(86 days)
BiTech bipolar scissors are designed for dissecting, cutting and bipolar coagulation of tissue during general surgical procedures.
The BiTech Bipolar Scissors has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.
BiTech bipolar scissors enable cutting and dissection with simulataneous bipolar coagulation. They can also be used for precise pinpoint or zone coagulation of blood-vessels and tissue. The various working lengths allow the scissors to be used for a large number of applications in open surgery.
A petented construction priciple, which was developed by Dr. J. Manushakian*, ensures that the scissors are both easy to use and to repair. The electrical contacts for both scissor blades are conducted via one section of the handle, i. e. the connection cable only needs to be attached to one ring, which significantly reduces reference duriong handling. The scissor blades are flexibly joined by means of a standard steel scissor screw which does not need to be insulated and, as a result, is not subject to wear.
The provided document describes a 510(k) notification for the BiTech Bipolar Scissors. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics in the way a novel device might.
Therefore, the document does not contain the detailed information required for the requested output regarding acceptance criteria and the comprehensive study that proves the device meets those criteria. Specifically:
- No specific acceptance criteria are listed for device performance in terms of accuracy, sensitivity, specificity, etc.
- No study is described that details a test set, training set, ground truth establishment, or expert adjudication for performance evaluation.
- There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm-only study.
Instead, the submission relies on demonstrating compliance with recognized performance standards for safety and electrical equipment, and stating substantial equivalence to existing devices.
Here's what can be extracted from the document, tailored to the spirit of your request where possible, but acknowledging the limitations of this type of submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance / Compliance |
|---|---|---|
| Safety - General | DIN EN 60601-1 | Compliant |
| Safety - HF Surgical Equipment | DIN EN 60601-2-2 | Compliant |
| Safety - Electrosurgical Devices | ANSI/AAMI HF18-2001 | Compliant |
| Functionality | Substantial Equivalence to Predicate Devices (Ethicon K981361, Enable K972558) | Device functions as "dissecting, cutting and bipolar coagulation of tissue" similar to predicates. |
| Sterilization | User sterilization via validated steam process (DIN EN 554, 137°C/280°F, 3 bar, min. 15 min) | Device is provided non-sterile and can be sterilized as per specified method. |
| Cleaning/Maintenance | User cleaning via specified enzymatic and non-corrosive agents, soft brush, warm water, rinse, complete dryness. | User instructions provided for cleaning and maintenance. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This submission relies on substantial equivalence and compliance with engineering standards, not on a clinical performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No ground truth establishment by experts for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set described.
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 not an AI-assisted diagnostic device, nor is an MRMC study mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For this type of device and submission, the "ground truth" for safety and efficacy is generally considered to be the established performance and safety record of the predicate devices and compliance with recognized industry standards.
8. The sample size for the training set
- Not applicable. No training set is described.
9. How the ground truth for the training set was established
- Not applicable. No training set is described.
Summary of the Study/Evidence:
The "study" in a 510(k) submission like this is primarily a bench-testing and documentation effort to demonstrate:
- Compliance with recognized electrical and safety standards: DIN EN 60601-1, DIN EN 60601-2-2, and ANSI/AAMI HF18-2001. This would involve testing the device against the specific requirements and clauses within those standards.
- Substantial equivalence to legally marketed predicate devices: Ethicon (K981361) and Enable (K972558). This involves comparing the technological characteristics, intended use, and performance claims of the BiTech Bipolar Scissors to these established predicates. The document implies that the "patented construction principle" and how electrical contacts are conducted are key differentiating features, but these are presented as improvements in usability and repair, not as fundamentally altering the safety or efficacy compared to predicates for the stated intended use.
- Provision of validated user instructions: For cleaning, maintenance, and sterilization, ensuring the device can be safely and effectively prepared for use.
The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device...and have determined the device is substantially equivalent...to legally marketed predicate devices..." This confirms the FDA's acceptance of the manufacturer's demonstration of substantial equivalence based on the provided documentation and compliance with the mentioned standards.
§ 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.