The SIRA™ RFA Electrosurgical Device supplies energy for use in electrosurgery and is indicated for use in intraoperative coaqulation and ablation of soft tissue. The SIRA™ RFA Device is to be used in conjunction with a radiofrequency (RF) electrosurgical generator for use in open abdominal surgical procedures. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Device Description

The SIRA™ RFA Electrosurqical Device is used for the simultaneous administration of RF energy and saline for the coagulation and ablation of soft tissue in open intraoperative procedures. The SIRA™ RFA Electrosurgical Device is comprised of a 4cm diameter electrode array, a handle (shaft), a co-extruded cable, an integrated electrical RF switch and timer, a main cable, and a fluid administration set.

AI/ML Overview

The provided text describes a 510(k) summary for the SIRA™ RFA Electrosurgical Device, which demonstrates substantial equivalence to a predicate device. This type of submission relies on comparisons to an already legally marketed device rather than establishing new acceptance criteria based on independent clinical trials for novel devices. Therefore, the information typically found in a clinical study report for a new device's acceptance criteria, such as specific performance metrics like sensitivity, specificity, or AUC, and detailed study designs (sample size, ground truth methodology, expert qualifications, adjudication methods, MRMC studies, standalone performance), is not explicitly stated in this document.

However, based on the provided text, we can infer and summarize the "acceptance criteria" through the lens of performance testing and substantial equivalence, and describe the studies conducted to support these claims.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission, the "acceptance criteria" are implied by the demonstration of substantial equivalence to the predicate device and the successful completion of various performance tests as part of the overall safety and effectiveness evaluation. The reported device performance aligns with these successful test outcomes.

Acceptance Criteria (Implied by Substantial Equivalence and Testing)	Reported Device Performance (Summary from Text)
Technological Equivalence: Similar electrosurgical function (RF energy + saline for coagulation/ablation), sterile, single-use, disposable, integrated cable, electrical insulation, user control of RF energy/duration, similar accessories.	Demonstrated through comparative analysis and testing that minor differences in saline flow control and working end size do not raise new questions of safety or effectiveness. The depth of treatment created by both devices is equivalent when energy is applied at similar durations and levels.
Software Performance: Software performs as intended.	Software verification and validation demonstrated that the software performs as intended.
Electrical Safety: Compliance with IEC 60601-1 and IEC 60601-2-2.	Electrical safety testing (IEC 60601-1 and IEC 60601-2-2) was conducted and results were passing.
Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2.	Electromagnetic compatibility (IEC 60601-1-2) testing was conducted and results were passing.
Biocompatibility: Patient-contacting components are biocompatible.	Biocompatibility of the patient-contacting components of the device was established.
Sterility: All required components are sterile.	Sterility validation was established for all required components.
Mechanical Performance: Device functions mechanically as intended.	Performance bench testing, including mechanical testing, demonstrated the device functioned as intended.
Dimensional Conformance: Dimensions are within acceptable ranges.	Dimensional testing was performed and the device functioned as intended.
Functional Performance: Device performs its intended functions (e.g., coagulation/ablation).	Functional tests and performance bench testing confirmed the device functioned as intended.
Safety and Effectiveness (In Vivo): Safe and effective in an animal model.	In vivo testing in an animal model was performed to evaluate and establish the safety and effectiveness of the subject device.
Usability: Intended users can use the device as intended without significant errors or difficulty leading to harm.	Usability testing demonstrated that intended users can use the device as intended to coagulate/ablate soft tissues without patterns of perceptible use errors or difficulty that could result in serious harm to the user or patient.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each test set (e.g., how many devices for mechanical testing, how many animals for in vivo testing, how many users for usability testing). It also does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective, though generally, performance testing for 510(k) devices (especially bench and animal studies) are prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish a "ground truth" in the way it would for an AI/algorithm-based diagnostic device (e.g., radiologists interpreting images). The "ground truth" for the performance tests would be established by the physical and biological outcomes measured in the lab or animal models by qualified researchers/technicians following established scientific protocols. For usability testing, "experts" would be the intended users (e.g., surgeons) whose ability to use the device safely and effectively is observed. No specific number or qualifications are given beyond "intended users."

4. Adjudication Method for the Test Set

Not applicable in the context of this 510(k) submission and the types of performance tests described. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in clinical evaluations involving subjective interpretations, such as image analysis by multiple readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study is mentioned. This type of study is usually relevant for AI-powered diagnostic tools to assess the impact of AI assistance on human reader performance. The SIRA™ RFA device is an electrosurgical tool, not a diagnostic AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not directly applicable as the SIRA™ RFA device is a physical electrosurgical tool, not a standalone AI algorithm. Its performance is inherent in its design and function, tested both in bench and in vivo settings, with human interaction being a fundamental part of its intended use. The "software verification and validation" would be the closest analogue to a standalone evaluation of its control system.

7. The Type of Ground Truth Used

The "ground truth" for the various performance tests consists of:

Engineering/Physical Measurements: Established standards and measurements for electrical safety, EMC, mechanical properties, and dimensions.
Biological Outcomes: In vivo testing in an animal model to evaluate safety and effectiveness (e.g., extent of coagulation/ablation, absence of adverse events).
Biocompatibility Standards: Established criteria for material safety in contact with biological tissues.
Sterility Assurance Levels: Defined standards for ensuring device sterility.
Usability Observations: Direct observation and assessment of intended users performing tasks with the device to identify errors or difficulties.

8. The Sample Size for the Training Set

Not applicable. The SIRA™ RFA Device is not an AI/machine learning algorithm that requires a "training set" of data. Its design and manufacturing process are validated through engineering and biological testing, not by learning from labeled datasets.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this device.

Summary

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January 16, 2019

Innoblative Designs, Inc. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, Pennsylvania 19103

Re: K181071

Trade/Device Name: SIRA RFA Electrosurgical Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: December 18, 2018 Received: December 18, 2018

Dear Janice Hogan:

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

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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 (OS) 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.

Image /page/1/Picture/5 description: The image shows a digital signature. The signature is by Long H. Chen -S. The date of the signature is 2019.01.16 16:05:02 -05'00'.

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 on last page

_ Over-The-Counter Use (21 CFR 801

510(k) Number (if known)

K181071

Device Name

SIRA™ RFA Electrosurgical Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

& Prescription Use (Part 21 CFR 801 Subpart D) 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 (7/17) Page 1 of 1 FDA

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510(k) SUMMARY

Innoblative Designs, Inc.'s SIRA™ Device

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Tyler Wanke, President and CEO Innoblative Designs, Inc. 4660 Ravenswood Avenue Chicago, IL 60640 Phone: 920-450-7529

Date Prepared: January 14, 2019

Name of Device

SIRA™ RFA Electrosurgical Device

Common or Usual Name

Electrosurgical Device

Classification

21 CFR 878.4400, Class II, product code GEI

Predicate Device

Medtronic Aquamantys Malleable Bipolar Sealer with Light (K073495)

Intended Use / Indications for Use

Device Description

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Technological Characteristics

The SIRA™ RFA Electrosurgical Device has similar technological characteristics as its predicate device.

The designs of both the SIRA™ RFA Electrosurgical Device and Aquamantys predicate consist of an electrode tip/shaft assembly extended out of an ergonomically designed body. Both the SIRA™ RFA and the Aquamantys devices deliver bipolar radiofrequency energy coupled with 0.9% saline to coagulate soft tissue. Both devices are sterile, single-patient use, and disposable. Further, both the subject and predicate device consist of an integrated cable assembly that connects the devices to an electrosurgical generator. Furthermore, both the subject and predicate devices are electrically insulated, except for the shaft that is electrically active. Both the subject device and Aquamantys predicate allow the user to control the level of RF energy and duration. In addition, both the subject and predicate devices are required to be used with similar accessories, including a 0.9% saline bag, an IV pole, and an external electrosurgical generator.

Although the saline flow for the subject device is controlled by a manual flow regulator with settings of 5-300 ml/hr, whereas the saline flow for the predicate Aquamantys is controlled by an automatic saline pump with low, medium, and high settings, this minor difference does not raise new questions of safety or effectiveness because both devices provide an appropriate mechanism for saline infusion. In addition, the overall size of the working end of the SIRA™ RFA device is larger than the predicate device's electrodes, which can result in larger contact surface area than the predicate with each ablation lesion delivery. However, the differences in dimensions do not raise new questions of safety or effectiveness. Furthermore, comparative testing demonstrates that the depth of treatment created by both devices is equivalent when energy is applied at similar durations, with similarly applied energy levels.

Therefore, the SIRA™ RFA Electrosurgical Device has very similar technological characteristics as its predicate device and is substantially equivalent.

Performance Data

The following nonclinical performance testing has been conducted to support the substantial equivalence of the SIRA™ RFA Electrosurgical Device to its predicate. In all instances, the subject device functioned as intended.

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. Software verification and validation was performed, and demonstrated that the software performs as intended.
Electrical safety (IEC 60601-1 and IEC 60601-2-2) and electromagnetic compatibility . (IEC 60601-1-2) testing was conducted and results were passing.
Biocompatibility of the patient-contacting components of the device was established. .
. Sterility validation was established for all required components.
Performance bench testing, including predicate comparative testing, mechanical testing, . dimensional testing, functional tests.
In vivo testing in an animal model was performed to evaluate and establish the safety and effectiveness of the subject device.
. Usability testing to demonstrate that the intended users of the device can use the device as intended to coagulate/ablate soft tissues without patterns of perceptible use errors or difficultly that could result in serious harm to the user or patient.

Substantial Equivalence

The SIRA™ RFA Electrosurgical Device has the same indications for use and similar indications for use, as well as very similar technological characteristics, and principles of operation as its predicate device. The minor technological differences between the subject and the predicate device do not raise different questions of safety or effectiveness. Performance testing of the device has demonstrated that the device performs as intended and thus, is substantially equivalent.

Conclusion

The SIRA™ RFA Electrosurgical Device has been evaluated in performance testing. Testing demonstrates that the device performs as intended. The SIRA™ RFA Electrosurgical Device is substantially equivalent to its predicate device.

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.