(90 days)
No
The device description and performance studies focus on the physical delivery of microwave energy and its effect on tissue, with no mention of AI/ML algorithms for analysis, decision-making, or control. The interface is described as "software free controlled" and relies on simple dial settings.
Yes
The device is intended for the coagulation of soft tissue during non-invasive procedures, which is a therapeutic function aimed at treating or alleviating a condition.
No
Explanation: The device is described as a system for "coagulation of soft tissue during non-invasive procedures" and "to effect thermal heating in the tissue" for the purpose of "coagulating (ablation) a predefined volume of tissue." These functions are therapeutic, not diagnostic.
No
The device description explicitly states that the system consists of a power generator, cable, applicator, and disposable tip, which are hardware components. It also mentions a "software free controlled interface" on the generator.
Based on the provided information, the Swift System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the "coagulation of soft tissue during non-invasive procedures." This describes a therapeutic action performed directly on the patient's tissue, not a test performed on a sample taken from the patient.
- Device Description: The device delivers microwave energy to heat and ablate tissue. This is a physical intervention, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information about a patient's condition.
The Swift System is a therapeutic device used for tissue ablation.
N/A
Intended Use / Indications for Use
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.
Product codes
NEY
Device Description
The Swift® System is a microwave-based system intended to delivery energy through a surface contact applicator into targeted soft tissue for the purpose of coagulating (ablation) a predefined volume of tissue. The Swift® System consists of a compact, lightweight power generator with a software free controlled interface, cable and applicator with a single use disposable tip. The generator is intended to generate microwave energy at a frequency of 8GHz, maximum output power of 20Watts, and the distal end of the applicator radiates the microwave energy to effect thermal heating in the tissue. A typical surface area would be around 5mm diameter but would depend on the power & time selected.
The Swift® System interface is extremely intuitive with only two dials requiring to be set which are; output power (watts) & treatment duration (seconds). The applicator/cable connection and the generator/cable connection have been designed to only be connected in a certain way with a single, simple connection mechanism. This prevents the possibility of system malfunction due to incorrect setup or confusion. While the Swift® applicator tip has been designed to prevent re-use and hence mitigate the possibility of cross-contamination should the device not been changed from patient to patient.
The Swift® System comprises of the following components:
- Swift® Generator
- Swift® Applicator handpiece ●
- . Swift® Applicator tip
- . Swift® Interconnect Cable
- . Swift® Footswitch (optional).
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)
Ex vivo and In Vivo testing
In the animal study conducted, 4 pigs underwent 11 treatments. There were no procedure related complications or premature deaths in this study. The safety and feasibility of the Swift® System were evaluated by macroscopic and histological evaluation of the treated tissue. The studies demonstrated that the Swift® System can safely create a thermal ablation similar to that which is constructed using other microwave devices.
In the in-vivo comparison studies between the subject Swift® System and the comparative predicate datasets from MTCS, DTS-LT, Accu20s, and Emprint, the Swift® System demonstrated a comparable trend in performance between the subject and the elected predicate example data. In terms of energy density this has been added to performance comparison relating to the predicate examples.
With reference to the IFU data for the MTCS and DTS-LT predicate systems the mean and range of energy densities (J/mm² and J/mm³) was compared with the ex-vivo test data across porcine muscle, liver and kidney tissues measured with the Swift® System. The Swift® System is able to deliver a marginally lower average area energy density in J/mm² than both the MTCS and DTS-LT systems; it also achieves a maximum area energy density less than both systems.
This suggests that the treatment performance of Swift® System in terms of average area energy density due to the utilisation of a higher frequency (8GHz) but lower power was comparable in terms of performance to that of the un-cooled MTCS which reported equivalent average energy densities.
The Swift® System also recorded lower average volumetric energy density that the cooled DTS-LT which reported higher energy densities possibly due to the impact of cooling reducing the effective ablation zone.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
October 18, 2018
Emblation Ltd Mairi Macfadyen Director of Regulatory & Quality Forrester Lodge, Inglewood Alloa. FK10 2HU United Kingom
Re: K181941
Trade/Device Name: Swift System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: NEY Dated: July 13, 2018 Received: July 20, 2018
Dear Mairi Macfadyen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
FDA
Long H. Chen -S 2018.10.18 09:36:56 -04'00'
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K181941
Device Name Swift System
Indications for Use (Describe)
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.
| 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) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the | |
| time to review instructions, search existing data sources, gather and maintain the data needed and complete | |
| and review the collection of information. Send comments regarding this burden estimate or any other aspect | |
| of this information collection, including suggestions for reducing this burden, to: | |
| Department of Health and Human Services | |
| Food and Drug Administration | |
| Office of Chief Information Officer | |
| Paperwork Reduction Act (PRA) Staff | |
| PRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of | |
| information unless it displays a currently valid OMB number." |
3
Image /page/3/Picture/1 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 black, with the "em" portion in red. The logo is simple and modern, with a focus on the company name.
510K Summary
I. SUBMITTER
Emblation Limited Forrester Lodge, Inglewood, Alloa, FK10 2HU, UK Phone: +44 (0) 1259 236 132 +44 (0) 1259 210 430 Fax:
Contact Person: Mairi MacFadyen Director of Regulatory and Quality
Date Prepared: October 17, 2018
II. DEVICE
| Name of Device: | Swift® 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: | Microwave Tissue Coagulation System (MTCS) |
|---|---|
| Common Name: | Microwave ablation system and accessories |
| 510K Number: | K072870 |
| Manufacturer: | Foundry Newco X, Inc |
| Trade Name: | DTS G2 System |
| Common Name: | Microwave ablation system and accessories |
| 510K Number: | K082819 |
| Manufacturer: | Miramar Lab, Inc |
| Trade Name: | Emprint Ablation System |
| Common Name: | Microwave ablation system and accessories |
| 510K Number: | K133821 |
| Manufacturer: | Covidien LLC |
| Reference Device | |
| Trade Name: | Miradry System MD4000 |
| Common Name: | Microwave ablation system and accessories |
| 510K Number: | K180396 |
| Manufacturer: | Miramar Lab, Inc |
4
Image /page/4/Picture/1 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 line running through it. To the right of the oval is the word "emblation" in red and black font. The "em" is in red, while the "blation" is in black.
IV. DEVICE DESCRIPTION
The Swift® System is a microwave-based system intended to delivery energy through a surface contact applicator into targeted soft tissue for the purpose of coagulating (ablation) a predefined volume of tissue. The Swift® System consists of a compact, lightweight power generator with a software free controlled interface, cable and applicator with a single use disposable tip. The generator is intended to generate microwave energy at a frequency of 8GHz, maximum output power of 20Watts, and the distal end of the applicator radiates the microwave energy to effect thermal heating in the tissue. A typical surface area would be around 5mm diameter but would depend on the power & time selected.
The Swift® System interface is extremely intuitive with only two dials requiring to be set which are; output power (watts) & treatment duration (seconds). The applicator/cable connection and the generator/cable connection have been designed to only be connected in a certain way with a single, simple connection mechanism. This prevents the possibility of system malfunction due to incorrect setup or confusion. While the Swift® applicator tip has been designed to prevent re-use and hence mitigate the possibility of cross-contamination should the device not been changed from patient to patient.
The Swift® System comprises of the following components:
- Swift® Generator
- Swift® Applicator handpiece ●
- . Swift® Applicator tip
- . Swift® Interconnect Cable
- . Swift® Footswitch (optional).
V. INDICATIONS FOR USE
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.
Both the Swift® System and predicate devices have the same intended use for the coagulation of soft tissue. The Indications for Use statement for the Swift® System is not identical to the predicate devices; however, the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate.
5
Image /page/5/Picture/2 description: The image is a logo for a company called "emblation". The logo consists of a red oval shape with a stylized black and white "M" inside of it. To the right of the oval is the company name, with the "em" in red and the "blation" in black.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Microwave coagulation is the technological principle for both the Swift® System and predicate devices. 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 the size of the target area.
At a high level, the subject and predicate devices are based on the following same technological elements:
- . Applicator/antenna - used to treat the target tissue
- The subject and predicate devices share equivalent microwave feed network, o coaxial connectors, cabling and materials (Emprint)
- The subject and predicate devices share similar system architecture, medical PSU family/vendor, power regulation scheme, applicator identity technique (Emprint)
- The subject and predicate devices share similar hardware architecture, O materials, caseworks (Emprint)
- The subject and predicate devices share similar radiating antenna method, o ceramic dielectric waveguide (MTCS, DTS)
- The subject and predicate devices share similar applicator architecture, (MTCS, o DIS)
- User controlled ●
- The subject and predicate devices share similar control interfaces and similar alert features (Emprint)
- Software free
- o The subject and predicate devices share similar software free, hardware logic based control systems (Emprint)
The following technological differences exist between the Swift® System and predicate devices:
- Microwave frequency the subject and predicate devices differ in that the Swift® ● System operates at 8 GHz , the subject and predicate devices differ in that the MTCS/DTS treatment system operates at 2.45 GHz/ 5.8 GHz, the subject and predicate devices differ in that the Emprint operates at 2.45 GHz
- . Cooling
- o The Swift® System and predicate devices differ in that the Swift® System does not require cooling to apply a surface contact low power (10W) ablation.
- o The subject and predicate devices differ in that the MTCS/DTS requires cooling to apply a surface contact sub-dermal higher power treatment. (60W)
- The subject and predicate devices differ in that the Emprint system requires o cooling to deliver 100W via miniature coaxial structures for interstitial and percutaneous application
6
Image /page/6/Picture/1 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 text. The "em" is in red, while the "blation" is in black.
- Sterile ●
- o The Swift® applicator tip is provided as non-sterile and deemed equivalent in use to that of reference device, miraDry System MD4000, K180396. miraDry is a derivative of DTS G2 but includes a non-sterile bioTip.
- The Swift® applicator tip and predicate devices differ in that the predicates are O sterilised for interoperative and percutaneous applications.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination, using the same methods used for the predicate devices.
The biocompatibility evaluation was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The following tests were performed:
- Cytotoxicity ●
- Sensitization ●
- Irritation ●
- Systemic toxicity
- Hemolysis
Electrical safety and EMC testing were conducted and the Swift® System complies with all applicable Medical electrical equipment standards for safety and essential performance as follows;
Ex vivo and In Vivo testing
In the animal study conducted, 4 pigs underwent 11 treatments. There were no procedure related complications or premature deaths in this study. The safety and feasibility of the Swift® System were evaluated by macroscopic and histological evaluation of the treated tissue. The studies demonstrated that the Swift® System can safely create a thermal ablation similar to that which is constructed using other microwave devices.
In the in-vivo comparison studies between the subject Swift® System and the comparative predicate datasets from MTCS, DTS-LT, Accu20s, and Emprint, the Swift® System demonstrated a comparable trend in performance between the subject and the elected predicate example data. In terms of energy density this has been added to performance comparison relating to the predicate examples.
With reference to the IFU data for the MTCS and DTS-LT predicate systems the mean and range of energy densities (J/mm² and J/mm³) was compared with the ex-vivo test data across porcine muscle, liver and kidney tissues measured with the Swift® System. The Swift® System is able to deliver a marginally lower average area energy density in J/mm² than both the
7
Image /page/7/Picture/1 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. 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.
MTCS and DTS-LT systems; it also achieves a maximum area energy density less than both systems.
This suggests that the treatment performance of Swift® System in terms of average area energy density due to the utilisation of a higher frequency (8GHz) but lower power was comparable in terms of performance to that of the un-cooled MTCS which reported equivalent average energy densities.
The Swift® System also recorded lower average volumetric energy density that the cooled DTS-LT which reported higher energy densities possibly due to the impact of cooling reducing the effective ablation zone.
VIII. CONCLUSIONS
No new characteristics have been determined that could impact performance, safety or effectiveness compared to the predicate examples and it can be concluded that the Swift® System is equivalent in terms to the nominated predicate devices.