(76 days)
3M, Birtcher, ValleyLab
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No
The description focuses on the physical connection and conversion of electrical signals without any mention of data processing, algorithms, or learning capabilities.
No
The device is an adapter for a grounding pad used with an electrosurgical unit (ESU). It does not directly treat or diagnose a condition; its purpose is to ensure compatibility between different components of an electrical circuit used during surgery.
No
The device is an adapter that facilitates the connection of an electrosurgical grounding pad to an electrosurgical cautery machine. It does not perform any diagnostic function; its sole purpose is to ensure compatibility between different connection types for electrosurgical procedures.
No
The device description explicitly states it is a physical adapter made of materials, designed to convert one type of electrical connection to another. This indicates a hardware device, not software.
Based on the provided information, the DeRoyal Grounding Pad Adapter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The DeRoyal Grounding Pad Adapter is a physical adapter used to connect an electrosurgical grounding pad to an electrosurgical unit (ESU) machine. Its function is purely electrical and mechanical, ensuring compatibility between different connectors.
- Intended Use: The intended use clearly states its purpose is to make an electrical connection compatible between a grounding pad and an ESU machine. It does not involve the analysis of any biological specimens.
- Device Description: The description focuses on its function as a connector and the materials used for that purpose. There is no mention of analyzing samples or providing diagnostic information.
Therefore, the DeRoyal Grounding Pad Adapter falls under the category of a surgical accessory or a component of an electrosurgical system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DeRoyal Grounding Pad Adapter is indicated for use whenever the ESU machine requires a grounding pad of the type provided by SurgiMate, or the connector on the SurgiMate pad does not match the intended jack of the ESU machine but its use would make the electrical connection compatible.
Product codes
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Device Description
DeRoyal Surgical Electrosurgical Grounding Pad Adapter functions in the same manner as predicate devices in that it sed to connect one type of electrosurgical grounding pad to a particular type of jack on the electrosurgical cautery ... achine being used.
Device Design/Materials Used/Physical Properties: The DeRoyal Grounding Pad Adapter is made of materials commonly used for their 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)
3M, Birtcher, ValleyLab
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
IN -3 1996
DeRoval Industries, Inc. Electrosurgical Grounding Pad Adapters
510(k) Summary
SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED
SUBMITTER INFORMATION
NAME: DeRoyal 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 Grounding Pad Adapters Electrosurgical Grounding Pad Adapters Electrosurgical Cutting & Coagulation Device & Accessories
PREDICATE OR LEGALLY MARKETED DEVICES
зм Birtcher ValleyLab
DEVICE DESCRIPTION
" : DeRoyal Surgical Electrosurgical Grounding Pad Adapter functions in the same manner as predicate devices in that it sed to connect one type of electrosurgical grounding pad to a particular type of jack on the electrosurgical cautery ... achine being used.
Device Design/Materials Used/Physical Properties: The DeRoyal Grounding Pad Adapter is made of materials commonly used for their 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 Grounding Pad Adapter is indicated for use whenever the ESU machine requires a grounding pad of the type provided by SurgiMate, or the connector on the SurgiMate pad 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 grounding pad | |
| connector | Same | |
| Output Connector | Target machine connector | Same |
| Sterility | Non-sterile | Same |
| Circuit | Direct wiring from input | |
| connector to output connector | Same |