(43 days)
The PlasmaBlade T is a monopolar, single use, sterile, disposable device intended for use with the AEX Generator. The device delivers RF energy concurrent with saling and coagulation of soft tissue and bone and RF energy for cutting and coagulation of soft tissue. It is intended for, but not limited to. General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal, Thoracic, and Open abdominal surgery procedures.
The PlasmaBlade T should not be used on small appendages or body parts, as in circumcision. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
The proposed single-use disposable accessory device, the PlasmaBlade T monopolar handpiece, provides the hemostatic capabilities of the Aquamantys SBS 5.0 Handpiece (Cleared under K111732, K132974) and the cutting and coagulative capabilities of the PEAK PlasmaBlade 3.0S (Previously cleared under K093695).
The proposed PlasmaBlade T Handpiece device is a monopolar, single use, disposable device and is provided sterile. The devices are not intended for reuse or resterilization. The PlasmaBlade T handpiece consists of an enamel coated insulated blade electrode with an uncoated circular electrode, an insulated telescoping shaft, handle with three integrated controls, and a co-extruded cable assembly to provide both power and saline. The seven-pin electrical connector is designed to be plugged into the AEx Generator (Cleared under K143175).
The proposed PlasmaBlade T Handpiece is a disposable device, that when connected to the AEX Generator (K143175), uses monopolar RF energy for the resection and coagulation of soft tissue and bone. The proposed PlasmaBlade T Handpiece device provides similar resection and coagulative effect to the predicate device, the PlasmaBlade 3.0S Monopolar Handpiece (Cleared under K093695).
In addition to the monopolar cutting and coagulation capabilities the proposed PlasmaBlade T Handpiece device also uses monopolar RF energy concurrent with saline delivery to provide a broader coagulative effect; similar to the predicate Aquamantys SBS 5.0 Handpiece (Cleared under K111732, K132974), this result is trademarked as Transcollation® Technology by Medtronic. The proposed PlasmaBlade T Handpiece device also has a pump header tubing segment and saline bag spike tubing allowing the user to manually connect the device to saline source in the OR as well as the AEX Generator's peristaltic pump. This ensures the device is connected for saline delivery at the same time as the device is connected electrically to the proposed AEX Generator.
This document describes a 510(k) premarket notification for the PlasmaBlade T device, an electrosurgical cutting and coagulation device. The information provided focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:
Key Takeaway: The provided document is a 510(k) submission, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving a novel device meets specific (and often more stringent) acceptance criteria through exhaustive clinical trials typically associated with a "new" device. For 510(k)s, "acceptance criteria" are generally tied to showing that the new device performs as safely and effectively as the predicate, often through a combination of bench testing and, sometimes, animal studies. Clinical trials (human studies) are usually not required for 510(k)s unless there are significant differences in technology or indications from the predicate that raise new questions of safety or effectiveness.
Based on the information, here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a formal table of quantitative acceptance criteria with corresponding performance metrics like one might see for an AI-driven diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate devices through various non-clinical tests.
| Acceptance Criterion (Implicitly Met) | Reported Device Performance (Summary of Evidence) |
|---|---|
| Functional Equivalence: Device performs as intended for cutting and coagulation of soft tissue/bone and hemostatic sealing with saline. | The PlasmaBlade T monopolar handpiece provides: |
- "hemostatic capabilities of the Aquamantys SBS 5.0 Handpiece" (Predicate K111732, K132974)
- "cutting and coagulative capabilities of the PEAK PlasmaBlade 3.0S" (Predicate K093695).
"The proposed PlasmaBlade T Handpiece device provides similar resection and coagulative effect to the predicate device, the PlasmaBlade 3.0S Monopolar Handpiece."
"The proposed PlasmaBlade T Handpiece device also uses monopolar RF energy concurrent with saline delivery to provide a broader coagulative effect; similar to the predicate Aquamantys SBS 5.0 Handpiece." |
| Similar Tissue Effect (Safety): The thermal damage profile imparted on tissue is comparable to predicate devices. | "The in-vivo testing determined the zone of thermal damage imparted on the tissue by the proposed devices was comparable to the predicates." |
| Biocompatibility: Device materials are suitable for contact with tissue. | "Biocompatibility" testing was conducted and passed. (No specific performance data given, but implied acceptance by passing this test). |
| Sterilization Efficacy: The device can be effectively sterilized. | "Sterilization" testing was conducted and passed. |
| Electrical Safety/Electromagnetic Compatibility (EMC): The device meets electrical safety and EMC standards. | "Electrical Safety/EMC" testing was conducted and passed. |
| Mechanical Integrity/Durability: The device maintains its mechanical integrity through transit, shelf life, and during use. | "Transit," "Shelf Life," "Mechanical Testing," and "Activation Testing" were conducted and passed. |
Study Type: Non-Clinical Performance Testing (Bench and Animal) to demonstrate substantial equivalence.
2. Sample Size and Data Provenance for the Test Set:
- Sample Size: The document does not specify exact sample sizes for each type of bench testing (e.g., number of devices tested for sterilization, number of cycles for activation testing). For the in-vivo animal model, it states that testing was "completed" but does not give the number of animals or trials.
- Data Provenance: Not explicitly stated, but typically, these tests are conducted in a laboratory setting (e.g., Medtronic's R&D facilities or contracted labs) within the country of manufacture or testing. The document implies these were conducted specifically for this submission, making them prospective data for the purpose of this regulatory filing. There is no mention of country of origin for the data specifically.
3. Number of Experts and Qualifications for Ground Truth Establishment:
This question is largely not applicable to this type of device and study.
- This is not an AI/diagnostic device where human expert labels establish ground truth on patient data.
- Ground truth for functional performance (e.g., cutting, coagulation, thermal spread) in bench and animal studies is established through direct physical/physiological measurement and observation, not through expert consensus on interpretation. For instance, the "zone of thermal damage" is a measurable characteristic of tissue effect.
- The FDA guidance document mentioned ("Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff") served as the standard against which the tests were designed and evaluated by the manufacturer's engineers and scientists.
4. Adjudication Method for the Test Set:
Not applicable in the context of expert adjudication for diagnostic labeling. Performance testing involves direct measurement and comparison to predefined criteria or predicate device performance. Engineer/scientist review of test results would be the "adjudication" (verification) method for non-clinical studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was NOT done.
- The device is an electrosurgical instrument, not an imaging or diagnostic AI device where human readers interpret cases. The human "user" is a surgeon performing a procedure, not "reading" data.
- The study focuses on the device's physical and functional performance, not on improving human reader interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Technically, all the studies described (bench and animal) are "standalone" in the sense that they are evaluating the device's intrinsic performance characteristics without a human user's interpretive decision-making being part of the primary endpoint.
- The "human-in-the-loop" for this device is the surgeon using it during a procedure for its intended purpose (cutting, coagulating, sealing), not interpreting data generated by the device. The non-clinical studies assess the device's ability to perform these actions comparably to predicates.
7. Type of Ground Truth Used:
The ground truth for the performance claims in this submission is established through:
- Physical/Chemical Measurements: For sterilization, electrical safety, mechanical integrity, shelf-life.
- Direct Observation/Measurement on Animal Tissue: For functional performance related to cutting, coagulation, and critically, the "zone of thermal damage imparted on the tissue." This is akin to a pathological/physiological ground truth as it directly measures the device's effect on biological tissue.
- Comparison to Predicate Device Performance: The primary "ground truth" for substantial equivalence is the established safe and effective performance of the predicate devices. The new device must demonstrate comparable performance across the relevant tests.
8. Sample Size for the Training Set:
Not applicable. This device is hardware (an electrosurgical instrument), not an algorithm that requires a "training set" of data in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. (See point 8).
In summary, the 510(k) submission for the PlasmaBlade T device relies on comprehensive non-clinical testing (bench and animal studies) to demonstrate substantial equivalence to its predicate devices. The "acceptance criteria" are implicitly met by showing that the new device performs comparably to the predicates in terms of safety and effectiveness across various functional and physical tests, including the critical aspect of tissue effect (thermal damage). Clinical human studies were not required for this type of device and submission pathway.
§ 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.