(60 days)
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.
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.
The provided text is a 510(k) Summary for a medical device called the "swiftPro™ System." This document is part of a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
After reviewing the document, there is no mention of an acceptance criteria table, device performance metrics (like sensitivity, specificity, accuracy, etc.), or any study involving human readers or experts for establishing ground truth. The submission is primarily focused on demonstrating the substantial equivalence of the swiftPro™ System with added accessories (Battery Pack, Charging Dock) to its previously cleared version (K222388).
The document details:
- Device Description: The swiftPro™ System is an electrosurgical cutting and coagulation device, specifically a microwave ablation system for soft tissue coagulation during non-invasive procedures. The new submission is for optional accessories (battery pack and charging dock) that allow for cordless operation. The core functionality and hand-held microwave generator remain unchanged from the predicate device.
- Comparison to Predicate Device: The submission explicitly states that the swiftPro™ hand-held microwave generator is identical to that in the predicate device. The primary change is the introduction of an additional energy source (battery).
- Performance Data: The performance data primarily consists of bench testing to demonstrate that the new power options do not negatively impact the device's performance. It also includes compliance with various standards related to biocompatibility, electrical safety, electromagnetic compatibility, software verification/validation, cybersecurity, and human factors/usability engineering.
Therefore, since the request is to "Describe the acceptance criteria and the study that proves the device meets the acceptance criteria" for a diagnostic or AI-assisted device, and the provided text describes an electrosurgical device with a focus on hardware modifications and safety/performance standards, much of the requested information (like sensitivity/specificity, MRMC studies, expert ground truth, etc.) is not applicable or not present in this type of 510(k) submission.
Attempting to answer based on the provided text, while acknowledging the limitations:
-
A table of acceptance criteria and the reported device performance:
The document does not explicitly provide a table of acceptance criteria with corresponding performance numbers in the way one would for a diagnostic device (e.g., sensitivity, specificity). Instead, the "acceptance criteria" are implied by compliance with various medical device standards and the demonstration of "substantial equivalence" through bench testing. The key "performance" demonstrated is that the addition of battery power does not alter the clinical functionality or safety/effectiveness of the microwave energy delivery compared to the predicate device.Acceptance Criteria (Implied) Reported Device Performance (Summary from text) Biocompatibility Compliance (ISO10993) Performed and complies with Cytotoxicity, Sensitisation, Irritation, Systemic toxicity, Pyrogenicity. Note: SWF-BAT01 and SWF-CHG01 are not designed for patient contact, but their materials (Cycoloy HC1204 HF Resin) are biocompatible and same as hand-held microwave generator & applicator tip. Electrical Safety & EMC Compliance (IEC 60601-1, -2-6, -1-2, IEC 62133-2) System and accessories comply with all applicable medical electrical equipment standards for safety and essential performance, specifically mentioning these IEC standards. The additional accessories comply with electrical safety and IEC 60601 requirements. Software V&V Compliance (IEC 62304, FDA Guidance) Software and firmware updated to accommodate battery functions, in accordance with IEC 62304 and FDA guidance. This implies successful verification and validation. Cybersecurity Assessment Assessment to mitigate cybersecurity vulnerabilities completed. (Note: Device is not networked, no OTS software for internet connection). Human Factors & Usability Engineering Compliance (ANSI/AAMI HE75, IEC 60601-1-6, IEC 62366-1, FDA Guidance) System and accessories comply with applicable requirements of these standards. Performance Equivalence with various power options Bench testing in ex vivo tissue demonstrated performance equivalence when powered by battery vs. wired options. Assessment of impact of battery charge levels on performance was carried out (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. Mechanical & Material Equivalence (for core device) The hand-held microwave generator is identical to the predicate in materials and design. Dimensions and weight are unchanged for the core unit; new accessories have documented dimensions/weight. Applicator tip functionality and material composition are unchanged. Clinical Functionality Preservation The clinical functionality of delivering treatment via the swiftPro™ System remains unchanged with the addition of battery power. The same frequency and magnitude of microwave energy are delivered. Indications for Use Preservation Indications for use are identical to the predicate device. -
Sample sizes used for the test set and the data provenance:
The document mentions "bench testing in ex vivo tissue" but does not specify the sample size for this testing. It refers to a "CN-901 CAIRN Power Source Bench Equivalence Test Report" where further details might be found, but these are not in the provided text.
Data Provenance: The testing appears to be primarily laboratory/bench testing rather than clinical data from a specific country. It is not an AI/diagnostic study, so terms like "retrospective or prospective" don't directly apply in the usual sense. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable. The device is an electrosurgical tool, not a diagnostic AI. "Ground truth" in this context would likely refer to engineering specifications and performance benchmarks, not medical diagnoses established by experts. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as this is for diagnostic interpretations, not a medical device's physical/electrical performance. -
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:
Not applicable. This is not an AI-assisted diagnostic device, nor does it involve human readers in an interpretative capacity. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device does not have a standalone AI algorithm for performance evaluation. Its "performance" refers to how it delivers microwave energy and its safety as a physical device. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For this type of device, the "ground truth" for performance testing (bench testing) would be established by validated measurement techniques against pre-defined engineering and safety specifications (e.g., power output, temperature, electrical safety limits). For instance, for power output, the ground truth would be what an independent, calibrated power meter measures. -
The sample size for the training set:
Not applicable. This device does not use machine learning in a way that would require a "training set" for an AI model. Its software/firmware updates accommodate hardware changes, implying traditional software engineering verification and validation, not AI model training. -
How the ground truth for the training set was established:
Not applicable. As there's no training set for an AI model, there's no ground truth to establish for it.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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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Image /page/4/Picture/0 description: The image shows the logo for "emblation". The logo consists of a red oval shape on the left side, with a white and black wave-like design inside. To the right of the oval is the word "emblation" in black and red letters. The "em" is in red, while the "blation" is in black.
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: +44(0) 1786 657 204
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 | |||
|---|---|---|---|
| ProductCode | Product Name | Description | Previouslycleared 510 (k)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 | URTA disposable applicator which includes device identification, re-use mitigation and a biological barrier. | K222388 |
| SWF-AT03 | swiftPro™ Applicator Tip | LRTA 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™ Systemand Accessories(Subject) | swiftPro™ System(Predicate) | Comments |
|---|---|---|---|
| 510(k) Number | Unknown | K222388 | N/A |
| ClassificationRegulation 21 CFR878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 | Identical |
| Product Code | NEY | NEY | Identical |
| 510(k) Holder/Manufacturer | Emblation Limited | Emblation Limited | Identical |
| Indicationsfor Use | The swiftPro™ Systemis a surface-basedcoagulation of softtissue during non-invasive procedures.The swiftPro™ Systemis not indicated for usein cardiac procedures. | The swiftPro™ Systemis a surface-basedcoagulation of softtissue during non-invasive procedures.The swiftPro™ Systemis not indicated for usein cardiac procedures. | Identical |
| DimensionsWidth x Height xDepth | Hand-held MicrowaveGenerator:245x75x135mm(10x3x5.3 inch)Additional accessorieshave the followingdimensions:Charging Dock: 305 x95 x 110 mm (12 x 3.8 x4.4 inches)Battery Pack: 105 x 30 x65 mm (4.2 x 1.2 x 2.6inches) | Hand-held MicrowaveGenerator:245x75x135mm(10x3x5.3 inch) | Identical - thedimensions of the hand-held microwavegenerator areunchanged.New - Charging Dockand Battery Packdimensions added. |
| Weight | Hand-held MicrowaveGenerator: Less than0.75kg (~1.65lbs)Additional accessorieshave the followingweight:Charging Dock: Lessthan 0.8 kg (~1.75 lbs)Battery Pack: Less than0.25 kg (~0.55 lbs) | Hand-held MicrowaveGenerator: Less than0.75kg (~1.65lbs) | Identical - the weight ofthe hand-heldmicrowave generator isunchanged.New - Weight of theCharging Dock andBattery Pack added. |
| Material | Enclosure Material:Handpiece - ABS/PCCYCOLOYTMResin HC1204HFApplicator Tip material:ABS/PC CYCOLOYTMResin HC1204HFBiobarrier material –SILPURAN®6000/70 Liquid SiliconeRubberThe enclosure of theadditional accessories,including the chargingdock and battery pack,is manufactured fromthe same material(CYCOLOY HC1204 HFResin) as the hand-heldmicrowave generatorand applicator tips. | Enclosure Material:Handpiece - ABS/PCCYCOLOYTMResin HC1204HFApplicator Tip material:ABS/PC CYCOLOYTMResin HC1204HFBiobarrier material –SILPURAN®6000/70 Liquid SiliconeRubber | IdenticalNew accessories aremanufactured using thesame material as thehand-held microwavegenerator and applicatortips. |
| Generator | Yes | Yes | Identical |
| Microwave | Microwave | Same frequency andmagnitude of microwaveenergy is delivered totarget tissues. | |
| Mains Power and/orBattery | Mains Power | An additional energysource battery option isadded. | |
| 0-10 in 1power levelincrements = treatment,6W = GeneratorTip ATO2 restrictsdelivered energy to 6Woutput (corresponds topower level setting of10) | 0-10 in 1power levelincrements = treatment,6W = GeneratorTip ATO2 restrictsdelivered energy to 6Woutput (corresponds topower level setting of10) | Identical | |
| BF | BF | Identical | |
| 0-10 secs | 0-10 secs | Identical |
Comparison Table
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Image /page/7/Picture/0 description: The image shows the word "emblation" with the "em" in red and the "blation" in black. To the left of the word is a red circle with a white and black design inside. The design is a stylized "M" shape with a black line running through the middle of the white shape.
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Image /page/8/Picture/0 description: The image shows the logo for "emblation". The logo consists of a red circle with a white and black wave-like design inside, followed by the word "emblation" in red and black lettering. The "em" is in red, while the "blation" is in black.
Energy
| MaximumMicrowavePower | increments = treatment,6W = GeneratorTip ATO2 restrictsdelivered energy to 6Woutput (corresponds topower level setting of10) | increments = treatment,6W = GeneratorTip ATO2 restrictsdelivered energy to 6Woutput (corresponds topower level setting of10) | Identical |
|---|---|---|---|
| Isolation | BF | BF | Identical |
| Time settings | 0-10 secs | 0-10 secs | Identical |
| Max coagulationcycle | 15-20 minutes buttreatment dependant &limited by applicator tipused to 10 secondsmax. | 15-20 minutes buttreatment dependant &limited by applicator tipused to 10 secondsmax. | Identical |
| Vacuum | No | No | Identical |
| Shut Offs/Alarms | Alerts:MSM overtemp, Expiredtip, No applicatordetected, Reflection,Manual Switch StatusSystem error, SD CardError, Service error,Now includes; lowbattery, battery error | Alerts:MSM overtemp, Expiredtip, No applicatordetected, Reflection,Manual Switch StatusSystem error, SD CardError, Service error | The low battery andbattery error functions,previously present in thepredicate hand-heldmicrowave generator,have now beenactivated.If an error is detectedwith the battery, an Errorindicator will flashorange. |
| Software/Firmware Platform | Yes | Yes | Both the applicationsoftware and firmwarehave been updated toaccommodate minorimprovements for thecharging dock andbattery pack elements. |
| Hardware control | Yes | Yes | Same |
| Monitoredparameters | Power,Time,Reuse status,Applicator connectedReflected powerNow includes; BatteryCharge | Power,Time,Reuse status,Applicator connectedReflected power | Battery charge indicatorhas been added. Whena battery pack isconnected to swiftPro™this section shows thecharge level of theconnected battery. |
| Display parameters | Set Power(Unit 1-10)Set Time/TreatmentTime (secs),Settings MenuDevice InformationScreen BrightnessSelectionAuto/Manual ModeSelectionSet Time and DateRecall Treatment Menu | Set Power(Unit 1-10)Set Time/TreatmentTime (secs),Settings MenuDevice InformationScreen BrightnessSelectionAuto/Manual ModeSelectionSet Time and DateRecall Treatment Menu | Identical |
| Manual orautomaticsetting | Manual orAutomatic can beselected. | Manual orAutomatic can beselected. | Identical |
| Operation Mode | PWM & fixed frequency | PWM & fixed frequency | Identical |
| Surface Applicator/Antenna | Surface Applicator | Surface Applicator | Identical |
| Patient contact partsupplied sterile | No - Patient contactparts supplied non-sterile (disposableapplicator tips) | No - Patient contactparts supplied non-sterile (disposableapplicator tips) | Identical |
| Applicator/Antenna Design | Ceramic waveguideDisposable siliconebarrier | Ceramic waveguideDisposable siliconebarrier | Identical |
| Applicator/Antenna head Size | Applicator Tipapproximately 4 cmx 3 cmSilicone/Ceramiccontact face6.7 mm diameter | Applicator Tipapproximately 4 cmx 3 cmSilicone/Ceramiccontact face6.7 mm diameter | Identical |
| Applicator/Antenna Use | Soft tissue coagulation | Soft tissue coagulation | Identical |
| Rigid shaft | Yes | Yes | Identical |
| Footswitch | No | No | Identical |
| Tissue Tempmonitoring | N/A | N/A | N/A |
| Max applicatorsurface Temp (non-active areas) | 42°C | 42°C | Identical |
| OperationProcedure | Surface use | Surface use | Identical |
| Average energydensity of surfaceapplication(Area J/mm2) | 10 J/mm2Set power level 10Set time 1 Seconds6J delivered | 10 J/mm2Set power level 10Set time 1 Seconds6J delivered | Identical |
| Electrical 60601 &EMCCompliant | Yes | Yes | The additionalaccessories comply withthe requirements ofelectrical safety and IEC60601. |
| IP Rating | IP20 | IP22 | Different, IP22 rating notrequired for professionalhealthcare facility. |
| Biocompatible | Yes | Yes | SWF-BAT01 swiftPro™Battery Pack – is notdesigned to come incontact with patients. It'smade from the materialCycoloy HC1204 HFResin, which isbiocompatible and thesame material used inthe hand-heldmicrowave generator &Applicator Tip.SWF-CHG01SwiftPro TM ChargingDock - is not designedto come in contact withpatients. It's made fromthe material CycoloyHC1204 HFResin, complies withbiocompatibilitystandards ISO10993and the same materialused in the hand-heldmicrowave generator &Applicator Tip. |
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Image /page/9/Picture/0 description: The image shows the logo for "emblation". The logo consists of a red circle with a white and black wave-like design inside, followed by the word "emblation" in red and black. The "em" part of the word is in red, while the "blation" part is in black.
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Image /page/10/Picture/0 description: The image shows the logo for "emblation". The logo consists of a red circle with a white and black ribbon-like design inside, followed by the word "emblation" in red and black text. The "em" is in red, and the "blation" is in black.
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Image /page/11/Picture/0 description: The image is a logo for a company called "emblation". The logo consists of a red circle with a stylized white and black wave inside of it. To the right of the circle is the company name, with the "em" in red and the "blation" in black.
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.
§ 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.