(64 days)
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Not Found
No
The document describes a standard bipolar surgical scissor and cable, with no mention of AI, ML, image processing, or data-driven performance metrics.
No.
The device is used to cut and coagulate soft tissue in open surgical procedures, which are surgical interventions, not therapeutic treatments.
No
The device is described as a surgical tool used to cut and coagulate tissue during open surgical procedures, which are therapeutic actions, not diagnostic ones. Its function is to perform physical alterations to tissue and not to provide information for diagnosis.
No
The device description clearly states it is a physical surgical instrument (scissors) that connects to an electrosurgical generator via a cable. It is a hardware device, not software only.
Based on the provided information, the ETHICON Bipolar Scissor is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "cut and coagulate soft tissue in open surgical procedures." This describes a surgical instrument used directly on the patient's tissue during a procedure.
- Device Description: The description details a surgical tool that connects to an electrosurgical generator to perform cutting and coagulation. This is consistent with a surgical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition. IVDs are used to diagnose diseases or conditions based on the analysis of biological samples.
Therefore, the ETHICON Bipolar Scissor is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
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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).
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
soft tissue
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Preclinical laboratory and benchtop evaluations (complies with ANSI/AAMI HF-18) were performed to ensure that the device functions as intended. Clinical data was deemed unnecessary to support the Premarket Notification. Sufficient data has been gathered from pre-clinical and benchtop testing to assess the safety and effectiveness characteristics of the new device.
Key Metrics
Not Found
Predicate Device(s)
EVERSHEARS II Bipolar Laparoscopic Scissors
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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大960476
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
1
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
| Indications
Statement | The ETHICON Bipolar Scissors are non-sterile, reusable devices
intended to facilitate cutting and bipolar coagulation of soft tissue
in open surgical procedures. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | The new device is technologically the same as the predicate
except that the device is not designed for endoscopic procedures.
This difference does not raise any new questions of safety and
effectiveness. |
| Performance Data | Preclinical laboratory and benchtop evaluations (complies with
ANSI/AAMI HF-18) were performed to ensure that the device
functions as intended. Clinical data was deemed unnecessary to
support the Premarket Notification. Sufficient data has been
gathered from pre-clinical and benchtop testing to assess the
safety and effectiveness characteristics of the new device. |
| Conclusions | Based on the 510(k) summaries and 510(k) statements (21 CFR
807) and the information provided herein, we conclude that the
new device is substantially equivalent to the Predicate Device
under the Federal Food, Drug and Cosmetic Act. |
| Contact | John D. Paulson, Ph.D
Director, Regulatory Affairs
ETHICON, Inc.
Rt. #22 West
Somerville, NJ 08876-0151 |
| Date | January 31, 1996 |
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