(58 days)
The DeRoyal Cautery Pencil Adapter is indicated for use whenever the ESU machine requires a Cautery Pencil of the type provided by SurgiMate, or the connector on the SurgiMate Pencil does not match the intended jack of the ESU machine but its use would make the electrical connection compatible.
The DeRoyal Surgical Electrosurgical Cautery Pencil Adapter functions in the same manner as predicate devices in that it is used to connect one type of electrosurgical Cautery Pencil to a particular type of jack on the electrosurgical cautery machine being used.
Device Design/Materials Used/Physical Properties: The DeRoyal Cautery Pencil Adapter is made of materials commonly used for its purpose. The concept of use is that the adapter converts one type of connection to another type of connection without any alteration of the circuit or any impact on the original circuit.
This 510(k) summary describes a device that is an adapter for electrosurgical cautery pencils. It explicitly states that the device "functions in the same manner as predicate devices" and "converts one type of connection to another type of connection without any alteration of the circuit or any impact on the original circuit." The provided text does not contain a study demonstrating performance against acceptance criteria in the way a diagnostic or therapeutic medical device submission might. Instead, it relies on a comparative analysis to predicate devices to establish substantial equivalence.
Therefore, the following answers are based on the information provided, which indicates a lack of a formal performance study with acceptance criteria as would be typical for more complex devices.
Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)
Given that this is a 510(k) for an electrosurgical cautery pencil adapter and the submission focuses on substantial equivalence, the "acceptance criteria" and "reported device performance" are primarily demonstrated through direct comparison to legally marketed predicate devices, rather than through a separate, quantitative performance study as might be seen for a diagnostic or therapeutic device. The core acceptance criterion is that the adapter performs identically to predicate devices in its function of enabling electrical connection without altering the circuit.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Substantial Equivalence Claim) | Reported Device Performance (Summary) |
|---|---|
| Electrical Circuit Integrity: Converts connection type without altering the electrical circuit. | "converts one type of connection to another type of connection without any alteration of the circuit or any impact on the original circuit." |
| Material Compatibility: Made of materials commonly used for the purpose. | "The DeRoyal Cautery Pencil Adapter is made of materials commonly used for its purpose." |
| Intended Use Fulfillment: Allows connection of specific cautery pencils to ESU machines when direct connection is incompatible. | "indicated for use whenever the ESU machine requires a Cautery Pencil... or the connector... does not match the intended jack... but its use would make the electrical connection compatible." |
| Sterility Status: Non-sterile. | "Non-sterile" (Matching predicate devices). |
| Input Connector: Accepts proprietary cautery pencil connector. | "Proprietary cautery pencil connector" (Matching predicate devices). |
| Output Connector: Connects to target machine connector. | "Target machine connector" (Matching predicate devices). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. No dedicated "test set" in the context of a performance study is described. The evaluation is based on a design and functional comparison to predicate devices.
- Data Provenance: Not applicable. The submission relies on a comparison of device characteristics rather than data from a study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No "ground truth" establishment by experts for a test set is described. The claim is based on the device's design and functional similarity to predicate devices already on the market.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring adjudication is described.
5. 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 adapter, not an AI-powered diagnostic tool, so an MRMC study is irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a passive adapter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the typical sense for a performance study. The "ground truth" for this submission is implicitly the established safety and effectiveness profile of the predicate devices to which the DeRoyal adapter is compared. The claim is that the adapter achieves equivalence by performing the same function using similar materials and design principles.
8. The sample size for the training set
- Not applicable. There is no training set for this type of device.
9. How the ground truth for the training set was established
- Not applicable. 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.