Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a device using ultrasound and saline for tissue dissection and wound debridement. There is no mention of AI, ML, image processing, or any data-driven algorithms. The predicate devices are also ultrasonic or hydrosurgery systems without apparent AI/ML components.

Therapeutic

Yes
The device is described as being used for "selective dissection and fragmentation of tissue, wound debridement... and cleansing irrigation of the site," indicating its use in treating wounds and tissues, which aligns with the definition of a therapeutic device.

Diagnostic

No

The device description indicates its purpose is for tissue dissection, fragmentation, wound debridement, and cleansing irrigation, which are therapeutic actions, not diagnostic ones. It is used to remove tissue and debris, not to identify or characterize disease.

SaMD (Software as a Medical Device)

No

The device description explicitly states the system "uses ultrasound" and "saline for irrigation," indicating the presence of hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use describes a procedure performed directly on a patient's tissue (dissection, fragmentation, debridement, irrigation). This is a therapeutic or surgical intervention, not a diagnostic test performed on samples taken from the body.
Device Description: The device uses ultrasound and saline for direct interaction with tissue and wounds. This aligns with a therapeutic or surgical device, not a device that analyzes biological samples.
Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue samples, etc.) or the use of reagents, which are typical characteristics of IVD devices.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to physically interact with and treat tissue.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

FQH; LFL; NRB

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Not Found

Key Metrics

Not Found

Predicate Device(s)

K050776, K012753, K060782, K050129

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

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

Intended Use / Indications for Use

Product codes

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

Description of the training set, sample size, data source, and annotation protocol

Description of the test set, sample size, data source, and annotation protocol

Summary of Performance Studies

Key Metrics

Predicate Device(s)

Reference Device(s)

Predetermined Change Control Plan (PCCP) - All Relevant Information

510(k) Summary

807.92(a)(1)

Submitter Information

Predicate Device(s)

Device Description

Intended Use(s)

国际官网官网官网 正版官

ຂວາງຂາຍອ່ວຂາຍປົວ ໄຂວigolourilวອT

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Indications for Use

国际官网官网官网正版官