(269 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on basic microwave energy delivery and control, not complex algorithmic processing.
Yes.
The device is intended for the coagulation of soft tissue, which is a therapeutic intervention.
No
The device description clearly states its purpose is for "coagulation of soft tissue during non-invasive procedures" and it is a "hand-held microwave generator intended to provide the functionality of the Swift® microwave treatment system." This indicates a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "hand-held microwave generator" and includes physical components like a generator, applicator tip assembly, cradle, and applicator tips. It also details hardware-related testing like biocompatibility, electrical safety, EMC, and bench testing. While it contains embedded software, it is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "coagulation of soft tissue during non-invasive procedures." This describes a therapeutic action performed directly on the patient's tissue.
- Device Description: The device is a "hand-held microwave generator" that delivers "microwave energy to the tissue to effect thermal heating." This is a physical intervention on the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on samples.
The device is a therapeutic medical device that uses microwave energy for tissue coagulation.
N/A
Intended Use / Indications for Use
The swiftProTM System is a surface based device intended for the coagulation of soft tissue during non-invasive procedures.
The swiftProTM System is not indicated for use in cardiac procedures.
Product codes (comma separated list FDA assigned to the subject device)
NEY
Device Description
The swiftPro® system is a hand-held microwave generator intended to provide the functionality of the Swift® microwave treatment system in a compact and portable package. The system comprises a hand-held microwave generator and an applicator tip assembly. The generator produces microwave energy at a frequency of 8 GHz with a maximum output power of 6 Watts, the output power is restricted depending on the applicator tip attached, which delivers the microwave energy to the tissue to effect thermal heating, The swiftPro® System interface is intuitive with a quick setup for setting treatment; output power level & treatment duration (seconds). The applicator tip and the handheld generator have been designed to be only connected in a certain way with a single, simple connection mechanism. This prevents the possibility of system malfunction due to incorrect setup or confusion. The SwiftPro® applicator tips have been designed to prevent re-use to mitigate the risk of cross-contamination.
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)
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: The applicator tips were subject to biocompatibility testing, the swiftPro® System uses the same type of applicator tip as the predicate and the following Biocompatibility tests were completed in accordance with ISO10993: Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process:
- · Cytotoxicity
- · Sensitisation
- · Irritation
- · Systemic toxicity
- · Pvrogenicitv
Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted and the swiftPro® system complies with all the applicable Medical electrical equipment standards for safety and essential performance.
Software Verification and Validation Testing: The swiftPro® System includes embedded software which has been developed for use with an STM32 device, which incorporates a 32-bit ARM Cortex-M4 microcontroller. The embedded software produced for the swiftProTM System includes source code, object files, executable load images, and all software documentation required for compliance with IEC 62304:2006 (AMD1: 2015) and FDA quidance for software contained in medical devices.
Cybersecurity: Throughout the lifecycle of the product, an assessment to mitigate cybersecurity vulnerabilities has been completed. The following have been documented:
- Software Bill of Materials ●
- Threat Modelling ●
- . Total Product Lifecycle
- Security Architecture
- . Cybersecurity Testing
- . Labelling
Human Factors and Usability Engineering: The swiftPro® system complies with all the applicable reguirements 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: Equivalence bench testing, including ex-vivo, within a common subset of settings has been performed to assess the common performance equivalence of the swiftPro® handheld system in comparison to the predicate device (K181941). The bench testing proves the swiftPro® System performs substantially equivalent to the predicate device.
- Thermal effects analysis in ex-vivo porcine skin .
- Thermal effects analysis in ex-vivo bovine liver, porcine kidney and porcine muscle ●
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 4, 2023
Emblation Ltd. % Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030-0172
Re: K222388
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: April 3, 2023 Received: April 4, 2023
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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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,
Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.05.04 08:54:38 -04'00'
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222388
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 swiftProTM 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/3/Picture/0 description: The image shows the logo for "emblation". The logo consists of a red oval shape with a white and black wave-like design inside it. To the right of the oval is the word "emblation" in black letters, with the "em" in red.
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 Forrester Lodge. Inalewood Alloa, FK10 2HU, UK Phone: +44(0) 1259 236 132 Fax: +44(0) 1259 210 430
Contact Person: Mairi MacFayden Chief Requlatory Officer
Date Prepared: May 2, 2023
II. DEVICE
| Name of Device: | swiftPro® System |
|---|---|
| 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
| Trade Name: | Swift® System |
|---|---|
| Common Name: | Microwave ablation system and accessories |
| 510(k) Number: | K181941 |
| Manufacturer: | Emblation Limited |
| Regulatory Class: | II |
| Product Code: | NEY |
This predicate has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The swiftPro® system is the subject of this application and is substantially equivalent to the device described and cleared in K181941, the subject device is an all-encompassing version of the Swift® System.
The swiftPro® system is a hand-held microwave generator intended to provide the functionality of the Swift® microwave treatment system in a compact and portable package. The system comprises a hand-held microwave generator and an applicator tip assembly. The generator produces microwave energy at a frequency of 8 GHz with a maximum output power of 6 Watts, the output power is restricted depending on the applicator tip attached, which delivers the microwave energy to the tissue to effect thermal heating, The swiftPro® System interface is intuitive with a quick setup for setting treatment; output power level & treatment duration (seconds). The applicator tip and the handheld generator have been designed to be only connected in a certain way with a single, simple connection mechanism. This prevents the possibility of system malfunction due to incorrect setup or confusion. The SwiftPro® applicator tips have been designed to prevent re-use to mitigate the risk of cross-contamination.
4
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 stylized "e" inside. The "e" is made up of a white and black line. To the right of the oval is the word "emblation" in black font.
The SwiftPro® system compromises of the following components:
- SwiftPro® Handheld Generator
- · SwiftPro® Cradle
- · SwiftPro® URT Applicator tip (non-sterile, single use)
- · SwiftPro® LRT Applicator tip (non-sterile, single use)
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
Microwave coagulation is the technological principle for both the swiftPro® System and predicate device. It is based on the use of microwave energy for the coagulation of soft tissue, where the user has the ability to select the desired power and time limits based on size of the target area.
The technological characteristics are the same regarding frequency and magnitude of microwave energy delivered to a target tissue through the existing applicator/antenna design as used in the existing Swift® System (predicate) in a controlled manner for the purpose of coagulation of soft tissue. The main differences relate to the addition of FPGA firmware and a software user interface which replicates the core experience (treatment power/time settings and a single button to enable/disable energy deposition) of using the existing Swift device.
The operation of the swiftPro® user interface is controlled via device-embedded software, responsible for handling user inputs and providing system status indications. Microwave control and functionality and system safety is provided by firmware. Both the application software and firmware are installed on devices located on the System Controller Module (microcontroller IC and FPGA respectively). However, both the subject device and predicate have hardware or firmware (FPGA) based safety controls, the addition of software controls relates purely to improve user experience.
The predicate device operation is controlled by a digital logic state machine which, by its nature, requires a high number of components to implement for this approach to be capable of providing the level of functionality required. This component count requires a number of large PCBAs - and interconnecting components - to support, and therefore results in a larqe system footprint and high cost.
The swiftPro® system replicates this functionality through use of embedded software, significantly reducing the system real estate consumed by PCBAs and their peripherals and allows for a high degree of compact integration in the system architecture. The inclusion of software within the design also permits the system functionality to be enhanced, and results in further streamlining of the system by permitting a graphical user interface (GUI) to be implemented, removing the need for discrete LED indicators as present in the Swift® system. The GUI has been designed to replicate the experience of using the existing swift® device.
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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 with a white and black wave-like design inside, followed by the word "emblation" in red and black letters. The "em" part of the word is in red, while the "blation" part is in black.
SwiftPro® Handheld Generator Treatment System
The swiftPro® handheld generator is constructed from control PC-ABSs which are the same biocompatible materials as the applicator tip with an integrated user interface. Includes functional indicators, display auditory feedback, and programmable system control capability. The handheld generates microwave power up to 6W using hardware controlled internally requlated microwave source. The output signal from the SwiftPro™ generator is provided by the integrated user interface. The output power can be varied from 1W increments to 6W using pulse width modulation (PWM) techniques. This provides regulated microwave energy at a central frequency of 8GHz and provides real-time reflected power monitoring which ensures that the treatment is progressing as normal and that the handheld generator is performing as expected.
The swiftPro® System does not require a handpiece or cable to operate as it is an all-encompassing device and this is the main reason for the device weighing less and smaller than the predicate device. The design is different from the predicate device but the differences do not affect the fundamental principles of technology.
SwiftPro® Applicator Tip
The swiftPro® Applicator tip is identical to the predicate in design and materials used. There are no technological differences. The swiftPro® Applicator Tips are mechanically, physically, and electricaly identical to the Swift® SWF-AT01 Applicator Tip, differing only in the value of resistor fitted to their (internal) PCBA which denotes the Tip DUID.
| Device
Feature | swiftPro® System | Swift® System
(Predicate) | Comments |
|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Regulation
21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 | Same |
| Product Code | NEY | NEY | Same |
| 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. | The Swift® System is a surface-based
device intended for the coagulation of
soft tissue during non-invasive
procedures.
The Swift® System is not indicated
for use in cardiac procedures. | Same |
| Dimensions
Width x Height x Depth | 245x75x135mm
(10x3x5.3 inch) | 300x90x300mm
(11.8x3.5x11.8 inch) | Different, the subject
device is smaller |
| Weight | Less than 0.75kg (~1.65lbs) | Less than 4.5kg (~10 lbs) | Different, the subject
device is lighter |
| Material | Enclosure Material:
Handpiece - ABS/PC CYCOLOY™
Resin HC1204HF
Tip material: ABS/PC CYCOLOY™
Resin HC1204HF
Biobarrier material – SILPURAN®
6000/70 Liquid Silicone Rubber | Enclosure Material:
Handpiece - ABS/PC CYCOLOY™
Resin HC1204HF
Generator - Aluminium
Interconnect Cable- Silicone Rubber
TEKBOND TB1723
Tip material - ABS/PC CYCOLOY™
Resin HC1204HF
Biobarrier material - SILPURAN®
6000/70 Liquid Silicone Rubber | Different but as detailed
where there is analogy
between the devices
they are constructed
from the same material |
| Power Supply | 24Vdc | 90-645Vac | Different, the subject
device requires lower
power and can use a
low voltage dc adaptor |
| Generator | Yes | Yes | Same |
| Energy | Microwave | Microwave | Same |
| Microwave Output
Frequency | 8 GHz | 8 GHz | Same |
| Maximum Microwave
Power | 0-10 in 1power level increments =
treatment,
6W = Generator
Tip ATO2 restricts delivered energy to | 0-10W in 1W increments =
treatment,
20W = Generator
Tip ATO1 restricts delivered energy to | Different, but as
detailed swiftPro®
performs within the
equivalent AT01
(predicate) output |
| level setting on generator of 10) | generator setting) | range. | |
| Time settings | 0-10 secs | 0-10 secs | Same |
| Coagulation cycle | Maximum 15 minutes but treatment
dependant & limited by applicator
tips (AT02 and AT03). | Maximum 15 mins but treatment
dependant & limited by applicator
(AT01). | Different, two tip (AT02
and AT03) options to
segregate energy
delivery. |
| Shut Offs/
Alarms | Alerts:
MSM overtemp, Expired tip, No
applicator detected, Reflection,
Manual Switch Status System error,
SD Card Error, Service error | Alerts:
MSM overtemp, Expired tip, No
applicator detected, Reflection,
Continuous wave/Swept
Manual Switch Status System error | Existing alerts &
descriptive Icons have
been reused. Additional
alerts have been
incorporated into
swiftPro® System for
expanded functionality. |
| Software/
Firmware Platform | Yes | No | Addition of FPGA
firmware and a
software user interface |
| Hardware control | Yes | Yes | Same, implemented in
FPGA firmware |
| Monitored parameters | Power, Time, Reuse status,
Applicator connected
Reflected power | Power, Time, Reuse status,
Applicator connected
Reflected power | Expanded parameters
based on additional
system functions. |
| Display parameters | Set Power (1-10 units)
Set Time/Treatment Time (secs),
Settings Menu
Alerts
Device Information
Screen Brightness Selection
Auto/Manual Mode Selection
Set Time and Date
Recall Treatment Menu | Set Power (1 -10 Watts)
Set Time/Treatment Time
(mins/secs),
Actual power delivered (% of set),
Alerts | Different due to power
setting unit change but
having equivalent
output.
As with the predicate
device, the system
monitors its own
applied and reflected
power and will display
an alert in the event of
a trip. |
| Manual or automatic
setting | Manual or
Automatic can be selected. | Manual or
Automatic, via (footswitch) can be
selected. | Same, excludes
footswitch as was never
utilised in the market |
| Operation Mode | PWM & fixed frequency | PWM/& Swept | Different due to fixed
frequency |
| Surface Applicator/
Antenna | Surface
Applicator | Surface
Applicator | Same |
| Patient contact part
supplied sterile: | Non-sterile
disposable applicator tip | Non-sterile
disposable applicator tip | Same |
| Applicator/
Antenna Design | Ceramic waveguide
Disposable silicone barrier | Ceramic waveguide
Disposable silicone barrier | Same |
| 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
Cable constructed of coaxial cable
Handpiece approximately 12 cm x 3
cm | Same Applicator/
Antenna head size but
system no longer
incorporates a separate
handpiece and
interconnect cable |
| Max applicator surface
Temp (non-active
areas) | 42°C | 42°C | Same |
| Operation Procedure | Surface use | Surface use | Same |
| 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 10W
Set time 1 Seconds
10J set, 6J delivered | Same (in terms of
energy delivered) |
Comparison Table
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Image /page/6/Picture/0 description: The image contains 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 black and white design inside. The design is a curved line that starts at the top of the circle and ends at the bottom.
7
Image /page/7/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 lettering. The "embla" part of the word is in red, while the "tion" part is 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
The applicator tips were subject to biocompatibility testing, the swiftPro® System uses the same type of applicator tip as the predicate and the following Biocompatibility tests were completed in accordance with ISO10993: Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process:
- · Cytotoxicity
- · Sensitisation
- · Irritation
- · Systemic toxicity
- · Pvrogenicitv
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted and the swiftPro® system complies 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 60601-1-11:2015 Medical electrical equipment – Part1-11: General requirements for basic safety and essential performance – Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- IEC 60601-2-6: 2012 + AMD1:2016 Medical electric equipment Part 2: Particular reguirements 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.
Software Verification and Validation Testing
The swiftPro® System includes embedded software which has been developed for use with an STM32 device, which incorporates a 32-bit ARM Cortex-M4 microcontroller. The embedded software produced for the swiftPro™ System includes source code, object files, executable load images, and all software documentation required for compliance with IEC 62304:2006 (AMD1: 2015) and FDA quidance for software contained in medical devices.
Cybersecurity
The swiftPro® system is not intended to be used as a networked medical device, nor does it contain any offthe-shelf (OTS) software to support connection to a private or public internet. The device does not incorporate an OTS operating system or OTS software/drivers which supported hard-wired or wireless network connections. Throughout the lifecycle of the product, an assessment to mitigate cybersecurity vulnerabilities has been completed. The following have been documented:
- Software Bill of Materials ●
- Threat Modelling ●
- . Total Product Lifecycle
- Security Architecture
- . Cybersecurity Testing
- . Labelling
8
Image /page/8/Picture/0 description: The image is a logo for a company called "emblation". The logo consists of a red oval shape with a stylized "e" inside of it. The "e" is made up of two curved lines, one black and one white. The word "emblation" is written in black letters to the right of the oval shape. The font is sans-serif and the letters are all lowercase.
Human Factors and Usability Engineering
The swiftPro® system complies with all the applicable reguirements 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
Equivalence bench testing, including ex-vivo, within a common subset of settings has been performed to assess the common performance equivalence of the swiftPro® handheld system in comparison to the predicate device (K181941). The bench testing proves the swiftPro® System performs substantially equivalent to the predicate device.
- Thermal effects analysis in ex-vivo porcine skin .
- Thermal effects analysis in ex-vivo bovine liver, porcine kidney and porcine muscle ●
VIII. CONCLUSIONS
The difference between the subject device (swiftPro® System) and the predicate device (Swift® System) technological characteristics do not raise any new or different questions regarding safety and effectiveness. The performance testing demonstrates the subject device is as safe and effective as the predicate device as indicated for use.