(14 days)
The Switch-Blade® disposable scissor tips are supplied sterile and are intended for single use. The disposable scissor tips in conjunction with the reusable scissor shaft are intended to be connected to an Electrosurgical Unit via cables to allow high frequency monopolar cutting and coagulation of tissue.
The Switch-Blade® scissor tip product family consists of three configurations differing only in size and shape. The Switch-Blade® is supplied sterile in an individual Tyvek® pouch; six of these pouches are placed in 6 unit box (i.e. sales unit). The product is intended to be single use and is used in conjunction with catalog numbers 90-1050, 90-1150 or 90-1250 to achieve electrosurgical cutting and coagulation of tissue. The device consists of metal and polymer components.
This document is a 510(k) premarket notification for a medical device (Switch-Blade® Disposable Scissor Tips), not a study report. Therefore, it does not contain the detailed data analysis typically found in a clinical study proving device performance against acceptance criteria. Instead, it focuses on demonstrating "substantial equivalence" to predicate devices. As such, many of the requested data points (like sample size for test sets, number of experts for ground truth, MRMC studies, etc.) are not applicable or provided in this type of regulatory submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria or provide performance metrics in a test vs. acceptance criteria table. Instead, it relies on demonstrating equivalence to predicate devices and adherence to relevant standards.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Explicitly Stated as Quantitative Acceptance Criteria (e.g., a specific percentage for accuracy, sensitivity, or specificity). The submission focuses on substantial equivalence to predicate devices and compliance with relevant standards. | The device's performance characteristics are stated to be "dictated by national and international standard (i.e. 60601-2-2, 60601-2-18 and AAMI HF 18(same as 60601-2-18)) and are therefore the same" as its predicates. |
| Compliance with electrical safety standards (IEC 60601-2-2 and 606-1-2-18) | Testing has been and/or will be performed prior to product release. |
| Biocompatibility (ISO 10993) | Testing has been and/or will be performed prior to product release. |
| Sterility Assurance (ISO 11135) | Testing has been and/or will be performed prior to product release, including load 3 testing. |
| Functions as a sterile disposable (single use) electrosurgical scissor tip for monopolar cutting and coagulation of tissue. | The document asserts that the device "remains essentially the same as the previously marketed version of this device in both function and indication for use" and that it "functions on the well established methods/characteristics of monopolar high frequency electro-surgery." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document refers to "testing performed to show compliance with stated standards" but does not detail sample sizes for any specific performance tests.
- Data Provenance: Not explicitly detailed. The tests referenced (electrical safety, biocompatibility, sterility) would typically be laboratory-based and controlled, rather than originating from real-world retrospective or prospective clinical data for device performance metrics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable/not specified. This type of submission relies on engineering and laboratory testing for compliance with standards, not expert-adjudicated ground truth as would be common in diagnostic AI studies.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not specified, as there is no mention of a human-adjudicated test set. Tests are likely based on objective measurements against defined standard limits.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No. This is a premarket notification for a surgical instrument, not a diagnostic AI system, and therefore, MRMC studies are not relevant or conducted for this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a surgical instrument (scissor tips), not an algorithm or AI system. Its performance is always in conjunction with a human surgeon and an electrosurgical unit.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this device's performance is compliance with established national and international standards for electrical safety, biocompatibility, and sterility, as well as functional equivalence to predicate devices (e.g., successful cutting and coagulation in a lab setting). It is based on controlled laboratory testing and adherence to engineering specifications and regulatory standards, not expert consensus, pathology, or outcomes data in the traditional sense of a diagnostic medical device study.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a physical surgical instrument. It does not have a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this device.
§ 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.