ornecrotic tissue), and cleansingirrigation of the site for theremoval of debris, exudates,fragments, and other matter.	K062544	High-Intensity Low-FrequencyUltrasound (35kHz)	Saline Irrigation & ContactProbe	Arobella Medical AR1000Ultrasonic Wound TherapySystem	Ultrasound for selective tissuedissection and fragmentationand irrigation of wound bedover course of treatment	Applicator size/positioning/contact-surface, frequency andduration of treatments;irrigation flowrate	Hospital, clinic, in-home, orintraoperative settings	Probe - Autoclave or SteamSterilize; Shroud - SterileSingle-Use PackagedDisposable	Probe (Horn & Tip) - Ti-6Al-4V	Probe - Reusable, SinglePatient Use Post-Sterilization,User-Sterilizable
Smith & Nephew(wound.smith-nephew.com/us/Home.asp) VersaJetHydrosurgery System	Wound debridement, softtissue debridement, andcleansing of surgical site andburns	K991383 / K011612 /K060782	Pressurized Fluid Stream &Evacuation	Saline Irrigation Jet / SuctionNozzle	Smith & Nephew(wound.smith-nephew.com/us/Home.asp) VersaJetHydrosurgery System	Pressurized stream andevacuation cuts, ablates, andremoves tissue and foreignmatter and surgically resects/removes material	Applicator positioning,frequency and duration oftreatments: flow andevacuation rate	Hospital, clinic, orIntraoperative settings	Probe/Pump - Sterile Single-Use Packaged Disposable	Probe - AISI Type 300?Disposable Pump Housing -Polymer Resin	Probe/Pump - Disposable,Single Patient Use Only

K091038 Page 4/8

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· :

... .. .. . :

	Arobella Medical AS1000Ultrasonic Wound TherapySystem	Celleration(www.celleration.com) MistTherapy System	DeRoyal (TAVTECH Ltd.)(www.deroyal.com; altwww.tav-tech.com) JetOx-ND System	Arobella Medical AR1000Ultrasonic Wound TherapySystem	Smith & Nephew(wound.smith-nephew.com/us/Home.asp) VersaJetHydrosurgery System
UltrasoundIntensity	Variable 10%~100%$(0.1-0.5 W/cm^2)$	Preset based on wound size$(0.1-0.5 W/cm^2)$	No ultrasound effect	Variable 10%~100%$(0.1-2.0 W/cm^2)$	No ultrasound effect
OperationalModes	Continuous or pulsedultrasound	Continuous ultrasound	Continuous flowstream	Continuous or pulsedultrasound	Continuous flowstream
CouplingInterface	Sterile oxygenated-fluid(saline) stream	Sterile saline mist	Sterile oxygenated-fluid(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(Oxygen & Fluid Valving)	Button & Fluid Valving OnApplicator Body	Oxygen & Fluid Valving	Foot Pedal & Panel Buttons(Fluid Valving)	Panel Buttons (Fluid Valving)
Treatment Time	Varies on wound size(1-5 minutes)	Varies on wound size(3-20 cm)	Varies on wound size(3-10 minutes)	1-5 minutes	1-5 minutes
TreatmentDistance	5~15 mm	5-15 mm	10-25 mm	Contact with applicator probe	Contact with cutting stream
TreatmentPattern	Mesh (Top-Bottom, Left-Right)	Mesh (Top-Bottom,Left-Right)	Mesh (Top-Bottom,Left-Right)	Depends on tissueselected for removal	Depends on tissueselected for removal
Debridement	Maintenance	Maintenance	Maintenance	Selective / Volumetric Ablation	Precision cutting

5 .

K09 1038 Page 5/e

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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:

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.
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.
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.
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).

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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

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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.

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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

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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

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Indications for Use

510(k) Number (if known): KC91038

Device Name: AS1000 Ultrasonic Wound Therapy System

Indications for Use:

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

Regulation Number and Section

§ 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.