(174 days)
No
The description focuses on hardware components, power delivery, cooling systems, and user interface for setting parameters. There is no mention of AI/ML terms, image processing for analysis, or data sets for training/testing algorithms. The software mentioned is for system control and verification, not for complex data analysis or decision-making typically associated with AI/ML in medical devices.
Yes
The device is indicated for the "ablation (coagulation) of soft tissue," specifically for the "partial or complete ablation of non-resectable liver tumors," which signifies a medical intervention designed to treat a disease or condition.
No
The device is described as an "ablation (coagulation) of soft tissue" system that applies microwave energy to produce "tissue heating effects generating tissue necrosis," indicating a therapeutic rather than diagnostic function.
No
The device description explicitly states it is a "self-contained stand-alone system of hardware and software" and details multiple hardware components including a cart, Power Distribution Module, microwave ablation probes, a microwave source, power amplifiers, and a CO2 based cooling system.
Based on the provided information, the NEUWAVE™ Microwave Ablation System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the ablation (coagulation) of soft tissue in surgical settings. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device delivers microwave energy to heat and destroy tissue. This is a physical intervention, not a test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The NEUWAVE™ system is a therapeutic device used to treat tissue directly.
N/A
Intended Use / Indications for Use
The NEUWAVE™ Microwave Ablation System and Accessories are indicated for the ablation (coagulation) of soft tissue in percutaneous, open surgical and in conjunction with laparoscopic surgical settings, including the partial or complete ablation of non-resectable liver tumors.
The NEUWAVE™ Microwave Ablation System is not indicated for use in cardiac procedures.
Product codes
NEY
Device Description
The NEUWAVE™ Microwave Ablation System is a self-contained stand-alone system of hardware and software designed for the ablation of soft tissue which applies microwave energy to produce tissue heating effects generating tissue necrosis.
The system consists of three major components (1) a cart which contains the components necessary to deliver microwave power to the microwave ablation probes, monitor and control system functions, a graphical user interface for the user to interact with the system and a CO2 based cooling system, (2) a Power Distribution Module (PDM), and (3) a range of microwave ablation probe accessories for energy delivery.
The system has a single 2.45 GHz signal microwave source with three 140W microwave power amplifiers, a touch-screen graphical user interface, and a CO2 based cooling system for limiting the temperature of the ablation probe, handle, and cable.
The CO2 cooling system enables the Tissu-Loc function, which involves formation of an ice ball to adhere the probe in place prior to starting ablation therapy. This helps eliminate probe migration during imaging (CT scans, ultrasounds, etc.) and additional probe placement. The cooling system is responsible for controlling the pressure of the incoming CO2 gas from two E-sized CO2 cylinders located on the back of the system.
The graphical user interface allows the user to set, adjust and activate the power setting per probe, time setting for each probe, ability to synchronize ablation initiation on probes, ablation activation, cauterization activation, audible volume, probe temperature, and Tissu-Loc function.
Up to three (3) NEUWAVE Ablation Probes can connect to the PDM at once and the PDM allows power to be transferred from the system generator to the ablation probes.
The microwave ablation probes are accessories which transfer microwave energy from the system cart to the target tissue to create regions of thermal necrosis. Each probe contains thermocouples that monitor the temperature of the probes can be used for surgical mode or ablation mode with various limits of maximum selectable power and time based on the probe type.
NEUWAVE™ LK, and NEUWAVE™ PR ablation probes are available in either 17- gauge or 15- gauge cannulas and are available in 15 cm and 20 cm lengths. These probes have a cable length of 1.4m.
NEUWA VE™ LN ablation probes are available only in 17-gauge cannulas and are available in 15 cm and 20 cm lengths. These probes have a cable length of 1.4m.
The model NEUWAVE™ SR ablation probes have a 13-gauge cannula and are available in a 25 cm length only. NEUWAVE™ SR probes have a cable length of 1.4m.
NEUWAVE™ Surgical PR Ablation Probes have a 15-gauge cannula and a 15 cm length. These probes have a 2.9m cable length and the probe tip has a non-stick coating that facilitates repeat ablations/Planar Coagulation and helps prevent ablated tissue from adhering to the tip of the probe.
The antenna of the NEUWAVE™ PR probe is designed to limit the length of the ablation for instances when a shorter ablation zone is desired. NEUWAVE™ PR Probes were developed to provide physicians with an additional ablation probe option with a different ablation burn pattern compared with NEUWAVE™ LK/LN/SR probes. The NEUWAVE™ PR probes are designed to produce ablations that quickly encompass the tip of the probe while limiting the overall length of the ablation compared with other NEUWAVE ablation probes.
The wide selection of ablation probes provides physicians with the opportunity to select the length, stiffness, burn pattern and number of probes to use to create a wide variety of ablation zone sizes and shapes.
A surgical clip is a single use sterile surgical accessory designed to hold two microwave ablation probes together in a parallel configuration at a fixed distance apart to facilitate planar coagulation of soft tissue during a surgical resection.
An optional footswitch accessory can be connected to the system to control power delivery in Surgical Mode.
Ablation Confirmation software (previously cleared under K192427) is available as an optional feature for the NEUWAVE™ Microwave Ablation System. When this option is supplied, a second monitor is provided with the cart which hosts the Ablation Confirmation graphical user interface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, non-resectable liver tumors
Indicated Patient Age Range
Not Found
Intended User / Care Setting
percutaneous, open surgical and in conjunction with laparoscopic surgical settings
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)
Nonclinical Testing: Design Verification testing was completed to assure that the modified NEUWAVE™ Microwave Ablation System and Accessories meets its design and performance specifications. Electrical safety testing, electromagnetic compatibility testing and ex-vivo ablation tissue testing was conducted.
- Electrical Safety Testing per IEC 60601-1 3rd Edition: Pass
- Electromagnetic compatibility (EMC) testing per IEC 60601-1-2 4th Edition: Pass
- Ex-vivo tissue ablation testing: Demonstrated ablation zone dimensions of the subject and predicate devices are substantially equivalent for identical power settings. Pass
Software verification testing was conducted and passed as recommended by Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
August 11, 2022
Image /page/0/Picture/1 description: The image shows 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.
NeuWave Medical Inc. Mohamed Shariff Associate Director, Regulatory Affairs 3529 Anderson Street Madison, Wisconsin 53704
Re: K220472
Trade/Device Name: NEUWAVE Microwave Ablation System and Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: NEY Dated: July 6, 2022 Received: July 7, 2022
Dear Mohamed Shariff:
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. 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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
Colin Kejing Chen, Ph.D. Acting 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
NEUWAVE™ Microwave Ablation System and Accessories
Indications for Use (Describe)
The NEUWAVE™ Microwave Ablation System and Accessories are indicated for the ablation (coagulation) of soft tissue in percutaneous, open surgical and in conjunction with laparoscopic surgical settings, including the partial or complete ablation of non-resectable liver tumors.
The NEUWAVE™ Microwave Ablation System is not indicated for use in cardiac procedures
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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3
Image /page/3/Picture/1 description: The image shows the logo for NeuWave Medical, a part of the Ethicon family of companies. The logo features a green circular icon with a white wave-like design on the left. To the right of the icon is the text "NeuWave Medical" in a simple, sans-serif font, with the words "PART OF THE ETHICON™ FAMILY OF COMPANIES" appearing in a smaller font size below.
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Date: | August 8, 2022 |
|---|---|
| Submitter Name/Address: | NeuWave Medical, Inc. |
| Part of the Ethicon Family of | |
| Companies 3529 Anderson Street | |
| Madison, WI 53704 | |
| Contact Person: | Mohamed Shariff |
| Associate Director, Regulatory Affairs | |
| Tel: (856) 449 9609 | |
| Fax: (608) 512 1508 | |
| Email: msharif3@its.jnj.com | |
| FDA Establishment Registration # | 3008769756 |
| Device Identification | |
| Trade/Proprietary Name: | NEUWAVE™ Microwave Ablation System |
| Classification Name: | Electrosurgical Cutting and |
| Coagulation Device and Accessories | |
| Product Code: | NEY |
| CFR Section: | 21 CFR 878.4400 |
| Device Class: | Class II |
| Classification Panel: | General and Plastic Surgery Devices |
4
Predicate Device
The NEUWAVE™ Microwave Ablation System and Accessories is substantially equivalent to the following currently marketed device:
NEUWAVE™ Microwave Ablation System and Accessories cleared under K200081 on November 13, 2020.
Indications for Use
The NEUWAVE™ Microwave Ablation System and Accessories are indicated for the ablation (coagulation) of soft tissue in percutaneous, open surgical and in conjunction with laparoscopic surgical settings, including the partial or complete ablation of non-resectable liver tumors.
The NEUWAVE" Microwave Ablation System is not indicated for use in cardiac procedures.
Device Description
The NEUWAVE™ Microwave Ablation System is a self-contained stand-alone system of hardware and software designed for the ablation of soft tissue which applies microwave energy to produce tissue heating effects generating tissue necrosis.
The system consists of three major components (1) a cart which contains the components necessary to deliver microwave power to the microwave ablation probes, monitor and control system functions, a graphical user interface for the user to interact with the system and a CO2 based cooling system, (2) a Power Distribution Module (PDM), and (3) a range of microwave ablation probe accessories for energy delivery.
The system has a single 2.45 GHz signal microwave source with three 140W microwave power amplifiers, a touch-screen graphical user interface, and a CO2 based cooling system for limiting the temperature of the ablation probe, handle, and cable.
The CO2 cooling system enables the Tissu-Loc function, which involves formation of an ice ball to adhere the probe in place prior to starting ablation therapy. This helps eliminate probe migration during imaging (CT scans, ultrasounds, etc.) and additional probe placement. The cooling system is responsible for controlling the pressure of the incoming CO2 gas from two E-sized CO2 cylinders located on the back of the system.
The graphical user interface allows the user to set, adjust and activate the power setting per probe, time setting for each probe, ability to synchronize ablation initiation on probes, ablation activation, cauterization activation, audible volume, probe temperature, and Tissu-Loc function.
Up to three (3) NEUWAVE Ablation Probes can connect to the PDM at once and the PDM allows power to be transferred from the system generator to the ablation probes.
The microwave ablation probes are accessories which transfer microwave energy from the system cart to the target tissue to create regions of thermal necrosis. Each probe contains thermocouples that monitor the temperature of the probes can be used for surgical mode or ablation mode with various limits of maximum selectable power and time based on the probe type.
5
NEUWAVE™ LK, and NEUWAVE™ PR ablation probes are available in either 17- gauge or 15- gauge cannulas and are available in 15 cm and 20 cm lengths. These probes have a cable length of 1.4m.
NEUWA VE™ LN ablation probes are available only in 17-gauge cannulas and are available in 15 cm and 20 cm lengths. These probes have a cable length of 1.4m.
The model NEUWAVE™ SR ablation probes have a 13-gauge cannula and are available in a 25 cm length only. NEUWAVE™ SR probes have a cable length of 1.4m.
NEUWAVE™ Surgical PR Ablation Probes have a 15-gauge cannula and a 15 cm length. These probes have a 2.9m cable length and the probe tip has a non-stick coating that facilitates repeat ablations/Planar Coagulation and helps prevent ablated tissue from adhering to the tip of the probe.
The antenna of the NEUWAVE™ PR probe is designed to limit the length of the ablation for instances when a shorter ablation zone is desired. NEUWAVE™ PR Probes were developed to provide physicians with an additional ablation probe option with a different ablation burn pattern compared with NEUWAVE™ LK/LN/SR probes. The NEUWAVE™ PR probes are designed to produce ablations that quickly encompass the tip of the probe while limiting the overall length of the ablation compared with other NEUWAVE ablation probes.
The wide selection of ablation probes provides physicians with the opportunity to select the length, stiffness, burn pattern and number of probes to use to create a wide variety of ablation zone sizes and shapes.
A surgical clip is a single use sterile surgical accessory designed to hold two microwave ablation probes together in a parallel configuration at a fixed distance apart to facilitate planar coagulation of soft tissue during a surgical resection.
An optional footswitch accessory can be connected to the system to control power delivery in Surgical Mode.
Ablation Confirmation software (previously cleared under K192427) is available as an optional feature for the NEUWAVE™ Microwave Ablation System. When this option is supplied, a second monitor is provided with the cart which hosts the Ablation Confirmation graphical user interface.
6
Comparison of Intended Use and Indications for Use
The subject device and predicate device have the same Intended Use and Indications for Use as shown in the table below.
| Predicate Device | Subject Device | |
|---|---|---|
| Device | ||
| Characteristics | NEUWAVE™ Microwave Ablation System | |
| and Accessories (K200081) | NEUWAVE™ | |
| Microwave Ablation | ||
| System and Accessories | ||
| with updated Hardware | ||
| and Software | ||
| Intended Use | To thermally ablate soft tissue using microwave | |
| energy. | Same | |
| Indications for Use | The NEUWAVE™ Microwave Ablation System | |
| and Accessories are indicated for the ablation | ||
| (coagulation) of soft tissue in percutaneous, open | ||
| surgical and in conjunction with laparoscopic | ||
| surgical settings, including the partial or complete | ||
| ablation of non-resectable liver tumors. |
The NEUWAVE™ Microwave Ablation
System is not indicated for use in cardiac | Same |
7
Comnarison of Technological Characteristics with Predicate Device
The subject and the predicate devices are similar in terms of technological characteristics as microwave devices used to ablate soft tissue.
The subject device NEUWAVE™ Microwave Ablation System includes some updated but functionally equivalent hardware components which were implemented due to component obsolescence, and a corresponding software update to support the updated hardware. No changes were made that impact the delivery of microwave energy and no changes were made to NEUWAVE™ Ablation probes or accessories.
| Predicate Device | Subject Device | ||
|---|---|---|---|
| Feature/Specification | NEUWAVE™ Microwave Ablation | ||
| System and Accessories (K200081) | NEUWAVE™ | ||
| Microwave Ablation | |||
| System and | |||
| Accessories with | |||
| updated Hardware | |||
| and Software | |||
| Software Version | V3.1.0 software | V3.1.1 | |
| Probe Applications | Percutaneous, open surgical and in conjunction | ||
| with laparoscopic surgical settings. | Same | ||
| User Interface Modes | Surgical and Ablation Mode | Same | |
| Power Delivery Initiation | |||
| Method | User Interface, Footswitch (Footswitch | ||
| available in Surgical Mode only) or Finger- | |||
| Switch | Same | ||
| Predicate Device | Subject Device | ||
| Feature/Specification | NEUWAVETM Microwave Ablation | ||
| System and Accessories (K200081) | NEUWAVETM | ||
| Microwave Ablation System and | |||
| Accessories with updated Hardware | |||
| and Software | |||
| Probe dimensions | |||
| NEUWAVETM LK Probe | Diameter: 15 gauge, Length: 15 cm and 20 cm | ||
| Diameter: 17 gauge, Length: 15 cm and 20 cm | Same | ||
| NEUWAVETM LN Probe | Diameter: 17 gauge, Length: 15 cm and 20 cm | Same | |
| NEUWAVETM SR Probe | Diameter: 13 gauge, Length: 25 cm | Same | |
| NEUWAVETM PR Probe | Diameter: 15 gauge, Length: 15 cm and 20 cm | ||
| Diameter: 17 gauge, Length: 15 cm and 20 cm | Same | ||
| NEUWAVETM Surgical | |||
| PR Probe | Diameter: 15 gauge, Length: 15 cm | Same | |
| Generator Maximum Output Power | |||
| NEUWAVETM LK Probe | Ablation Mode | ||
| and Surgical | |||
| Mode: | Single Probe is 140W, | ||
| Two Probes is 95W, | |||
| Three Probes is 65W | Same | ||
| NEUWAVETM LN Probe | |||
| NEUWAVETM SR Probe | |||
| NEUWAVETM PR Probe | Ablation Mode: | Single Probe is 65W, Two | |
| Probes is 65W, Three | |||
| Probes is 65W | Same | ||
| Surgical Mode: | Single Probe is 95W, Two | ||
| Probes is 95W, Three | |||
| Probes is 65W | |||
| NEUWAVETM Surgical | |||
| PR Probe | Ablation Mode: | Single Probe is 80W, Two | |
| Probes is 80W, Three | |||
| Probes is 80W | Same | ||
| Surgical Mode: | Single Probe is 120W, | ||
| Two Probes is 120W, | |||
| Three Probes is 80W | |||
| Antenna Design | Triaxial Antenna for NEUWAVETM LK Probe, | ||
| NEUWAVETM LN Probe and NEUWAVETM | |||
| SR Probe | Same | ||
| Modified Triaxial Antenna for NEUWAVETM | |||
| PR Probe and NEUWAVEM Surgical PR | |||
| Probe | Same | ||
| Predicate Device | Subject Device | ||
| Feature/Specification | NEUWAVE™ Microwave Ablation | ||
| System and Accessories (K200081) | NEUWAVE™ | ||
| Microwave Ablation | |||
| System and | |||
| Accessories with | |||
| updated Hardware | |||
| and Software | |||
| Settable Parameters | |||
| Power | NEUWAVE™ LK Probe, NEUWAVE™ LN | ||
| Probe and NEUWAVE™ SR | |||
| Probe: 20W-140W in 5W | |||
| NEUWAVE™ PR Probe: | |||
| 20W-95W in 5 W increments | |||
| (Ablation Mode maximum is 65W) | |||
| NEUWAVE™ Surgical PR Probes: | |||
| 20W-120W in 5 W increments | |||
| (Ablation Mode maximum is 80W) | Same | ||
| Target Ablation Time | Up to 10 minutes as limited by software. | ||
| User may ablate for additional time after 10 | |||
| minutes of ablation completion. | Same | ||
| Planar Coagulation Time | 5 seconds - 1 Minute | Same | |
| Accessories | Dual Probe Clip | ||
| CT Table Mounting Adapter for PDM | |||
| Surgical Table Mounting Adapter for PDM | |||
| Foot switch (Locking USB or Standard USB) | Same |
8
9
10
Performance Data
Nonclinical Testing
Design Verification testing has been completed to assure that the modified NEUWAVE™ Microwave Ablation System and accessories meets its design and performance specifications; this testing is summarized in the following table. Electrical safety testing, electromagnetic compatibility testing and ex-vivo ablation tissue testing was conducted in accordance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices. The subject device passed the system level test performance criteria with providing evidence of substantial equivalence between the subject and predicate device.
| Test Performed | Description | Pass/Fail |
|---|---|---|
| Electrical Safety | ||
| Testing | Electrical Safety testing was undertaken per IEC 60601-1 3rd | |
| Edition to demonstrate that the NEUWAVETM Microwave | ||
| Ablation System with NEUWAVETM Probes is electrically | ||
| safe | Pass | |
| Electromagnetic | ||
| compatibility | ||
| (EMC) testing | Electromagnetic compatibility (EMC) testing was | |
| undertaken per IEC 60601-1-2 4th Edition to demonstrate | ||
| that the NEUWAVETM Microwave Ablation System with | ||
| NEUWAVETM Probes complies with the requirements for | ||
| immunity, radiated and conducted emissions | Pass | |
| Ex-vivo tissue | ||
| ablation testing | Ex-vivo tissue testing was conducted to demonstrate | |
| ablation zone dimensions of the subject and predicate | ||
| devices are substantially equivalent for identical power | ||
| settings. | Pass |
Software verification testing was conducted, and results passed as recommended by Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005.
Clinical Data
No clinical data was generated or is required to support of this Premarket 510(k) Notification.
Cybersecurity
Updates to the underlying operating system were performed to strengthen the cybersecurity posture of the system. Also, an assessment was performed to assure conformance to the FDA's "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" guidance document.
11
Sterilization
No sterilization data was generated or required to support of this Premarket 510(k) Notification.
Biocompatibility
No biocompatibility data was generated or required to support of this Premarket 510(k) Notification.
Standards
- 60601-1:2005+C1;A2, Medical Electrical Equipment, Part 1: General Requirements For Basic . Safety And Essential Performance
- 60601-1:2014 Ed.3, Medical Electrical Equipment, Part 1: General Requirements For Basic ● Safety And Essential Performance
- 60601-1-6:2010 Ed.3+A1, Medical Electrical Equipment Part 1-6: General Requirements For ● Basic Safety And Essential Performance - Collateral Standard: Usability
- 60601-2-6:2012 Ed.2, Medical Electrical Equipment Part 2-6: Particular Requirements For The Basic Safety & Essential Performance Of Microwave Therapy Equipment
- 60601-2-18:2009 Ed.3, Medical Electrical Equipment Part 2-18: Particular Requirements For ● The Basic Safety And Essential Performance Of Endoscopic Equipment
Conclusion
There are no differences in fundamental technological characteristics of the subject and predicate devices, and the minor changes implemented do not impact the essential performance of the subject device system and accessories. Based on the intended use, technological characteristics, and validation/verification data, the modified NEUWAVE™ Microwave Ablation System and Accessories is substantially equivalent to the predicate.