(79 days)
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No
The provided text describes a standard electrosurgical device for suction and coagulation and makes no mention of AI or ML technology.
No.
A therapeutic device is one that treats a disease or condition. This device is used for surgical procedures like fluid evacuation and tissue coagulation, which are actions performed during surgery, not treatments in themselves.
No
The device is described as being used for surgical procedures involving fluid evacuation and tissue coagulation, not for diagnosing conditions. Its intended use focuses on treatment during surgery.
No
The device description clearly states it is a "disposable device" and a "Bipolar Suction Coagulator," which are physical hardware components used in surgical procedures. The performance studies also reference standards for "Medical Electrical Equipment" and "Electrosurgical Devices," further indicating a hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "soft tissue surgical procedures that require slow to rapid fluid evacuation and low energy output for the coagulation of the tissue". This describes a device used on the patient during surgery, not a device used to test samples from the patient outside the body.
- Device Description: The description reiterates the surgical use case.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used directly on the patient's tissue.
N/A
Intended Use / Indications for Use
The Bipolar Suction Coagulator (Angled) is a disposable device, designed to be used in soft tissue surgical procedures that require slow to rapid fluid evacuation and low energy output for the coagulation of the tissue i.e., neurosurgery, endoscopic, sinusoidial, ENT, OB-GYN and plastic surgery.
Product codes
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Device Description
The Bipolar Suction Coagulator (Angled) is a disposable device, designed to be used in soft tissue surgical procedures that require slow to rapid fluid evacuation and low energy output for the coagulation of the tissue i.e., neurosurgery, endoscopic, sinusoidial, ENT, OB-GYN and plastic surgery.
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
The Bipolar Suction Coagulator (Angled) has been performance tested in accordance with and complies with the requirements of the applicable sections of the following standards: IEC 601-1-2 (1988). Medical Electrical Equipment Part 1; General Requirements for the Safety. IEC 601-2-2 (1991), Medical Electrical Equipment Part 2; Particular Requirements for the Safety of High Frequency Surgical Equipment. ANSI/AAMI HF 18 (1993), Electrosurgical Devices
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
K 9652 41
SUMMARY OF SAFETY AND EFFECTIVENESS
The Bipolar Suction Coagulator (Angled) is a disposable device, designed to be used in soft tissue surgical procedures that require slow to rapid fluid evacuation and low energy output for the coagulation of the tissue i.e., neurosurgery, endoscopic, sinusoidial, ENT, OB-GYN and plastic surgery.
Biological safety has been assured through the selection of materials which demonstrate appropriate levels of biocompatibility. The materials have been tested in accordance with ISO Standard 10993-1, Biological Evaluation of Medical Devices, Part 1 (external communicating device, blood path indirect, contact duration category "A").
Sterilization safety has been assured to a sterility assurance level (SAL) of 106. Sterility has been validated in accordance with and complies with the requirements of the applicable sections of the following standards:
100% Ethylene Oxide (EtO) sterilization: EtO Sterilization of Medical Devices (ST27- 1988).
The Bipolar Suction Coagulator (Angled) has been performance tested in accordance with and complies with the requirements of the applicable sections of the following standards:
IEC 601-1-2 (1988). Medical Electrical Equipment Part 1; General Requirements for the Safety.
IEC 601-2-2 (1991), Medical Electrical Equipment Part 2; Particular Requirements for the Safety of High Frequency Surgical Equipment.
ANSI/AAMI HF 18 (1993), Electrosurgical Devices
The Bipolar Suction Coagulator (Angled) is substantially equivalent in function and intended use to the Bipolar Suction Coagulator, 510(k) K960455.