(56 days)
No
The description focuses on the device's mechanism of action (RF energy and saline) and its physical components, with no mention of AI or ML.
Yes.
The device delivers RF energy and saline for haemostatic sealing and coagulation of soft tissue and bone, and monopolar RF energy for cutting soft tissue, which are direct interventions for treating medical conditions.
No
The device is described as a "hemostatic sealing and cutting device" that delivers RF energy and saline for "haemostatic sealing and coagulation of soft tissue and bone and monopolar RF energy for cutting of soft tissue." Its function is therapeutic (sealing and cutting tissue), not diagnostic (identifying or characterizing a medical condition).
No
The device description clearly outlines a physical, single-use, sterile, disposable device with a handpiece, electrodes, and connections for saline and RF energy. It also mentions bench performance testing involving physical attributes like cable pulls, saline tube pulls, and shaft deflection. This indicates a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "haemostatic sealing and coagulation of soft tissue and bone and monopolar RF energy for cutting of soft tissue" during surgical procedures. This is a therapeutic and surgical function performed directly on the patient's body.
- Device Description: The description details a device that delivers RF energy and saline for surgical purposes, with electrodes and buttons for sealing and cutting. This aligns with a surgical instrument, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's condition
- Using reagents or assays
- Performing tests outside of the body (in vitro)
The device is a surgical tool used in vivo (within the living body) for therapeutic purposes (hemostasis and cutting).
N/A
Intended Use / Indications for Use
The Aquamantys3 BSC 9.1S is a monopolar/bipolar, single use, sterile, disposable device intended for use with the Aquamantys3 Pump Generator. The device delivers bipolar RF energy concurrent with saline for haemostatic sealing and coagulation of soft tissue and bone and monopolar RF energy for cutting of soft tissue. It is intended for, but not limited to, orthopaedic, spine, thoracic, and open abdominal surgery.
The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
Product codes
GEI
Device Description
The proposed Aquamantys3 BSC 9.1S is a sterile, single-use hemostatic sealing and cutting device. The device employs bipolar radiofrequency (RF) energy and saline for hemostatic sealing and coagulation, and monopolar radio-frequency (RF) energy for cutting. The device is equipped with a dual electrode tip with saline orifices on both sides of the inner electrode at its distal end. Saline and RF energy are supplied to the device from lines on the proximal end of the hand piece. The cassette provides the electrical connection and saline fluid delivery from the Aquamantys3 Generator. The hand piece is equipped with an on-off Transcollation® Sealing Saline button that simultaneously activates both bioolar RF and saline flow for hemostatic sealing using both electrodes. The hand piece is equipped with an on-off Cut button that activates the monopolar RF energy for cutting on a single electrode.
The Aquamantys3 BSC 9.1S applies the same fundamental scientific technology as the existing Medtronic Advanced Energy Bipolar Sealers, with the addition of monopolar RF energy applied without saline, as is seen in the predicate Medtronic Advanced Energy Aquamantys3 8.2L Bipolar Sealer with Cutting (K111285). The device's hand piece is equipped with two activation buttons; the distal vellow button activates monopolar RF energy for cutting, and the proximal blue button activates bipolar RF energy concurrent with saline flow for hemostatic sealing and coagulation. The cord of the Aquamantys3 BSC 9.1S terminates in a cassette that is designed to uniquely insert into the Aquamantys3 Pump Generator, providing simultaneous connection to both RF power and the peristaltic pump. The main differences between the proposed and predicate devices are as follows:
- . Tip Configuration
- Hand piece design, including: .
- Ergonomic feel o
- Improved look and design O
- Materials o
- Ergonomic feel o
- Overall length of device
- Malleable shaft
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue and bone, orthopaedic, spine, thoracic, and open abdominal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Aquamantys3 BSC 9.1S has undergone bench performance testing to verify and validate the performance features and specifications. The testing included:
- visual.
- static cable pulls,
- dynamic cable pulls, .
- static saline tube pulls, .
- . air leak and flow,
- hipot testing, .
- saline flow testing,
- cassette separation,
- shaft deflection/pull,
- electrode pull,
- continuity
- biocompatibility assessment,
- animal tissue testing, and
- electrical safety .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K11285
Reference Device(s)
Not Found
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