(126 days)
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 AR1000 system uses ultrasound for selective tissue dissection and fragmentation and saline for irrigation of the wound bed over course of treatment.
The provided text is a 510(k) summary for the AR1000 Ultrasonic Wound Therapy System. It details the device description, intended use, and comparison to predicate devices. However, it does not include information about acceptance criteria, study design, sample sizes for test/training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, or results of MRMC or standalone studies.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance.
- Sample sized used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
- If a standalone study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
The document primarily focuses on demonstrating substantial equivalence to existing devices based on technical characteristics and intended use, rather than presenting clinical study results with specific performance metrics and acceptance criteria.
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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 | TreatmentSetting | TreatmentVariable | AgentMechanism | AgentDelivery | Device Agent | 510(K) or PMASubmission/CFR Citation | Indications ForUse | COMPARISONTABLE |
| Smith & Nephew | VersaJet Hydrosurgery System | K060782 | Hospital, clinic, in-home, orintraoperative settings | Applicator size/positioning/contact-surface, frequencyand duration oftreatments; irrigationflow rate | Ultrasound forselective tissuedissection andfragmentation andirrigation of woundbed over course oftreatment | Irrigation & ContactProbe | High IntensityUltrasound & Irrigation35kHz / ? | To Be Submitted | Selective dissection &fragmentation of tissuewound debridement(acute and chronicwounds, burns,diseased or necrotictissue), and cleansingirrigation of the site forthe removal of debris,exudates, fragments,and other matter. Maypromote healing ofwound or tissue. | Arobella MedicalAR1000 UltrasonicWound TherapySystem |
| Celleration | Celleration Mist Therapy System | K050129 | Hospital, clinic, in-home, orintraoperativesettings | Applicator size/positioning,frequency andduration oftreatments | General cavitation(thermal agitationand fragmentation)of wounds andtissues | Contact Probe | High IntensityUltrasound22.5kHz / ? | K050776(AUSS-6 UltrasonicSurgical AspiratorSystem) | Ultrasonicdebridement ofwounds (includingburns, diabeticulcers, bedsores,and vaginal ulcers),soft tissues, andcleansing surgicalsites | Misonix(www.misonix.com)SonicOne™Ultrasonic WoundDebridementSystem |
| Intraoperativesetting | Applicator size/positioning,frequency andduration oftreatments | General cavitation(thermal agitationand fragmentation)of wounds andtissues | Contact Probe | High IntensityUltrasound25kHz / ? | K012753 | Selected dissectionand fragmenting oftissue at theoperation siteduring multi-medicaldiscipline surgery(General Surgery,Neuro, Thoracic,Urology, andGastro-intestinal) | Soring GmbhMedizintechnik(www.soering.com)Sonoca 180UltrasoundDissection | |||
| Hospital, clinic, orin-home settings | Applicatorpositioning,frequency andduration oftreatments; Mistflow rate | Ultrasound woundcleansing andmaintenancedebridement | Atomized Irrigant &Non-Contact Probe | High IntensityUltrasound40kHz / ? | K032378 / K050129 | Promotes woundhealing throughwound cleansingand maintenancedebridementby the removal ofyellow slough, fibrin,tissue exudatesand bacteria | Celleration(www.celleration.com) Mist TherapySystem | |||
| Hospital, clinic, orintraoperativesettings | Applicatorpositioning,frequency andduration oftreatments: flow andevacuation rate | Pressurized streamand evacuationcuts, ablates, andremoves tissue andforeign matter andsurgically resects/removes material | Irrigation/SuctionNozzle | Pressurized FluidStream &Evacuation | K991383 / K011612/ K060782 | Wounddebridement, softtissue debridement,and cleansing ofsurgical site andburns | Smith & Nephew(wound.smith-nephew.com/us/Home.asp) VersaJetHydrosurgerySystem |
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.
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KO63544
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国际官网官网官网 正版官
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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
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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
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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
N/A