Who is the manufacturer of AR1000 ULTRASONIC WOUND THERAPY SYSTEM?

Arobella Medical, LLC filed the 510(k) submission for AR1000 ULTRASONIC WOUND THERAPY SYSTEM (K062544).

What is the FDA product code for AR1000 ULTRASONIC WOUND THERAPY SYSTEM?

LFL. as a Class U device in the SU panel.

What is the regulatory pathway for AR1000 ULTRASONIC WOUND THERAPY SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for AR1000 ULTRASONIC WOUND THERAPY SYSTEM?

SonicOne Ultrasonic Wound Debridement System (K050776); Sonoca 180 Ultrasound Dissection (K012753); VersaJet Hydrosurgery System (K060782); Celleration Mist Therapy System (K050129).

Who can help prepare an FDA 510(k) submission like AR1000 ULTRASONIC WOUND THERAPY SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

AR1000 ULTRASONIC WOUND THERAPY SYSTEM

K062544 · Arobella Medical, LLC · LFL · Jan 3, 2007 · SU

Device Facts

Record ID	K062544
Device Name	AR1000 ULTRASONIC WOUND THERAPY SYSTEM
Applicant	Arobella Medical, LLC
Product Code	LFL · SU
Decision Date	Jan 3, 2007
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

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.

Device Story

AR1000 Ultrasonic Wound Therapy System utilizes ultrasonic energy for selective tissue dissection, fragmentation, and wound debridement; saline irrigation removes debris, exudates, and necrotic tissue. Device operates via high-intensity ultrasound; clinician-controlled applicator positioning and treatment duration. Used in hospital, clinic, or intraoperative settings to facilitate wound healing and site cleansing. Output is mechanical fragmentation of tissue and irrigation flow; healthcare providers use output to clear wound beds and prepare sites for healing. Benefits include efficient removal of slough, fibrin, and bacteria from wound surfaces.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison to legally marketed predicate devices.

Technological Characteristics

Ultrasonic surgical instrument; utilizes high-intensity ultrasound for tissue fragmentation and saline irrigation. System includes an applicator for contact-based treatment. Operates via ultrasonic energy (frequency range typical of surgical debridement systems). Connectivity: Standalone. Sterilization: Not specified.

Indications for Use

Indicated for selective tissue dissection, fragmentation, and wound debridement in patients with acute or chronic wounds, burns, or diseased/necrotic tissue, including site cleansing/irrigation.

Predicate Devices

SonicOne Ultrasonic Wound Debridement System (K050776)
Sonoca 180 Ultrasound Dissection (K012753)
VersaJet Hydrosurgery System (K060782)
Celleration Mist Therapy System (K050129)

Reference Devices

AUSS-6 Ultrasonic Surgical Aspirator System (K050776)
Celleration Mist Therapy System (K032378)
VersaJet Hydrosurgery System (K991383)
VersaJet Hydrosurgery System (K011612)

Related Devices

K131096 — AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM · Arobella Medical, LLC · May 16, 2014
K091038 — AS 1000 ULTRASOUND WOUND THERAPY SYSTEM · Arobella Medical, LLC · Jun 19, 2009
K050129 — CELLERATION MIST THERAPY SYSTEM 5.1 · Celleration, Inc. · May 17, 2005
K011612 — MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM · Hydrocision, Inc. · Jun 22, 2001
K140782 — ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR · Celleration, Inc. · Aug 13, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ 510(k) Summary AR1000 Arobella Medical, LLC JAN - 3 2007 K062544 1/2 ## 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 Allison Scott 11460 N. Meridian St., Suite 150 Carmel, IN 46032 Phone: (317) 569-9500 x106 Facsimile: (317) 569-9520 Contact Person: Allison Scott Date: August 29, 2006 807.92(a)(2) | Trade Name: | AR1000 Ultrasonic Wound Therapy System | |-------------------------|--------------------------------------------| | Common Name: | Ultrasonic Wound Therapy System | | Classification Name(s): | Jet Lavage; Ultrasonic Surgical Instrument | | Classification Number: | FQH; LFL; NRB | 807.92(a)(3) ## Predicate Device(s) | Misonix, Inc. | SonicOne Ultrasonic Wound Debridement System | K050776 | | | | | | | | | |----------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| | Soring Gmbh | Sonoca 180 Ultrasound Dissection | K012753 | Treatment Setting | Treatment Variable | Agent Mechanism | Agent Delivery | Device Agent | 510(K) or PMA Submission/ CFR Citation | Indications For Use | COMPARISON TABLE | | Smith & Nephew | VersaJet Hydrosurgery System | K060782 | Hospital, clinic, in- home, or intraoperative settings | Applicator size/ positioning/contact- surface, frequency and duration of treatments; irrigation flow rate | Ultrasound for selective tissue dissection and fragmentation and irrigation of wound bed over course of treatment | Irrigation & Contact Probe | High Intensity Ultrasound & Irrigation 35kHz / ? | To Be Submitted | Selective dissection & 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. May promote healing of wound or tissue. | Arobella Medical AR1000 Ultrasonic Wound Therapy System | | Celleration | Celleration Mist Therapy System | K050129 | Hospital, clinic, in- home, or intraoperative settings | Applicator size/ positioning, frequency and duration of treatments | General cavitation (thermal agitation and fragmentation) of wounds and tissues | Contact Probe | High Intensity Ultrasound 22.5kHz / ? | K050776 (AUSS-6 Ultrasonic Surgical Aspirator System) | Ultrasonic debridement of wounds (including burns, diabetic ulcers, bedsores, and vaginal ulcers), soft tissues, and cleansing surgical sites | Misonix (www.misonix.com) SonicOne™ Ultrasonic Wound Debridement System | | Intraoperative setting | Applicator size/ positioning, frequency and duration of treatments | General cavitation (thermal agitation and fragmentation) of wounds and tissues | Contact Probe | High Intensity Ultrasound 25kHz / ? | K012753 | Selected dissection and fragmenting of tissue at the operation site during multi-medical discipline surgery (General Surgery, Neuro, Thoracic, Urology, and Gastro-intestinal) | Soring Gmbh Medizintechnik (www.soering.com) Sonoca 180 Ultrasound Dissection | | | | | Hospital, clinic, or in-home settings | Applicator positioning, frequency and duration of treatments; Mist flow rate | Ultrasound wound cleansing and maintenance debridement | Atomized Irrigant & Non-Contact Probe | High Intensity Ultrasound 40kHz / ? | K032378 / K050129 | Promotes wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates and bacteria | Celleration (www.celleration.co m) Mist Therapy System | | | | | Hospital, clinic, or intraoperative settings | Applicator positioning, frequency and duration of treatments: flow and evacuation rate | Pressurized stream and evacuation cuts, ablates, and removes tissue and foreign matter and surgically resects/ removes material | Irrigation/Suction Nozzle | Pressurized Fluid Stream & Evacuation | K991383 / K011612 / K060782 | Wound debridement, soft tissue debridement, and cleansing of surgical site and burns | Smith & Nephew (wound.smith- nephew.com/us/ Home.asp) VersaJet Hydrosurgery System | | | | 807.92(a)(4) ## Device Description The AR1000 system uses ultrasound for selective tissue dissection and fragmentation and saline for irrigation of the wound bed over course of treatment. 807.92(a)(5) ## Intended Use(s) Selective dissection and fragmentation of tissue, wound debridement (acute and chro ic wounds, burns, diseased or necrotic tissue), and cleansing irrigation of the site for the remo al of debris, exudates, fragments, and other matter. {1}------------------------------------------------ KO63544 ัวโป โยธิประกูตจังหวัดอันด์ ## 国际官网官网官网正版官 # ຂວາງຂາຍອ່ວຂາຍປົວ ໄຂວigolourilวອT : スノニ {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/13 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design resembling a bird or human figure with outstretched arms. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure. ### Public Health Service JUL 2 2009 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Arobella Medical, LLC c/o Mr. Eliaz Babaev President & Chief Executive Officer 5929 Baker Road, Suite 470 Minnetonka, Minnesota 55345 Re: K062544 Trade/Device Name: AR1000 Ultrasonic Wound Therapy System Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LFL Dated: December 12, 2006 Received: December 13, 2006 Dear Mr. Babaev: This letter corrects our substantially equivalent letter of January 3, 2007. 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 (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 {3}------------------------------------------------ Page -Mr. Eliaz Babaev 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 forth in the quality systems (OS) 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, ly yours, I. Melkerson Mark N. Melkerson Division of Surgical, Orthoped and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health {4}------------------------------------------------ K062544 ## Indications for Use 510(k) Number (if known): 长O62544 Device Name: AR1000 Ultrasonic Wound Therapy System Indications for Use: 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. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) ಳ (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Sdo DSP D.K (Division Sign-Off) Division of General, Restorative, and Neurological Devices **510(k) Number** L062544