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 judgement would require the use of an ultrasonic aspirator with sharp debridement.
The SonicOne Ultrasonic Wound Care System 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 handpiece sheaths.
The provided text describes the Misonix SonicOne Ultrasonic Wound Care System and Accessories, focusing on its substantial equivalence to predicate devices rather than independent clinical studies with specific acceptance criteria and performance metrics. Therefore, many of the requested sections regarding acceptance criteria, study data, and ground truth establishment cannot be fully populated from the given information.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria (if stated) | Reported Device Performance (if stated) |
|---|---|---|
| Safety Standards | Compliance with: | The device has been designed and tested to pass the following voluntary standards: - IEC 60601-1 (Medical Electrical Equipment, Part 1: General Requirements for Safety)- IEC 60601-1-2:2001 (Medical Electrical Equipment General Requirements for EMC)- FCC Part 18 (EMC Requirements)- 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 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) |
| Performance (Functional) | Not explicitly stated. | The SonicOne is stated to be "identical to the AUSS-6 Ultrasonic Surgical Aspirator cleared under 510K #K050776." It is also considered substantially equivalent in "Mode of Operation, Hardware Design and Output Parameters" to the predicate devices. This implies it meets the performance characteristics of those cleared devices. |
| Clinical Efficacy | Not explicitly stated. | "The FDA has cleared all indications for use in the predicates. As such, no additional clinic data was obtained in anticipation of this submission." This refers to a determination of substantial equivalence based on predicate devices' clearance, not a new clinical study. |
Study Details (Based on Substantial Equivalence Claim)
-
Sample size used for the test set and the data provenance:
- No direct test set for performance on patients was used for this 510(k) submission. The submission relies on the substantial equivalence to predicate devices (Arobella Medical LLC AR 1000 Ultrasonic Wound Therapy System K062544 and Misonix Inc. Alliger Ultrasonic Surgical System AUSS-6 K050776).
- Therefore, there is no specific data provenance (country of origin, retrospective/prospective) for a new clinical test set.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No new clinical test set with ground truth established by experts was used for this submission. The basis for clearance is substantial equivalence to already cleared devices and their established indications for use.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No new clinical test set requiring adjudication was performed as part of this 510(k).
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a physical medical device (ultrasonic wound care system), not an AI/software-based diagnostic or assistive tool. Therefore, MRMC studies and AI effect sizes are irrelevant to this submission.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not contain software and is not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the purpose of this 510(k), the "ground truth" for efficacy is implicitly the established safety and effectiveness of the predicate devices for their cleared indications. The submission argues that the SonicOne is substantially equivalent in design and function, therefore sharing the same safety and efficacy profile.
-
The sample size for the training set:
- Not applicable. This device does not use machine learning or AI, so there is no training set in the context of AI.
-
How the ground truth for the training set was established:
- Not applicable. See above.
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DEC - 1 2011 K112782
Exhibit E 510(k) SUMMARY - Misonix SonicOne 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.
1. Submitter's Identification
| Submitter's Name: | MISONIX INCORPORATED |
|---|---|
| Address: | 1938 New Highway, Farmingdale, NY 11735 |
| Telephone Number: | 516-694-9555 |
| Contact Person: | Ronald R. Manna |
| Date Prepared: | August 9, 2010 |
2. Name of Device
| Proprietary Name: | Misonix SonicOne Ultrasonic Wound Care Systemand Accessories |
|---|---|
| Common/Usual Name: | Ultrasonic Surgical SystemUltrasonic Surgical Aspirator |
| Classification Name: | Instrument, Ultrasonic Surgical |
3. Predicate Device Information
| Predicate Devices | Arobella Medical LLC AR 1000 Ultrasonic WoundTherapy System K062544Misonix Inc. Alliger Ultrasonic Surgical SystemAUSS-6 K050776Microtek Medical Inc. Equipment Drapes K050322 | |
|---|---|---|
| 4. | Device Description | The SonicOne Ultrasonic Wound Care System iscomprised of a generator, which feeds a 22.5 kHzelectrical signal to a piezoelectric crystals mountedin a hand-held handpiece; the crystals then vibrateat the same frequency. The titanium tip attached tothe handpiece amplifies the vibration. An irrigationunit is provided to introduce irrigation solution tothe operative site. Accessories include probe tips,wrenches, sterile and non sterile tube sets and sterileSurgical Procedure bags and handpiece sheaths. |
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KII2782
- The Misonix SonicOne Ultrasonic Would Care System and 5. Intended Use: 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 judgement would require the use of an ultrasonic aspirator with sharp debridement.
Comparison to Predicate Device SonicOne Ultrasonic Wound Care System 6. and Accessories are similar in design, material and operating parameters to the Misonix Inc. AUSS-6 Ultrasonic Surgical Aspirator and the Arobella Medical LLC AR 1000 Ultrasonic Wound Therapy System.
7. Safety and Performance Data
The Misonix SonicOne Ultrasonic Wound Care System and Accessories have been designed and tested to pass the following Voluntary Standards:
| IEC 60601-1* | Medical Electrical Equipment, Part 1: General Requirements for Safety |
|---|---|
| IEC 60601-1-2:2001 | Medical Electrical Equipment General Requirements for EMC |
| FCC Part 18 | EMC Requirements |
| 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 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 |
- This device does not contain software. 7. Software Validation
- Validation statements are contained in Exhibit J. 8. Sterilization Validations
-
- Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
The SonicOne is identical to the AUSS-6 Ultrasonic Surgical Aspirator cleared under 510K #K050776. Therefore, no new Non-Clinical Tests have been performed in anticipation of this submission.
P. 2/3
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Discussions of Clinical Tests Performed 10.
The FDA has cleared all indications for use in the predicates. As such, no additional clinic data was obtained in anticipation of this submission.
Conclusions 11.
Misonix Inc. can state that the SonicOne is substantially equivalent in Mode of Operation, Hardware Design and Output Parameters to the Arobella Medical AR 1000 and the Misonix Inc. AUSS-6. Based upon the system and hardware validations described herein, the Misonix Inc. believes the SonicOne Ultrasonic Wound Care System and Accessories pose no new issues of safety or efficacy when used for soft and hard tissue ablation during wound treatment.
P.3/3
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC - 1 2011
Misonix Inc. % Mr. Ronald R. Manna 1938 New Highway Farmingdale, New York 11735
Re: K112782
Trade/Device Name: Misonix SonicOne® Ultrasonic Wound Care System and Accessories Regulation Number: 21 CFR 878.4410 Regulation Name: Low energy ultrasound wound cleaner Regulatory Class: Class II Product Code: NRB, FQH Dated: November 02, 2011 Received: November 03, 2011
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
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Page 2 - Mr. Ronald R. Manna
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 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 vours.
Sincerely yours,
Erine Keith.
for 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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Exhibit C Indications for Use Statement
i12782
Device Name: Misonix SonicOne ® 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)
Prescription Use X. (Per 21 CFR 801.109)
or
Over-The-Counter Use
Neil R.P. Dych for Nixon
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112782
8
§ 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.