(246 days)
The Solero Microwave Tissue Ablation (MTA) System is indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not indicated for cardiac use.
The Solero Microwave Tissue Ablation (MTA) System is a softwarecontrolled, microwave generator with an integrated peristaltic pump that surgically ablates soft tissue through sterile applicators. The system may be used during open procedures for the ablation of soft tissue.
The Solero Generator is distributed with a main power cable and a footswitch, which may be used as an alternate means of controlling microwave activation in place of the microwave button on the front of the generator. Power is delivered through the disposable Solero Applicator, which are provided separately. A chilled saline source is required to maintain the Solero Applicators at an appropriate temperature.
The provided text describes a 510(k) premarket notification for the Solero Microwave Tissue Ablation (MTA) System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance against them in the way clinical studies for algorithms typically would.
However, I can extract information related to the device's technical specifications and the safety and performance testing conducted. It's important to note that the term "acceptance criteria" here refers to the performance specifications the device aims to meet to be considered substantially equivalent to existing devices, and the "study" is the testing outlined to demonstrate this equivalence.
Here's an attempt to structure the requested information based on the provided text, recognizing that it's not a typical algorithm performance study report:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerically defined thresholds in a table format for performance metrics like sensitivity, specificity, accuracy, etc., as one would find for an AI diagnostic device. Instead, it describes compliance with design controls and recognized standards, and functional characteristics compared to predicate devices. The "reported device performance" is primarily qualitative, aiming to show similar functionality and safety.
| Feature / Performance Area | Acceptance Criteria (Implied / Stated Goal) | Reported Device Performance (as demonstrated by testing) |
|---|---|---|
| Ablation Size and Duration | Near spherical volumes, scalable to approximately 4 cm diameter in ≤ 6 minutes (similar to predicate). | Achieves Near spherical volumes, scalable to approximately 4 cm diameter in ≤ 6 minutes. |
| Tip Puncture Force | Meets predetermined performance specifications. | Test conducted. (Result: demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Flexural Tip Strength | Meets predetermined performance specifications. | Test conducted. (Result: demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Removal Force | Meets predetermined performance specifications. | Test conducted. (Result: demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Flow Rate | Meets predetermined performance specifications. | Test conducted. (Result: demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Bag Spike | Meets predetermined performance specifications. | Test conducted. (Result: demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Cartridge Connection Force | Meets predetermined performance specifications. | Test conducted. (Result: demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Cartridge Alignment | Meets predetermined performance specifications. | Test conducted. (Result: demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Device Recognition | Meets predetermined performance specifications. | Test conducted. (Result: demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Power Output | 60 to 140 watts in 20 watt increments (matches predicate). | Achieves 60 to 140 watts in 20 watt increments. |
| Shaft to Applicator Tip Tensile | Meets predetermined performance specifications. | Test conducted. (Result: demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Handle to Shaft Tensile | Meets predetermined performance specifications. | Test conducted. (Result: demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Umbilical to Handle Tensile | Meets predetermined performance specifications. | Test conducted. (Result: demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Umbilical to Cartridge Tensile | Meets predetermined performance specifications. | Test conducted. (Result: demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Pump Tubing to Cartridge Tensile | Meets predetermined performance specifications. | Test conducted. (Result: demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Pump Tubing to Bag Spike Tensile | Meets predetermined performance specifications. | Test conducted. (Result: demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Saline Temperature | Temperatures below 48°C (Coolant warning at 38°C, alarm/termination at 48°C) (similar to predicate). | Achieves Temperatures below 48°C, alerts user when coolant begins to become warm (38°C), and alarm will sound and microwave energy delivery will terminate when coolant in tip reaches 48°C. |
| Multiple Ablations | Demonstrates ability to perform multiple ablations as intended. | Test conducted. (Result: demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Track Ablation | Characterizes ablation track. | Test conducted. |
| Temperature Control | Maintains prescribed temperature ranges/limits. | Test conducted. (Result: Demonstrated effective temperature control, specifically with the 48°C cutoff). |
| Dielectric Strength | Meets electrical safety criteria. | Test conducted. (Result: Demonstrated meeting predetermined performance specifications as part of design control requirements and conformance to IEC 60601-1-2). |
| Cartridge Connection / Attachment / Removal Force | Meets predetermined performance specifications for secure and easy handling. | Tests conducted. (Result: Demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Generator Hardware Testing | Meets functional and safety requirements for generator hardware. | Test conducted. (Result: Demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Complex Programmable Logic Device | Meets functional and safety requirements. | Test conducted. (Result: Demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Reliability Testing | Demonstrates reliable operation over intended lifespan. | Test conducted. (Result: Demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Safety in Animal Studies | Similar safety profile to predicate devices, without unexpected adverse events (assessed from animal behavior, ECG's, etc.). | Two GLP compliant animal studies performed, assessing animal behavior, ECG's, respiration rates, and temperature. The devices' safety at highest power (140W) and time (6 minutes) was specifically evaluated and compared to the predicate, demonstrating substantial equivalence in safety. |
| Performance in Animal Studies | Similar performance characteristics to predicate devices, particularly in ablation efficacy. | Two GLP compliant animal studies performed, establishing substantial equivalence to the predicate and reference devices, and assessing fundamental operational characteristics. The study aimed to support recommended ablation settings. |
| Human Factors | Usable and safe for intended users and use environments. | Simulated Use / Human Factors Testing conducted to evaluate the application of the system. (Result: No specific findings or acceptance criteria for human factors are detailed, but the testing was performed to ensure usability). |
| Electrical Safety (IEC 60601-1) | Conforms to IEC 60601-1 standards. | Conformance testing to IEC 60601-1 "Medical Electrical Equipment – Part 1: General Requirements for Safety" was completed. |
| Electromagnetic Compatibility (IEC 60601-1-2) | Conforms to IEC 60601-1-2 standards. | Conformance testing to IEC 60601-1-2 "Medical Electrical Equipment – Part 2: General Requirements for Basic Safety and Essential Performance – Collateral Standard Electro Magnetic Compatibility - Requirements and Test" was completed. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test set: The document describes "verification and validation activities" and "performance characterization" using:
- Three different ex-vivo tissues: bovine liver, porcine kidney, and porcine lung.
- Two GLP compliant animal studies: one to evaluate substantial equivalence and fundamental operational characteristics, and a second to specifically compare safety and performance at high power/time in an acute porcine model during open surgical procedure.
- Sample Size: The exact number of tissue samples or animals used in these studies is not specified in the provided text.
- Data Provenance:
- Ex-vivo tissue: "bovine liver, porcine kidney, and porcine lung." (origin not specified)
- Animal studies: Prospective, specifically "two GLP compliant animal studies were performed." "Porcine model" for the second study. (Country of origin not specified).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is not an AI algorithm requiring expert ground truth labeling in the typical sense for diagnostic or prognostic tasks. The "ground truth" for this device's performance would be the direct measurement of ablation size, temperature, electrical parameters, and physiological responses (e.g., animal behavior, ECGs) in the animal models, along with successful completion of functional tests.
Therefore, the concept of "experts establishing ground truth" as applied to AI studies is not directly applicable here. The expertise required would be in veterinary care, pathology (for assessing ablation zones post-mortem), and engineering for device measurement and analysis as part of GLP studies. The document does not specify the number or qualifications of such experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 consensus are typically used for establishing ground truth from expert interpretations in AI diagnostic studies. This is not applicable to the type of device and testing described (functional, electrical, ex-vivo, and animal studies). The results are based on objective measurements and observations within a GLP (Good Laboratory Practice) framework, which implies rigorous, standardized methodology and data recording.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader, multi-case comparative effectiveness study with human readers and AI assistance was not done. This device is a medical instrument (Microwave Tissue Ablation System), not an AI-powered diagnostic or assistive tool for human interpretation. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question generally applies to AI algorithms. The Solero Microwave Tissue Ablation System is a physical medical device. The "performance" being evaluated is the device's ability to ablate tissue, its safety characteristics, and its compliance with electrical and mechanical standards. These are inherently "standalone" in the sense that they describe the device's intrinsic function, but not in the context of an "algorithm only" performance. The device does have software control, described as "software-controlled, microwave generator," and "complex programmable logic device" testing was done, which would evaluate the software's performance as part of the overall system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for evaluating this device's performance includes:
- Direct physical measurements: Puncture force, flexural strength, flow rates, tensile strengths, power output, temperatures, and dielectric strength.
- Pathology: For ex-vivo tissue and animal studies, the dimensions and characteristics of the ablated tissue volumes would be assessed pathologically post-procedure.
- Physiological data: In animal studies, this included animal behavior, ECGs, respiration rates, and temperature.
- Compliance with standards: Verification that the device meets the specifications outlined in recognized standards like IEC 60601-1 and IEC 60601-1-2.
8. The sample size for the training set
This question is relevant for machine learning algorithms. The provided document concerns a physical medical device. There is no mention of a "training set" in the context of an algorithm being developed or trained.
9. How the ground truth for the training set was established
As there is no mention of a "training set", this question is not applicable.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines above them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 5, 2017
Ms. Kasey E. Newcomb Specialist I, Regulatory Affairs Angiodynamics, Inc. 26 Forest Street Marlborough, MA 01752
Re: K162449
Trade/Device Name: Solero Microwave Tissue Ablation (MTA) System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NEY Dated: March 31, 2017 Received: April 3, 2017
Dear Ms. Newcomb:
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. 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 [SELECT ONE: Part 801 [or, for IVDs only] Parts 801 and 809]); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS)
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regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K162449
Device Name
Solero Microwave Tissue Ablation (MTA) System
Indications for Use (Describe)
The Solero Microwave Tissue Ablation (MTA) System is indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not indicated for cardiac use.
Type of Use (Select one or both, as applicable) Over-The-Counter Use (21 CFR 801 Subpart C) X Prescription Use (Part 21 CFR 801 Subpart D)
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510(k) Summary – Solero Microwave Tissue Ablation (MTA) System
Date Prepared: April 28, 2017
A. Submitter Information
| Submitter | Angiodynamics Inc. |
|---|---|
| 26 Forest St | |
| Marlborough, MA 01752 | |
| Tel: | (508) 658-7813 |
| Fax: | (508) 263-7976 |
| Contact: | Kasey E. Newcomb, |
| Regulatory Affairs, Specialist I | |
| Email: | knewcomb@angiodynamics.com |
Or
Linda J. Varroso AngioDynamics, Inc. 26 Forest Street Marlborough, MA 01752 Tel: (508) 658-7967 Fax: (508) 263-7976 lvarroso@angiodynamics.com
B. Trade Name System
| Trade Name: | Solero Microwave Tissue Ablation (MTA)System |
|---|---|
| Common Name: | Microwave Tissue Ablation System andAccessories |
| Classification Name: | Electrosurgical Cutting and Coagulation Deviceand Accessories |
| Regulation Number | 21CFR 878.4400 |
| Product Code: | NEY |
| Class: | II |
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C. Predicate Devices
| Primary Predicate: | K122762 Acculis Accu2I pMTA Applicator and SulisVpMTA Generator |
|---|---|
| Reference Device: | K113237 NeuWave Medical, Inc - Certus 140 System |
| Common Name: | Microwave Ablation System and Accessories |
| Classification Name: | Electrosurgical Cutting and Coagulation Deviceand Accessories |
| Regulation Number | 21CFR 878.4400 |
| Product Code | NEY |
| Class: | II |
D. Device Description
The Solero Microwave Tissue Ablation (MTA) System is a softwarecontrolled, microwave generator with an integrated peristaltic pump that surgically ablates soft tissue through sterile applicators. The system may be used during open procedures for the ablation of soft tissue.
The Solero Generator is distributed with a main power cable and a footswitch, which may be used as an alternate means of controlling microwave activation in place of the microwave button on the front of the generator. Power is delivered through the disposable Solero Applicator, which are provided separately. A chilled saline source is required to maintain the Solero Applicators at an appropriate temperature.
E. Indications for Use
The Solero Microwave Tissue Ablation (MTA) System and Accessories is indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.
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F. Technological Characteristics
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| Solero Microwave Tissue | K122762 | K113237 | |
| Ablation (MTA) System | Acculis Accu2i pMTA | NueWave | |
| Feature | Applicator and Sulis VpMTA | Certus 140 2.45 GHz | |
| Generator | Ablation System and | ||
| Accessories | |||
| Indications For Use | The Solero MicrowaveTissue Ablation (MTA)System is indicated for theablation of soft tissue duringopen procedures. TheSolero MTA System is notindicated for cardiac use. | Acculis Accu2i pMTAApplicator with Sulis VpMTA Generator softwarerelease 2.1 is indicated forthe intraoperativecoagulation of soft tissue. | The NeuWave MedicalCertus 140'M 2.45 13HzAblation System andAccessories are intended forthe ablation (coagulation) ofsoft tissue in percutaneous,open surgical and inconjunction withlaparoscopicsurgical settings. |
| Applicator Features | Applicator with umbilicalcable, IV spike, saline tubingand cartridge connector | Applicator with umbilicalcable, IV spike, saline tubingand cartridge connector | Applicator with a handle, acannula, a radiating sectionand a faceted tip forinsertion |
| Generator Features | Generator touch screendisplay provides informationon ablation/coagulationtime, microwave deliveredpower, and system specificinformation | Generator touch screendisplay provides informationon ablation/coagulationtime, microwave deliveredpower, temperature probereadings and system specificinformation | Generator touch screendisplay provides informationon ablation time, power,probe temperature andsystem specific information |
| Operating Principle | Generator deliversmicrowave energy to theapplicator tip to thermallytarget tissue, resulting incoagulation and ablation | Generator deliversmicrowave energy to theapplicator tip to thermallytarget tissue, resulting incoagulation and ablation | Generator deliversmicrowave energy to theapplicator tip to thermallytarget tissue, resulting incoagulation and ablation |
| Ablated/Coagulated Tissue | Near spherical volumes,scalable to approximately 4cm diameter in ≤ 6 minutes | Near spherical volumes,scalable to approximately 4cm diameter in ≤ 6 minutes | < 4cm ablation in all tissues(PR),< 7 cm ablations in liver,< 6 cm in kidney (LK) |
| Applicator PatientContacting Materials | Silicone coated shaft | Silicone coated shaft | Stainless steel, insulatedshaft |
| Applicators Length | Standard: 14 cmIntermediate: 19 cmLong: 29 cm | Standard: 14 cmIntermediate: 19 cmLong: 29 cm | 15 cm20 cm |
| Applicators Outer Diameter | Stainless steel shaft 1.83mmStainless steel shaft withsilicone coating ≤2mm | 1.83 mm | 1.47mm |
| Thermocouple Location | 2.7cm from the tip | 2.7cm from the tip | Unspecified |
| Subject Device | Predicate Device | Reference Device | |
| Solero Microwave TissueAblation (MTA) System | K122762 | K113237 | |
| Feature | Acculis Accu2i pMTAApplicator and Sulis VpMTAGenerator | NueWaveCertus 140 2.45 GHzAblation System andAccessories | |
| Max Tip Temperature | Temperatures below 48°C,they alert the user when thecoolant begins to becomewarm (38°C), and an alarmwill sound and microwaveenergy delivery willterminate when the coolantin the tip reaches 48°C | Temperatures below 48°C,they alert the user when thecoolant begins to becomewarm (38°C), and an alarmwill sound and microwaveenergy delivery willterminate when the coolantin the tip reaches 48°C | Unspecified |
| Cable Length | 295.25cm for allapplicator lengths | Standard: 200.1cmIntermediate: 192.0cmLong: 176.1cm | Unspecified |
| Generator Frequency | 2.45 GHz | 2.45 GHz | 2.45 GHz |
| Reflected Power Threshold | -5.4 dB | -5.4 dB | Unspecified |
| System Output PowerRange | 60 to 140 watts in 20 wattincrements | 60 to 140 watts in 20 wattincrements | 95W per channel or up to140W in a single channel |
| Microwave Generation | Solid-state microwavegenerator | Magnetron | Unspecified |
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G. Safety and Performance
The results of verification and validation activities were performed in accordance with design control requirements per 21 CFR 820.30 and demonstrate that the proposed device Solero Microwave Tissue Ablation (MTA) System meets predetermined performance specifications.
Performance testing that was completed included:
- . Tip Puncture Force
- Flexural Tip Strength ●
- Removal Force
- Flow Rate
- Bag Spike
- Cartridge Connection Force ●
- Cartridge Alignment
- Device Recognition
- Power Output
- Shaft to Applicator Tip Tensile
- Handle to Shaft Tensile
- Umbilical to Handle Tensile ●
- Umbilical to Cartridge ● Tensile
- . Pump Tubing to Cartridge Tensile
- . Pump Tubing to Bag Spike Tensile
- Saline Temperature
- Multiple Ablations
- Track Ablation ●
- Temperature Control ●
- Dielectric Strength ●
- Cartridge Connection
- Pump Compatibility
- Cartridge Attachment Force ●
- Cartridge Removal Force
- . Generator Hardware testing
- Complex programmable logic device
- . Reliability Testing
The performance evaluation plan included testing per the following recognized standards to assess conformance to IEC 60601 (300 Edition).
| IEC 60601-1 | Medical Electrical Equipment – Part 1: GeneralRequirements for Safety |
|---|---|
| IEC 60601-1-2 | Medical Electrical Equipment – Part 2: GeneralRequirements for Basic Safety and EssentialPerformance – Collateral Standard ElectroMagnetic Compatibility - Requirements and Test |
Human Factors Evaluation:
Simulated Use / Human Factors Testing has been conducted to evaluate the application of the Solero Microwave Tissue Ablation (MTA) System (i.e., Solero System) when used to ablate soft tissue.
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Animal Studies:
Performance characterization was performed on three difference exvivo tissue; bovine liver, porcine kidney, and porcine lung, as these are considered to be comparable to human tissue. Testing was performed at varying time settings and power limits. The purpose of this testing was to support the recommended ablation settings, as well as demonstrate substantial equivalence to the predicate device.
Two GLP compliant animal studies were performed. The first study was to evaluate and establish substantial equivalence of the Solero Microwave Tissue Ablation (MTA) System to its predicate device Acculis Accu2I pMTA Applicator and SulisVPMTA Generator (K122762) and reference device Certus 140 System (K113237). The study also looked at the fundamental operational characteristics for the Solero MTA System. Safety was assessed from: animal behavior, ECG's, respiration rates, and temperature.
The second study's objective was to evaluate the safety and performance of the Solero Microwave Tissue Ablation (MTA) System to its predicate device Acculis Accu21 pMTA Applicator and SulisVpMTA Generator (K122762) during open surgical procedure in an acute porcine model. This study specifically evaluated and compared the safety at the highest power (140W) and time (6 minutes) of the two devices.
H. Substantial Equivalence Conclusion
The proposed device is equivalent with respect to the basic system design and function to that of the predicate device and reference device. The differences between the predicate, reference device and proposed device do not raise new questions of safety or effectiveness.
§ 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.