(133 days)
The Pivotal devices are sterile, disposable, general surgical instruments for use in endoscopic or open surgical procedures to dissect, transect, manipulate, coagulate, and/or grasp tissue.
The Pivotal instrument and similar currently marketed devices are intended to cut, grasp, manipulate, and coagulate tissue during surgical procedures. The similar marketed endoscopic devices are designed to be used with monopolar electrosurgery and are disposable devices supplied sterile to the user. These devices are available in a variety of blade and jaw configurations. These devices have similar thermoplastic ringed handles that open and close the jaws. The grasper devices are all equipped with a ratchet mechanism that allows the tissue to be held in the jaws without the need for applying constant pressure on the ringed handles.
The provided text is a 510(k) summary for the Pivotal Grasper, Pivotal Dissector, and Pivotal Scissors. This document is focused on demonstrating substantial equivalence to already marketed devices, rather than establishing specific performance acceptance criteria through a clinical study. Therefore, most of the requested information about acceptance criteria and a study proving the device meets them (especially in the context of AI development or human-in-the-loop performance) is not applicable to this type of regulatory submission.
The document states:
- "The Pivotal instrument is substantially equivalent to like devices in commercial distribution."
- "The Pivotal instruments perform the same function and have the same intended use as instruments distributed by Ethicon, United States Surgical Corporation (USSC), and Richard-Allan Medical."
- "The Pivotal instrument complies with the applicable safety, performance, and labeling requirements of the American National Standard Institute and the Association for the Advancement of Medical Instrumentation ANSI/AAMI HF18-1993 Standard for Electrosurgical Devices and ANSI/AAMI ESI-1993 Safe Current Limits for Electromedical Apparatus."
- "The method of sterilization and the method used to validate our sterilization process are in compliance with the ANSI/AAMI/ISO 1135-1994 Medical Devices-Validation and routine control of ethylene oxide sterilization."
Based on this, here's what can be extracted and what cannot:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria (as defined by referenced standards) | Reported Device Performance |
|---|---|
| Electrosurgical Safety: Compliance with ANSI/AAMI HF18-1993 Standard for Electrosurgical Devices | Complied |
| Electrosurgical Safety: Compliance with ANSI/AAMI ES1-1993 Safe Current Limits for Electromedical Apparatus | Complied |
| Sterilization: Compliance with ANSI/AAMI/ISO 1135-1994 Medical Devices-Validation and routine control of ethylene oxide sterilization | Complied |
| Substantial Equivalence: Perform same function and have same intended use as predicate devices (Ethicon, USSC, Richard-Allan Medical instruments) | Found to be substantially equivalent. |
| Material Equivalence: Components of similar materials (stainless steels, thermoplastics, braided fiberglass/epoxy, Teflon®) as predicate devices. | Equivalent materials used. |
| Tip Configuration Equivalence: Tip configurations (scissors, dissectors, graspers) equivalent to predicate devices. | Equivalent tip configurations. |
2. Sample size used for the test set and data provenance:
- Not applicable / Not specified. This document describes a substantial equivalence submission, which typically relies on comparisons to already proven predicate device designs and performance, not a new clinical test set with human readers, AI, or specific clinical outcomes. The "test set" here refers to the engineering evaluation against standards and predicate devices rather than a patient dataset.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Not applicable / Not specified. Ground truth in the context of this submission refers to technical standards compliance and functional equivalence, established through engineering analysis and comparison, not expert consensus on medical images or patient data.
4. Adjudication method for the test set:
- Not applicable / Not specified. Adjudication methods like 2+1 or 3+1 are used for expert consensus on ambiguous medical cases; this is not relevant to a substantial equivalence submission for surgical instruments.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and its effect size:
- No. An MRMC study is not relevant to this type of device and submission. This is a 510(k) for basic surgical instruments, not an AI or imaging device that would involve human readers.
6. If a standalone (algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a manual surgical instrument, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for this submission is compliance with established industry standards (ANSI/AAMI) for electrosurgical safety and sterilization, and demonstrated functional and material equivalence to legally marketed predicate devices. There is no clinical outcomes data or pathology results mentioned.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of this 510(k) submission. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for this type of device.
In summary, the provided document is a regulatory submission demonstrating substantial equivalence for surgical instruments using engineering and material comparisons to predicate devices and compliance with existing standards. It does not involve the types of studies (e.g., AI performance, multi-reader studies) described in the prompt.
§ 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.