(540 days)
The Sonatherm is indicated for the laparoscopic or intraoperative ablation of soft tissue from the ultrasound focal zone back to the surface of the targeted treatment area in General Surgery.
Sonatherm 600 Ultrasonic Lesion Generating System is comprised of a generator, which feeds a 3 to 5 MHz electrical signal to one or more piezoelectric crystals mounted in a hand-held handpiece; the crystals then vibrate at the same frequency. A Coupling Fluid Recirculation System is provided to provide a temperature stabilized coupling/coolant fluid surrounding the Transducer crystal(s). The fluid is contained by a flexible membrane surrounding the transducer head. A user interface provides Input Controls and Output Readouts for Operator.
In operation, the Transducer Membrane is placed against the organ to be treated. When the unit is engaged, the transducer will vibrate, create acoustic waves in the coupling fluid that then couples to the organ tissue and propagates into it. The waves converge to a focal point that concentrates the energy within a finite tissue volume. As the temperature of the tissue rises above the ablation point, the tissue necroses. The treatment head is moved under Operator control to treat a preselected volume of tissue from the focal point back to the surface of the organ.
The Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating System is an ultrasonic surgical system designed for the laparoscopic or intraoperative ablation of soft tissue. The provided document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study report in the way a clinical trial might. Therefore, the information typically found in acceptance criteria and study design for AI/CADe devices, such as sensitivity, specificity, or reader performance, is not directly applicable or available in this document.
However, based on the provided text, we can infer the "acceptance criteria" were related to safety and engineering performance, and the "study" involved non-clinical tests to demonstrate that the device met these engineering and safety standards and was substantially equivalent to existing devices.
Here's an interpretation of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists "Voluntary Standards" and "Non-Clinical Tests for Determination of Substantial Equivalence." These effectively serve as the acceptance criteria and the methods used to demonstrate performance for pre-market notification (510k) of this type of medical device.
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance (Summary from document) |
|---|---|---|
| Safety Standards | UL 2601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety | "designed to and will be tested to pass" |
| EN 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety | "designed to and will be tested to pass" | |
| FCC Part 18 EMC Requirements | "designed to and will be tested to pass" | |
| EN 60601-1-2:2001 Electromagnetic Compatibility | "designed to and will be tested to pass" | |
| Non-Clinical Engineering Performance | Output Frequency Measurements | Performed, results led to conclusion of substantial equivalence. |
| Output Power Measurements | Performed, results led to conclusion of substantial equivalence. | |
| Focal Length Accuracy Measurements (Schlieren Photos) | Performed, results led to conclusion of substantial equivalence. | |
| Life Tests | Performed, results led to conclusion of substantial equivalence. | |
| Input Power Measurements | Performed, results led to conclusion of substantial equivalence. | |
| EMI Tests | Performed, results led to conclusion of substantial equivalence. | |
| Dielectric Tests on Mains Circuits | Performed, results led to conclusion of substantial equivalence. | |
| Patient Current Leakage and Patient Sink Current Measurements | Performed, results led to conclusion of substantial equivalence. | |
| Power Line Ground Leakage Measurements | Performed, results led to conclusion of substantial equivalence. | |
| Dielectric Tests on Patient Circuits | Performed, results led to conclusion of substantial equivalence. | |
| Sterilization/Disinfection | Sterilization or Disinfection Protocol Validation for all Reusable Components | Performed. "Validation statements are contained in Exhibit J." |
| Performance Modeling/Accuracy | In Vitro Targeting Accuracy Measurements | Performed, results led to conclusion of substantial equivalence. |
| Computer Modeling of Lesion Creation vs Time and Focal Depth | Performed, results led to conclusion of substantial equivalence. |
The document concludes that "Based upon an analysis of the operating characteristic specifications, Output of Engineering Tests, FMEA Analysis and Voluntary Consensus Standard Investigations, Misonix, Inc. has concluded that the Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating System is substantially equivalent" to the predicate devices. This implies that the device successfully met the criteria in all the listed tests and analyses.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of this device and report. The tests conducted were non-clinical engineering and performance characterization tests, not studies on a "test set" of patient data.
- Data Provenance: Not applicable. The tests were conducted internally by the manufacturer (Misonix, Inc.) through "Output of Engineering Tests," "FMEA Analysis," and investigations into "Voluntary Consensus Standard."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the sense of expert consensus on patient data, is not mentioned as part of the 510(k) submission for this device, which relies heavily on engineering and performance testing against established standards and comparison to predicate devices. The "ground truth" here would be the physical properties and performance parameters measured in a lab setting.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no "test set" of patient cases requiring expert adjudication.
5. 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 an ultrasonic lesion generating system, not an AI/CADe diagnostic tool that would involve human readers or image interpretation. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm for diagnostic interpretation in this device. The device itself performs the therapeutic function, with operator control. The document explicitly states: "There is no software associated with this product."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests would have been engineering specifications, physical measurements, and compliance with recognized voluntary standards. For example, for "Focal Length Accuracy Measurements," the ground truth would be the accurately measured focal length of the device compared to its design specification. For "In Vitro Targeting Accuracy Measurements," the ground truth would be the actual ablated tissue volume/shape in an in vitro model compared to the intended or predicted ablation.
8. The sample size for the training set
Not applicable. As noted, there is no software or AI component that would require a training set.
9. How the ground truth for the training set was established
Not applicable. No training set exists.
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JAN 2 6 2006
510(k) SUMMARY - Misonix Inc Sonatherm 600 Ultrasonic Lesion C Exhibit E
is summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92.
K 042096
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: | July 14, 2004 |
| Date Revised: | October 28, 2005 |
2. Name of Device
| Proprietary Name: | Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating System |
|---|---|
| Common/Usual Name: | Ultrasonic Surgical System |
| Classification Name: | Instrument. Ultrasonic Surgical |
Predicate Device Information
Rita Medical Systems Model 500 (K983214) and 1500 RF (K993944) Generator Systems and Accessories AFx Inc. Microwave Surgical System and Accessories (K003978) Endocare Cryocare Surgical System (K011074). Radionics RFG-3C RF Lesion Generator (K901540)
Sonatherm 600 Ultrasonic Lesion Generating System is comprised of a न Device Description generator, which feeds a 3 to 5 MHz electrical signal to one or more piezoelectric crystals mounted in a hand-held handpiece; the crystals then vibrate at the same frequency. A Coupling Fluid Recirculation System is provided to provide a temperature stabilized coupling/coolant fluid surrounding the Transducer crystal(s). The tluid is contained by a Hexible membrane surrounding the transducer head. A user interface provides Input Controls and Output Readouts for Operator.
In operation, the Transducer Membrane is placed against the organ to be treated. When the unit is engaged, the transducer will vibrate, create
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K 042096
acoustic waves in the coupling fluid that then couples to the organ tissue and propagates into it. The waves converge to a focal point that concentrates the energy within a finite tissue volume. As the temperature of the tissue rises above the ablation point, the tissue necroses. The treatment head is moved under Operator control to treat a preselected volume of tissue from the focal point back to the surface of the organ.
- The Sonatherm is indicated for the laparoscopic or intraoperative ablation 5. Intended Use: of soft tissue from the ultrasound focal zone back to the surface of the targeted treatment area in General Surgery.
6. Comparison to Predicate Device
Sonatherm 600 Ultrasonic Lesion Generating System is similar in clinical use, safety and outcome to the Rita Medical Systems Model 500 (K983214) and 1500 RF (K993944) Generator Systems and Accessories, the AFx Inc. Microwave Surgical System and Accessories (K003978), the Endocare Cryocare Surgical System (K011074) and the Radionics RFG-3C RF Lesion Generator and accessories (K901540B). Although housed differently, all of the aforementioned devices allow the surgeon to target selected tissue for ablation in either laparoscopic or intraoperative modes and provide controlled energy input to the organ to facilitate said ablation. In the case of the Sonatherm 600, this volume is located from the focal point back to the surface of the organ. Ablated tissue may then be removed surgically or left intact for absorption and removal by the bodies normal cleansing mechanisms. Such treatment has been shown to be safe and efficacious over many decades of clinical use.
7 Safety and Performance Data
The Sonatherm 600 Ultrasonic Lesion Generating System has been designed to and will be tested to pass the following Voluntary Standards:
UL 2601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety F.N 60601-1 Medical Electrical Equipment, Part 1 : General Requirements for Safety EN 60601-1-2:2001 Electromagnetic Compatibility FCC Part 18 EMC Requirements
There is no software associated with this product. 8. Software Validation
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K O 4 2 O 9 6
Validation statements are contained in Exhibit J. 9. Sterilization Validations
10. Non-Clinical Tests for Determination of Substantial Equivalence:
Output Frequency Measurements Output Power Measurements Focal Length Accuracy Measurements (Schlieren Photos) 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 Sterilization or Disinfection Protocol Validation for all Reusable Components In Vitro Targeting Accuracy Measurements Computer Modeling of Lesion Creaton vs Time and Focal Depth
11. Conclusions
Based upon an analysis of the operating characteristic specifications, Output of Engineering Tests, FMEA Analysis and Voluntary Consensus Standard Investigations, Misonix, Inc. has concluded that the Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating System is substantially equivalent to the Rita Medical Systems Model 500 (K983214) and 1500 RF (K993944) Generator Systems and Accessories, the AEx Inc. Microwave Surgical System and Accessories (K003978), the Endocare Surgical System (K011074) and the Radionics RFG-3C RF Lesion Generator and accessories.
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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 features a stylized depiction of an eagle or bird with three lines forming its body and wings. The bird is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES (USA)" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 6 2006
Mr. Ronald R. Manna Vice President, Regulatory Affairs Misonix, Inc. 1938 New Highway Farmingdale, New York 11735
Re: K042096
Trade/Device Name: Sonatherm 600 Ultrasonic Lesion Generating System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: NTB Dated: November 17, 2005 Received: November 17, 2005
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
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Page 2 - Mr. Manna
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
fabare Brechin
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Exhibit C
510(k) Number (if known): K042096
Device Name: Sonatherm 600 Ultrasonic Lesion Generating System
Indications for Use:
The Sonatherm is indicated for the laparoscopic or intraoperative ablation of soft tissue from the ultrasound focal zone back to the surface of the targeted treatment area in General Surgery.
Prescription Use __ ど (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Barbara Bush for Nixon
Division of General, Restorative, and Neurological Devices
510(k) Number K042096
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.