(407 days)
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Single Use Hand Switch Monopolar Forceps with Smoke Evacuation (CD954)
The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery. -
Single Use Hand Switch Bipolar Forceps with Smoke Evacuation (CD955)
The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery. -
Single Use Hand Switch Monopolar Forceps (CD956)
The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure. -
Single Use Hand Switch Bipolar Forceps (CD957)
The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure.
Modern Medical Electrosurgical Monopolar Forceps and Bipolar Forceps have been designed as active electrosurgical instruments to grasp, manipulate coagulate selected soft tissue. These stainless steel forceps are connected through a suitable active electrosurgical cable (monopolar or bipolar) to the specified output terminal of an electrosurgical generator. The forceps are intended for use with rated accessory voltage of 2.0kVp. The forceps are offered sterile (EtQ) and either as with or without smoke evacuation system which include four models, such as CD954, CD955, CD956 and CD957.
The provided document is a 510(k) premarket notification from the FDA for Monopolar and Bipolar Forceps. It details the device's characteristics and its substantial equivalence to previously cleared predicate devices. Crucially, this document is for electrosurgical cutting and coagulation devices and accessories, not an AI/ML-driven medical device. Therefore, the concepts of acceptance criteria for AI models, such as sample size for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, and training set information, are not applicable to this submission.
The document focuses on demonstrating that the new device is as safe and effective as its predicate devices, primarily through comparative performance testing data (physical, electrical, and biological properties) rather than algorithmic performance.
Here's a breakdown of the relevant information provided in the document:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present acceptance criteria in a formal table with quantitative targets for "performance" as one might expect for an AI/ML model (e.g., accuracy, sensitivity, specificity). Instead, "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices across various characteristics. The "reported device performance" is the demonstration that these characteristics are equivalent, or that any differences do not raise new safety or effectiveness concerns.
The tables (e.g., Table 1, Table 2) present a Side-by-Side Comparison (Subject-Predicate Comparison) for different models of the proposed device against their respective predicate devices. The "Result" column indicates "Equivalent" or "Not Equivalent." For items marked "Not Equivalent," an explanation is provided to argue why this difference does not impact safety or effectiveness.
Examples from the tables:
| Compared Items | Proposed Device (K210315) Performance | Predicate Device Performance | Result | Comments on difference/equivalent evidence |
|---|---|---|---|---|
| Classification Name | Electrosurgical, Cutting and Coagulation Accessories | Electrosurgical, Cutting and Coagulation Accessories | Equivalent | |
| Regulation | 878.4400 | 878.4400 | Equivalent | |
| Intended use | The device is intended to be used as active electrosurgical devices where monopolar electrosurgical coagulation is desired during surgery and are intended to grasp, manipulate coagulate selected soft tissue. | The OLSEN Medical Electrosurgical Monopolar and Bipolar Forceps are intended to be used as active electrosurgical devices where monopolar or bipolar electrosurgical cutting and coagulation is desired during surgery and are intended to grasp, manipulate cut or coagulate selected soft tissue. | Equivalent | Evidence: IFU (Indications for Use). The slight difference in wording ("cut or coagulate" vs. "coagulate") is addressed by demonstrating the proposed device still falls within the established use of similar devices. |
| Sterility | ETO | Irradiation (Predicate K032327), or ETO (Predicate K200372) | Equivalent | ETO sterilization validation have been done for this device. Evidence: EO validation report number R-EO2011; Evidence: IFU. (The document states ETO validation for the proposed device and compares it to both ETO and Irradiation from predicates, concluding equivalence based on validated process.) |
| Tip Material | Stainless Steel | Stainless Steel | Equivalent | Evidence: Material Technical Data Sheet. |
| Size (distal tips) | 0.1-1.2mm | 0.5-1.5mm (K130669) | ||
| 0.5-2.0mm (K032327) | Not Equivalent | Tip Size doesn't increase any risk for the product. Evidence: Simulation test report 956MVPE1N-2111123R; Evidence: IFU. (This is a key example of a difference being justified.) | ||
| Electrical Safety Testing | IEC 60601-2-2 | IEC 60601-2-2 | Equivalent | Evidence: DSS_GZES200802563702-IEC 60601-2-2. (Demonstrates compliance with relevant electrical safety standards). |
| Functionality | With smoke evacuation (for specific models) | Without smoke evacuation (K032327) | Not Equivalent | The smoke evacuation is a feature that be added to the forceps to increase convenience of functionality, without altering the intended use or risk profile (relative to a predicate) of the proposed device. Instead, smoke evacuation functionality. Evidence: Simulation test report. 955MVPE1N-2111121F. (Another key example of a new feature being justified as not raising new safety/effectiveness concerns). |
| Shelf life | 3 years | 3 years | Equivalent | Evidence: Labeling. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify a "test set" in the context of an AI/ML model with a specific sample size of cases (e.g., images). Instead, it refers to performance testing on the physical device:
- "Performance Testing included comparative device use on porcine tissue: kidney, liver and muscle for both Cut mode and Coagulation mode..."
- This indicates prospective in-vitro/ex-vivo testing rather than data from human subjects.
- The origin of the tissue (e.g., country) is not specified.
- The "sample size" would likely refer to the number of porcine tissue samples or the number of tests performed, which is not numerically detailed but implied to be sufficient for the required validation per the referenced FDA guidance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not applicable to this type of device submission. Ground truth for an electrosurgical device typically comes from:
- Engineering specifications and measurements: e.g., electrical safety tests, material properties.
- Established biological models: e.g., the observed effect of electrosurgical current on porcine tissue.
- Compliance with recognized consensus standards: e.g., ISO, IEC standards for sterility, biocompatibility, electrical safety.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no human interpretation or subjective assessment of "cases" that would require an adjudication method. The performance tests are objective measurements (e.g., resistance levels, temperature, visible coagulation effects that meet predefined criteria).
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:
Not applicable. This is a medical device, not an AI/ML-driven diagnostic or assistive system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. There is no standalone algorithm. The device is a physical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is established through:
- Compliance with recognized standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2 for electrical safety, ISO 11135:2014/AMD 1:2018 for sterility, ISO 10993 series for biocompatibility.
- Comparative functional testing: Performance tests on porcine tissue to demonstrate similar coagulation/cutting effects as the predicate devices.
- Material and design specifications: Data sheets for materials, design drawings, and manufacturing processes ensure the device is constructed as intended and is equivalent to predicates.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device. There is no concept of a "training set."
9. How the ground truth for the training set was established:
Not applicable. As there is no training set, there is no ground truth for it to establish.
§ 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.