(308 days)
Not Found
GE LOGIQ E10s (K211524)
No
The description focuses on the mechanical process of focused ultrasound and the system's hardware and software for localization, planning, and treatment delivery. There is no mention of AI/ML in the device description, intended use, or performance studies. The software is described as having a "Major level of concern" and undergoing standard V&V testing, which is typical for medical device software but doesn't indicate AI/ML. The image fusion function is a standard image processing technique, not necessarily AI/ML.
Yes.
The device is indicated for the "non-invasive destruction of liver tumors," which directly addresses and treats a medical condition.
No
The device is primarily a therapeutic device for non-invasive destruction of liver tumors. While it uses ultrasound images for localization and planning, and is integrated with a diagnostic ultrasound system (GE LOGIQ E10s), its core function is treatment delivery, not diagnosis.
No
The device description explicitly states the system is comprised of reusable medical equipment and disposable components, including a Treatment Cart containing hardware and software, a Support Arm and Frame, a Treatment Arm/Micropositioning System, and a Treatment Head containing a Therapy Transducer. It also integrates with a GE LOGIQ E10s ultrasound system. This clearly indicates the device is not software-only.
Based on the provided information, the Edison System is not an IVD (In Vitro Diagnostic) 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 about a person's health. This testing is done outside the body (in vitro).
- Edison System Function: The Edison System is a therapeutic device that uses focused ultrasound to treat liver tumors within the patient's body (in vivo). It directly interacts with and modifies tissue inside the patient.
- Intended Use: The intended use clearly states "non-invasive destruction of liver tumors," which is a therapeutic action, not a diagnostic test performed on a specimen.
- Device Description: The description details a system for delivering focused ultrasound pulses to induce cavitation and mechanically destroy tissue in situ.
- Lack of Specimen Handling: There is no mention of collecting or analyzing biological specimens.
- Integration with Diagnostic Ultrasound: While it integrates with a diagnostic ultrasound system (GE LOGIQ E10s) for imaging and targeting, the Edison System itself is the therapeutic component. The diagnostic ultrasound is used for guidance and monitoring, not for performing an in vitro diagnostic test.
Therefore, the Edison System is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Edison System is indicated for the non-invasive destruction of liver tumors, including unresectable liver tumors, using a non-thermal, mechanical process of focused ultrasound.
Product codes
QGM
Device Description
The HistoSonics Edison™ System (the "System") provides users with a means to identify, target and destroy tissue non-invasively via non-ionizing, non-thermal, mechanical process of focused ultrasound.
By delivering high amplitude, very short (microsecond), focused ultrasound pulses the device can induce acoustic cavitation at a known focal location in the form of a "bubble cloud". The bubble cloud is a cluster of microbubbles that form, rapidly expand and rapidly collapse, imparting stress and strain on target soft tissue. After a number of pulses, soft tissue within the bubble cloud is mechanically destroyed, resulting in a homogenous acellular lysate with limited to no recognizable cellular structures. The bubble cloud appears hypoechoic (bright) when viewed on diagnostic (B-mode) ultrasound. Additionally, the bubble cloud is detectable audibly.
The System is comprised of reusable medical equipment and disposable, single-patient use components. Reusable portions of the System include the Treatment Cart and a Support Arm and Frame that is used to contain ultrasound medium (degassed water) that acoustically couples the System to the patient. Disposable aspects of the System include a clear, acoustically transparent and deformable membrane that holds the ultrasound medium as well as various non-active accessories used during patient setup.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound, MRI, CT, PET
Anatomical Site
Liver
Indicated Patient Age Range
Subject is ≥18 years of age
Intended User / Care Setting
The Edison System must be administered under the direct supervision of a qualified and trained physician, after appropriate evaluation.
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
A multicenter non-randomized, prospective single arm study involving 8 sites (U.S.) and 6 (OUS) sites with 44 subjects. The pooled data contains 21 subjects treated in the US and 23 subjects treated in Europe.
Primary effectiveness endpoint: technical success, defined as the treatment volume/treatment dimensions being greater than or equal to the targeted tumor with complete tumor coverage as assessed by a CT or MRI imaging obtained 70% performance goal for the primary effectiveness endpoint was met with 95.5% [95% CI 83.72 = 100%] of the lesions having achieved technical success within 36 hours of the procedure.
Primary safety endpoint: index-procedure device-related major complications of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or higher at 30-days as adjudicated by an independent Clinical Events Committee (CEC) with a performance goal set at 25%. All 44 subjects enrolled were included in the analysis of the primary safety endpoint. The
N/A
0
DE NOVO CLASSIFICATION REQUEST FOR EDISON SYSTEM
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Focused ultrasound system for non-thermal, mechanical tissue ablation. This device uses focused ultrasound to mechanically ablate soft tissue. The device is not intended to thermally ablate tissue.
NEW REGULATION NUMBER: 21 CFR 878.4405
CLASSIFICATION: Class II
PRODUCT CODE: QGM
BACKGROUND
DEVICE NAME: Edison System
SUBMISSION NUMBER: DEN220087
DATE DE NOVO RECEIVED: December 2, 2022
SPONSOR INFORMATION:
HistoSonics, Inc. 16305 36th Avenue N Plymouth, Minnesota 55446
INDICATIONS FOR USE
The Edison System is indicated as follows:
The Edison System is indicated for the non-invasive destruction of liver tumors, including unresectable liver tumors, using a non-thermal, mechanical process of focused ultrasound.
LIMITATIONS
The sale, distribution, and use of the Edison System are restricted to prescription use in accordance with 21 CFR 801.109.
Use of The Edison System must be administered under the direct supervision of a qualified and trained physician, after appropriate evaluation.
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The Edison System has not been evaluated for the treatment of any specific disease or condition. The safety and effectiveness of the device for the treatment of cancer has not been established.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS.
DEVICE DESCRIPTION
The HistoSonics Edison™ System (the "System") provides users with a means to identify, target and destroy tissue non-invasively via non-ionizing, non-thermal, mechanical process of focused ultrasound.
By delivering high amplitude, very short (microsecond), focused ultrasound pulses the device can induce acoustic cavitation at a known focal location in the form of a "bubble cloud". The bubble cloud is a cluster of microbubbles that form, rapidly expand and rapidly collapse, imparting stress and strain on target soft tissue. After a number of pulses, soft tissue within the bubble cloud is mechanically destroyed, resulting in a homogenous acellular lysate with limited to no recognizable cellular structures. The bubble cloud appears hypoechoic (bright) when viewed on diagnostic (B-mode) ultrasound. Additionally, the bubble cloud is detectable audibly.
The System is comprised of reusable medical equipment and disposable, single-patient use components. Reusable portions of the System include the Treatment Cart and a Support Arm and Frame that is used to contain ultrasound medium (degassed water) that acoustically couples the System to the patient. Disposable aspects of the System include a clear, acoustically transparent and deformable membrane that holds the ultrasound medium as well as various non-active accessories used during patient setup.
The System is functionally integrated with a GE LOGIQ E10s ultrasound system (K211524), which is provided by HistoSonics with each Edison System. The LOGIO E10s is provided with a preset configuration designed to optimize viewing of the bubble cloud. This configuration falls within the available performance parameters of the LOGIQ E10s covered by K211524.
2
Image /page/2/Picture/0 description: The image shows a medical device with several labeled components. The device includes a treatment cart labeled as '1', a user interface with a touchscreen and control panel labeled as '2', and a treatment arm/micropositioning system labeled as '3'. Additionally, there is a treatment head with a therapy transducer and integrated ultrasound imaging probe labeled as '4', and a support arm with a frame and patient membrane labeled as '5'.
The Treatment Cart is mobile and contains all hardware and software components necessary to localize, plan and deliver treatments. The Treatment Cart includes a large touchscreen user interface and control panel, a high voltage power supply, integrated amplifier circuitry, waveform generator boards, Control PC, and Treatment Arm/Micropositioning System with connected Treatment Head.
The System user interface guides the user step by step through the required workflow including Patient Preparation, Localize, Plan and Treat.
The treating physician uses the user interface to assess ultrasound images to localize the targeted tissue and define a Planned Treatment Volume (PTV) comprised of a target contour and margin
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contour. During targeting, the diagnostic ultrasound probe can be extended up to 5 cm in the Z axis to reduce the offset of the ultrasound medium, thereby improving the targeting process versus a non-extended probe. An optional workflow enables the physician to view DICOM images (MRI, CT and PET) adjacent to the live ultrasound to aid the target identification process. Additionally, an image fusion function is an optional workflow that allows physician to fuse the live ultrasound image from the GE LOGIQ E10s onto the previously obtained DICOM images.
The Treatment Arm/Micropositioning System is comprised of a six degree of freedom (6 DOF) dual encoded robotic arm and is used to direct the movement of the Treatment Head. The Treatment Arm provides mechanical support to the Treatment Head (containing the Therapy Transducer and the coaxially aligned GE LOGIQ E10s Diagnostic Imaging Probe) and allows gross and fine positioning prior to initiating therapy. The Treatment Head is available in two configurations with different maximum treatment depths to provide physicians with options based on target anatomy. Both Treatment Heads are supplied with the System.
Electronic signals from the Treatment Cart are applied to the Therapy Transducer to create a bubble cloud at a known focal point. Note that the bubble cloud location is fixed relative to the position of the Treatment Head. The System uses the software-controlled Micropositioning System to move the Treatment Head, and the resulting bubble cloud, through a programmed treatment pathway to enable treatment delivery at all bubble cloud locations included as part of the PTV.
SUMMARY OF NONCLINICAL/BENCH STUDIES
The following non-clinical test were leveraged to demonstrate safety and effectiveness for the subject device's indication for use.
BIOCOMPATIBILITY/MATERIALS
The Edison System, per the patient contact classification and Table A.1 of the FDA Biocompatibility guidance entitled, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", has two components categorized as Skin Contacting, surface device with limited (1.0 x 10%L and platelet >50 x 10%L
- 8. Subject has an International Normalized Ratio (INR) score of 2.0 mg/dL or estimated glomerular filtration rate (EGFR) 40 days prior to the planned index-procedure date
-
- Subject has planned bevacizumab treatment prior to completion of the 30-day follow-up visit
-
- Subject has previous treatments with chemotherapy and/or radiotherapy that has not been discontinued ≥2 weeks prior to the planned index-procedure date and has not recovered (CTCAE grade 1 or better) from related toxicity (except alopecia and peripheral neuropathy)
-
- Subject has previous treatment with immunotherapies that has not been discontinued >4 weeks prior to the planned index-procedure and has not recovered from related toxicity (CTCAE grade 1 or better)
-
- Subject has a life expectancy less than six ($ 70% For
subjects with two treatments, technical success was to be evaluated at ≤36 hours post the second procedure. |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Secondary effectiveness
endpoint | Technique efficacy defined as the lack of a nodular or mass-like
area of enhancement within or along the edge of the treatment
volume assessed via CT or MR imaging at 30-days post-
procedure (second procedure if applies). [Core Laboratory
Adjudicated] [30-Day post-index procedure] |
| Primary safety endpoint | Safety success was determined using index procedure related
major
complications, including device-related events defined as
Common Terminology Criteria for Adverse Events (CTCAE)
(v 5.0) grade 3 or higher toxicities observed up to 30-days post |
- Subject has a life expectancy less than six ($ 70% For
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| | index-procedure (if second procedure applies). [Clinical Events Committee Adjudicated] [30-Day post-index procedure].
A safety performance goal of 25% was established and the study hypothesis was as follows:
Null hypothesis: major complications patient incidence rate >25%
Alternative hypothesis: major complications patient incidence rate 20 | 0 | 0 | 0 |
1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1.
Table 9: Metastatic subject liver tumor burden
| Category | Sub-category | US, n (%) | EU/UK, n (%) | Total, n (%) |
|---|---|---|---|---|
| Number of liver | ||||
| tumors | 1-5 | 7 (70.0) | 10 (62.5) | 17 (65.4) |
| 6-10 | 2 (20.0) | 1 (6.3) | 3 (11.5) | |
| 11-15 | 0 | 0 | 0 | |
| 16-20 | 0 | 1 (6.3) | 1 (3.8) | |
| >20 | 1 (10.0) | 3 (18.8) | 4 (15.4) |
Safety definitions and reporting requirements
Safety analysis included description of all Adverse Events (AEs) which were followed through the 1-year follow up visit with 30 day reporting for the primary safety endpoint. AEs were further subdivided as Serious Adverse Events (SAEs) if they met the following criteria:
-
- Death,
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-
- serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following:
- o A life-threatening illness or injury. or
- A permanent impairment of a body structure or a body function, or
- Hospitalization or prolongation of patient hospitalization, or o
- Medical or surgical intervention to prevent life threatening illness or injury or o permanent impairment to a body structure or a body function, or
- Chronic disease, o
-
- fetal distress, fetal death or a congenital physical or mental impairment or birth defect
Note: Planned hospitalization for a pre-existing condition, or a procedure required by the protocol, without serious deterioration in health, is not considered a serious adverse event.
Additional definitions include the following descriptions. An Adverse Device Effect (ADE) is an adverse event-related to the use of an investigational medical device. A Serious Adverse Device Effect (SADE) is an adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event. An Unanticipated Adverse Device Effect (UADE) is an adverse device effect which by its nature, incidence, severity, or outcome has not been identified in the current version of the risk analysis report. An Unanticipated Serious Adverse Device Effect (USADE) is a serious adverse device effect which by its nature, incidence, severity, or outcome has not been identified in the current version of the risk analysis report.
Safety and Effectiveness Results
Effectiveness Endpoints:
The primary effectiveness endpoint was technical success, defined as the treatment volume/treatment dimensions being greater than or equal to the targeted tumor with complete tumor coverage as assessed by a CT or MRI imaging obtained 70% performance goal for the primary effectiveness endpoint was met with 95.5% [95% CI 83.72 = 100%] of the lesions having achieved technical success within 36 hours of the procedure.
Post-procedure CT findings were corroborated with the histopathology results from the preclinical acute animal study. The clinical study leveraged this information to support effectiveness, in lieu of collecting post-treatment liver biopsy samples to demonstrate adequate ablation.
Safety Endpoints:
The primary safety endpoint of the clinical studies was defined as index-procedure device-related major complications of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or higher at 30-days as adjudicated by an independent Clinical Events Committee (CEC) with a
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performance goal set at 25%. A performance goal of 25% was selected to encompass the reported literature range of major complications (2.0%-11.2%8) for other liver ablation techniques, within the bounds of a 95% Confidence Interval (CI). All 44 subjects enrolled were included in the analysis of the primary safety endpoint. The 3) and an effectiveness performance goal of >70% technical success defined as treatment volume/treatment dimensions being greater than or equal to the targeted tumor with complete tumor coverage as assessed by a CT or MRI imaging obtained 70% technical ablation success with 95.5% [95% CI 83.72 - 100%] or 42/44 of the liver lesions having achieved technical ablation success within 36 hours of the procedure. Limitations of the clinical study enrollment size (N=44), short term ablation-centric technical success endpoints, and use in patients with unresectable liver tumors leads to uncertainty with regards to the magnitude and duration of clinical benefit. However, the 95.5% technical ablation success rate is consistent with the technical success rates of other liver ablation methods reported in literature (47.7%-94.8%1-7). In comparison to available ablative alternatives, the device is able to destroy liver tumors without the need for percutaneous access. This provides significant patient benefit from the perspectives of reduced infection risk at the insertion site or along the insertion route, preclusion of insertion pain, and an alternative option for patients who do not wish or cannot undergo invasive surgical procedures. As an additional benefit to patients the device's intended function requires real-time imaging of the ablation zone and the procedure would not require alternative imaging modalities such as CT or MRI to evaluate the results of ablation.
It is probable that the device provides ancillary benefits to both the patient and the operator. Active cavitation of tissue can be seen and monitored on ultrasound, which allows real-time visualization of target ablation tissues. If abnormalities are identified during use, visualization of the target allows users to halt or modify energy delivery in response. If particular target areas are difficult to visualize on ultrasound, the software contained within the subject device allows users to review CT or MRI images as an additional reference during ultrasound ablation. Finally, it is
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probable that human error and could be reduced due the automation feature provided by the subject device, as the device provides precise, increment throughout a pre-planned treatment volume as demonstrated by the adequate verification, and pre-clinical testing.
The risks of the Edison System's technology and clinical study limitations are mitigated by the special controls and labeling. Specifically, labeling include warnings for the risk of liver failure due to destruction of liver tissue and use limitations based on the clinical data of ablation area of no more than 2 lesions ablated. 3cm or less in diameter. Additionally, labeling includes language that the Edison System has not been evaluated for the treatment of cancer and is not intended for the treatment of cancer or any other specific disease or condition.
Patient Perspectives
This submission did not include specific information on patient perspectives for this device.
Benefit/Risk Conclusion
In conclusion, given the available information above, for the following indication statement:
The Edison System is indicated for the non-invasive destruction of liver tumors, including unresectable liver tumors, using a non-thermal, mechanical process of focused ultrasound.
The probable benefits outweigh the probable risks for the Edison System. The device provides benefits, and the risks can be mitigated by the use of general controls and the identified special controls.
CONCLUSION
The De Novo request for the Edison System is granted and the device is classified as follows:
Product Code: OGM Device Type: Focused ultrasound system for non-thermal, mechanical tissue ablation Regulation Number: 21 CFR 878.4405 Class: II
References:
-
- Shady W, Petre EN, Gonen M, et al. Percutaneous Radiofrequency Ablation of Colorectal Cancer Liver Metastases: Factors Affecting Outcomes -- A 10-vear Experience at a Single Center. Radiology. 2016:278(2):601-611. doi:10.1148/radiol.2015142489
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- Solbiati L, Ahmed M, Cova L, Ierace T, Brioschi M, Goldberg SN. Small liver colorectal metastases treated with percutaneous radiofrequency ablation: local response rate and long-term survival with up to 10-year follow-up. Radiology. 2012;265(3):958-968. doi:10.1148/radiol.12111851
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- Wahl DR, Stenmark MH, Tao Y, et al. Outcomes After Stereotactic Body Radiotherapy or Radiofrequency Ablation for Hepatocellular Carcinoma. J Clin Oncol. 2016;34(5):452-459. doi:10.1200/JCO.2015.61.4925
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- Zhang L, Wang N, Shen Q, Cheng W, Qian GJ. Therapeutic efficacy of percutaneous radiofrequency ablation versus microwave ablation for hepatocellular carcinoma. PloS One. 2013;8(10):e76119. doi:10.1371/journal.pone.0076119
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- Pompili M, Saviano A, de Matthaeis N, et al. Long-term effectiveness of resection and radiofrequency ablation for single hepatocellular carcinoma