(80 days)
Cardioblate 49313 Surgical Ablation Pen: The Cardioblate surgical ablation pen is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
Cardioblate 49314 XL Surgical Ablation Pen: The Cardioblate XL surgical ablation pen is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
The Cardioblate Surgical Ablation devices (Pen and XL Pen, Model 49313 and 49314 respectively) are hand held, single use, monopolar, RF ablation devices for use in cardiac surgery. Each device has a saline irrigation system to deliver fluid at the contact point between the tissue and electrode tip to cool the tissue during RF energy delivery. The devices are intended for intermittent operation. The proposed Cardioblate Pen and XL Pen devices are intended for use with the Valleylab™ FT10 Energy Platform (VLFT10GEN) with software version 3.0.0 or higher. These devices are sterile, nonpyrogenic, disposable, and single use only. They are sterilized using ethylene oxide.
The document you provided is a 510(k) Pre-Market Notification from the FDA for a medical device (Cardioblate Surgical Ablation Pen). This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study for novel performance claims.
Therefore, the information typically requested in your prompt (acceptance criteria, specific study details with sample sizes, expert ground truth, MRMC, standalone performance, training set details) is not present in this document because it describes a different type of regulatory submission.
Here's why and what information can be extracted:
Why the requested information is not present:
- Acceptance Criteria & Device Performance Table, Study Details, Ground Truth, MRMC, Standalone Performance, Training Set: The 510(k) pathway focuses on showing that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, or if it has different technological characteristics, that it does not raise different questions of safety and effectiveness and that data demonstrates it is as safe and effective as the predicate. Clinical efficacy or performance studies with detailed statistical acceptance criteria for novel claims, as might be found in a De Novo or PMA submission, are generally not required for 510(k) clearances unless substantial equivalence cannot be established through other means (e.g., bench testing, non-clinical data).
- Expert Ground Truth & Adjudication: These are typical for studies assessing diagnostic accuracy, often with human interpretation. The Cardioblate Pen is a surgical ablation device, not a diagnostic or imaging device, so these concepts are not applicable in the context described.
What is present in the document:
- Device Description: The Cardioblate Surgical Ablation devices (Pen and XL Pen) are hand-held, single-use, monopolar, RF ablation devices for cardiac surgery, designed to be used with the Valleylab™ FT10 Energy Platform. They use a saline irrigation system to cool tissue during RF energy delivery.
- Indications for Use: To ablate cardiac tissue during cardiac surgery using radiofrequency energy.
- Comparison to Predicate Devices (K080509): The new devices have the same intended use, contraindications, technological characteristics, operating principle, design features, performance specifications, patient-contacting components, materials, and shelf life. Differences include a new plug connector for compatibility with the Valleylab™ FT10 Energy Platform, updated IFU and labeling (including eIFU), and packaging changes for the standard pen.
- Performance Testing (Non-Clinical): To demonstrate substantial equivalence, the following verification testing was performed:
- Mechanical: To ensure compliance with IEC 60601-1 and IEC 60601-2-2 standards and Medtronic internal requirements.
- Electrical: To ensure compliance with IEC 60601-1 and IEC 60601-2-2 electrical requirements.
- Electromagnetic compatibility: To ensure compliance with IEC 60601-1-2 standard requirements.
- Benchtop Lesion Verification: Comparative lesion verification testing using a soft tissue model to demonstrate "substantially equivalent ablation performance" of the subject and predicate systems. No specific metrics or acceptance criteria for this "substantially equivalent performance" are provided in this summary.
- Usability: To verify and validate usability requirements, including normal use cases, foreseeable worst-case scenarios, and primary operating functions.
- Packaging: Sterile barrier system performance testing in accordance with ISO 11607-1.
- Conclusion: The verification and validation test results demonstrate substantial equivalence to the predicate, with differences not raising new questions of safety and effectiveness.
In summary, based only on the provided document, I cannot fulfill the detailed request regarding acceptance criteria and study particulars because the document is a 510(k) summary, which focuses on substantial equivalence through non-clinical testing rather than detailed clinical performance studies with the specific metrics you've asked for.
§ 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.