(60 days)
Not Found
No
The 510(k) summary explicitly states that there have been no alterations to the design or material of the core device and that the clinical functionality remains unchanged. The submission is solely for the addition of optional power accessories. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended for the "coagulation of soft tissue during non-invasive procedures," which is a therapeutic function.
No
Explanation: The device is described as "intended for the coagulation of soft tissue during non-invasive procedures," indicating it is for treatment, not diagnosis. The functions described are related to delivering treatment via microwave energy for tissue coagulation.
No
The device description explicitly lists hardware components such as a hand-held microwave generator, DC power cable, cradle, applicator tips, battery pack, charging dock, and charging dock DC power adaptor. The submission is for incorporating optional hardware accessories.
Based on the provided text, the swiftPro™ System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "coagulation of soft tissue during non-invasive procedures." This describes a therapeutic or surgical intervention performed directly on the patient's body.
- Device Description: The device is a "surface-based device" that uses a "microwave generator" and "applicator tips" to deliver treatment. This is consistent with a device used for physical intervention, not for analyzing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on sample analysis
- Using reagents or assays
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The swiftPro™ System directly treats tissue, which is not the function of an IVD.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
NEY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains 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"
1
(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
2
and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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 | |||
|---|---|---|---|
| Product | |||
| Code | Product Name | Description | Previously |
| cleared 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 | URT | |
| A disposable applicator which includes device identification, re-use mitigation and a biological barrier. | K222388 | ||
| SWF-AT03 | swiftPro™ Applicator Tip | LRT | |
| 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
and Accessories
(Subject) | swiftPro™ System
(Predicate) | Comments |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Unknown | K222388 | N/A |
| Classification
Regulation 21 CFR
878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 | Identical |
| Product Code | NEY | NEY | Identical |
| 510(k) Holder/
Manufacturer | Emblation Limited | Emblation Limited | Identical |
| Indications
for Use | The swiftPro™ System
is a surface-based
coagulation of soft
tissue during non-
invasive procedures.
The swiftPro™ System
is not indicated for use
in cardiac procedures. | The swiftPro™ System
is a surface-based
coagulation of soft
tissue during non-
invasive procedures.
The swiftPro™ System
is not indicated for use
in cardiac procedures. | Identical |
| Dimensions
Width x Height x
Depth | Hand-held Microwave
Generator:
245x75x135mm
(10x3x5.3 inch)
Additional accessories
have the following
dimensions:
Charging Dock: 305 x
95 x 110 mm (12 x 3.8 x
4.4 inches)
Battery Pack: 105 x 30 x
65 mm (4.2 x 1.2 x 2.6
inches) | Hand-held Microwave
Generator:
245x75x135mm
(10x3x5.3 inch) | Identical - the
dimensions of the hand-
held microwave
generator are
unchanged.
New - Charging Dock
and Battery Pack
dimensions added. |
| Weight | Hand-held Microwave
Generator: Less than
0.75kg (~1.65lbs)
Additional accessories
have the following
weight:
Charging Dock: Less
than 0.8 kg (~1.75 lbs)
Battery Pack: Less than
0.25 kg (~0.55 lbs) | Hand-held Microwave
Generator: Less than
0.75kg (~1.65lbs) | Identical - the weight of
the hand-held
microwave generator is
unchanged.
New - Weight of the
Charging Dock and
Battery Pack added. |
| Material | Enclosure Material:
Handpiece - ABS/PC
CYCOLOYTM
Resin HC1204HF
Applicator Tip material:
ABS/PC CYCOLOYTM
Resin HC1204HF
Biobarrier material –
SILPURAN®
6000/70 Liquid Silicone
Rubber
The enclosure of the
additional accessories,
including the charging
dock and battery pack,
is manufactured from
the same material
(CYCOLOY HC1204 HF
Resin) as the hand-held
microwave generator
and applicator tips. | Enclosure Material:
Handpiece - ABS/PC
CYCOLOYTM
Resin HC1204HF
Applicator Tip material:
ABS/PC CYCOLOYTM
Resin HC1204HF
Biobarrier material –
SILPURAN®
6000/70 Liquid Silicone
Rubber | Identical
New accessories are
manufactured using the
same material as the
hand-held microwave
generator and applicator
tips. |
| Generator | Yes | Yes | Identical |
| | | | |
| Microwave | Microwave | Same frequency and
magnitude of microwave
energy is delivered to
target tissues. | |
| Mains Power and/or
Battery | Mains Power | An additional energy
source battery option is
added. | |
| 0-10 in 1power level
increments = treatment,
6W = Generator
Tip ATO2 restricts
delivered energy to 6W
output (corresponds to
power level setting of
10) | 0-10 in 1power level
increments = treatment,
6W = Generator
Tip ATO2 restricts
delivered energy to 6W
output (corresponds to
power level setting of
10) | 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
| Maximum
Microwave
Power | increments = treatment,
6W = Generator
Tip ATO2 restricts
delivered energy to 6W
output (corresponds to
power level setting of
10) | increments = treatment,
6W = Generator
Tip ATO2 restricts
delivered energy to 6W
output (corresponds to
power level setting of
10) | Identical |
|---------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Isolation | BF | BF | Identical |
| Time settings | 0-10 secs | 0-10 secs | Identical |
| Max coagulation
cycle | 15-20 minutes but
treatment dependant &
limited by applicator tip
used to 10 seconds
max. | 15-20 minutes but
treatment dependant &
limited by applicator tip
used to 10 seconds
max. | Identical |
| Vacuum | No | No | Identical |
| Shut Offs/
Alarms | Alerts:
MSM overtemp, Expired
tip, No applicator
detected, Reflection,
Manual Switch Status
System error, SD Card
Error, Service error,
Now includes; low
battery, battery error | Alerts:
MSM overtemp, Expired
tip, No applicator
detected, Reflection,
Manual Switch Status
System error, SD Card
Error, Service error | The low battery and
battery error functions,
previously present in the
predicate hand-held
microwave generator,
have now been
activated.
If an error is detected
with the battery, an Error
indicator will flash
orange. |
| Software/
Firmware Platform | Yes | Yes | Both the application
software and firmware
have been updated to
accommodate minor
improvements for the
charging dock and
battery pack elements. |
| Hardware control | Yes | Yes | Same |
| Monitored
parameters | Power,
Time,
Reuse status,
Applicator connected
Reflected power
Now includes; Battery
Charge | Power,
Time,
Reuse status,
Applicator connected
Reflected power | Battery charge indicator
has been added. When
a battery pack is
connected to swiftPro™
this section shows the
charge level of the
connected battery. |
| Display parameters | Set Power
(Unit 1-10)
Set Time/Treatment
Time (secs),
Settings Menu
Device Information
Screen Brightness
Selection
Auto/Manual Mode
Selection
Set Time and Date
Recall Treatment Menu | Set Power
(Unit 1-10)
Set Time/Treatment
Time (secs),
Settings Menu
Device Information
Screen Brightness
Selection
Auto/Manual Mode
Selection
Set Time and Date
Recall Treatment Menu | Identical |
| Manual or
automatic
setting | Manual or
Automatic can be
selected. | Manual or
Automatic can be
selected. | Identical |
| Operation Mode | PWM & fixed frequency | PWM & fixed frequency | Identical |
| Surface Applicator/
Antenna | Surface Applicator | Surface Applicator | Identical |
| Patient contact part
supplied sterile | No - Patient contact
parts supplied non-
sterile (disposable
applicator tips) | No - Patient contact
parts supplied non-
sterile (disposable
applicator tips) | Identical |
| Applicator/
Antenna Design | Ceramic waveguide
Disposable silicone
barrier | Ceramic waveguide
Disposable silicone
barrier | Identical |
| Applicator/
Antenna head Size | Applicator Tip
approximately 4 cm
x 3 cm
Silicone/Ceramic
contact face
6.7 mm diameter | Applicator Tip
approximately 4 cm
x 3 cm
Silicone/Ceramic
contact face
6.7 mm diameter | Identical |
| Applicator/
Antenna Use | Soft tissue coagulation | Soft tissue coagulation | Identical |
| Rigid shaft | Yes | Yes | Identical |
| Footswitch | No | No | Identical |
| Tissue Temp
monitoring | N/A | N/A | N/A |
| Max applicator
surface Temp (non-
active areas) | 42°C | 42°C | Identical |
| Operation
Procedure | Surface use | Surface use | Identical |
| Average energy
density of surface
application
(Area J/mm2) | 10 J/mm2
Set power level 10
Set time 1 Seconds
6J delivered | 10 J/mm2
Set power level 10
Set time 1 Seconds
6J delivered | Identical |
| Electrical 60601 &
EMC
Compliant | Yes | Yes | The additional
accessories comply with
the requirements of
electrical safety and IEC
60601. |
| IP Rating | IP20 | IP22 | Different, IP22 rating not
required for professional
healthcare facility. |
| Biocompatible | Yes | Yes | SWF-BAT01 swiftPro™
Battery Pack – is not
designed to come in
contact with patients. It's
made from the material
Cycoloy HC1204 HF
Resin, which is
biocompatible and the
same material used in
the hand-held
microwave generator &
Applicator Tip.
SWF-CHG01
SwiftPro TM Charging
Dock - is not designed
to come in contact with
patients. It's made from
the material Cycoloy
HC1204 HF
Resin, complies with
biocompatibility
standards ISO10993
and the same material
used in the hand-held
microwave 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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Image /page/12/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 curved line running through it. To the right of the oval is the word "emblation" in red and black letters. The "em" is in red, while the "blation" is in black.
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.