(26 days)
Diathermic Slitter (FlushKnife) DK2618J and DK2623J are intended to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. The devices are indicated for ablation, incision, dissection, avulsion, coagulation and hemostasis of tissue within the digestive tract.
Diathermic Slitter (FlushKnife) is sterile and intended for single used electrosurgical instruments that remove tissue and control bleeding by use of high-frequency ("HF") electrical current. The device is comprised of a proximal handle with slider that is connected to a flexible resin tube. The flexible resin tube covers and insulates the operation wire and slitter (when retracted). The operation wire controls the mechanical function of and delivers high frequency (HF) electrical current to the slitter. The proximal end of the operation wire is connected to the slider, which allows the operator to manually control the extension and retraction of the distal end of the operation wire connects to the slitter, which is located at the distal tip of the device. The device connects to a HF electrosurgical power supply unit by an active cord ("A-Cord") connector. HF electrical current generated by a HF electrosurgical power supply unit flows to the slitter from the HF electrosurgical power supply unit via the A-cord, the A-cord connector, and the operation wire. The distal tip of the device is inserted through the forceps channel of the specified endoscope. Once inserted, the operator can extend the slitter from the tip of the endoscope using the slitter is extended to the target site of a patient. Cleavage, resection, incision, ablation, hemostasis, coagulation, or excision of tissue is achieved by delivering HF current to the target tissue through the slitter. The device is provided sterile for single-use only. The device can supply sterile water or fluids to its distal end target site via a water/fluid supply channel. The port for the water/fluid supply channel is located on the handle at the proximal end of the device. The sterile water or fluid also aids in the removal of debris, blood and extraneous material from the distal end of the device or a target site. To supply sterile water or fluid to the distal end target site, a syringe filled with water or fluid is connected to the water/fluid inlet at the proximal handle. Besides a syringe, alternate delivery methods can also be used to supply sterile water or fluid to the distal end target site of the device.
The provided text describes a 510(k) submission for a medical device called the "Fujifilm Diathermic Slitter (FlushKnife)," which is a modified version of a previously cleared device. The submission focuses on demonstrating substantial equivalence to the predicate device, especially regarding a minor modification: the addition of compatible sterile fluids and alternate delivery systems.
Here's an analysis of the acceptance criteria and study information provided, focusing on what's explicitly stated and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a detailed table with specific numerical acceptance criteria and a corresponding reported performance for each criterion. It mentions categories of performance testing but does not quantify them.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Fluid supply | The device met the pre-defined acceptance criteria for the test. |
| Temperature rise | The device met the pre-defined acceptance criteria for the test. |
| Dielectric voltage | The device met the pre-defined acceptance criteria for the test. |
| Durability | The device met the pre-defined acceptance criteria for the test. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The text states "Fujifilm conducted the following performance testing," but no details about sample sizes or the origin of the test data (e.g., country of origin, retrospective/prospective) are mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/provided. The performance testing described (fluid supply, temperature rise, dielectric voltage, durability) are engineering/functional tests, not tests that require expert-established ground truth related to clinical outcomes or interpretations.
4. Adjudication Method for the Test Set
This information is not applicable/provided. As above, the tests mentioned are functional performance tests, not clinical evaluations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is an electrosurgical instrument for cutting tissue, not an imaging or diagnostic device that would typically involve human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The concept of "standalone performance" for an algorithm does not apply to this device. This is a physical electrosurgical instrument, not an AI or algorithmic device. The performance tests described (fluid supply, temperature rise, dielectric voltage, durability) are inherent to the device's physical function.
7. The Type of Ground Truth Used
The ground truth for the performance tests would be established through engineering specifications and standards relevant to medical device safety and performance. For example:
- Fluid supply: Met predefined flow rates or delivery volumes.
- Temperature rise: Stayed within safe operating temperature limits.
- Dielectric voltage: Withstood specified voltage without breakdown.
- Durability: Maintained functional integrity after a specified number of uses or cycles.
These are not "expert consensus," "pathology," or "outcomes data" in the typical clinical sense, but rather objective measurements against established engineering benchmarks.
8. The Sample Size for the Training Set
This information is not applicable/provided. As this is a physical medical instrument and not an AI or machine learning device, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the same reason as point 8.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).