(141 days)
No
The summary describes a robotic arm controlled by software to deliver focused ultrasound based on a treatment plan. There is no mention of AI or ML being used for image analysis, treatment planning, or any other function. The software controls the robotic arm based on a pre-determined plan, not through learning or adaptive algorithms.
Yes
The intended use explicitly states "non-invasive destruction of liver tumors" using a "non-thermal, mechanical process of focused ultrasound," indicating a direct therapeutic action on the body.
No
The device is primarily a therapeutic device designed for the non-invasive destruction of liver tumors using focused ultrasound (histotripsy). While it contains a coaxially aligned diagnostic ultrasound probe and is functionally integrated with a GE LOGIQ E10s ultrasound system, these components are used for targeting and monitoring the therapeutic process, not primarily for diagnosing medical conditions.
No
The device description explicitly states that the system is comprised of reusable medical equipment and disposable components, including a Treatment Cart, Support Arm, Treatment Arm/Micropositioning System, Treatment Head containing a therapy transducer and diagnostic ultrasound probe, and disposable membranes. This indicates significant hardware components beyond just software.
Based on the provided information, the Edison System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "non-invasive destruction of liver tumors" using focused ultrasound. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device description details a system that delivers focused ultrasound pulses to mechanically destroy tissue. This is a physical intervention, not a test performed on samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information based on those analyses. The system's purpose is to treat, not to diagnose.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Edison System's function is entirely therapeutic.
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 (comma separated list FDA assigned to the subject device)
QGM
Device Description
The HistoSonics Edison System (the "System") provides users with a means to identify, target and destroy liver tumors entirely non-invasively using histotripsy, a non-ionizing, non thermal, mechanical process of focused ultrasound. Histotripsy is created by delivering high amplitude, very short (microsecond), focused ultrasound pulses designed to induce controlled 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 collapse, imparting significant stress and strain on soft tissue, including liver tissue. After an adequate number of pulses (less than a few seconds at each bubble cloud location), liver tissue within the bubble cloud is mechanically destroyed, resulting in an acellular lysate with limited to no recognizable cellular structures. Acoustic cavitation (and bubble cloud formation) is only created when there is sufficient negative pressure to exceed the cavitation threshold, making it a threshold phenomenon.
The System is comprised of reusable medical equipment and disposable, single-patient use components intended for use in a professional healthcare environment. 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 set up. The Treatment Cart includes a Treatment Arm/Micropositioning System which is comprised of a six degree of freedom (6 DOF), dual encoded robotic arm. At the end of the arm is the Treatment Head which contains the histotripsy therapy transducer and a coaxially aligned diagnostic ultrasound probe. System software controls the Treatment Arm to direct the bubble cloud through the planned treatment volume.
The System is functionally integrated with a GE LOGIQ E10s ultrasound system (K211524), which is provided by HistoSonics with each Edison System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Liver
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional Healthcare Environment
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)
Design verification and validation testing was conducted and demonstrated that the Edison System meets defined product specification and its intended use. The design verification and validation testing included:
- Acoustic Characterization in accordance with IEC 60601-2-62:2013 Medical electrical equipment- Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment.
- Software Testing in accordance with ISO 62304:2015 Medical device software – Software life cycle processes.
- System and Subsystem Verification Testing
A GLP compliant preclinical study was conducted in a porcine model undergoing histotripsy procedure utilizing the predicate and modified Edison System. All acceptance criteria were met. Therefore, the design of the modified Edison System meets the intended use. The results from the testing demonstrate that the subject device does not raise any different questions of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "HUMAN SERVICES-USA" around the edge. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
March 13, 2024
HistoSonics, Inc. Daniel Kosednar VP Regulatory Affairs 16305 36th Avenue N Suite 300 Plymouth, Minnesota 55446
Re: K233466
Trade/Device Name: Edison System Regulation Number: 21 CFR 878.4405 Regulation Name: Focused Ultrasound System For Non-thermal, Mechanical Tissue Ablation Regulatory Class: Class II Product Code: QGM Dated: February 14, 2024 Received: February 14, 2024
Dear Daniel Kosednar:
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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.03.13 14:52:35 -04'00' Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical
2
and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Edison System
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
HistoSonics, Inc. Traditional 510(k) Edison® System
1. Submitter
510(k) Submitter:
HistoSonics, Inc. 16305 36th Avenue N, Suite 300 Plymouth, MN 55446 U.S.A.
Contact Person:
Dan Kosednar VP of Regulatory Affairs Phone: 608-213-5327 Fax: 734-929-9020 Email: dan.kosednar@histosonics.com
Date Prepared: 13 March 2024
2. Subject Device
| Trade Name: | Edison® System |
|---|---|
| Classification Name: | Focused ultrasound system for non-thermal, mechanical tissue ablation |
| Regulation Number: | 21 CFR Part 878.4405 |
| Product code: | QGM |
3. Predicate Device
| Device Name: | Edison System |
|---|---|
| De Novo: | DEN220087 |
| Classification Name: | Focused ultrasound system for non-thermal, mechanical tissue ablation |
| Regulation Number: | 21 CFR Part 878.4405 |
| Product code: | QGM |
4. 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.
5. Device Description
The HistoSonics Edison System (the "System") provides users with a means to identify, target and destroy liver tumors entirely non-invasively using histotripsy, a non-ionizing, non
5
thermal, mechanical process of focused ultrasound. Histotripsy is created by delivering high amplitude, very short (microsecond), focused ultrasound pulses designed to induce controlled 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 collapse, imparting significant stress and strain on soft tissue, including liver tissue. After an adequate number of pulses (less than a few seconds at each bubble cloud location), liver tissue within the bubble cloud is mechanically destroyed, resulting in an acellular lysate with limited to no recognizable cellular structures. Acoustic cavitation (and bubble cloud formation) is only created when there is sufficient negative pressure to exceed the cavitation threshold, making it a threshold phenomenon.
The System is comprised of reusable medical equipment and disposable, single-patient use components intended for use in a professional healthcare environment. 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 set up. The Treatment Cart includes a Treatment Arm/Micropositioning System which is comprised of a six degree of freedom (6 DOF), dual encoded robotic arm. At the end of the arm is the Treatment Head which contains the histotripsy therapy transducer and a coaxially aligned diagnostic ultrasound probe. System software controls the Treatment Arm to direct the bubble cloud through the planned treatment volume.
The System is functionally integrated with a GE LOGIQ E10s ultrasound system (K211524), which is provided by HistoSonics with each Edison System.
6. Summary of Characteristics Compared to Predicate Devices
The Edison System under review is substantially equivalent to the Edison System cleared under DEN220087. The Edison System has the same technological characteristics as the predicates, that is, they operate in the same manner through the non-thermal, mechanical destruction of liver tumors by using non-invasive focused ultrasound.
Overall, the subject and primary predicate devices are all based on the same technological aspects as follows:
- . no change to the core histotripsy parameters or dose
- no increase in the level or amount of focused ultrasound energy delivered
- same thermal cooling table applied
6
The following primary technological differences exist between the subject and predicate devices:
- . Larger bubble cloud size of ~3x3x11mm (subject device) versus a ~3x3x6mm (predicate device) via the use of dynamic electronic micro-steering.
- . 3cm diameter sphere treated with the predicate device would take a minimum of 23 minutes while the subject device will take a minimum of approximately 13 minutes.
See table below for a detailed summary of the characteristics compared to the predicate device.
| Characteristic | Edison System
(Predicate Device)
DEN220087 | Edison System
(Subject Device) | |
|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Product Name | Edison System | Same | |
| Device Classification | Class II | Same | |
| FDA Product Code | QGM | Same | |
| Indication 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. | Same | |
| Anatomical Site | Liver | Same | |
| Use Environment | Professional Healthcare
Environment | Same | |
| Software Version | 2.0.1 | 2.1.2 | |
| Integrated
Diagnostic
Ultrasound System | GE LOGIQ E10s (K211524) | Same | |
| Treatment Cart | | | |
| Generator | 64-channel amplifier | 64-channel amplifier updated
for manufacturability, no
functional changes | |
| High Voltage Power
Supply | 5 amp max current (3.5 amp
average draw) power supply | 10 amp max current (3.5 amp
average draw) power supply | |
| Power Distribution
Box | 1U Rackmount, 12V power
supply | 2U Rackmount 12V power
supply | |
| Uninterruptable
Power Supply (UPS) | Not applicable | 1U Rackmount, 770 Watt
output with 120VAC input | |
| Characteristic | Edison System
(Predicate Device)
DEN220087 | Edison System
(Subject Device) | |
| Required Workflow | | | |
| System Setup | Required steps include Log-in,
Position Treatment Arm,
Attach/Select Treatment Head,
Position Imaging Probe,
Submerge Treatment Head,
Calibrate Crosshairs, and Patient
Registration | Same | |
| Patient Preparation
(Localize) | Required steps include Patient
Preparation, Patient Coupling,
Wheel Lock and Calibrate
Resistance Detection | Same | |
| Plan | Required steps include Position
Contours, Verify Set-up by
surveying the plan to assure
that the resistance is
acceptable, Mark Muscle Layer
and Verify Plan | Same | |
| Treat | Required steps include Calibrate
Crosshairs In Vivo, Establish
Voltage Settings and Automated
Treatment | Same | |
| System Shutdown | Required steps include Remove
Treatment Head and Move
Treatment Arm to Storage
position | Same | |
| Optional Workflow | DICOM Image
Viewer | IMFusion Software v2.45.15 | Same |
| | Image Fusion
Workflow | Workflow steps include Breath
Hold and Image Sweep,
Review/Trim recording,
Establish Registration Points,
Fuse and Review/Accept Results | Same |
| Characteristic | Edison System
(Predicate Device)
DEN220087 | Edison System
(Subject Device) | |
| Treatment Head | | | |
| Treatment Heads
Available | 2 – 52 element and 56 element | Same | |
| Integrated
Diagnostic
Ultrasound Imaging
Probe | GE C1-6-D | GE C1-6VN-D | |
| Imaging Probe
Rotation | +/- 180 degrees in X/Y | Same | |
| Imaging Probe
Translation | + 5cm translation in Z | Same | |
| Imaging Probe
Mounting | Coaxial | Same | |
| Imaging refresh
rate | Continuous, Live stream | Same | |
| Histotripsy Therapy Parameters | | | |
| Bubble Cloud Size | ~3x3x6mm | ~3x3x11mm | |
| Treatment plan size
range | • no more than a 2:1 ratio from
largest to smallest diameter
• no less than 15 mm in any
diameter (X, Y, Z)
• no more than 40 mm in any
diameter (X, Y, Z) | • no more than a 1.5:1 ratio from
largest to smallest
diameter
• no less than 20 mm in any
diameter (X, Y, Z)
• no more than 40 mm in any
diameter (X, Y, Z) | |
| Focal Steering -
Static Focus | Static Focal Steering to achieve
1 cm to 2 cm extended depth
from natural focus | Same | |
| Focal Steering -
Dynamic Micro-
steering | Feature available but not
incorporated | Automated Focal micro-
steering to achieve larger
bubble cloud | |
| Thermal Profile | Thermally-safe treatment
protocol embedded in software. | Same | |
| Minimum
treatment time for
3cm Diameter
Sphere | ~23 min | ~13 min | |
| Characteristic | Edison System
(Predicate Device)
DEN220087 | Edison System
(Subject Device) | |
| Accessories / Patient Coupling Solution | | | |
| Support Arm with
attached bedrail
clamp and
upper/lower frame | 3DOF, multi-joint arm
1" bedrail clamp
Molded Frame components | Same | |
| Patient membrane | Proprietary Styrene-ethylene-
butylene-styrene (SEBS)
membrane overmolded on
molded polypropylene frame | Same | |
| Patient/Membrane
Coupling Oil | Castor Oil | Same | |
| Membrane Cradle | Silicone web | Same | |
| Bubble Evacuation
Tool | Off the shelf catheter and
syringe | Custom molded bulb and
tube design | |
| Inspection Mirror | Included | Same | |
| Ultrasound
Coupling Media | Degassed Water | Same | |
7
8
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The bench and in-vivo animal study conducted demonstrate that the minor technological differences do not raise any different questions of safety and effectiveness and the subject device is as safe and effective as the predicate devices. In conclusion, the Edison System under review is substantially equivalent to the predicate device.
7. Performance Data
In accordance with the required device Special Controls, non-clinical performance testing was performed on the modified Edison System which demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance documents. The following performance data was provided in support of the substantial equivalence determination.
Design Verification and Validation Testing Data:
Design verification and validation testing was conducted and demonstrated that the Edison System meets defined product specification and its intended use. The design verification and validation testing included:
- . Acoustic Characterization in accordance with IEC 60601-2-62:2013 Medical electrical equipment- Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment.
10
- . Software Testing in accordance with ISO 62304:2015 Medical device software – Software life cycle processes.
- . System and Subsystem Verification Testing
Cybersecurity Compliance Information:
Information demonstrating compliance with section 525B of the FD&C Action per current "FDA Guidance: Cybersecurity in Medical Devices - Quality System Considerations and Content of Premarket Submissions" was provided in this submission.
Animal Study Data:
A GLP compliant preclinical study was conducted in a porcine model undergoing histotripsy procedure utilizing the predicate and modified Edison System. All acceptance criteria were met. Therefore, the design of the modified Edison System meets the intended use. The results from the testing demonstrate that the subject device does not raise any different questions of safety and effectiveness.
Additional Considerations Specific to Special Controls:
Changes to the subject device did not require further testing in support of IEC 60601-1:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance or IEC 60601-1-2:2020 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.
There have been no device changes that impacted the critical tasks associated with the modified Edison System and therefore the previously conducted usability testing in accordance with ISO 62366-1:2020 Medical devices – Part 1: Application of usability enqineering to medical devices is still applicable.
Finally, there have no changes to the patient contacting accessories that would impact the devices compliance with the following standards:
- . ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing;
- . ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity;
- . ISO 10993-10:2021 Biological evaluation of medical devices -- Part 10: Tests for skin sensitization;
- . ISO 10993-23:2021 Biological evaluation of medical devices -- Part 23: Tests for irritation; and
11
- . FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" September 8, 2023.
8. Substantial Equivalence Discussion
The Edison System under review has the same intended use, indications for use, anatomical site, principle of operation, and technological characteristics as the predicate device identified in this submission.
Furthermore, the design verification and validation testing performed demonstrate the subject device meets defined product specification and intended use. In addition, the bench and GLP animal comparison testing with the predicate device demonstrate that the subject device has comparable performance to the predicate device and the minor technological characteristics differences do not raise any different questions of safety and effectiveness.
Based on the indications for use, technological characteristics, performance testing, and comparison to the predicate device, the Edison System has been shown to be substantially equivalent to the predicate device identified in this submission.