(107 days)
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No
The description details a standard electrosurgical instrument with manual control of current flow by the surgeon. There is no mention of any automated decision-making, learning, or data processing that would indicate AI/ML.
No
The device is described as an electrosurgical instrument intended to cut tissue and control bleeding through coagulation, which are surgical functions, not therapeutic in the sense of treating a disease or condition. It facilitates a surgical procedure rather than directly providing therapy.
No
The device is described as an electrosurgical instrument intended to cut tissue and control bleeding through coagulation, which are therapeutic actions, not diagnostic ones.
No
The device is a physical electrosurgical instrument with blades, a handle, and a connection to a power generator, clearly indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring or compatibility purposes.
- Device Function: The CTS MIDCAB/SVH Bipolar Scissors is an electrosurgical instrument used to cut and coagulate tissue directly within the body during surgical procedures. It operates on the patient's tissue, not on a specimen taken from the patient.
- Intended Use: The intended use clearly states it's for "cutting tissue and control bleeding through coagulation, in general and cardiothoracic surgery." This is an in vivo (within the living body) application.
The device description and intended use clearly indicate it's a surgical tool used directly on the patient, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The CTS MIDCAB/SVH Bipolar Scissors is intended to cut tissue and control bleeding through coagulation, in general and cardiothoracic surgery, including minimally invasive direct coronary artery bypass ("MIDCAB") and saphenous vein harvesting procedures.
Product codes
21CFR878.4400
Device Description
The CTS MIDCAB/SVH Bipolar Scissors is an electrosurgical instrument which consists of a pair of scissor blades which are connected to a handle instrument and an electrosurgical generator. Electric current flows from the electrode to the stainless steel cutting surface of the blades and from the stainless steel cutting surface of one blade to the stainless steel cutting surface of the other blade. The flow of the electric current down the electrode is controlled by the power generator. The overall length of the device, which consists of the handle, tube and blades, is approximately 13 inches. The power cord connecting the handle to the power control unit is approximately 120 inches. The blades are approximately 0.5 inches in length.
The surgeon places the opened scissors across the tissue to be cut and depresses the actuation lever while moving the scissors forward against the tissue. By energizing the power control unit on the actuation lever, the surgeon can simultaneously cut and coagulate the target tissue. Alternately, the power control unit may be controlled via a foot pedal. The surgeon can vary the current flow rate according to the tissue and the amount of bleeding encountered. The power setting used for the CTS Bipolar Scissors is 20-30 watts.
The CTS Bipolar Scissors is provided sterile, nonpyrogenic and for single use.
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
surgeon
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
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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
JAN 16 1997
510(k) Summary CardioThoracic Systems, Inc. CTS MIDCAB™ /SVH™ Bipolar Scissors 510(k) Notification K_963930
GENERAL INFORMATION
| Manufacturer: | CardioThoracic Systems, Inc.
10600 N. Tantau Avenue
Cupertino, California
(408) 342-1700
(408) 342-1717 FAX
Est. Reg. No. (awaiting issuance) |
| --------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Contact Person: | Michael J. Billig
Vice President, Regulatory, Quality, and Clinical Research |
| ----------------- | --------------------------------------------------------------------------------- |
|---|
September 26, 1996
Date Prepared:
DEVICE DESCRIPTION
| Classification: | Class II |
|---|---|
| Trade Name: | CTS MIDCAB™/SVH™ Bipolar Scissors |
| Generic/Common Name: | Electrosurgical cutting and coagulation device and accessories |
| 21CFR878.4400 |
PREDICATE DEVICES
- (1) Symbiosis Bipolar Scissors
- (2) Everest Medical Bipolar Scissors
- (3) Valley Forge Bi-Tech Bipolar Coagulator/Cutting System
- (4) Valleylab Force 2 and Force 4 Electrosurgical Generators
INTENDED USE
The CTS MIDCAB/SVH Bipolar Scissors is intended to cut tissue and control bleeding through coagulation, in general and cardiothoracic surgery, including minimally invasive direct coronary artery bypass ("MIDCAB") and saphenous vein harvesting procedures.
1
PRODUCT DESCRIPTION
The CTS MIDCAB/SVH Bipolar Scissors is an electrosurgical instrument which consists of a pair of scissor blades which are connected to a handle instrument and an electrosurgical generator. Electric current flows from the electrode to the stainless steel cutting surface of the blades and from the stainless steel cutting surface of one blade to the stainless steel cutting surface of the other blade. The flow of the electric current down the electrode is controlled by the power generator. The overall length of the device, which consists of the handle, tube and blades, is approximately 13 inches. The power cord connecting the handle to the power control unit is approximately 120 inches. The blades are approximately 0.5 inches in length.
The surgeon places the opened scissors across the tissue to be cut and depresses the actuation lever while moving the scissors forward against the tissue. By energizing the power control unit on the actuation lever, the surgeon can simultaneously cut and coagulate the target tissue. Alternately, the power control unit may be controlled via a foot pedal. The surgeon can vary the current flow rate according to the tissue and the amount of bleeding encountered. The power setting used for the CTS Bipolar Scissors is 20-30 watts.
The CTS Bipolar Scissors is provided sterile, nonpyrogenic and for single use.
SUBSTANTIAL EQUIVALENCE
The CTS MIDCAB/SVH Bipolar Scissors is substantially equivalent to the above identified predicate devices. The CTS Bipolar Scissors is substantially equivalent to the predicate devices with regard to intended use, function, physical characteristics, materials and sterilization method. The CTS, Symbiosis and Everest devices are all bipolar scissors which cut tissue and coagulate soft tissue through the use of bipolar technology. All three devices are connected to the same or similar electrosurgical generators and use similar power ranges for operation.
SUMMARY
As contained in this 510(k) summary, the CTS MIDCAB/SVH is substantially equivalent to the predicate devices identified.