(476 days)
No
The description focuses on hardware modifications and a microprocessor-controlled user interface, with no mention of AI or ML algorithms for image analysis, treatment planning, or other functions.
Yes
The device is described as an "ablation" device, which means it is used to destroy or remove tissue, performing a therapeutic function.
No
The device is described as an ablation device that uses focused ultrasound to create thermal lesions in soft tissue for therapeutic purposes, not for diagnosing conditions.
No
The device description explicitly mentions hardware components such as a HIFU transducer, a microprocessor controlled LCD user interface, and an integrated transducer positioning device.
Based on the provided information, the Sonatherm 600i is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Sonatherm 600i Function: The Sonatherm 600i is a surgical device that uses focused ultrasound to ablate (destroy) soft tissue directly within the body during laparoscopic or open surgery. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states "ablation of soft tissue," which is a treatment procedure, not a diagnostic test performed on a sample outside the body.
Therefore, the Sonatherm 600i falls under the category of a surgical or therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes
NTB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, Prostate tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
General Surgery
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of nonclinical tests
Sonatherm 600i Targeting Accuracy Test Report
Thermal Mapping of Ablation Region
Validation of Imaging Operation
Total Acoustic Power Tests of Transducers
Summary of clinical tests
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Sonatherm 600 Ultrasonic Lesion Generating System, K042096, Endocare CryoCare™ Surgical System with CryoGuide™ K002615, Endocare CryoCare CS Surgical System K032333, Endocare CryoCare CS Surgical System K050347
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Summary
.
K070779
510(k) Summary
Page 1 42
| Sponsor's Name,
Address, Phone &
Fax: | MISONIX INCORPORATED
1938 New Highway, Farmingdale, NY 11735
Phone: 631 694 9555 x 123
Fax: 631 694 1322 |
|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ronald R. Manna |
| Date Prepared: | 7/7/08 |
| Device Trade Name | Sonatherm 600i Ultrasonic Lesion Generating System |
| Device Common
Name: | Sonatherm 600i |
| Proposed Class,
Classification Name
and Number, and
Product Code: | Class II
Electrosurgical cutting and coagulation device and accessories
21 CFR 878.4400
Product Code: NTB |
| Predicate Devices: | Sonatherm 600 Ultrasonic Lesion Generating System, K042096
Endocare CryoCare™ Surgical System with CryoGuide™
K002615
Endocare CryoCare CS Surgical System K032333
Endocare CryoCare CS Surgical System K050347 |
| 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. |
| Intended 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 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 |
| Summary of
Technological
Characteristics: | 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. |
| Summary of
nonclinical tests | Sonatherm 600i Targeting Accuracy Test Report
Thermal Mapping of Ablation Region
Validation of Imaging Operation
Total Acoustic Power Tests of Transducers |
| Summary of clinical
tests | 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. |
| Conclusions from
nonclinical and
clinical 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 |
1
K 070 719
.
:
2
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.
3
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
4
Indications for Use
Device Name: Sonatherm 600i 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 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.
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
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