(59 days)
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No
The description focuses on ultrasonic fragmentation, emulsification, and aspiration of tissue, along with electrosurgical capabilities. There is no mention of AI, ML, image processing, or data-driven algorithms.
No.
The device is described as a surgical device for fragmenting, emulsifying, and aspirating soft tissue during surgery, which is an interventional function rather than a therapeutic one.
No
The device is described as an ultrasonically vibrating surgical device that fragments, emulsifies, and removes soft tissue, and also has electrosurgical capability for cutting or coagulating tissue. Its intended use is during laparoscopic and thoracoscopic surgery for tissue removal, not for diagnosing conditions.
No
The device description clearly outlines multiple hardware components, including an ultrasonically vibrating surgical device, a Soft Start Circuit Board, and various accessories like tips and flues. The performance studies also focus on hardware aspects like dielectric withstand and trocar insertion/extraction.
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 used "during laparoscopic and thoracoscopic surgery were the fragmentation, emulsification and aspiration of soft tissue is desirable." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a surgical device that uses ultrasonic vibration, irrigation, and aspiration to remove tissue. This is consistent with a surgical tool, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to physically remove tissue during surgery.
N/A
Intended Use / Indications for Use
The CUSA System 200 with Soft Start, and the CUSA Lap™ Accessory are to be used during laparoscopic and thoracoscopic surgery were the fragmentation, emulsification and aspiration of soft tissue is desirable.
Product codes
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Device Description
The CUSA System 200 is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. The CUSA Lap™ Accessory can be used only with CUSA 200 Systems equipped with Soft Start circuitry and currently available CUSA handpieces. The Accessory consists of a Laparoscopic Extended Life Tip, Laparoscopic Flue, Laparoscopic Sterilizer Case and Tray, Laparoscopic Extended Life Tip Torquing Socket wrench, and Soft Start Circuit Board with External Activation Switch. The CUSA System 200 with soft start and the CUSA Lap™ Accessory may be used with the CUSA Electrosurgical Module (CEM), which will provide electrosurgical capability. This provides the surgeon with the option of delivering cutting or coagulating current through the CUSA tip to the surgical site.
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 CUSA System 200 with soft start and the CUSA Lap™ Accessory have been tested and shown to meet the following requirements:
Reliability Testing:
- Dielectric withstand (60 Hz) of the flue
- Trocar insertion/extraction capability
Biocompatibility Testing:
Patient contact materials of the CUSA handpiece and CUSA Lap™ Accessory have been shown to be biocompatible and remain the same as those of legally marketed products.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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N/A
0
Image /page/0/Picture/0 description: The image shows a date and a code. The date is January 6, 1997, and it is written as ". JAN J 6 1997". The code is "K 964601" and is written in a handwritten style. The code is likely an identification or tracking number.
SUMMARY OF SAFETY AND EFFECTIVENESS FOR
CUSA System 200 with Soft Start, and CUSA Lap™ Accessory
Intended Use
The CUSA System 200 with Soft Start, and the CUSA Lap™ Accessory are to be used during laparoscopic and thoracoscopic surgery were the fragmentation, emulsification and aspiration of soft tissue is desirable.
Product Description
The CUSA System 200 is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. The CUSA Lap™ Accessory can be used only with CUSA 200 Systems equipped with Soft Start circuitry and currently available CUSA handpieces. The Accessory consists of a Laparoscopic Extended Life Tip, Laparoscopic Flue, Laparoscopic Sterilizer Case and Tray, Laparoscopic Extended Life Tip Torquing Socket wrench, and Soft Start Circuit Board with External Activation Switch. The CUSA System 200 with soft start and the CUSA Lap™ Accessory may be used with the CUSA Electrosurgical Module (CEM), which will provide electrosurgical capability. This provides the surgeon with the option of delivering cutting or coagulating current through the CUSA tip to the surgical site.
Safety and Performance
The CUSA System 200 with soft start and the CUSA Lap™ Accessory have been tested and shown to meet the following requirements:
Reliability Testing:
-
Dielectric withstand (60 Hz) of the flue
-
Trocar insertion/extraction capability
Biocompatibility Testing:
Patient contact materials of the CUSA handpiece and CUSA Lap™ Accessory have been shown to be biocompatible and remain the same as those of legally marketed products.