(69 days)
No
The device description and performance studies focus on the mechanical and electrical aspects of ultrasonic debridement, with no mention of AI or ML technologies.
Yes.
The device is used for the debridement of wounds, which is a therapeutic intervention.
No
The device is indicated for debridement and cleansing of wounds, which are treatment-oriented actions, not diagnostic ones.
No
The device description explicitly details hardware components such as a generator, handpiece with piezoelectric crystals and titanium tip, and an irrigation unit, along with various accessories. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for the debridement and cleansing of wounds and surgical sites. This is a therapeutic or surgical procedure performed directly on the patient's body.
- Device Description: The device description details a system that uses ultrasonic vibrations and irrigation to physically interact with tissue. This is consistent with a surgical or therapeutic device, not a device that analyzes samples taken from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are specifically designed to be used in vitro (outside the living body) to examine specimens. This device operates in vivo (within the living body) to perform a physical procedure.
N/A
Intended Use / Indications for Use
The Misonix SonicOne Ultrasonic Would Care System and Accessories are indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers. bedsores and vaginal ulcers. soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.
Product codes
NRB, FQH
Device Description
The SonicOne Plus Ultrasonic Wound Care System and Accessories is comprised of a generator, which feeds a 22.5 kHz electrical signal to a piezoelectric crystals mounted in a hand-held handpiece; the crystals then vibrate at the same frequency. The titanium tip attached to the handpiece amplifies the vibration. An irrigation unit is provided to introduce irrigation solution to the operative site. Accessories include Probe tips, Wrenches, Sterile and non sterile Tube sets and sterile Surgical Procedure bags and sterile Handpiece Sheaths.
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
The FDA has cleared all indications for use in the predicates. As such, no additional clinic data was obtained in anticipation of this submission.
Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows: Output Frequency Measurements Output Power Measurements (No Load to Maximum Load) Tip Displacement Measurements Irrigation Flowrate Measurements Life Tests Input Power Measurements EMI Tests Dielectric Tests on Mains Circuits Patient Current Leakage and Patient Sink Current Measurements Power Line Ground Leakage Measurements Dielectric Tests on Patient Circuits
Key Metrics
Not Found
Predicate Device(s)
SonicOne Ultrasonic Wound Care System and Accessories K112782, Alliger Ultrasonic Surgical System AUSS-7 K070313
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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KI2-3980
Exhibit E 510(k) SUMMARY
Misonix SonicOne Plus Ultrasonic Wound Care System and Accessories
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92.
Submitter's Identification 1 .
| Submitter's Name: | MISONIX INCORPORATED |
|---|---|
| Address: | 1938 New Highway, Farmingdale, NY 11735 |
| Telephone Number: | 516-694-9555 |
| Contact Person: | Ronald R. Manna |
| Date Prepared: | December 20, 2012 |
2. Name of Device
| Proprietary Name: | Misonix SonicOne Plus Ultrasonic Wound Care System
and Accessories |
|--------------------|-----------------------------------------------------------------------|
| Common/Usual Name: | Ultrasonic Surgical System
Ultrasonic Surgical Aspirator |
| Name: | Low Energy Ultrasonic Wound Cleaner |
| C.F.R. Section | 21 CFR 878.4410 |
| Product Codes: | NRB, FQH |
3. Predicate Device Information
Predicate Devices SonicOne Ultrasonic Wound Care System and Accessories K112782 Misonix Inc. Alliger Ultrasonic Surgical System AUSS-7 K070313 Microtek Medical Inc. Equipment Drapes K050322 Device Description The SonicOne Plus Ultrasonic Wound Care System and Accessories is comprised of a generator, which feeds a 22.5 kHz electrical signal to a piezoelectric crystals mounted in a hand-held handpiece; the crystals then vibrate at the same frequency. The titanium tip attached to the handpiece amplifies the vibration. An irrigation unit is provided to introduce irrigation solution to the operative site. Accessories include Probe tips, Wrenches, Sterile and non
1
sterile Tube sets and sterile Surgical Procedure bags and sterile Handpiece Sheaths.
5. Intended Use:
The Misonix SonicOne Ultrasonic Would Care System and Accessories are indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers. bedsores and vaginal ulcers. soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.
6. Comparison to Predicate Device
SonicOne Plus Ultrasonic Wound Care System and Accessories are similar in design, material and operating parameters to the Misonix Inc. AUSS-7 Ultrasonic Surgical Aspirator and the Misonix Inc. SonicOne Ultrasonic Wound Care System
7. Safety and Performance Data
The Misonix SonicOne Plus Ultrasonic Wound Care System and Accessories have been designed and tested to pass the following Voluntary Standards:
| UL 60601-1 2nd Edition | Medical Electrical Equipment, Part 1: General Requirements for Safety |
|---|---|
| IEC 60601-1* 2nd Edition | Medical Electrical Equipment, Part 1: General Requirements for Safety |
| ISO 10993-1:2009 | Biological evaluation of medical devices —Part 1: Evaluation and testing |
| ISO 10993-7:2008 | Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
| ISO 14971:2007 | Medical devices -- Application of risk management to medical devices |
| ISO 15223-1:2007/A1:2008 | Medical devices—Symbols to be used with medical device labels, labeling, and information to be |
| supplied—Part 1: General requirements | |
| ISO 11607:2006 | Packaging for Terminally Sterilized Medical Devices |
| ISO 11135:2007 | Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| IEC 62304: 2006 | Medical Device Software-Software Life Cycle Processes |
| IEC 60601-1-4 | General Requirements for safety-Programmable electrical medical systems |
| FCC Part 18 | EMC Requirements |
-
- This device contains software. Software has been cleared under Software Validation FDA 510k #K070313. The software and its documentation meets all of the requirements of the FDA guideline "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and ISO 60601-1-4.
-
- Sterilization Validations Items supplied sterile have been validated for sterility to ANSI/AAMI/ISO 11135:1994 or latest edition and ISO 11135:2007. For items to be reprocessed, cleaning/disinfecting/sterilization instructions are validated to insure appropriate level of cleaning/disinfection/sterilization when instructions are followed.
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10. Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Output Frequency Measurements Output Power Measurements (No Load to Maximum Load) Tip Displacement Measurements Irrigation Flowrate Measurements Life Tests Input Power Measurements EMI Tests Dielectric Tests on Mains Circuits Patient Current Leakage and Patient Sink Current Measurements Power Line Ground Leakage Measurements Dielectric Tests on Patient Circuits
Discussions of Clinical Tests Performed | | .
The FDA has cleared all indications for use in the predicates. As such, no additional clinic data was obtained in anticipation of this submission.
l 2. Conclusions
Misonix Inc. can state that the SonicOne Plus Ultrasonic Wound Care System and Accessories is substantially equivalent in Mode of Operation, Hardware Design and Output Parameters to the Misonix Inc. AUSS-7 and the SonicOne Ultrasonic Wound Care System. Based upon the system and hardware validations described herein, the Misonix Inc. believes the SonicOne Plus Ultrasonic Wound Care System and Accessories poses no new issues of safety or efficacy when used for tissue ablation during wound debridement.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings outstretched, symbolizing protection and care.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center- WO66-G609 Silver Spring, MD 209930002
Letter dated: March 5, 2013
Misonix, Incorporated % Mr. Ronald Manna Vice President, Regulatory Affairs 1938 New Highway Farmingdale, New York
Re: K123980
Trade/Device Name: SonicOne Plus Ultrasonic Wound Care System and Accessories Regulation Number: 21 CFR 878.4410 Regulation Name: Low energy ultrasound wound cleaner Regulatory Class: II Product Code: NRB, FQH Dated: February 11, 2013 Received: February 14, 2013
Dear Mr. Manna:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K123980
Exhibit C INDICATIONS FOR USE STATEMENT
Device Name: SonicOne Plus Ultrasonic Wound Care System and Accessories
The Misonix SonicOne Ultrasonic Would Care System and Accessories are indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Long H. Chen = -A
for MXM
(Division Sign-off) Division of Surgical Devices 510(k) Number K123980