(64 days)
The intended use of the ETHICON Bipolar Scissor is to cut and coagulate soft tissue in open surgical procedures.
The ETHICON Bipolar Scissors are non-sterile, reusable devices intended to facilitate cutting and bipolar coagulation of soft tissue in open surgical procedures.
The ETHICON Bipolar Scissors are available in various standard sizes and shapes similar to conventional surgical scissors. These scissors can be connected to the bipolar output mode on electrosurgical generators to facilitate dissection, transection, and bipolar coagulation.
The ETHICON Bipolar Scissors are designed for use with the ETHICON Bipolar Cable (Accessory). The ETHICON Bipolar Cable is used to connect the ETHICON Bipolar Scissors to the generator (ESU).
The provided text describes a medical device, the ETHICON Bipolar Scissors and Accessory Cable, and its claim of substantial equivalence to a predicate device. However, it does not contain the specific information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria.
Here's why and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance: This information is not present. The document states "Preclinical laboratory and benchtop evaluations (complies with ANSI/AAMI HF-18) were performed to ensure that the device functions as intended," but it does not list specific criteria or performance metrics.
2. Sample Size Used for the Test Set and Data Provenance: This information is not provided. The document mentions "pre-clinical and benchtop testing," but no details on sample size, type of test specimens, or their origin are given.
3. Number of Experts Used to Establish Ground Truth and Qualifications: This is not applicable as there is no mention of an expert-adjudicated test set or ground truth establishment in this context.
4. Adjudication Method: Not applicable due to the lack of an expert-adjudicated test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This was not done. The document explicitly states "Clinical data was deemed unnecessary to support the Premarket Notification."
6. Standalone (Algorithm Only) Performance: This is not applicable as the device is a physical surgical instrument, not an AI algorithm.
7. Type of Ground Truth Used: Not applicable. The "ground truth" for a physical device would typically be defined by engineering specifications and performance standards, which are referred to implicitly by "complies with ANSI/AAMI HF-18" but not explicitly detailed.
8. Sample Size for the Training Set: Not applicable. There is no mention of a training set as this is not an AI/algorithmic device.
9. How the Ground Truth for the Training Set was Established: Not applicable.
In summary, the provided text describes the device, its intended use, and indicates that it underwent pre-clinical and benchtop testing in compliance with a standard (ANSI/AAMI HF-18) to ensure it functions as intended. However, it does not detail specific acceptance criteria, performance metrics, or the methodology of a study that would demonstrate meeting those criteria in the way a diagnostic or AI device submission would.
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SECTION 7
SUMMARY OF SAFETY AND EFFECTIVENESS
| 510(k) Summary of Safety and Effectiveness | Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency. |
|---|---|
| NEW DEVICE NAME ETHICON Bipolar Scissors and Accessory Cable | |
| PREDICATE DEVICE NAME: EVERSHEARS II Bipolar Laparoscopic Scissors | |
| 510(K) SUMMARY | |
| Device Description | The ETHICON Bipolar Scissors are available in various standard sizes and shapes similar to conventional surgical scissors. These scissors can be connected to the bipolar output mode on electrosurgical generators to facilitate dissection, transection, and bipolar coagulation. |
| The ETHICON Bipolar Scissors are designed for use with the ETHICON Bipolar Cable (Accessory). The ETHICON Bipolar Cable is used to connect the ETHICON Bipolar Scissors to the generator (ESU). | |
| Intended Use | The intended use of the ETHICON Bipolar Scissor is to cut and coagulate soft tissue in open surgical procedures. |
| Continued on next page |
ETHICON Bipolar Scissors and Accessory Cable ETHICON, Inc.
K
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SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
| IndicationsStatement | The ETHICON Bipolar Scissors are non-sterile, reusable devicesintended to facilitate cutting and bipolar coagulation of soft tissuein open surgical procedures. |
|---|---|
| TechnologicalCharacteristics | The new device is technologically the same as the predicateexcept that the device is not designed for endoscopic procedures.This difference does not raise any new questions of safety andeffectiveness. |
| Performance Data | Preclinical laboratory and benchtop evaluations (complies withANSI/AAMI HF-18) were performed to ensure that the devicefunctions as intended. Clinical data was deemed unnecessary tosupport the Premarket Notification. Sufficient data has beengathered from pre-clinical and benchtop testing to assess thesafety and effectiveness characteristics of the new device. |
| Conclusions | Based on the 510(k) summaries and 510(k) statements (21 CFR807) and the information provided herein, we conclude that thenew device is substantially equivalent to the Predicate Deviceunder the Federal Food, Drug and Cosmetic Act. |
| Contact | John D. Paulson, Ph.DDirector, Regulatory AffairsETHICON, Inc.Rt. #22 WestSomerville, NJ 08876-0151 |
| Date | January 31, 1996 |
6
§ 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.