(241 days)
Bipolar Micro-Coagulation Forceps are intended to remove tissue and control bleeding.
Bipolar Micro-Coagulation Forceps are electrosurgical tools available with different handles and different tip designs. The Bipolar Micro-Coagulation Forceps can be connected through an appropriate bipolar cable to an electrosurgical generator. The Bipolar Micro-Coagulation Forceps can be disassembled for cleaning and sterilization. The Bipolar Micro-Coagulation Forceps are delivered in unsterile condition and have to be sterilized prior to each use.
This document is a 510(k) premarket notification for the "Bipolar Micro-Coagulation Forceps" by Gunter Bissinger Medizintechnik GmbH. It describes the device and demonstrates its substantial equivalence to a predicate device, K150959, Sutter Bipolar Forceps - Calvian.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as quantitative metrics in the provided document, which is typical for a 510(k) for a Class II electrosurgical device where substantial equivalence to a predicate is the primary goal. Instead, equivalence in various characteristics is demonstrated. The "Result" column typically indicates "Substantially Equivalent," implying that the device's performance aligned with the predicate or relevant standards to demonstrate safety and effectiveness.
| Criteria Category | Specific Characteristic | Predicate Device Performance / Standard | Reported Device Performance / Compliance | Result |
|---|---|---|---|---|
| Indications for Use | Intent to remove tissue and control bleeding | Intended to remove tissue and control bleeding | Intended to remove tissue and control bleeding | Substantially Equivalent |
| Regulation Number | 878.4400 | 878.4400 | 878.4400 | Substantially Equivalent |
| Product Code | GEI | GEI | GEI | Substantially Equivalent |
| Device Class | II | II | II | Substantially Equivalent |
| Prescription / OTC | Prescription | Prescription | Prescription | Substantially Equivalent |
| Device Design | Electrosurgical tools with different handles & tip designs | Electrosurgical tool with different handle styles & tip sizes | Electrosurgical tools with different handles & different tip designs | Substantially Equivalent |
| Material | Stainless Steel, Plastic Material | Stainless Steel, Plastic Material | Stainless Steel, Plastic Material | Substantially Equivalent |
| Tip Size [mm] | 0.35 – 2.8 | 0.7 - 2.5 | 0.35 – 2.8 | Substantially Equivalent |
| Shaft Length [mm] | 15 | 18 | 15 | Substantially Equivalent |
| HF-mode | Bipolar | Bipolar | Bipolar | Substantially Equivalent |
| Maximum peak voltage | 300 Vp | 500 Vp | 300 Vp | Substantially Equivalent |
| Delivered Condition | Unsterile | Unsterile | Unsterile | Substantially Equivalent |
| Single Use | No (Reusable) | No (Reusable) | No (Reusable) | Substantially Equivalent |
| Safety Standard | Meets IEC 60601-2-2 | Meets IEC 60601-2-2 | Meets IEC 60601-2-2 | Substantially Equivalent |
| Biocompatibility | Complies with ISO 10993-1 (Cytotoxicity, Sensitization, Irritation) | Complies with ISO 10993-1 (Cytotoxicity, Sensitization, Irritation) | Passed (Evaluation proofs biological safety) | Substantially Equivalent |
| Electrical Safety | Complies with IEC 60601-1 and IEC 60601-2-2 (Mechanical stability, Insulation, HF leakage/electrical strength, Power frequency) | Complies with IEC 60601-1 and IEC 60601-2-2 | Passed all performed tests | Substantially Equivalent |
| Sterilization/Shelf Life | Validated cleaning & sterilization procedures | Validated cleaning & sterilization procedures | Validated cleaning & sterilization procedures | Substantially Equivalent |
| Thermal Effects | Thermal damage comparable to predicate | Thermal damage comparable to predicate | Functions and characteristics did not display any major difference | Substantially Equivalent |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size (Test Set): The document mentions that "Three different tissue types were used" for evaluating thermal effects. However, it does not specify the number of samples or repetitions for each tissue type, neither does it mention specific patient data. For the other tests (Biocompatibility, Electrical Safety, Sterilization), the sample size typically refers to the number of devices tested to meet the respective standard, which is not explicitly quantified here beyond stating the tests were performed.
- Data Provenance: Not explicitly stated. Given the applicant is in Germany, it's highly likely the testing was conducted in Germany or a location deemed acceptable for gaining regulatory approval. The study type is not specified as retrospective or prospective, but as it involves testing of the physical device it would inherently be "prospective" for the specific tests performed (e.g., electrical safety, thermal effects).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this type of device submission. The submission is for an electrosurgical tool, not an AI/diagnostic device that requires expert review for ground truth establishment. The ground truth for this device is based on physical performance measurements, compliance with international standards (IEC, ISO), and direct comparison to a legally marketed predicate device.
4. Adjudication Method for the Test Set
This information is not applicable for the same reason mentioned above. Adjudication methods like 2+1 or 3+1 are relevant for studies involving human interpretation (e.g., reading medical images) to establish a consensus ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic tools or AI systems where human readers interpret cases. This submission is for a physical surgical instrument.
6. Standalone Performance Study (Algorithm Only)
This information is not applicable. This device is a physical surgical instrument, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Compliance with Recognized Standards: Meeting the requirements of IEC 60601-1, IEC 60601-2-2 for electrical safety, and ISO 10993-1 for biocompatibility. These standards define the acceptable performance and safety limits.
- Direct Comparison to a Legally Marketed Predicate Device: The key "ground truth" or benchmark here is the performance and characteristics of the Sutter Bipolar Forceps - Calvian (K150959). The study aimed to demonstrate that the proposed device performs "as intended" and is "substantially equivalent" to the predicate.
- Laboratory Testing: Directly measuring physical properties, electrical characteristics, and thermal effects in a controlled environment.
8. Sample Size for the Training Set
This information is not applicable. There is no "training set" for this type of medical device as it does not involve machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This information is 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.