(155 days)
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.
The NEUWAVE Microwave Ablation System is a self-contained stand-alone system of hardware and software designed for the ablation of soft tissue, including the partial or complete ablation of non-resectable liver tumors, via applying microwave energy to produce tissue heating effects generating tissue necrosis.
The system consists of three major components:
- (1) The system 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) Power Distribution Module (PDM), which allows power to be transferred from the system generator to the ablation probes.
- (3) Range of microwave ablation probe accessories for energy delivery.
The system cart 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 Esized CO2 cylinders located on the back of the cart.
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 cart 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 probe. The probes can be used for Surgical Mode or Ablation Mode with various limits of maximum selectable power based on the probe type.
The antenna of the NEUWAVE PR probe family 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.
There are 2 changes covered by this 510(k) submission:
-
- A new Microwave Ablation Probe, the Surgical PR Probe (PRS35), available for use with the NEUWAVE System.
-
- Updates to the NEUWAVE System software to accommodate the new PRS35 probe and to implement various enhancements to the user experience and correct minor software anomalies that do not impact safety or effectiveness.
The new NEUWAVE Surgical PR Ablation Probe (PRS35) has a 11/13-gauge and 35cm length cannula with a 2.9m cable in length. The proposed PRS35 probe uses a similar cannula and antenna design to the predicate probes PRS15 & NWSR25, and the ablation pattern also closely resembles the above stated predicate. The longer cannula length is a primary purpose of the new probe to enable access to targets farther from the skin surface due to insufflation in laparoscopic procedures.
The subject embedded software utilizes the existing firmware and software architecture design, technological characteristics and functions but incorporates enhancements and features as described below:
- Procedure Profiles
- PRS35 Probe Support ●
- Planning: Time and Power Guide available without probe ●
- Cybersecurity
- Misc. Bug fixes ●
- Additional Languages to support country specific registration globally (Finnish, Norwegian, Turkish)
No changes were made to the currently marketed family of NEUWAVE Ablation Probes nor to any hardware aspects of the currently marketed NEUWAVE system cleared under K220472.
The selection of available 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.
The provided text describes the 510(k) summary for the NEUWAVE™ Microwave Ablation System and Accessories, specifically focusing on the addition of a new probe (PRS35) and software updates. It states that all acceptance criteria were met, but it does not provide a detailed table of acceptance criteria with reported device performance, information on sample sizes, ground truth establishment methods, or the specifics of a study proving all acceptance criteria were met.
Therefore, many of the requested items cannot be definitively answered from the provided text.
Here is a summary of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document states: "All testing passed, and all acceptance criteria were met." however, it does not specify what those acceptance criteria were or provide a table of performance data against them.
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided text. The document highlights "Nonclinical Testing" including "Probe Ablation Performance Testing in ex-vivo liver, kidney, muscle and lung tissue," but does not explicitly state the sample sizes (e.g., number of probes, number of ex-vivo tissue samples) or the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable / Not available. This type of information is typically relevant for studies involving human interpretation (e.g., imaging studies). For a microwave ablation system, the "ground truth" for non-clinical performance likely refers to measurable physical outcomes (e.g., ablation zone size, temperature profiles) in ex-vivo tissue, which would not typically involve expert consensus in the same way. The document does not mention any expert involvement for establishing ground truth in the non-clinical tests.
4. Adjudication Method for the Test Set
Not applicable / Not available. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies. For the non-clinical performance testing of a microwave ablation system, this concept does not directly apply.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "No clinical data was generated in support of this Premarket 510(k) Notification." Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, implicitly for the software updates. The submission includes "Software Verification and Validation" testing, which would assess the algorithm's performance in a standalone manner. However, no specific performance metrics of the software algorithm itself (e.g., accuracy of a particular feature) are provided. The software updates are described as accommodating the new PRS35 probe, implementing user experience enhancements, and correcting minor anomalies.
7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the "Probe Ablation Performance Testing in ex-vivo liver, kidney, muscle and lung tissue," the ground truth would likely be physical measurements (e.g., dimensions of the ablation zone, temperature reached) observed directly from the ex-vivo tissue after ablation. The document does not specify the exact methodology, but for such a device, these are standard methods.
8. Sample Size for the Training Set
Not applicable / Not available. The document describes a "510(k) premarket notification," which is for demonstrating substantial equivalence to a predicate device, not for a new device requiring a de novo clearance or PMA where extensive training data for AI/ML models might be detailed. The software updates mentioned are for "enhancements to the user experience and correct minor software anomalies" and "PRS35 Probe Support," not for developing a new AI/ML algorithm that would typically require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As the device submission does not describe the development of a new AI/ML algorithm requiring a training set, the establishment of ground truth for a training set is not relevant to the provided information.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
November 16, 2023
NeuWave Medical, Inc. Mohamed Shariff Director of Regulatory Affairs 3529 Anderson Street Madison, Wisconsin 53704
Re: K231738
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: November 17, 2023 Received: October 13, 2023
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 (the 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.
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).
{1}------------------------------------------------
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 Date: 2023.11.16 15:59:44 Trumbore -S -05'00' Mark Trumbore, 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K231738
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) |
|---|
| ------------------------------------------------- |
1ZI Prescription Use (Part 21 CFR 801 Subpart D)
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 0MB number."
{3}------------------------------------------------
Page 24 of 119
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image is a logo for NeuWave Medical, a part of the Ethicon family of companies. The logo features a green sphere with a white wave design on the left side. To the right of the sphere is the text "NeuWave Medical" in a simple, sans-serif font. Below the company name, in smaller letters, it says "PART OF THE ETHICON™ FAMILY OF COMPANIES".
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: | November 15, 2023 |
|---|---|
| Company: | NeuWave Medical Inc.3529 Anderson StreetMadison, WI 53704 |
| FDA Establishment# | 3008769756 |
| Company Contact: | Eleanor ZhouSenior RA Program LeadPhone: 908-427-2178Email: ezhou@its.jnj.com |
| Allison FrancisRegulatory Affairs SpecialistPhone: 508-728-7585E-mail: afranc52@its.jnj.com | |
| Device InformationProprietary Name: | NEUWAVETM Microwave Ablation System |
| Proprietary Name: | NEUWAVE™ Microwave Ablation System and Accessories |
|---|---|
| Common Name: | System, Ablation, Microwave and Accessories |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| Device Class: | Class II |
| Product Code: | NEY |
| CFR Section: | 21 CFR 878.4400 |
Predicate Device
The NEUWAVE Microwave Ablation System and Accessories is substantially equivalent to the following currently marketed device:
Predicate Device - NEUWAVE Microwave Ablation System and Accessories [K220472 with predicate probe PRS15 (originally cleared as part of K200081) & NWSR25 (originally cleared as part of K130399)]
NEUWAVE Microwave Ablation System 510(k) Summary Page 1 of 7
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for NeuWave Medical. The logo consists of a green circle with a white wave design inside, followed by the text "NeuWave Medical" in a simple, sans-serif font. Below the company name, in smaller letters, it says "PART OF THE ETHICON™ FAMILY OF COMPANIES".
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, including the partial or complete ablation of non-resectable liver tumors, via applying microwave energy to produce tissue heating effects generating tissue necrosis.
The system consists of three major components:
- (1) The system 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) Power Distribution Module (PDM), which allows power to be transferred from the system generator to the ablation probes.
- (3) Range of microwave ablation probe accessories for energy delivery.
The system cart 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 Esized CO2 cylinders located on the back of the cart.
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 cart to the ablation probes.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows a circular logo with a light green background. A stylized white wave-like design is prominently displayed in the center of the circle. The logo has a glossy appearance, suggesting a three-dimensional effect.
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 probe. The probes can be used for Surgical Mode or Ablation Mode with various limits of maximum selectable power based on the probe type.
The antenna of the NEUWAVE PR probe family 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.
There are 2 changes covered by this 510(k) submission:
-
- A new Microwave Ablation Probe, the Surgical PR Probe (PRS35), available for use with the NEUWAVE System.
-
- Updates to the NEUWAVE System software to accommodate the new PRS35 probe and to implement various enhancements to the user experience and correct minor software anomalies that do not impact safety or effectiveness.
The new NEUWAVE Surgical PR Ablation Probe (PRS35) has a 11/13-gauge and 35cm length cannula with a 2.9m cable in length. The proposed PRS35 probe uses a similar cannula and antenna design to the predicate probes PRS15 & NWSR25, and the ablation pattern also closely resembles the above stated predicate. The longer cannula length is a primary purpose of the new probe to enable access to targets farther from the skin surface due to insufflation in laparoscopic procedures.
The subject embedded software utilizes the existing firmware and software architecture design, technological characteristics and functions but incorporates enhancements and features as described below:
- Procedure Profiles
- PRS35 Probe Support ●
- Planning: Time and Power Guide available without probe ●
- Cybersecurity
- Misc. Bug fixes ●
- Additional Languages to support country specific registration globally (Finnish, Norwegian, Turkish)
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image is a circular logo with a light green background. A white, stylized wave design is in the center of the circle. The logo has a glossy appearance, suggesting it may be a button or icon.
No changes were made to the currently marketed family of NEUWAVE Ablation Probes nor to any hardware aspects of the currently marketed NEUWAVE system cleared under K220472.
The selection of available 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.
Comparison of Subject Device and Predicate Device
The following table compares the subject device to the predicate device with respect to indications for use, and technological characteristics, forming the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.
| DeviceCharacteristics | Predicate Device | Subject Device |
|---|---|---|
| NEUWAVE Microwave Ablation System and AccessoriesK220472 with predicate probe PRS15&NWSR25 | NEUWAVE Microwave AblationSystem and Accessories with Added35cm Surgical PR Probe | |
| Intended Use | To thermally ablate soft tissue using microwave energy | Same |
| Indications for Use | The NEUWAVE™ Microwave Ablation System andAccessories are indicated for the ablation (coagulation) ofsoft tissue in percutaneous, open surgical and inconjunction with laparoscopic surgical settings, includingthe partial or complete ablation of non-resectable livertumors.The NEUWAVE Microwave Ablation System is notindicated for use in cardiac procedures. | Same |
| Principles ofOperation | The NEUWAVE Ablation Probes are used in conjunctionwith the NEUWAVE Microwave Ablation System.Microwave energy is generated by the NEUWAVEMicrowave Ablation system and delivered to the ablationprobe. The probe converts the currents flowing on thecoaxial cable conductors into radiated microwave energyin the tissue. The microwave energy is applied to the targettissue, heating the tissue to the point of necrosis. | Same |
| Software Version | V3.1.1 | V3.2.0 |
| Probe Applications | Percutaneous, open surgical and in conjunction withlaparoscopic surgical settings. | Same |
| User Interface Modes | Surgical and Ablation Mode | Same |
| Power DeliveryInitiation Method | User Interface, Footswitch (Footswitch available inSurgical Mode only) or FingerSwitch | Same |
| Predicate Device | Subject Device | |
| DeviceCharacteristics | NEUWAVE Microwave Ablation System and AccessoriesK220472 with predicate probe PRS15&NWSR25 | NEUWAVE Microwave AblationSystem and Accessories with Added35cm Surgical PR Probe |
| Probe Dimensions | NEUWAVE LK ProbeDiameter: 15 gauge, Length: 15cm and 20cmDiameter: 17 gauge, Length: 15cm and 20cm | The probe dimensions for thepredicate device(s) remainsunchanged this 510k proposes tointroduce:NeuWave Surgical PR Probe (PRS35)Diameter: 11/13 gauge, Length: 35cm |
| NEUWAVE LN ProbeDiameter: 17 gauge, Length: 15cm and 20cm | ||
| NEUWAVE SR 25 Probe (Predicate Probe 1)Diameter: 13 gauge, Length: 25cm | ||
| NEUWAVE PR ProbeDiameter: 15 gauge, Length: 15cm and 20cmDiameter: 17 gauge, Length: 15cm and 20cm | ||
| NEUWAVE Surgical PRS15 Probe (Predicate Probe 2)Diameter: 15 gauge, Length: 15cm | ||
| Generator MaximumOutput Power | NEUWAVE LK Probe; NEUWAVE LN Probe;NEUWAVE SR ProbeAblation Mode and Surgical Mode: Single Probe is 140WTwo Probes is 95W, Three Probes is 65W | The generator maximum outputpower for the predicate device(s)remains unchanged. The proposednew probe maximum power outputis provided and falls within thealready available range.Ablation Mode: Single Probe is140W, Two Probes is 110W, ThreeProbes is 80WSurgical Mode: Single Probe is140W, Two Probes is 110W, ThreeProbes is 80W |
| NEUWAVE PR ProbeAblation Mode: Single Probe is 65W, Two Probes is65W, Three Probes is 65WSurgical Mode: Single Probe is 95W, Two Probes is 95W, | ||
| Three Probes is 65WNEUWAVE Surgical PR Probe | ||
| Ablation Mode:Single Probe is 80W, Two Probes is 80W, Three Probes is80W | ||
| Surgical Mode: Single Probe is 110W, Two Probes is110W, Three Probes is 80W | ||
| Antenna Design | NEUWAVE LK Probe; NEUWAVE LN Probe;NEUWAVE SR ProbeTriaxial Antenna | Same as PR Probe (ModifiedTriaxial Antenna) |
| NEUWAVE PR ProbeModified Triaxial Antenna | ||
| NEUWAVE Surgical PR ProbeModified Triaxial Antenna | Same | |
| Target Ablation Time | Up to 10 minutes as limited by software. User may ablatefor additional time after 10 minutes of ablationcompletion. | Same |
| Planar CoagulationTime | 5 seconds - 1 minute | Same |
| DeviceCharacteristics | Predicate Device | Subject Device |
| NEUWAVE Microwave Ablation System and AccessoriesK220472 with predicate probe PRS15&NWSR25 | NEUWAVE Microwave AblationSystem and Accessories with Added35cm Surgical PR Probe | |
| Accessories | Dual Probe ClipCT Table Mounting Adapter for PDMSurgical Table Mounting Adapter for PDMFoot switch (Locking USB or Standard USB) | Same |
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows a circular logo with a light green background. A stylized white wave-like design is prominently displayed in the center of the circle. The logo has a glossy appearance, suggesting it may be a digital icon or a representation of a brand.
NeuWave Medical
part of the ethicon™ family of companies
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows a circular logo with a light green background. A stylized white wave-like design is prominently displayed in the center of the circle. The logo has a glossy, three-dimensional appearance, suggesting a modern and clean aesthetic.
The subject and the predicate device are similar in terms of technological characteristics as microwave devices used to ablate soft tissue, including the partial or complete ablation of nonresectable liver tumors.
Sterilization
NeuWave Microwave Ablation Probes are provided to customers sterile. The probes are packed in thermoform plastic trays containing a single probe and sealed with a Tyvek lid prior to sterilization. The product is over-packed in an e-flute box to further protect the sterile barrier.
The validated sterilization method for NeuWave Ablation Probes is Ethylene Oxide. Device specific methods were developed using the "overkill" approach and validated per ISO 11135:2014. Results demonstrated a Sterility Assurance Level (SAL) of 106. There are no changes made to the sterilization method or process for this 510k.
Shelf Life
Accelerated aging tests were conducted to confirm the validity of the 48-month shelf life for ablation probes.
Biocompatibility
The NEUWAVE Ablation Probes are classified as an External Communicating Device, Tissue/bone/dentin patient contact, with a contact duration of (<24) hours. Based on this categorization, per Table A.1 of Annex A of ISO 10993-1, Cytotoxicity, Sensitization, Irritation, Systemic Toxicity and Material Mediated Pyrogenicity tests were performed. The results of all testing demonstrated that the Ablation Probes are biocompatible.
Performance Data
Nonclinical Testing
Design Verification testing has been completed to assure that the modified NEUWAVE Microwave Ablation System and accessories with the NEUWAVE Surgical PR probe meets its design and performance specifications; this testing included:
- Probe Physical Attribute Testing .
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image is a logo for NeuWave Medical, which is part of the Ethicon family of companies. The logo features a green circle with a white wave design on the left side. To the right of the circle is the text "NeuWave Medical" in a simple, sans-serif font. Below the company name is the text "PART OF THE ETHICON™ FAMILY OF COMPANIES" in a smaller font.
- Probe Ablation Performance Testing in ex-vivo liver, kidney, muscle and lung tissue ●
- Probe tissue adhesion testing
- Probe biocompatibility testing per ISO 10993 Series and FDA Guidance
- IEC 60601-1:'' Medical Electrical Equipment. Part 1: General Requirements For Basic ● Safety And Essential Performance"
- . IEC 60601-1: "Medical Electrical Equipment, Part 1: General Requirements For Basic Safety And Essential Performance"
- IEC 60601-1-6: "Medical Electrical Equipment Part 1-6: General Requirements For ● Basic Safety And Essential Performance - Collateral Standard: Usability"
- IEC 60601-2-6: "Medical Electrical Equipment Part 2-6: Particular Requirements For ● The Basic Safety & Essential Performance Of Microwave Therapy Equipment"
- IEC 60601-2-18: "Medical Electrical Equipment Part 2-18: Particular Requirements ● For The Basic Safety And Essential Performance Of Endoscopic Equipment"
All testing passed, and all acceptance criteria were met.
Software Verification and Validation
Software verification and validation testing was conducted, and documentation is provided within the submission as recommended by "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005.
Animal Data
No animal data was needed to support substantial equivalence.
Clinical Data
No clinical data was generated in support of this Premarket 510(k) Notification.
Conclusion
The subject device (PRS35) has the same intended use and is similar in technological characteristics to the predicate. The essential performance of the subject device system and accessories remain the same, with no change to safety or effectiveness. Based on the intended use, technological characteristics, and non-clinical performance data, the modified software of the NEUWAVE System with the newly designed PRS35 probe is substantially equivalent to the predicate device.
§ 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.