(221 days)
The Kepler MedTec Disposable Bipolar Cables are intended to connect an electrosurgical device to an electrosurgical generator. They are indicated for use with bipolar forceps during general surgical procedures.
The Kepler MedTec Disposable Bipolar Cable includes available in multiple colors. The Kepler MedTec Disposable Bipolar Cable is provided sterile.
Bipolar forceps (handpiece) are connected to a generator through a bipolar cable. The bipolar cable is flexible and delivers the electrical power from the generator to the binolar forcep. There is a male and female end termination on the cable. The male end termination (2-pin banana connector) is connected to the generator; the female end termination (2-pin plug type connector) to the bipolar forceps.
The Kepler MedTec Disposable Bipolar Cable is compatible with:
- Bipolar Forceps using standard US connection with 5.8 mm spaced pins .
- . VallyLab, Conmed, Medtronic and Bovie generators
The provided text describes a 510(k) premarket notification for a medical device, the Kepler MedTec Disposable Bipolar Cable. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials for efficacy.
Here's a breakdown of the acceptance criteria and the "study" (which in this case is primarily a comparison) that proves the device meets those criteria, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstration of Substantial Equivalence to Predicate) | Reported Device Performance (Kepler MedTec Disposable Bipolar Cable) |
|---|---|
| Intended Use/Indications for Use: Connecting an electrosurgical device to an electrosurgical generator; indicated for use with bipolar forceps during general surgical procedures. | Intended Use/Indications for Use: "Are intended to connect an electrosurgical device to an electrosurgical generator. Indicated for use with bipolar forceps during general surgical procedures." (Matches predicate) |
| Patient Usage: Single use disposable, provided sterile. | Patient Usage: "Single use disposable provided sterile." (Matches predicate) |
| Cable Length: Not explicitly an "acceptance criterion" but a feature for comparison. | Cable Length: 3660 mm (Equivalent to predicate's 366 cm). |
| Electrical Safety/EMC Compliance: IEC 60601-2-2 compliant. | Electrical Safety/EMC Compliance: "IEC 60601-2-2 compliant." Also explicitly stated: "Compliant with IEC 60601-2-2 (2006): Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment." (Matches predicate) |
| Sterilization Compliance: | "For EtO sterilization, compliant with ANSI/AAMI ISO 10993-7; ISO 11135-1; ISO 11137-1; ISO 11138-1" |
| Biocompatibility: | "Biocompatible" |
| Compatibility: | Compatible with "Bipolar Forceps using standard US connection with 5.8 mm spaced pins" and "VallyLab, Conmed, Medtronic and Bovie generators." (Implied acceptance criteria to function with common equipment) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of clinical testing. This submission did not involve a "test set" in the sense of patient data or clinical samples.
- Data Provenance: Not applicable. The "study" for this 510(k) is a comparison of technical specifications and intended use against a legally marketed predicate device, not a clinical data collection.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. Ground truth from experts is typically for diagnostic devices or those requiring expert interpretation of results, which is not the case for a disposable bipolar cable.
4. Adjudication Method for the Test Set
- Not applicable. There was no test set requiring adjudication in this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a MRMC comparative effectiveness study was not done. This type of study is for evaluating the diagnostic or therapeutic effectiveness of a device compared to a standard of care, often with human readers interpreting results. This is beyond the scope of demonstrating substantial equivalence for a disposable cable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No, a standalone (algorithm only) performance study was not done. This device is a passive accessory and does not involve algorithms or human-in-the-loop performance evaluation beyond its basic function of conducting electrical current safely.
7. The Type of Ground Truth Used
- The "ground truth" for this 510(k) submission is the specifications and performance of the legally marketed predicate device (DeRoyal Industries, Inc. - Disposable Bipolar Electrosurgical Cable, K970993). The manufacturer established that the new device's features, intended use, and technical compliance meet or exceed those of the predicate. This is a regulatory "ground truth" rather than a clinical ground truth.
8. The Sample Size for the Training Set
- Not applicable. This device does not involve a "training set" in the machine learning or clinical study sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There was no training set. The "ground truth" for showing substantial equivalence was established by comparing the Kepler MedTec Disposable Bipolar Cable's specifications and performance to the pre-existing FDA-cleared predicate device (DeRoyal Disposable Bipolar cables). The applicant asserts that the devices share the same intended use, target population, clinical setting, and technology, and that any differences do not raise new issues of safety or effectiveness.
§ 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.