(87 days)
The OSCAR™ Bipolar Scissors with OSCAR™ Bipolar Disposable Cartridges is intended to cut tissue and control bleeding through coagulation during open surgical procedures and in general surgery.
The OSCAR™ Bipolar Scissors is a reusable electrosurgical instrument consisting of an instrument handle with a pair of scissors blades which attaches to the OSCAR™ Bipolar Disposable Cartridges and an electrosurgical generator. Electric current flows between the electrodes in the cartridges and the stainless steel cutting surfaces of the blades. The electrosurgical generator controls the flow of the electric current down the electrode. The overall length of the device is between 4 and 11 inches. The power cord connecting the handle to the power control unit is approximately 120 inches. The blades are between 1 and 2 inches in length.
The surgeon places the opened scissors across the tissue to be cut and closes the scissors handle while moving the scissors across the tissue. Energizing the electrosurgical generator via the generator's footswitch, the surgeon can simultaneously cut and coagulate the target tissue. The surgeon can vary the current flow rate according to the tissue and the amount of bleeding encountered. The power setting for the OSCAR™ Bipolar Scissors is 20-30 watts.
Acceptance Criteria and Device Performance Study for OSCAR™ Bipolar Scissors with OSCAR™ Bipolar Disposable Cartridges (K981219)
Based on the provided 510(k) summary, the device's acceptance criteria and the study proving its performance are primarily established through a demonstration of substantial equivalence to legally marketed predicate devices. The document does not describe a traditional performance study with specific quantitative acceptance criteria for the OSCAR™ device itself, but rather relies on the equivalency to already approved devices.
Here's a breakdown of the requested information, reflecting the nature of a 510(k) submission for substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance (as demonstrated by substantial equivalence) |
|---|---|---|
| Intended Use | To cut tissue and control bleeding through coagulation during open surgical procedures and in general surgery. | The OSCAR™ Bipolar Scissors with OSCAR™ Bipolar Disposable Cartridges are intended to cut tissue and control bleeding through coagulation during open surgical procedures and in general surgery, which is stated to be substantially equivalent to predicate devices. |
| Function | Electrosurgical cutting and coagulation using bipolar technology. | Operates by electric current flowing between electrodes in cartridges and stainless steel cutting surfaces of blades, enabling simultaneous cutting and coagulation. This function is presented as substantially equivalent to predicate devices. |
| Physical Characteristics | Reusable handle, disposable cartridge containing scissors blades, connected to electrosurgical generator. Overall length between 4 and 11 inches, blades between 1 and 2 inches, power cord approx. 120 inches. | Device description matches these characteristics, and these are deemed substantially equivalent to predicate devices' physical characteristics. |
| Materials | Materials suitable for electrosurgical cutting and coagulation devices. | The materials used are considered substantially equivalent to those of predicate devices. (Specific material types are not detailed in the summary). |
| Sterilization Method | A validated sterilization method appropriate for surgical instruments. | The sterilization method is stated to be substantially equivalent to predicate devices' methods. (Specific method is not detailed in the summary). |
| Power Range | Operable with electrosurgical generators, typically in the 20-30 watts range. | The device operates with electrosurgical generators and uses a power setting of 20-30 watts, consistent with similar power ranges used by predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of this 510(k) summary. The submission relies on the existing safety and effectiveness profiles of the predicate devices rather than new performance data for a dedicated test set designed to establish new performance metrics for the OSCAR™ device.
- Data Provenance: Not applicable. The "data" here refers to the established performance and safety profiles of the cited predicate devices (e.g., Symbiosis Bipolar Scissors, Everest Medical Bipolar Scissors, CardioThoracic Systems MIDCAB/SVH Bipolar Scissors, Ethicon PowerStar Bipolar Scissors, ENABLE Bipolar Scissors), which were legally marketed prior to this submission. Information regarding their specific testing or data provenance is not provided here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. There was no specific "test set" in the traditional sense for the OSCAR™ device in this 510(k) submission, and therefore no ground truth established by experts specifically for the OSCAR™ device to meet new performance benchmarks. The ground truth is effectively the regulatory acceptance of the predicate devices.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable, as no specific test set requiring adjudication was used for the OSCAR™ device's performance claims.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Comparative Effectiveness Study: Not applicable. This device is a surgical instrument, not an AI-assisted diagnostic or interpretation tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Study: Not applicable. This device is a manual surgical instrument and does not involve an algorithm or AI.
7. The type of ground truth used
- Type of Ground Truth: The "ground truth" in this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices. The OSCAR™ Bipolar Scissors are shown to be substantially equivalent in intended use, function, physical characteristics, materials, and sterilization method to these pre-existing devices. This equivalency implicitly means that if the predicate devices are safe and effective, then a substantially equivalent new device will also be safe and effective.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. The device is not based on machine learning or AI, so there is no "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set.
§ 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.