(43 days)
The Estech Cobra Adhere Surgical System is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery. The System can be used during general surgery to coagulate soft tissues. The System may also be used to coagulate blood and soft tissue to produce hemostasis.
The Cobra Adhere Surgical System is an Electrosurgical Probe, with either a malleable or flexible shaft, used in conjunction with the Cobra Electrosurgical Unit (ESU). The System is intended for use by surgeons for the coagulation of cardiac and soft tissues during open surgical procedures.
This 510(k) submission does not contain a study to prove acceptance criteria for device performance. Instead, it relies on a "substantial equivalence" argument by asserting that the device is identical to an already legally marketed predicate device.
Here's why and what's present in the provided text:
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No Acceptance Criteria or Performance Data: The submission explicitly states: "No data supporting equivalence between the Estech Cobra Adhere Surgical System and the Boston Scientific Cobra Adhere Surgical System is necessary because both are the same device." This indicates that no new performance studies (and therefore no new acceptance criteria) were established for this specific device because it is considered a re-branding of an existing one.
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Reliance on Predicate Device: The core of the submission is the claim that the "Estech Cobra Adhere Surgical System is identical in nearly every way to the Boston Scientific Cobra Adhere Surgical System." The only difference cited is "labeling changes necessary to list a different final manufacturer." This implies that the Estech device inherits the performance and safety profile of the predicate device.
Given this, I cannot fill out the table and answer the study-specific questions as they pertain to a new performance study. However, I can summarize the information provided in the context of this "substantial equivalence" claim:
Summary of Device Equivalence Claim
The Estech Cobra Adhere Surgical System claims substantial equivalence to the Boston Scientific Cobra Adhere Surgical System. The basis for this claim is outlined below:
| Feature/Aspect | Estech Cobra Adhere Surgical System | Boston Scientific Cobra Adhere Surgical System (Predicate) | Comparison/Comment |
|---|---|---|---|
| Acceptance Criteria | Not explicitly defined (A new study was not performed). | Assumed to be met by the predicate device's prior marketing clearance. | The acceptance criteria for the Estech device are implicitly met by its claim of being identical to the predicate device, which had already established its safety and effectiveness. No new performance endpoints or targets were set for this 510(k). |
| Reported Device Performance | Not reported directly for this device. | Assumed to be the same as the predicate device. | Since the devices are asserted to be identical, the performance of the Estech device is considered to be the same as the Boston Scientific device. No new performance data is presented. |
Study-Specific Information (Based on the "Identical Device" Claim)
- Sample sized used for the test set and the data provenance: Not applicable. No new test set or data provenance is mentioned as this device is stated to be identical to the predicate.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new ground truth establishment for a test set was performed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No new test set for performance comparison was conducted.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an electrosurgical probe, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an electrosurgical probe, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No primary ground truth was established for this submission, as it relies on the predicate device's established safety and effectiveness.
- The sample size for the training set: Not applicable. This device is an electrosurgical probe; there is no mention of a "training set" in the context of machine learning or algorithms.
- How the ground truth for the training set was established: Not applicable.
Explanation of the "Identical Device" Argument:
- Manufacturing: "Both devices are manufactured by Boston Scientific on the same assembly line in San Jose of the exact same materials, processes and specifications."
- Sterilization: "Both are EtO sterilized in processes validated to ISO 11135."
- Indications for Use: "Both devices have identical indications for use."
Therefore, the review process for this device did not involve new performance studies against acceptance criteria but rather a verification of its sameness to the predicate 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.