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.

Device Description

The Solero Microwave Tissue Ablation (MTA) System and Accessories is a software-controlled, microwave generator with an integrated peristaltic pump that surgically ablates soft tissue through sterile applicators. It is used to deliver microwave energy into soft tissue for the purpose of microwave ablation.

The Solero MTA 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. The Solero Applicator is a surgically invasive, sterile single patient use device used to thermally ablate targeted soft tissue. The probe is specifically designed to deliver microwave energy at a frequency of 2.45 GHz from its distal end into soft tissue. A chilled saline source is required to maintain the Solero Applicators at an appropriate temperature.

The Solero MTA System includes an optional accessory, the Solero MTA Cart, that is used to assist transport of the Solero Generator, and to provide a resting surface during operation and storage.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Solero Microwave Tissue Ablation (MTA) System and Accessories. This notification seeks to demonstrate substantial equivalence to an existing predicate device, primarily due to manufacturing improvements and minor accessory additions, rather than a new clinical indication or significant technological change requiring extensive new performance studies against clinical endpoints.

Therefore, the information typically found in a clinical study evaluating a diagnostic AI device is largely absent here. This document pertains to an electrosurgical cutting and coagulation device, not an AI or diagnostic device that would have acceptance criteria based on classifications (sensitivity, specificity, AUROC, etc.). The "performance data" discussed relates to engineering and bench testing, as well as an animal study for ablation size comparison.

However, I can extract and structure the information that is present, aligning it as closely as possible to your requested format, and explicitly noting where the requested information is not applicable or not provided in the document.

Explanation of Applicability:
The questions asked (1 through 9) are highly specific to the evaluation of AI-powered diagnostic devices, often involving complex statistical analysis of classification performance, human reader studies, and ground truth establishment from medical experts or pathology. The Solero MTA System is a surgical device for tissue ablation, and its evaluation strategy focuses on safety, electrical compatibility, biocompatibility, and demonstration of equivalent physical performance (like ablation size) to a predicate device after minor design changes. Therefore, many of your requested points are not directly addressed or are not relevant to this type of device submission.

Acceptance Criteria and Device Performance (Solero Microwave Tissue Ablation (MTA) System and Accessories)

Given the nature of the device (a surgical tissue ablation system) and the 510(k) submission which focuses on substantial equivalence due to manufacturing changes, the "acceptance criteria" and "reported device performance" are primarily related to engineering specifications, safety standards, and comparative performance to the predicate device in an ex-vivo model. There are no clinical performance metrics like sensitivity, specificity, or AUROC for this type of device as it's not a diagnostic AI.

1. Table of Acceptance Criteria and Reported Device Performance

Criterion / Test Area	Acceptance Standard / Requirement	Reported Device Performance (Solero MTA System)
I. Engineering & Safety
Flow Rate	Conforms to specified design and performance requirements.	Met all specified design and performance requirements.
Power Output	Conforms to specified design and performance requirements.	Met all specified design and performance requirements.
Tensile Testing	Conforms to specified design and performance requirements.	Met all specified design and performance requirements.
Coolant Temperature	Conforms to specified design and performance requirements.	Met all specified design and performance requirements.
Ablations (System Function)	Conforms to specified design and performance requirements.	Met all specified design and performance requirements.
Leak Testing	Conforms to specified design and performance requirements.	Met all specified design and performance requirements.
Dielectric Strength	Conforms to specified design and performance requirements.	Met all specified design and performance requirements.
Pump Compatibility	Conforms to specified design and performance requirements.	Met all specified design and performance requirements.
Electrical Safety	Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-6.	Evaluated against and compliant with cited IEC standards.
Software Life Cycle	Compliance with IEC 62304.	Evaluated against and compliant with IEC 62304.
Usability Engineering	Compliance with IEC 62366-1.	Evaluated against and compliant with IEC 62366-1.
II. Biocompatibility	Compliance with ISO 10993 (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Pyrogenicity, Hemolysis).	Acceptable results for all required tests on the Solero MTA Applicator (patient-contacting part). Generator and Cart require no biocompatibility testing (non-patient contact).
III. Sterilization	Suitability of sterile packaging to protect device and ensure sterility; integrity and distribution cycle.	Testing confirmed packaging integrity, sterility (via EO), and distribution cycle robustness against extreme conditions, maintaining sterility and integrity within stated shelf life.
IV. Ablation Performance (Ex-Vivo)	Ablation size measurements comparable to predicate device.	The Solero MTA System created ablations consistently in ex-vivo bovine liver. Measurements of ablation size (length, width, and volume) were comparable to the predicate device at minimum, medium, and maximum energy settings. This demonstrates equivalent performance to the predicate device.

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 Description: The primary "test set" for performance evaluation was an ex-vivo bovine liver model.
Sample Size: For the ex-vivo animal study, ablations were performed at three energy settings (minimum, medium, maximum). Each setting was performed a minimum of three (3) separate times. This means a minimum of 9 ablations in total for both the test device and the predicate device for comparison.
Data Provenance: The study was conducted by AngioDynamics, presumably in the USA. The data is prospective for this ex-vivo study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable in the context of this device submission. For a tissue ablation device, "ground truth" for the ex-vivo study would typically involve direct physical measurement of the ablated tissue, not expert interpretation or consensus on diagnostic findings. The document does not specify who performed the measurements or their qualifications, as it's an engineering and animal model study rather than a clinical expert study.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This specific type of adjudication method is used in diagnostic studies (especially AI-assisted ones) to resolve discrepancies in expert interpretation of medical images or data. For an ex-vivo physical measurement study, such a method is not relevant.

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 MRMC study was done. This device is a surgical tool, not a diagnostic AI system or an AI-assisted diagnostic tool. Therefore, a study on human reader improvement with AI assistance is not relevant or applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. The Solero MTA System is not a standalone algorithm. It is a physical device operated by a human surgeon. While it has software controls, its "performance" is the physical ablation of tissue, not an algorithmic output like a diagnostic reading.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the ex-vivo animal study: The "ground truth" was direct physical measurement of ablation size (length, width, and volume) in the bovine liver tissue. This is objective measurement rather than expert consensus, pathology, or outcomes data, which are typically found in clinical studies or diagnostic evaluations.
For engineering/safety tests: Ground truth is defined by the objective pass/fail criteria of the respective engineering and safety standards (e.g., specific voltage/current ranges, leak rates, resistance to tensile forces, biological responses in biocompatibility tests).

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that undergoes a "training phase" with a dataset in the way a machine learning model does. The device's design is based on engineering principles and validated through testing, not iterative learning from a training set.

9. How the ground truth for the training set was established

Not applicable. As there is no "training set" for an AI algorithm, the concept of establishing ground truth for it does not apply here.

Summary

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March 7, 2023

AngioDynamics, Inc. Kasey Newcomb Regulatory Affairs Manager 26 Forest Street Marlborough, Massachusetts 01752

Re: K221883

Trade/Device Name: Solero Microwave Tissue Ablation (MTA) 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: February 10, 2023 Received: February 10, 2023

Dear Kasey 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. 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

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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,

MarkTrumbore -S	Digitally signed byMark Trumbore -SDate: 2023.03.0713:50:22 -05'00'
Mark Trumbore, Ph.D.
Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgicaland Infection Control Devices

Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known)

Device Name

Solero Microwave Tissue Ablation (System) and Accessories

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)

X Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (6/20)

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Confidential and Proprietary to AngioDynamics, Inc.

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510(K) SUMMARY FOR THE SOLERO MICROWAVE TISSUE ABLATION (MTA) SYSTEM AND ACCESSORIES

SUBMITTER A.

AngioDynamics, Inc. 26 Forest St. Marlborough, MA 01752 USA

B. CONTACT

Kasey E Newcomb Manager, Global Regulatory Affairs Tel: 508.658.7813 Email: knewcomb@angiodynamics.com

DEVICE ن

Trade Name:	Solero Microwave Tissue Ablation (MTA) System and Accessories
Common/Usual Name:	Microwave Tissue Ablation System and Accessories
Classification Name:	Electrosurgical Cutting and Coagulation Device(21 CFR § 878.4400, Class II, Pro-Code NEY)
Classification Panel:	General Surgery

PREDICATE DEVICE D.

510(k) Number:	K162449/K213067
Trade Name:	Solero Microwave Tissue Ablation (MTA) System
Common/Usual Name:	Microwave Tissue Ablation (MTA) System
Classification Name:	Electrosurgical Cutting and Coagulation Device(21 CFR § 878.4400, Class II, Pro-Code NEY)
Classification Panel:	General Surgery

E. DEVICE DESCRIPTION

The Solero MTA System includes an optional accessory, the Solero MTA Cart, that is used to assist transport of the Solero Generator, and to provide a resting surface during operation and storage.

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F. INDICATION FOR USE

The Solero Microwave Tissue Ablation (MTA) System and Accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.

G. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEVICE

The proposed Solero MTA System and the predicate Solero Microwave System are identical to one another (and therefore substantially equivalent) in all aspects, not limited to design, materials, manufacturing, specifications, dimensions, and indication for use. The difference is the proposed Solero MTA Applicator has been modified to improving manufacturability and fluid path reliability of applicator. Additionally, an umbilic able clip was added to aid in stabilizing the cable during use, if desired.

H. DEVICE MODIFICATIONS AND RISKS ASSOCIATED WITH THE DESIGN MODIFICATION(S)

Modifications made to the Solero MTA System were limited to the internal components of the applicator for the purpose of improving manufacturability and fluid path reliability of the Solero MTA Applicator. Additionally, a clip was added to the umbilicate cable to aid in stabilizing the cable during use.

The impact of the changes as described within K221883 was evaluated as part of the Risk Analysis activity in terms of new/existing risks and new/existing failure modes. The results of this Risk Analysis activity were compared to the current Risk Analysis; the conclusions drawn from this assessment, determined the proposed modifications did not impactor modify an existing risk nor necessitate a new or modified risk.

I. BIOCOMPATIBILITY

The Solero MTA Applicator is a sterile single-use disposable instrument. The A Solero MTA Applicator has met the biocompatibility testing requirements identified in ISO 10993: Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process. Specifically, the following tests were performed with acceptable results; cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, and hemolysis. Solero MTA Generator and Cart are hardware device with no patient contact and provided non-sterile. Biocompatibility testing was not performed.

J. ELECTRICAL SAFETY AND ELECRICAL COMPATIBILITY (EMC)

The proposed AngioDynamics Solero MTA System safety was evaluated against the following published consensus standard:

IEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
. IEC 60601-1-2: Medical Electrical Equipment – Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility Requirements and Tests
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 and essential performance of microwave therapy equipment
IEC 62366-1: Medical devices Part 1: Application of usability engineering to medical ● devices, including Amendment 1
IEC 62304: Medical device software Software life cycle processes .

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STERILIZATION/CLEANING/SHELF LIFE K.

The Solero MTA Applicator is sterilized via ethylene oxide (EO). A series of tests, performed by AngioDynamics and independent test houses, have been conducted to assess the suitability of the sterile packaging to protect the proposed Solero MTA System and ensure sterility within its stated shelf life at point of use. These tests confirm the packaging integrity, sterility and distribution cycle. Testing demonstrated that the packaging is robust enough to withstand extreme distribution conditions at the most extreme environmental conditions while maintaining packaging integrity and sterility.

L. PERFORMANCE DATA

A series of verification and validation tests were conducted on sterile finished Solero MTA Applicators in accordance with design control requirements to confirm that the device confirm conforms to specific requirements related to the intended use, physical characteristics, and performance and has equivalent performance with predicate device Solero MTA System. The Solero MTA System met all specified design and performance requirements below:

Flow Rate
Power Output ●
Tensile Testing
Coolant Temperature ●
Ablations
Leak Testing ●
Dielectric Strength
. Pump Compatibility

ANIMAL STUDY - EX-VIVO L.

AngioDynamics conducted a study of microwave ablations using the Solero MTA System in the ex-vivo bovine liver model. The purpose of this study is to evaluate and measure the tissue ablations created by the proposed Solero Microwave Ablation System as compared to the predicate device. Within this study the proposed Solero MTA System and the predicate Solero MTA System were used to perform three (i.e., minimum, medium, and maximum energy) ablation settings in ex-vivo bovine liver. Each setting was performed three (3) separate times, at minimum, to establish ablation size for both the test and control articles. Results from the study showed that the Solero MTA System is able to create ablations in ex vivo livers consistently. The measurements of ablation size were comparable to the predicate device at all 3 settings in length, width and volume of ablations.

I. CONCLUSIONS

The results of the non-clinical verification/validation and animal tissue testing support the comparison of similarities and differences. The results demonstrate the subject device and predicate devices are substantially equivalent.

Regulation Number and Section

§ 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.