(116 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing or specific performance metrics typically associated with AI/ML algorithms. The software testing described is standard for medical devices and does not indicate AI/ML functionality.
Yes
The device is indicated for the ablation of soft tissue, which is a therapeutic procedure aiming to remove or destroy abnormal tissue.
No
The device is described as a Microwave Tissue Ablation System indicated for the ablation of soft tissue, which is a treatment procedure, not a diagnostic one.
No
The device description explicitly states "The Solero Microwave Tissue Ablation (MTA) System and Accessories are indicated for the ablation of soft tissue during open procedures." This indicates a system that includes hardware components for tissue ablation, not just software. The performance studies also mention "System Integration Testing," further suggesting a hardware-software integrated system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is for the "ablation of soft tissue during open procedures." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: Reinforces the intended use of "ablation of soft tissue."
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The Solero Microwave Tissue Ablation (MTA) System is a therapeutic device used for destroying soft tissue within the body.
N/A
Intended Use / Indications for Use
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.
Product codes
NEY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Software correction verification and validation testing was conducted based on the impact of the software changes. Results from the following tests ensure that the changes did not create any unintended issues in the operation of the system overall:
- Unit Verification Testing
- BSP Verification Testing
- Integration Testing
- System Integration Testing
- Validation Testing
- Language Validation and Regression Testing
All testing completed successfully. Additionally, software testing was conducted in compliance with IEC 62304:2006+A1:2015 Medical Device Software – Software Life-cycle Processes.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 27, 2023
AngioDynamics, Inc. Kasey Newcomb Regulatory Affairs Manager 26 Forest Street Marlborough, Massachusetts 01752
Re: K223581
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 27, 2023 Received: February 27, 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
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,
| Mark
Trumbore -
S | Digitally signed
by Mark
Trumbore -S
Date: 2023.03.27
13:05:42 -04'00' |
| ------------------------- | ------------------------------------------------------------------------------------ |
|---|
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: 06/30/2023 |
| Indications for Use | See PRA Statement below. |
| Number ( if known ) | 581 |
|---|---|
| ---------------------------- | ----- |
510(k) Nu K223581
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740
Confidential and Proprietary to AngioDynamics, Inc.
3
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 Email: knewcomb@angiodynamics.com
C. DEVICE NAME
D.
| 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
| 510(k) Number: | 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
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.
ﻥ ﺍﻟﻤﺮﺍﺟﻊ ﻓﻲ ﺍﻟﻤﺮﺍﺟﻊ 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.
4
H. DEVICE MODIFICATIONS AND RISKS ASSOCIATED WITH THE DESIGN MODIFICATION(S)
An update has been made to the Solero MTA System software (Application SW from v1.0.5 to v2.0.1 and IFS from v2.5.2 to v3.0.0) to further reduce the probability of "Error 0001" during boot-up caused by NAND flash memory errors.
The impact of the changes as described within K223581 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 impact or modify an existing risk nor necessitate a new or modified risk.
I. BIOCOMPATIBILITY
The Solero MTA Generator is a hardware device with no patient contact. The patient contacting materials (Solero MTA Applicator) are identical to the predicate device. As this change is solely related to the software there is no impact to biocompatibility previously conducted in accordance with ISO 10993-1: Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process.
J. ELECTRICAL SAFETY AND ELECTRICAL 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 ●
K. STERILIZATION/CLEANING/SHELF LIFE
The Solero MTA Generator is a hardware device with no patient contact and is provided nonsterile, therefore, sterilization/shelf-life validation was not required or performed.
As this change is solely related to the software all sterilization (EO) and shelf-life testing for the Solero MTA Applicator is not impacted and previously conducted testing is still applicable.
L. PERFORMANCE DATA (SOFTWARE)
Software correction verification and validation testing was conducted based on the impact of the software changes. Results from the following tests ensure that the changes did not create any unintended issues in the operation of the system overall:
- Unit Verification Testing
- BSP Verification Testing ●
- Integration Testing ●
- System Integration Testing ●
- Validation Testing ●
- Language Validation and Regression Testing ●
5
All testing completed successfully. Additionally, software testing was conducted in compliance with IEC 62304:2006+A1:2015 Medical Device Software – Software Life-cycle Processes.
M. CYBERSECURITY
The proposed device does not contain any external wired and/or wireless communication interfaces (Wired: USB, ethernet, SD, CD, RGA, etc. or Wireless: Wi-Fi, Bluetooth, RF, inductive, Cloud, etc.).
N. CONCLUSIONS
The proposed device is equivalent with respect to the basic system design and function to that of the predicate device. The differences between the predicate device and subject device do not raise new questions of safety or effectiveness.