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 ablation area in General Surgery. The Sonatherm is not to be used for non-invasive ablation, i.e. leaving intervening tissue spared, and it is not indicated for the ablation of Prostate tissue.

Device Description

The Sonatherm 600i is a modification of the previously cleared Sonatherm 600 (K 042096). The Sonatherm 600i uses the same HIFU transducer, with the same ultrasonic lesion generating power output as the Sonatherm 600.

The Sonatherm 600i operates in the same manner as the Sonatherm 600. The Sonatherm 600i operates by utilizing a focused ultrasound transducer positioned at the surface of the targeted ablation area to create a thermal lesion from the focal point of the transducer back to the surface of the targeted area in an open field or laparoscopic scenario.

The Sonatherm 600i incorporates three changes to the Sonatherm 600: a microprocessor controlled LCD user interface; a visually aided focal point targeting system; an integrated transducer positioning device

The microprocessor controlled LCD user interface incorporates a graphical interface that makes the operation of the device easier. The integrated positioning device allows the user to verify the positioning of the Sonatherm 600i probe over the intended target volume. This reduces the chance for operator error.

AI/ML Overview

The Sonatherm 600i Ultrasonic Lesion Generating System, a modification of the previously cleared Sonatherm 600, was reviewed. This device generates thermal lesions for the laparoscopic or intraoperative ablation of soft tissue. The 510(k) summary provides details about its non-clinical testing.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state quantitative acceptance criteria or a specific table with "reported device performance" in the typical sense of a diagnostic device. However, it lists nonclinical tests performed to demonstrate substantial equivalence, which implicitly serve as the studies to meet underlying performance expectations for safety and effectiveness.

Acceptance Criteria Category (Implied)	Reported Device Performance/Study Conclusion
Targeting Accuracy	"Sonatherm 600i Targeting Accuracy Test Report": This report would demonstrate the device's ability to precisely direct the ultrasonic energy to the intended ablation area. While specific performance metrics (e.g., deviation from target in mm) are not provided in the summary, the existence of the report implies successful demonstration of adequate targeting for its intended use.
Thermal Lesion Generation	"Thermal Mapping of Ablation Region": This study would characterize the size, shape, and temperature distribution of the lesions created by the device. The goal is to confirm that the device generates consistent and effective thermal lesions within the soft tissue as intended, similar to the predicate device. Specific performance values are not given.
Imaging Operation Validation	"Validation of Imaging Operation": This test validates the functionality and accuracy of the visually aided focal point targeting system, ensuring it provides reliable guidance to the user. This would confirm that the integrated positioning device helps reduce operator error. Specific performance values are not given.
Acoustic Power Output	"Total Acoustic Power Tests of Transducers": This testing confirms that the transducer's power output is consistent with the predicate device (Sonatherm 600) and within safe and effective limits. The summary explicitly states: "The Sonatherm 600i uses the same HIFU transducer, with the same ultrasonic lesion generating power output as the Sonatherm 600," implying successful verification of this.
Overall Safety and Efficacy	Conclusion from Nonclinical Tests: "Based upon an analysis of the operating characteristic specifications, Risk Analysis, and Voluntary Consensus Standard Investigations, Misonix, Inc. has concluded that the Sonatherm 600i is substantially equivalent to the predicate devices and introduces no new safety or efficacy concerns."

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not specify a "test set" in the context of human data or a machine learning model. The studies described are non-clinical engineering and performance tests (e.g., targeting accuracy, thermal mapping). Therefore, information on sample size for a "test set" or data provenance (country of origin, retrospective/prospective) for patient data is not applicable as no clinical studies were performed, and the non-clinical tests would involve physical measurements and simulations, not patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. Since the studies involved non-clinical performance evaluations of a medical device (e.g., measuring power output, thermal profiles), the "ground truth" was established by engineering specifications, physical measurements, and comparison to the predicate device's known performance. No human experts were involved in establishing "ground truth" for patient data in this context.

4. Adjudication Method for the Test Set

This information is not applicable. As there was no test set of patient data requiring expert review, no adjudication method was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The 510(k) summary explicitly states: "No clinical testing is required because product did not change HIFU power output or type. Note: clinical data was also not required to clear the original device." Therefore, there is no effect size of human readers improving with or without AI assistance, as AI is not mentioned and clinical studies were not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The Sonatherm 600i is a physical medical device (ultrasonic lesion generating system), not an algorithm or an AI-powered system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" was established through:

Engineering specifications and design parameters: For acoustic power output.
Physical measurements and objective testing: For targeting accuracy and thermal mapping.
Validation against established performance standards: To demonstrate equivalent performance to the predicate device.

8. The Sample Size for the Training Set

This information is not applicable. As the device is a physical medical instrument and not an AI/machine learning model, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. There was no training set for an AI/machine learning model.

Summary

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510(k) Summary

K070779

510(k) Summary

Page 1 42

Sponsor's Name,Address, Phone &Fax:	MISONIX INCORPORATED1938 New Highway, Farmingdale, NY 11735Phone: 631 694 9555 x 123Fax: 631 694 1322
Contact Person:	Ronald R. Manna
Date Prepared:	7/7/08
Device Trade Name	Sonatherm 600i Ultrasonic Lesion Generating System
Device CommonName:	Sonatherm 600i
Proposed Class,Classification Nameand Number, andProduct Code:	Class IIElectrosurgical cutting and coagulation device and accessories21 CFR 878.4400Product Code: NTB
Predicate Devices:	Sonatherm 600 Ultrasonic Lesion Generating System, K042096Endocare CryoCare™ Surgical System with CryoGuide™K002615Endocare CryoCare CS Surgical System K032333Endocare CryoCare CS Surgical System K050347
Device Description :	The Sonatherm 600i is a modification of the previously clearedSonatherm 600 (K 042096). The Sonatherm 600i uses the sameHIFU transducer, with the same ultrasonic lesion generatingpower output as the Sonatherm 600.The Sonatherm 600i operates in the same manner as theSonatherm 600. The Sonatherm 600i operates by utilizing afocused ultrasound transducer positioned at the surface of thetargeted ablation area to create a thermal lesion from the focalpoint of the transducer back to the surface of the targeted area inan open field or laparoscopic scenario.The Sonatherm 600i incorporates three changes to theSonatherm 600: a microprocessor controlled LCD user interface;a visually aided focal point targeting system; an integratedtransducer positioning deviceThe microprocessor controlled LCD user interface incorporates agraphical interface that makes the operation of the device easier.The integrated positioning device allows the user to verify thepositioning of the Sonatherm 600i probe over the intended targetvolume. This reduces the chance for operator error.
Intended Use:	The Sonatherm is indicated for the laparoscopic or intraoperativeablation of soft tissue from the ultrasound focal zone back to thesurface of the targeted ablation area in General Surgery. TheSonatherm is not to be used for non-invasive ablation, i.e.leaving intervening tissue spared, and it is not indicated for theablation of Prostate tissue
Summary ofTechnologicalCharacteristics:	The Sonatherm 600i operates in the same manner as theSonatherm 600. The Sonatherm 600i operates by utilizing afocused ultrasound transducer positioned at the surface of thetargeted ablation area to create a thermal lesion from the focalpoint of the transducer back to the surface of the targeted area inan open field or laparoscopic scenario.
Summary ofnonclinical tests	Sonatherm 600i Targeting Accuracy Test ReportThermal Mapping of Ablation RegionValidation of Imaging OperationTotal Acoustic Power Tests of Transducers
Summary of clinicaltests	No clinical testing is required because product did not changeHIFU power output or type. Note: clinical data was also notrequired to clear the original device.
Conclusions fromnonclinical andclinical tests	Based upon an analysis of the operating characteristicspecifications, Risk Analysis, and Voluntary ConsensusStandard Investigations, Misonix, Inc. has concluded that theSonatherm 600i is substantially equivalent to the predicatedevices and introduces no new safety or efficacy concerns

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K 070 719

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 9 2008

Misionix Incorporated % Mr. Ronald Manna VP, Regulatory Affairs 1938 New Highway Farmingdale, New York 11735

Re: K070779

Trade/Device Name: Sonatherm 600i 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: April 9, 2008 Received: April 11, 2008

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 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.

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Page 2 - Mr. Ronald Manna

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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.

Mark M. Millican

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use

K070779

Device Name: Sonatherm 600i Ultrasonic Lesion Generating System

Indications for Use:

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Calvare bucuro

Division of General, Restorative, and Neurological Devices

510(k) Number K670779

Page 1 of l

Regulation Number and Section

§ 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.