(192 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 device description of the Solero MTA System from the previous cleared K162449, has not been modified with the exception of the addition of the Solero MTA Cart as an optional accessory to the Solero MTA System.
The Solero MTA Cart is an optional accessory, that allows for transport, storage, and maneuverability of the system pre- and post-use. The Solero MTA Cart provides a shelf that is designed to securely hold the Solero MTA Generator in place. Once on the cart, the Solero MTA Generator is at an appropriate working height. The Solero MTA Cart has an incorporated IV pole for holding the chilled saline source used for maintaining the Solero Applicator at an appropriate temperature. There is a cable management system built into the Solero MTA Cart that allows for the mains power cable and footswitch to be stored for transporting the device or storage. The Solero MTA System can be transported using the handle on the cart. There is a tray on the stand of the cart intended to hold Directions for Use and Operators Manual. The Solero MTA Cart sits on four rotating casters that can all be locked into place during use, storage, or as appropriate during transit.
The provided text describes a 510(k) premarket notification for the Solero MTA Cart, an accessory to the Solero Microwave Tissue Ablation (MTA) System. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-based medical device.
The document is a regulatory submission for a physical accessory (a cart) for an existing medical device, not a software or AI-driven device. Therefore, the questions related to AI performance metrics (like sample size for test/training sets, expert consensus, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this submission.
Here's a breakdown of what is available in the document, which pertains to the physical accessory:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a formal table of acceptance criteria with corresponding performance data. Instead, it describes general safety and functional requirements.
| Acceptance Criteria (Inferred) | Reported Device Performance (Summary from text) |
|---|---|
| Appropriate worksurface height | Carts worksurface heights are appropriate for performing microwave tissue ablation procedures. |
| No rough surfaces, sharp corners, sharp edges | No rough surfaces, sharp corners and/or edges. |
| Rotating locking casters | Four (4) rotating locking casters. Casters successfully completed 5,000 full "on" and "off" cycles without failure, wear, or permanent deformation. |
| Accommodates generator | Frame/shelf accommodates a specific microwave tissue ablation generator. |
| Tray/shelf for accessories storage | Includes tray/shelf for accessories storage. |
| Cable management system | Cable management system (hooks) allows power cords, connection leads, cables, footswitch, etc, to be properly stored. |
| Manageable by single user | Cart movement is manageable by a single user. |
| Integrated IV pole (for Solero MTA Cart) | Solero MTA Cart incorporates an IV pole for holding the chilled saline source. (This is a differentiating feature from the reference device). |
| Electrical safety (related to isolation) | All isolation electronics are contained within the Solero MTA Generator. A separate isolation transformer is not required for the cart. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a hardware accessory; testing was likely bench testing and functional evaluations rather than clinical studies with patient data.
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)
Not applicable. Ground truth and expert consensus are irrelevant for a physical cart accessory.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader mult-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
Not applicable. This device is not AI-driven.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
Summary of the study that proves the device meets the acceptance criteria:
The document states that the following performance testing was used to substantiate safety and effectiveness:
- IEC 60601-1: General Requirements for Basic Safety and Essential Performance: This likely involved electrical safety, mechanical stability, and general design integrity testing according to international standards for medical electrical equipment.
- Packaging Testing: Ensures the device can be transported without damage.
- Functional Testing including (e.g. electromagnetic compatibility and coexistence in a simulated use environment): This would involve testing the cart's ability to perform its intended functions (transport, hold generator, provide IV pole), as well as ensuring it doesn't interfere with other electronic devices and operates correctly in a typical medical environment. Specific mention is made of the casters' durability: "The Solero MTA Cart's casters have successfully completed 5,000 full "on" and "off" cycles without failure of the locking holding power, wear or permanent deformation that would adversely affect the locking performance of the casters."
The document concludes that "The results of comparison of technology similarities and the non-clinical performance testing demonstrates that the subject device (cart accessory), when used as an accessory for the predicate device (Solero MTA System), is substantially equivalent to the predicate device when used without it." This suggests that the performed non-clinical tests (bench testing, functional evaluations, and comparison to a legally marketed predicate device's cart) were sufficient to demonstrate the safety and effectiveness for a 510(k) clearance for this type of accessory. No clinical studies are mentioned for the cart itself, as it has no direct patient contact and its function is primarily transport and support.
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February 28, 2019
AngioDynamics, Inc. Kasey Newcomb Regulatory Affairs Specialist II 26 Forest St. Marlborough, Massachusetts 01752
Re: K182250
Trade/Device Name: Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: NEY Dated: January 31, 2019 Received: February 1, 2019
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/cfpmr/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
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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jennifer R. Stevenson -S3
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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K182250
Device Name Solero Microwave Tissue Ablation (MTA) 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) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (7/17)
PSC Polylishing Sections (101)-443-6749 EF
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SOLERO MTA SYSTEM CART ACCESSORY 510(K) SUMMARY
SPONSOR A.
AngioDynamics, Inc. 26 Forest St. Marlborough, MA 01752 USA
B. CONTACT
Kasey E. Newcomb Specialist II, Global Regulatory Affairs Tel: 508.658.7813 Email: knewcomb@angiodynamics.com
DEVICE NAME ﺯ
| 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 |
D. PREDICATE DEVICE
| 510(k) Number: | K162449 |
|---|---|
| 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. REFERENCE DEVICE
| 510(k) Number: | K133821 |
|---|---|
| Trade Name: | Emprint Ablation System |
| Common/Usual Name: | Microwave Ablation System and Accessories |
| Classification Name: | Electrosurgical Cutting and Coagulation Device(21 CFR § 878.4400, Class II, Pro-Code NEY) |
| Classification Panel: | General Surgery |
F. DEVICE DESCRIPTION
The device description of the Solero MTA System from the previous cleared K162449, has not been modified with the exception of the addition of the Solero MTA Cart as an optional accessory to the Solero MTA System.
The Solero MTA Cart is an optional accessory, that allows for transport, storage, and maneuverability of the system pre- and post-use. The Solero MTA Cart provides a shelf that is designed to securely hold the Solero MTA Generator in place. Once on the cart, the Solero MTA Generator is at an appropriate working height. The Solero MTA Cart has an incorporated IV pole for holding the chilled saline source used for maintaining the Solero Applicator at an appropriate temperature. There is a cable management system built into the Solero MTA Cart that allows for the mains power cable and footswitch to be stored for transporting the device or storage. The Solero MTA System can be transported using the handle on the cart. There is a tray on the stand of the cart intended to hold
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Directions for Use and Operators Manual. The Solero MTA Cart sits on four rotating casters that can all be locked into place during use, storage, or as appropriate during transit.
G. 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.
H. STERILIZATION/CLEANING/SHELF LIFE
The Solero MTA Cart is a hardware device with no patient contact and is provided non-sterile, therefore sterilization validation was not required or performed.
The Solero MTA Cart Operators Manual states that the cart should be cleaned by wiping down all accessible surfaces with a clean cloth that is slightly dampened with 70% isopropyl alcohol cleaning solution.
The Solero MTA Cart is not manufactured with any electronic or materials that are expected to expire or degrade over time. The Solero MTA Cart's casters have successfully completed 5,000 full "on" and "off" cycles without failure of the locking holding power, wear or permanent deformation that would adversely affect the locking performance of the casters. There is no assigned shelf-life.
I. BIOCOMPATIBILITY
The Solero MTA Cart is a hardware device with no patient contact and provided non-sterile. Biocompatibility testing was not performed.
J. SUMMARY OF SIMILARITIES AND DIFFERENCES IN TECHNOLOGY CHARACTERISTICS
Reference device, Emprint Ablation System Cart, cleared via K133821, was used to support safety and effectiveness of the subject device. Both the subject device and specified reference device include the following technological characteristics:
- The carts worksurface heights are appropriate for performing microwave tissue ablation . procedures
- . No rough surfaces, sharp corners and/or edges
- Four (4) rotating locking casters ●
- Frame/shelf that accommodates a specific microwave tissue ablation generator. The ● microwave tissue ablation generators are not permanently installed on the cart.
- Includes tray/shelf for accessories storage
- Cable management system (hooks) that allow power cords, connection leads, cables, ● footswitch, etc, to be properly stored for either transporting or storage of microwave tissue ablation system
- . Cart movement is manageable by a single user
Technological characteristic that are different between the subject and specified reference device are as follows:
- Solero MTA Cart incorporates an IV pole for holding the chilled saline source used for . maintaining the Solero Applicator at an appropriate temperature. The specified reference device utilizes a separate IV pole that is positioned next to the cart.
- All isolation electronics are contained within the Solero MTA Generator. The specified . reference cart includes an isolation transformer. The Solero MTA Generator contains appropriate electrical isolation; therefore, a separate isolation transformer is not required.
K. PERFORMANCE DATA
The following performance testing was used to substantiate safety and effectiveness:
- . IEC 60601-1: General Requirements for Basic Safety and Essential Performance
- . Packaging Testing
- . Functional Testing including (e.g. electromagnetic compatibility and coexistence in a simulated use environment)
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L. CONCLUSIONS
The results of comparison of technology similarities and the non-clinical performance testing demonstrates that the subject device (cart accessory), when used as an accessory for the predicate device (Solero MTA System), is substantially equivalent to the predicate device when used without it.
§ 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.