(58 days)
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No
The description focuses on the device being a simple adapter for electrical connections, explicitly stating it does not alter the circuit or impact the original circuit. There is no mention of any computational or learning capabilities.
No
Explanation: The device is an adapter for a cautery pencil, which is an electrosurgical tool. The adapter itself does not perform any therapeutic function but rather facilitates the connection of a therapeutic device (the cautery pencil) to an ESU machine.
No
Explanation: The device is an adapter for connecting a cautery pencil to an electrosurgical unit. Its function is to facilitate the electrical connection for the cautery device, not to diagnose medical conditions or analyze patient data.
No
The device description clearly indicates it is a physical adapter made of materials, designed to connect two hardware components (cautery pencil and ESU machine). It does not mention any software component.
Based on the provided information, the DeRoyal Cautery Pencil Adapter is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The DeRoyal Cautery Pencil Adapter is a physical connector used to adapt one type of electrosurgical cautery pencil to a different type of jack on an electrosurgical machine. It facilitates the electrical connection for a surgical procedure performed on the patient, not a test performed on a sample from the patient.
- Intended Use: The intended use clearly states it's for use with an ESU machine and a cautery pencil, which are surgical tools used directly on the patient during a procedure.
- Device Description: The description focuses on its function as an electrical connector and its physical properties, not on analyzing biological samples.
Therefore, the DeRoyal Cautery Pencil Adapter is a surgical accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
DeRoyal Industries, Inc. Electrosurgical Cautery Pencil Adapters
510(k) Summary
SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED
SUBMITTER INFORMATION
NAME: DeRoval Industries, Inc. ADDRESS: 200 DeBusk Lane Powell, TN 37849
TELEPHONE: CONTACT: DATE OF PREPARATION:
(423) 938-7828 Debra F. Manning March 18, 1996
DEVICE NAMES
NAME: COMMON/USUAL NAME: CLASSIFICATION NAME (if known): DeRoyal Surgical (SurgiMate) Electrosurgical Cautery Pencil Adapters Electrosurgical Cautery Pencil Adapters Electrosurgical Cutting & Coagulation Device & Accessories
PREDICATE OR LEGALLY MARKETED DEVICES
ValleyLab Weck
:VICE DESCRIPTION
ne 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.
DEVICE INTENDED USE
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.
TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)
| Characteristic | DeRoyal Device | Other Devices |
|---|---|---|
| Input Connector | Proprietary cautery pencil | |
| connector | Same | |
| Output Connector | Target machine connector | Same |
| Sterility | Non-sterile | Same |
| Circuit | Direct wiring from input | |
| connector to output connector | Same |