(291 days)
The PEAK PlasmaBlade TnA Tonsil and Adenoid Tissue Dissection Device is indicated for cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including adenoidectomy and tonsillectomy (Pharyngeal, Tubal, Palatine).
The PEAK PlasmaBlade® TnA is a single-use, disposable, electrosurgical instrument consisting of two PlasmaBlade tips (Tonsil tip and Adenoid tip) designed to be attached to the PlasmaBlade ENT handpiece (cleared as the PEAK PlasmaBlade TnA handpiece via K083415). The device also includes a wire cleaning brush designed to remove eschar build up and maintain a clear channel for suction.
The Adenoid Tip consists of a wire electrode housed in a plastic tip with a bendable suction lumen that allows for the evacuation of tissue, fluids, and smoke. It connects to the suction shaft of the handpiece.
These device is used with PULSAR I (K073057), PULSAR II (K102029) and AEX (K143175) Electrosurgical Generators. It provides radio-frequency energy for cutting and coagulation of soft tissue. The PEAK PlasmaBlade ENT handpiece has integrated buttons for Cut and Coag, which may be used to operate the device, or it may be activated with an optional footswitch supplied with the Generators.
This FDA document is a 510(k) summary for the Medtronic PEAK PlasmaBlade TnA Tonsil and Adenoid Tissue Dissection Device. It describes the device, its intended use, and substantial equivalence to predicate devices, supported by non-clinical testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text.
Acceptance Criteria and Device Performance (as implied by the document):
The document does not explicitly state "acceptance criteria" in a quantitative table format with specified thresholds. Instead, it relies on demonstrating substantial equivalence to predicate devices. The implicit acceptance criteria are that the modifications to the device (specifically the Adenoid Tip) do not raise new issues of safety or effectiveness compared to the predicate devices.
The reported device performance is that it is "substantially equivalent" to predicate devices. The summary claims this equivalence based on characteristics, intended use, technology, and non-clinical testing.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| No new issues of safety raised | Confirmed through bench and pre-clinical testing that different technological characteristics do not raise new issues of safety or effectiveness. |
| No new issues of effectiveness raised | Confirmed through bench and pre-clinical testing that different technological characteristics do not raise new issues of safety or effectiveness. |
| Equivalent thermal effect | Comparative performance testing in an in-vivo animal model showed the thermal effect of the PEAK PlasmaBlade Adenoid Tip was substantially equivalent to the predicate device. |
| Functions for intended use | Designed for cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including adenoidectomy and tonsillectomy, similar to predicate. |
Study Details:
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "comparative performance testing conducted in an in-vivo animal model." It doesn't specify the number of animals or trials.
- Data Provenance: The "in-vivo animal model" suggests animal data, likely pre-clinical, rather than human clinical data. The location of the testing (country of origin) is not mentioned. It is a prospective study as it was conducted to verify and validate the modified device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was an in-vivo animal model study focused on thermal effects, not an expert-based clinical review or diagnostic accuracy study which would typically involve expert consensus. The "ground truth" here would relate to measurements of thermal tissue damage, which would be objectively measured using scientific methods.
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Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical imaging or diagnostic studies. For an in-vivo animal study measuring thermal effects, the "ground truth" would be determined by direct physical or biological measurements.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
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No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required for this product." MRMC studies typically involve human readers interpreting cases to assess diagnostic performance or impact on clinical decision-making.
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Effect size of human readers improvement: Not applicable, as no MRMC study was performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is a medical device for surgical intervention (electrosurgical instrument). The concept of "standalone algorithm performance" typically applies to AI/software as a medical device (SaMD) for diagnostic or predictive purposes. For an electrosurgical instrument, its performance is inherently "standalone" in mechanical/electrical function, but it always operates with a surgeon (human-in-the-loop). The non-clinical and pre-clinical testing assesses the device's physical performance characteristics (e.g., cutting, coagulation, thermal effect) independent of human variability in interpretation, but not in a "standalone algorithm" sense.
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The type of ground truth used:
- For the in-vivo animal model, the "ground truth" for comparative thermal effect likely involved direct measurement or histological assessment of tissue damage (e.g., depth of necrosis, adjacent tissue effects) caused by the device and the predicate device. For bench testing, it would involve objective physical measurements (e.g., power output, temperature, tissue cutting characteristics).
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The sample size for the training set:
- Not applicable. This device is a physical electrosurgical instrument, not an AI/machine learning algorithm that requires a "training set" of data.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
§ 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.