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510(k) Data Aggregation
(151 days)
swiftPro System (SWF-SPS); Swift System (SWF-SYS)
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 genital warts or cardiac procedures.
Specific Indication: Treatment of Common and Plantar Warts.
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 genital warts or cardiac procedures.
Specific Indication: Treatment of Common and Plantar Warts.
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 pre-defined volume of tissue. The Swift™ System serves as a predicate device to the swiftPro™ System, which was originally cleared under 510(k) K222388. The swiftPro™ System is a handheld microwave generator designed to provide the same functionality as the Swift™ System in a more compact package.
The Swift™ System (SWF-SYS) consists of the following components:
- Swift™ Microwave Generator (SWF-GE01)
- Swift™ Applicator Handpiece (SWF-HP01)
- Swift™ Interconnect Cable (SWF-CA01)
- Swift™ Applicator Tip (SWF-AT01)
The Swift™ System was previously cleared under 510(k) K181941.
The swiftPro™ System (SWF-SPS) consists of the following components:
- swiftPro™ Handheld Microwave Generator (SWF-HAN01)
- swiftPro™ DC Power Cable (SWF-DCA01)
- swiftPro™ Cradle (SWF-CRA01)
- swiftPro™ Applicator Tips (SWF-AT02, SWF-AT03)
The swiftPro™ System was initially cleared under 510(k) K222388 and subsequently received updated clearance under K240518 to include the swiftPro™ Charging Dock (SWF-CHA01) and Battery Pack (SWF-BAT01) for cordless operation.
There have been no modifications to the design, principles of operation, or materials used in the Swift™ and swiftPro™ Systems. The clinical functionality of delivering treatment remains unchanged.
Here's an analysis of the provided information regarding the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details a non-inferiority clinical study comparing the Swift™ System to cryotherapy for the treatment of common and plantar warts. The primary effectiveness endpoint was "Clearance of all treated warts, each of which is defined as "resolved" or "not resolved" based on the classification by the blinded site investigator assessing the treated warts at three months post final treatment (up to 5 warts in total per subject)."
The acceptance criteria for non-inferiority are not explicitly stated as a numerical threshold (e.g., "non-inferiority margin of X%"). Instead, the study's goal was to demonstrate that the Swift System was not worse than cryotherapy by a significant amount. However, the study failed to meet its primary endpoint for non-inferiority due to insufficient data. Despite this, the effectiveness results were very close, and safety data was favorable for the Swift System.
Given the information, we can construct the following table for effectiveness:
| Acceptance Criteria (Effectiveness - Implied from Non-Inferiority Study) | Reported Device Performance (Swift System) | Reported Performance (Cryotherapy - Comparator) |
|---|---|---|
| Non-inferiority to cryotherapy in clearance of all treated warts at 3 months post final treatment. | 38.8% clearance rate | 38.6% clearance rate |
| Conclusion on Effectiveness: | The analysis showed that the primary endpoint for non-inferiority was inconclusive (p=0.158). From a statistical perspective, there was insufficient data to conclude non-inferiority. From a clinical perspective, the response rates were nearly identical. |
Safety Acceptance Criteria and Performance (Implicit - reasonable assurance of safety)
The document primarily highlights the safety profile of the Swift System compared to cryotherapy. The implicit acceptance criterion would be a reasonable assurance of safety, with no serious adverse events and a comparable or better safety profile than the predicate.
| Acceptance Criteria (Safety - Implicit) | Reported Device Performance (Swift System) | Reported Performance (Cryotherapy - Comparator) |
|---|---|---|
| No serious adverse events related to the device. | No serious adverse events reported. | N/A (no serious adverse events related to Cryotherapy device mentioned) |
| Safety profile comparable to or better than the predicate/gold standard. | Fewer reported adverse events overall (~40% vs ~60%). Significantly larger proportion of subjects reported zero adverse events (18% vs 3%). Lower incidence of specific adverse events (pain, blistering, pruritus, paraesthesia, discoloration, hypersensitivity). Less post-treatment pain. | Higher reported adverse events overall (~60%). Lower proportion of subjects reported zero adverse events (3%). Higher incidence of specific adverse events. More post-treatment pain. |
| No new risks identified that have not been previously considered or assessed. | No new risks identified. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Randomized subjects: 119
- Evaluable Per Protocol Population (for primary endpoint): 93 subjects (49 in Swift System group, 44 in cryotherapy group)
- Data Provenance:
- Country of Origin: US
- Retrospective or Prospective: Prospective (Randomized, multi-site, open, parallel-group, controlled, blind-assessed clinical study).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document states "blinded site investigator assessing the treated warts." The number of investigators and their specific qualifications (e.g., dermatologists, years of experience) are not specified in this summary.
4. Adjudication Method for the Test Set
The primary endpoint involved assessment by a "blinded site investigator." There is no explicit mention of an adjudication method (e.g., 2+1, 3+1 consensus) if there were disagreements among investigators, or if multiple investigators were used per patient. The phrasing "blinded site investigator" suggests a single investigator making the assessment at each site, blind to the treatment arm.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This was a comparative clinical trial involving a device and a standard-of-care treatment, not an imaging-based "reader" study for diagnostic performance. Therefore, an effect size of human readers improving with AI vs. without AI assistance is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. The device itself is a microwave ablation system, not an AI/software algorithm for diagnosis or interpretation. The clinical study evaluated the device's therapeutic effect with human operators.
7. The Type of Ground Truth Used
The ground truth for the primary effectiveness endpoint was based on a clinical assessment by a blinded site investigator, using specific criteria:
- lesion no longer visible, and
- return of dermatoglyphics to the affected area, and
- no pain on lateral compression.
This is a form of expert clinical assessment/consensus based on predefined objective and subjective criteria.
8. The Sample Size for the Training Set
The document describes a single pivotal clinical study to support the expanded indication. This study is the dataset used to evaluate the device against the expanded indication. There is no mention of a separate training set for an algorithm, as this is a physical device, not an AI algorithm requiring a training phase in the context of this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
As there is no explicit training set for an algorithm mentioned in this summary, the question of how its ground truth was established is not applicable in this context. The clinical study described served as the primary evidence for the device's safety and effectiveness for its intended use.
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(90 days)
Swift System
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.
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).
The provided document describes the Swift System, a microwave-based device for coagulating soft tissue. The document focuses on establishing substantial equivalence to predicate devices for FDA 510(k) clearance rather than detailing specific acceptance criteria and a study proving device performance against those criteria in a typical AI/ML medical device context.
Based on the provided text, there is no information about:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set or its provenance for proving performance against specific criteria.
- Number of experts, their qualifications, or adjudication methods for establishing ground truth for a test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size of AI assistance on human readers.
- Standalone (algorithm-only) performance.
- The type of ground truth used (expert consensus, pathology, outcomes data in an AI/ML context).
- Sample size for a training set in an AI/ML context.
- How ground truth for a training set was established in an AI/ML context.
The document focuses on the following types of performance data to support substantial equivalence:
1. Biocompatibility Evaluation:
- Acceptance Criteria (Implied): Compliance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1.
- Study: Tests performed included Cytotoxicity, Sensitization, Irritation, Systemic toxicity, and Hemolysis.
- Results: The Swift System complies with these standards, implying it meets biological safety requirements.
2. Electrical Safety and EMC Testing:
- Acceptance Criteria (Implied): Compliance with applicable Medical electrical equipment standards for safety and essential performance.
- Study: Electrical safety and EMC testing were conducted.
- Results: The Swift System complies with all applicable standards.
3. Ex Vivo and In Vivo Testing:
- Acceptance Criteria (Implied): Demonstrate safe creation of thermal ablation similar to predicate devices. Comparable or lower average area and volumetric energy density compared to predicate devices for effective tissue coagulation.
- Study (Animal Study):
- Sample Size: 4 pigs underwent 11 treatments.
- Ground Truth/Evaluation: Macroscopic and histological evaluation of treated tissue.
- Results: No procedure-related complications or premature deaths. Demonstrated that the Swift System can safely create a thermal ablation similar to that constructed using other microwave devices.
- Study (In-vivo comparison studies):
- Comparison: Compared Swift System performance with "comparative predicate datasets" from MTCS, DTS-LT, Accu20s, and Emprint.
- Metrics: Mean and range of energy densities (J/mm² and J/mm³) were compared across porcine muscle, liver, and kidney tissues.
- Results: The Swift System demonstrated a comparable trend in performance to the predicate examples. It delivered a marginally lower average area energy density (J/mm²) than MTCS and DTS-LT and achieved a maximum area energy density less than both systems. It also recorded lower average volumetric energy density than the cooled DTS-LT. This suggested comparable performance.
Conclusion stated in the document: "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."
In summary, the provided text does not contain the specific details requested for acceptance criteria and study design as they would typically apply to an AI/ML device in the modern regulatory context (e.g., ground truth establishment, expert review, MRMC studies). The document describes typical premarket testing for an electrosurgical device to demonstrate substantial equivalence to predicates.
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