swiftPro™ System

K240518 · Emblation Limited · NEY · Apr 23, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K240518
• Device Name: swiftPro™ System
• Applicant: Emblation Limited
• Product Code: NEY · General, Plastic Surgery
• Decision Date: Apr 23, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The swiftPro™ System is a surface-based device intended for the coagulation of soft tissue during non-invasive procedures. The swiftPro™ System is not indicated for use in cardiac procedures.

Device Story

The swiftPro™ System is a microwave ablation device for soft tissue coagulation. It consists of a hand-held microwave generator, applicator tips, and power accessories. The device delivers controlled microwave energy to target tissues via a ceramic waveguide applicator tip. It is used in non-invasive procedures; operated by a clinician. The system now supports both AC-DC mains power and an optional rechargeable Lithium-Ion battery pack. The generator includes a software-controlled display for setting power levels (0-10) and treatment duration (0-10 seconds). The device monitors parameters including power, time, and battery charge. The output is used by the clinician to achieve tissue coagulation. The system is not networked and does not connect to the internet.

Clinical Evidence

Bench testing only. Performance equivalence was assessed by comparing the device's operation using battery versus mains power in ex vivo tissue. Testing evaluated the impact of battery charge levels on performance. Biocompatibility, electrical safety (IEC 60601-1, 60601-2-6), EMC, and usability testing were performed to support equivalence.

Technological Characteristics

Microwave ablation system. Materials: ABS/PC CYCOLOY HC1204HF resin (enclosure/applicator), SILPURAN 6000/70 liquid silicone rubber (biobarrier). Energy: Microwave, powered by AC-DC adapter or Lithium-Ion battery. Connectivity: Standalone, no network/internet capability. Sterilization: Non-sterile patient contact parts (disposable tips). Software: Firmware-controlled display and power management.

Indications for Use

Indicated for coagulation of soft tissue during non-invasive procedures. Not indicated for cardiac procedures.

Regulatory Classification

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.

Predicate Devices

• swiftPro™ System (K222388)

Submission Summary (Full Text)

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April 23, 2024

Emblation Limited % Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030-0172

Re: K240518

Trade/Device Name: swiftPro™ System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: NEY Dated: February 21, 2024 Received: February 23, 2024

Dear Angela Blackwell:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2024.04.23
08:11:45-04'00'

Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical

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

Enclosure

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# Indications for Use

Submission Number (if known)

K240518

Device Name

swiftPro™ System

Indications for Use (Describe)

The swiftPro™ System is a surface-based device intended for the coagulation of soft tissue during non-invasive procedures.

The swiftPro™ System is not indicated for use in cardiac procedures.

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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# 510(k) Summary

The 510(k) summary of safety and effectiveness information is submitted as part of the Premarket Notification in compliance with requirements of 21 CFR Part 807.92.

## I. SUBMITTER

Emblation Limited Emblation House, Castle Business Park Stirling, FK9 4TS, UK

Phone: [phone]

Contact Person: Mairi MacFadyen Chief Requlatory Officer

Date Prepared: February 2, 2024

#### II. SUBJECT DEVICE

| Name of Device | swiftPro™ System and Accessories |
|---------------------|-------------------------------------------------------------------------------|
| Common Name | Microwave ablation system and accessories |
| Classification Name | Electrosurgical Cutting & Coagulation Device and Accessories, 21 CFR 878.4400 |
| Regulatory Class | II |
| Product Code | NEY |

#### III. PREDICATE DEVICE

| Name of Device | swiftPro™ System |
|---------------------|-------------------------------------------------------------------------------|
| Common Name | Microwave ablation system and accessories |
| 510(k) Number | K222388 |
| Classification Name | Electrosurgical Cutting & Coagulation Device and Accessories, 21 CFR 878.4400 |
| Manufacturer | Emblation Limited |
| Regulatory Class | II |
| Product Code | NEY |

This predicate has not been subject to a design-related recall.

#### IV. DEVICE DESCRIPTION

The core swiftPro™ System, comprising the hand-held microwave generator (SWF-HAN01), DC power cable (SWF-DCA01), cradle (SWF-CRA01), and applicator tips (SWF-AT03), has previously received FDA clearance under K222388. This new 510(k) application has been submitted to incorporate optional accessories: the Battery Pack (SWF-BAT01), Charqing Dock (SWF-CHA01), and Charging Dock DC power adaptor (SWF-DCA02) for cordless operation.

The clinical functionality of delivering treatment via the swiftPro™ System remains unchanged. The only distinction is the introduction of an additional potential energy source. The power is supplied to swiftPro™ system by either a (external) medical-grade AC-DC adaptor with direct connection to the rear panel of the hand-held microwave generator or via a removable, rechargeable (optional) battery pack.

There haven't been any alterations to the design, or the material used in the swiftPro™ hand-held microwave generator. The operation of the subject device follows the same steps as the predicate device. The addition of the accessories does not have any effect on the mode of operation.

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Image /page/5/Picture/0 description: The image shows the logo for "emblation". The logo consists of a red oval shape on the left side, with a stylized white and black "M" shape inside. To the right of the oval is the word "emblation" in red and black lettering. The "em" is in red, while the "blation" is in black.

## Battery Pack (SWF-BAT01)

The swiftPro™ system can be powered by a battery (SWF-BAT01) which is mounted internally and secured within the hand-held microwave generator during treatment. The batteries used in swiftPro™ are custom, Lithium-Ion Smart batteries, which contain internal protections to mitigate potential faults. Smart battery authentication has been integrated to ensure that only an authentic battery powers the swiftPro™ microwave generator.

# Charging Dock (SWF-CHA01)

SwiftPro™ Charging Dock (SWF-CHG01) is designed to support the swiftPro™ system and charge the SWF-BAT01 Battery pack, either standalone, or when contained within the SWF-HAN01 hand-held microwave generator. SwiftPro™ Charging Dock can be used as an alternative power source for the system other than the swiftPro™ AC-DC desktop adapter SWFDC01. The charging dock also has a slot or "bay" with charging connections for a spare battery underneath the swiftPro™. The Charging Dock does not have any clinical function, any patient interactions nor any applied parts.

Table below provides a list of components comprising the swiftPro™ System and its accessories.

| swiftPro™ System | | | |
|------------------|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Product<br>Code | Product Name | Description | Previously<br>cleared 510 (k)<br>Number |
| SWF-MIC01 | swiftPro™ hand-held treatment system | A hand-held system containing SWF-HAN01 and SWF-DCA01. | K222388 |
| SWF-HAN01 | swiftPro™ hand-held microwave generator | A hand-held microwave generator containing the microwave amplifier and software-controlled display. | K222388 |
| SWF-DCA01 | swiftPro™ DC power adaptor | A medical grade isolated power supply. | K222388 |
| | Accessories | | |
| SWF-CRA01 | swiftPro™ Cradle | A table-top cradle to rest the hand-held treatment system on when not in use. | K222388 |
| SWF-AT02 | swiftPro™ Applicator Tip | URT<br>A disposable applicator which includes device identification, re-use mitigation and a biological barrier. | K222388 |
| SWF-AT03 | swiftPro™ Applicator Tip | LRT<br>A disposable applicator which includes device identification, re-use mitigation and a biological barrier. | K222388 |
| | Optional Accessories | | |
| SWF-BAT01 | swiftPro™ Battery Pack | Removable, rechargeable battery pack provides an alternative means of power to the SWF-HAN01. | - |
| SWF-CHA01 | swiftPro™ Charging Dock | The swiftPro™ Charging Dock is a table-top rest for the swiftPro™ hand-held microwave generator and provides a charging interface for the SWF-BAT01 Battery Pack which may be charged either as a standalone item or when it is installed within SWF-HAN01. | - |
| SWF-DCA02 | swiftPro™ Charging Dock DC power adaptor | A medical grade isolated power supply used to provide power to the Charging Dock. | - |

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Image /page/6/Picture/0 description: The image shows the logo for "emblation". The logo consists of a red oval shape on the left side, with a stylized white and black line running through it. To the right of the oval is the word "emblation" in a sans-serif font. The "em" part of the word is in red, while the "blation" part is in black.

#### V. INDICATIONS FOR USE

The swiftPro™ System is a surface-based device intended for the coagulation of soft tissue during noninvasive procedures.

The swiftPro™ System is not indicated for use in cardiac procedures.

## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The swiftPro™ hand-held microwave generator (SWF-HAN01), is identical to that used in the predicate device (K222388), therefore maintains the same technological characteristics in terms of materials and design. The existing applicator/antenna design delivers the same frequency and magnitude of microwave energy to target tissues in a controlled manner, serving the same intended purpose as the predicate.

The only technological distinction in the hand-held microwave generator (SWF-HAN01) lies in the introduction of an additional potential energy source. While the swiftPro™ System now offers the option of being powered by a battery and charging dock, it still retains the capability to be charged via the mains power cable.

While the option to power the swiftPro™ System via battery introduces different technological characteristics due to the energy source, it does not raise additional questions regarding safety and effectiveness. The clinical functionality of delivering treatment via the swiftPro™ System remains unchanged. The indication for use is the same with that of the predicate device. Non-clinical bench testing has demonstrated that the technological differences do not affect device performance data is provided to establish substantial equivalence with the predicate device.

#### SwiftPro™ Hand-held Microwave Generator

The hand-held microwave generator, is identical to that used in the predicate device, therefore maintains the same technological characteristics in terms of materials and design.

#### SwiftPro™ Applicator Tip

The functionality and material composition of the applicator tips have not undergone any changes between the predicate and subject device.

| Device Feature | swiftPro™ System<br>and Accessories<br>(Subject) | swiftPro™ System<br>(Predicate) | Comments |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Unknown | K222388 | N/A |
| Classification<br>Regulation 21 CFR<br>878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 | Identical |
| Product Code | NEY | NEY | Identical |
| 510(k) Holder/<br>Manufacturer | Emblation Limited | Emblation Limited | Identical |
| Indications<br>for Use | The swiftPro™ System<br>is a surface-based<br>coagulation of soft<br>tissue during non-<br>invasive procedures.<br>The swiftPro™ System<br>is not indicated for use<br>in cardiac procedures. | The swiftPro™ System<br>is a surface-based<br>coagulation of soft<br>tissue during non-<br>invasive procedures.<br>The swiftPro™ System<br>is not indicated for use<br>in cardiac procedures. | Identical |
| Dimensions<br>Width x Height x<br>Depth | Hand-held Microwave<br>Generator:<br>245x75x135mm<br>(10x3x5.3 inch)<br>Additional accessories<br>have the following<br>dimensions:<br>Charging Dock: 305 x<br>95 x 110 mm (12 x 3.8 x<br>4.4 inches)<br>Battery Pack: 105 x 30 x<br>65 mm (4.2 x 1.2 x 2.6<br>inches) | Hand-held Microwave<br>Generator:<br>245x75x135mm<br>(10x3x5.3 inch) | Identical - the<br>dimensions of the hand-<br>held microwave<br>generator are<br>unchanged.<br>New - Charging Dock<br>and Battery Pack<br>dimensions added. |
| Weight | Hand-held Microwave<br>Generator: Less than<br>0.75kg (~1.65lbs)<br>Additional accessories<br>have the following<br>weight:<br>Charging Dock: Less<br>than 0.8 kg (~1.75 lbs)<br>Battery Pack: Less than<br>0.25 kg (~0.55 lbs) | Hand-held Microwave<br>Generator: Less than<br>0.75kg (~1.65lbs) | Identical - the weight of<br>the hand-held<br>microwave generator is<br>unchanged.<br>New - Weight of the<br>Charging Dock and<br>Battery Pack added. |
| Material | Enclosure Material:<br>Handpiece - ABS/PC<br>CYCOLOYTM<br>Resin HC1204HF<br>Applicator Tip material:<br>ABS/PC CYCOLOYTM<br>Resin HC1204HF<br>Biobarrier material –<br>SILPURAN®<br>6000/70 Liquid Silicone<br>Rubber<br>The enclosure of the<br>additional accessories,<br>including the charging<br>dock and battery pack,<br>is manufactured from<br>the same material<br>(CYCOLOY HC1204 HF<br>Resin) as the hand-held<br>microwave generator<br>and applicator tips. | Enclosure Material:<br>Handpiece - ABS/PC<br>CYCOLOYTM<br>Resin HC1204HF<br>Applicator Tip material:<br>ABS/PC CYCOLOYTM<br>Resin HC1204HF<br>Biobarrier material –<br>SILPURAN®<br>6000/70 Liquid Silicone<br>Rubber | Identical<br>New accessories are<br>manufactured using the<br>same material as the<br>hand-held microwave<br>generator and applicator<br>tips. |
| Generator | Yes | Yes | Identical |
| | | | |
| Microwave | Microwave | Same frequency and<br>magnitude of microwave<br>energy is delivered to<br>target tissues. | |
| Mains Power and/or<br>Battery | Mains Power | An additional energy<br>source battery option is<br>added. | |
| 0-10 in 1power level<br>increments = treatment,<br>6W = Generator<br>Tip ATO2 restricts<br>delivered energy to 6W<br>output (corresponds to<br>power level setting of<br>10) | 0-10 in 1power level<br>increments = treatment,<br>6W = Generator<br>Tip ATO2 restricts<br>delivered energy to 6W<br>output (corresponds to<br>power level setting of<br>10) | Identical | |
| BF | BF | Identical | |
| 0-10 secs | 0-10 secs | Identical | |

# Comparison Table

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Energy

| Maximum<br>Microwave<br>Power | increments = treatment,<br>6W = Generator<br>Tip ATO2 restricts<br>delivered energy to 6W<br>output (corresponds to<br>power level setting of<br>10) | increments = treatment,<br>6W = Generator<br>Tip ATO2 restricts<br>delivered energy to 6W<br>output (corresponds to<br>power level setting of<br>10) | Identical |
|---------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Isolation | BF | BF | Identical |
| Time settings | 0-10 secs | 0-10 secs | Identical |
| Max coagulation<br>cycle | 15-20 minutes but<br>treatment dependant &<br>limited by applicator tip<br>used to 10 seconds<br>max. | 15-20 minutes but<br>treatment dependant &<br>limited by applicator tip<br>used to 10 seconds<br>max. | Identical |
| Vacuum | No | No | Identical |
| Shut Offs/<br>Alarms | Alerts:<br>MSM overtemp, Expired<br>tip, No applicator<br>detected, Reflection,<br>Manual Switch Status<br>System error, SD Card<br>Error, Service error,<br>Now includes; low<br>battery, battery error | Alerts:<br>MSM overtemp, Expired<br>tip, No applicator<br>detected, Reflection,<br>Manual Switch Status<br>System error, SD Card<br>Error, Service error | The low battery and<br>battery error functions,<br>previously present in the<br>predicate hand-held<br>microwave generator,<br>have now been<br>activated.<br>If an error is detected<br>with the battery, an Error<br>indicator will flash<br>orange. |
| Software/<br>Firmware Platform | Yes | Yes | Both the application<br>software and firmware<br>have been updated to<br>accommodate minor<br>improvements for the<br>charging dock and<br>battery pack elements. |
| Hardware control | Yes | Yes | Same |
| Monitored<br>parameters | Power,<br>Time,<br>Reuse status,<br>Applicator connected<br>Reflected power<br>Now includes; Battery<br>Charge | Power,<br>Time,<br>Reuse status,<br>Applicator connected<br>Reflected power | Battery charge indicator<br>has been added. When<br>a battery pack is<br>connected to swiftPro™<br>this section shows the<br>charge level of the<br>connected battery. |
| Display parameters | Set Power<br>(Unit 1-10)<br>Set Time/Treatment<br>Time (secs),<br>Settings Menu<br>Device Information<br>Screen Brightness<br>Selection<br>Auto/Manual Mode<br>Selection<br>Set Time and Date<br>Recall Treatment Menu | Set Power<br>(Unit 1-10)<br>Set Time/Treatment<br>Time (secs),<br>Settings Menu<br>Device Information<br>Screen Brightness<br>Selection<br>Auto/Manual Mode<br>Selection<br>Set Time and Date<br>Recall Treatment Menu | Identical |
| Manual or<br>automatic<br>setting | Manual or<br>Automatic can be<br>selected. | Manual or<br>Automatic can be<br>selected. | Identical |
| Operation Mode | PWM & fixed frequency | PWM & fixed frequency | Identical |
| Surface Applicator/<br>Antenna | Surface Applicator | Surface Applicator | Identical |
| Patient contact part<br>supplied sterile | No - Patient contact<br>parts supplied non-<br>sterile (disposable<br>applicator tips) | No - Patient contact<br>parts supplied non-<br>sterile (disposable<br>applicator tips) | Identical |
| Applicator/<br>Antenna Design | Ceramic waveguide<br>Disposable silicone<br>barrier | Ceramic waveguide<br>Disposable silicone<br>barrier | Identical |
| Applicator/<br>Antenna head Size | Applicator Tip<br>approximately 4 cm<br>x 3 cm<br>Silicone/Ceramic<br>contact face<br>6.7 mm diameter | Applicator Tip<br>approximately 4 cm<br>x 3 cm<br>Silicone/Ceramic<br>contact face<br>6.7 mm diameter | Identical |
| Applicator/<br>Antenna Use | Soft tissue coagulation | Soft tissue coagulation | Identical |
| Rigid shaft | Yes | Yes | Identical |
| Footswitch | No | No | Identical |
| Tissue Temp<br>monitoring | N/A | N/A | N/A |
| Max applicator<br>surface Temp (non-<br>active areas) | 42°C | 42°C | Identical |
| Operation<br>Procedure | Surface use | Surface use | Identical |
| Average energy<br>density of surface<br>application<br>(Area J/mm2) | 10 J/mm2<br>Set power level 10<br>Set time 1 Seconds<br>6J delivered | 10 J/mm2<br>Set power level 10<br>Set time 1 Seconds<br>6J delivered | Identical |
| Electrical 60601 &<br>EMC<br>Compliant | Yes | Yes | The additional<br>accessories comply with<br>the requirements of<br>electrical safety and IEC<br>60601. |
| IP Rating | IP20 | IP22 | Different, IP22 rating not<br>required for professional<br>healthcare facility. |
| Biocompatible | Yes | Yes | SWF-BAT01 swiftPro™<br>Battery Pack – is not<br>designed to come in<br>contact with patients. It's<br>made from the material<br>Cycoloy HC1204 HF<br>Resin, which is<br>biocompatible and the<br>same material used in<br>the hand-held<br>microwave generator &<br>Applicator Tip.<br>SWF-CHG01<br>SwiftPro TM Charging<br>Dock - is not designed<br>to come in contact with<br>patients. It's made from<br>the material Cycoloy<br>HC1204 HF<br>Resin, complies with<br>biocompatibility<br>standards ISO10993<br>and the same material<br>used in the hand-held<br>microwave generator &<br>Applicator Tip. |

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## VII. PERFORMANCE DATA

The following performance data were provided in support of substantial equivalence determination, using the either the same or similar methods and information used for the predicate device.

## Biocompatibility testing

Biocompatibility testing in accordance with ISO10993: Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process was performed:

- · Cytotoxicity
- · Sensitisation
- · Irritation
- · Systemic toxicity
- · Pyrogenicity

# Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted and the swiftPro™ system and accessories comply with all the applicable Medical electrical equipment standards for safety and essential performance.

- IEC 60601-1:2005 + AMD1:2012+AMD2:2020 Medical electrical equipment Part 1: General . requirements for basic safety and essential performance.
- . IEC 60601-2-6: 2012 + AMD1:2016 Medical electric equipment Part 2: Particular requirements for basic safety and essential performance of microwave therapy equipment.
- . IEC 60601-1-2:2014 +AMD1:2020 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances-Requirements and tests.
- IEC 62133-2:2017+AMD1:2021 Secondary cells and batteries containing alkaline or other non-acid . electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems

#### Software Verification and Validation Testing

The application of software and firmware for the SwiftPro™ system has been updated to accommodate the use of the battery pack and charging for system power, in accordance with IEC 62304:2006 (AMD1: 2015) and FDA quidance for software contained in medical devices.

#### Cybersecurity

The swiftPro™ system and accessories are not intended to be used as a networked medical device, nor do they contain any off-the-shelf (OTS) software to support connection to a private or public internet. The swiftPro™ system and accessories do not incorporate an OTS operating system or OTS software/drivers which supports hard-wired or wireless network connections. Throughout the lifecycle of the device, an assessment to mitigate cybersecurity vulnerabilities has been completed.

#### Human Factors and Usability Engineering

The swiftPro™ system and accessories comply with all the applicable requirements of the following standards:

- ANSI/ AAMI HE75:2009/R2013 American National Standard / Association for the Advancement of Medical Instrumentation. Human Factors Engineering - Design of Medical Devices
- IEC 60601-1-6:2010+AMD1:2013 +AMD2:2020, Medical electrical equipment General requirements for basic safety and essential performance. Collateral standard: Usability
- · IEC 62366-1:2015+AMD1:2020 Medical Devices. Application of Usability Engineering to Medical Devices
- FDA-2011-D-0469 Applying Human Factors and Usability Engineering to Medical Devices.

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## Bench Testing

An evaluation of the performance equivalence of the swiftPro™ device was conducted, using the different power supply options available. Bench testing involved assessing the performance equivalence of the device when powered by the battery and wired options in ex vivo tissue. Additionally, an assessment of the impact of battery charge levels on the performance of the swiftPro™ device was carried out. The CN-901 CAIRN Power Source Bench Equivalence Test Report assesses performance at various charge levels.

The bench testing proves the swiftPro™ System and Accessories performs substantially equivalent to the predicate device.

#### VIII. CONCLUSIONS

The swiftPro™ System and Accessories are considered equivalent to the predicate device, swiftPro™ System, K222388. The intended use, specifications and associated performance testing and data provided in this submission are sufficient to demonstrate this fact.

The subject device is operated in the same manner as the predicate, within the identical intended use case and environment, which have been deemed safe and effective.