(240 days)
The Dophi Electroporation System is intended for surgical ablation of soft tissue by irreversible electroporation.
The Electroporation System consists of Electroporation Power Generator, Electroporation Trigger Probe, Electroporation Standard Probe, Electroporation Fixator support and Foot Switch. The single-use Electroporation Trigger Probe with EO sterilization is the same as Electroporation Standard Probe and Electroporation Fixator support. The Electroporation Power Generator and Foot Switch are non-sterile and reusable. With the Electroporation System, a voltage applied between pairs of probes in a series of pulses. The waveform of the voltage is adjustable as determined by clinician-chosen parameters. These parameters include volts, pulse width, pulse frequency and the distance between probes. Up to six probes may be placed in an array within the tissue. The probes of the array are matched as pairs by the system. When probes are activated via a foot switch, the scheduled voltage is delivered to tissue between subsequent pairs of probes. Soft tissue between the probes is ablated.
The provided text is an FDA 510(k) premarket notification for a medical device, the "Electroporation System (N3000)". It outlines the device description, indications for use, comparison to a predicate device, and various tests performed to demonstrate substantial equivalence.
However, the document does not contain information regarding acceptance criteria and a study to prove the device meets these criteria in the context of AI/ML device performance metrics (e.g., sensitivity, specificity, AUC, human reader improvement with AI assistance).
The document primarily focuses on:
- Electrical Safety and Electromagnetic Compatibility: Compliance with IEC 60601 series.
- Biocompatibility Testing: Compliance with ISO 10993-1.
- Sterilization & Shelf Life: Compliance with ISO 11135 and ISO 11607.
- Software Validation: Compliance with FDA Guidance for the Content of Premarket Submissions for Software Functions.
- Animal Testing: An in-vivo animal study on porcine models to compare ablation volume and ECG trigger mode, and potential thermal ablation effect, between the subject and predicate devices.
The "Animal testing" section states: "The results show that the safety and efficacy of the tested articles are similar to those of the control articles." This is the closest the document comes to a performance claim, but it's not quantitative or related to AI/ML acceptance criteria.
Therefore, based solely on the provided text, I cannot fill out the requested table or provide information about the specific types of studies listed (MRMC, standalone algorithm performance, AI assistance effect size, etc.) because these details are not present in the given document.
The document clearly states: "Clinical studies were not required to demonstrate the substantial equivalence of the Electroporation System and the predicated device." This further indicates that no human clinical performance study, often where metrics like sensitivity/specificity and MRMC studies would be conducted for AI/ML devices, was performed or presented in this 510(k).
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 4, 2024
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Guofang Ma QARA Director No.1 XinXing Yilu Road, Emerging Industrial Cluster Area Zonghan Subdistrict Cixi. Zhejiang 315301 China
Re: K240376
Trade/Device Name: Electroporation System (N3000) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: OAB Dated: February 6, 2024 Received: September 4, 2024
Dear Guofang Ma:
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/cdrb/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 OS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-regulatory
{2}------------------------------------------------
assistance/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,
Long H. Chen = S Digitally signed by Long H.Chen-S
Date: 2024.10.04 13:21:09 -04'00'
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K240376
Device Name Dophi Electroporation System (N3000)
Indications for Use (Describe)
The Dophi Electroporation System is intended for surgical ablation of soft tissue by irreversible electroporation.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
K240376
510(k) Summary
This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92.
There is no prior submission for the device.
1 Submitter Information
- 510(k) Submitter/Holder: Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. No. 1 Xinxing Yilu Road, Emerging Industrial Cluster Area, Zonghan Subdistrict, Cixi City, Zhejiang, 315301,China
. Contact
Guofang Ma QARA Director Telephone: +86-010-64117355-8108 Fax: +86-010-64117355-8167 Email: QARA@surgnova.com
- Date Prepared: Oct. 01, 2024
2 Proposed Device Information
Trade/Proprietary Name: Dophi Electroporation System Common Name: Low energy direct current thermal ablation device Model: N3000 Device Classification Names: Low energy direct current thermal ablation device Regulations Number: 21 CFR 878.4400
Regulation Name: Electrosurgical cutting and coagulation device and accessories Product Code: OAB Device Class: II Panel: General & Plastic Surgery
3 Predicate Device
510(k) Number: K102329
Device Trade/Proprietary Name: NanoKnife® System Common Name: Low energy direct current thermal ablation device Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories
{5}------------------------------------------------
Regulation Number: 21 CFR 878.4400 Product Code: OAB Regulatory Class: Class II Panel: General & Plastic Surgery Manufacturer: AngioDynamics, Inc.
4 Device Description
The Electroporation System consists of Electroporation Power Generator, Electroporation Trigger Probe, Electroporation Standard Probe, Electroporation Fixator support and Foot Switch. See following table for details:
| Name | Model | |
|---|---|---|
| ElectroporationSystem | Electroporation Power Generator | NPG3000 |
| Electroporation Trigger Probe | NTP13, NTP18, NTP25 | |
| Electroporation Standard Probe | NSP13, NSP18, NSP25 | |
| Electroporation Fixator support | NFS06 | |
| Foot Switch | SJ-A01 |
| Table 1 Electroporation System | |
|---|---|
| -------------------------------- | -- |
The single-use Electroporation Trigger Probe with EO sterilization is the same as Electroporation Standard Probe and Electroporation Fixator support. The Electroporation Power Generator and Foot Switch are non-sterile and reusable.
With the Electroporation System, a voltage applied between pairs of probes in a series of pulses. The waveform of the voltage is adjustable as determined by clinician-chosen parameters. These parameters include volts, pulse width, pulse frequency and the distance between probes. Up to six probes may be placed in an array within the tissue. The probes of the array are matched as pairs by the system. When probes are activated via a foot switch, the scheduled voltage is delivered to tissue between subsequent pairs of probes. Soft tissue between the probes is ablated.
5 Indications for use
The Dophi Electroporation System is intended for surgical ablation of soft tissue by irreversible electroporation.
{6}------------------------------------------------
K240376
6 Comparison list of the technological characteristics
| Comparison Elements | Predicate DeviceNanoKnife System (K102329) | K240376Subject Device | |
|---|---|---|---|
| Generator | |||
| Product Name | Generator | Electroporation Power Generator | |
| Regulation No. | 21 CFR 878.4400 | 21 CFR 878.4400 | |
| Classification | II | II | |
| Product Code | OAB | OAB | |
| Indications for Use | The NanoKnife System with six outputs is indicatedfor surgical ablation of soft tissue. | The Dophi Electroporation System is intended for surgicalablation of soft tissue by irreversible electroporation. | |
| Technologicalcharacteristics | Working Principle | Equipment adopts the technology of the irreversible electroporation, to 1 mm in diameter of Probe into the soft tissueand is estimated as the computer technology and mapping field size and location, the release of high voltage electricalimpulses in the cell membrane lipid bilayer formed on nanoscale permanent perforation, destroy the balance in cellsinduce apoptosis. | Equipment adopts the technology of the irreversible electroporation, to 1 mm in diameter of Probe into the soft tissueand is estimated as the computer technology and mapping field size and location, the release of high voltage electricalimpulses in the cell membrane lipid bilayer formed on nanoscale permanent perforation, destroy the balance in cellsinduce apoptosis. |
| Working model | The system allow the User to select 90 PPM, 240PPM, or ECG synchronization | Pulse mode: 90PPMECG synchronization | |
| Probe number | Up to 6 monopole needles are supportedsimultaneouslyPort 1 contacts the trigger probe, and ports 2 to 6connect to the standard electrode | Up to 6 monopole needles are supported simultaneously.Port 1 contacts the trigger probe, and ports 2 to 6 connect tothe standard electrode. | |
| Pulse length | 20-100us | 20-100us | |
| Pulse number | 10-100pcs | 10-100pcs | |
| Electric field intensity | 500-3000V/cm | 700-3000V/cm | |
| Probe Pair Distance | 0 cm ~ 3 cm | 0 cm ~ 3 cm | |
| Exposed Length | 0 cm ~ 4 cm | 0 cm ~ 4 cm | |
| Voltage output | 500-3000V | 500-3000V | |
| Max Output Current | 50A | 50A | |
| Voltage supply: | 100–240 V, 50/60 Hz | 100-240V AC, 50/60Hz | |
| Probe | |||
| Product Name | Single Electrode Activation Probe;Standard Single Electrode Probe | Electroporation Trigger Probe;Electroporation Standard Probe | |
| Conditions of use | The standard Single Electrode Probe and Single Electrode Activation Probe are connected to the generator and intended for surgical ablation of soft tissue. | The Electroporation Probe is connected to the Electroporation power generator, and can be penetrated around the target lesion during the operation, and the high-voltage pulse energy outputted by the generator is transmitted to the target lesion | |
| Diameter | Single Electrode Activation Probe (Blue): 19GStandard Single Electrode Probe (White): 19G | Electroporation Trigger Probe (Orange): 19GElectroporation Standard Probe (White): 19G | |
| Specification | Single Electrode Activation Probe (Blue) 15 cm and 25 cmStandard Single Electrode Probe (White) 15 cm and 25 cm | Electroporation Trigger Probe (Orange): 13cm, 18cm, 25cmElectroporation Standard Probe (White): 13cm, 18cm, 25cm | |
| Electroporation Fixator Support | |||
| Function | The spacer is used to ensure that the two probes are kept parallel and the pitch of the two probes can be | The Electroporation Fixator Support is used to ensure that the two probes are kept parallel and the pitch of the two probes | |
| Foot Switch | adjusted. | can be adjusted. | |
| Function | The system incorporates a double trigger foot pedalsystem that prevents accidental delivery of procedure pulses. The foot pedals require the User tofirst arm the system by depressing the "Arm" footpedal, and then sequentially, depressing the "Pulse"foot pedal within 10 seconds of arming to deliverenergy to the patient. | The system uses a single pedal switch to control the excitationof test pulse and treatment pulse.When the progress bar Image: progress bar appears on the screen, keep stepon the Foot Switch until the progress bar reaches 100% Image: progress barand the excitation pulse starts |
{7}------------------------------------------------
{8}------------------------------------------------
K240376
{9}------------------------------------------------
7 Testing
The Electroporation System has been designed and tested in accordance with both mandatory and voluntary standards, the following testing have been performed on the proposed device demonstrate substantial equivalence to the predicate devices, including:
Electrical Safety and Electromagnetic Compatibility:
IEC 60601-1: 2020 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance
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
IEC 60601-1-8: 2020 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
Biocompatibility Testing:
The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility. The biocompatibility tests are in compliance with the standards of ISO 10993-1: Biological Evaluation of Medical Devices and FDA guidance "Use of international Standard ISO 10993-1", "Biological Evaluation of Medical Devices".
Sterilization & Shelf Life:
The Electroporation Probe and Electroporation Fixator support are sterilized by EO sterilization, and sterilization for the EO sterilization process has been conducted, and the result is in compliance with the ISO 11135 requirements. The sterilization process has been demonstrated SAL≤ 10-6.
Primary package verification for Electroporation Probe and Electroporation Fixator support have been conducted, and the results conform to the ISO 11607 requirements. The transportation package verification also have been conducted to ensure the package integrity.
The shelf life of the Electroporation Probe and Electroporation Fixator support is 3 years. The accelerated aging and real-time aging test results demonstrate that the device is intact within the 3-year shelf life cycle to ensure the aseptic integrity of the initial packaging and the sterility of the device, the function of the device conforms to the requirements.
Software:
The Software Validation is in compliance with FDA Guidance for the Content of Premarket
{10}------------------------------------------------
Submissions for Software Functions.
Animal testing
The in-vivo animal study was conducted on porcine model. It includes chronic animal study and acute animal study, the chronic animal study includes the ablation volume measurement and ECG trigger mode testing between subject device group and predicate device group. The acute animal study was conducted to compare the potential thermal ablation effect of subject device and predicate device. The results show that the safety and efficacy of the tested articles are similar to those of the control articles.
Clinical Study
Clinical studies were not required to demonstrate the substantial equivalence of the Electroporation System and the predicated device.
8 Determination of substantial equivalence
Results of the performance testing demonstrated that the technological differences between the predicate and subject device do not raise new or different questions of safety or effectiveness. The subject device Electroporation System is as safe and effective and substantially equivalent to the predicate device NanoKnife System (K102329).
§ 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.