(108 days)
For coagulation, transection, and resection of tissue. The ENDOPATH® EZ-RF Linear Cutter and Coagulation device has applications in open and minimally invasive surgical procedures for coagulation, transection, and resection of tissue. The bipolar feature is to be used only with the ERBE ERBOTOM ICC 350 or the Valleylab Force 2 electrosurgical generators.
delivers a line of bipolar coagulation . followed by two double-staggered rows of staples . . while simultaneously dividing the tissue. A safety lockout feature is incorporated into the cartridge. The line of bipolar coagulation delivered is approximately 37mm long with a 37mm staple line length, and a cut length of 35mm. A staple retaining cap on the cartridge protects the staples during shipping and transportation. The instrument is reloadable with a universal cartridge and is acceptable for use on tissue which can be compressed to a thickness of 2.0mm or less. The instrument is designed to be reloaded seven times for a maximum of eight firings per instrument. The ENDOPATH® EZ-RF Linear Cutter and Coagulation device is designed to have an integral Indicator Light on the Linear Cutter or an external Indicator Light device. The Linear Cutter connects to an RF electrosurgical generator with an integrated cord from the Linear Cutter to the generator or the external Indicator Light device. The Indicator Light device illuminates when current is flowing above a reference current threshold.
This is not an AI/ML medical device. The provided text describes a surgical stapler and coagulation device, the ENDOPATH® EZ-RF Linear Cutter and Coagulation device, and its pre-clinical laboratory evaluations. It does not mention any AI or machine learning components, nor does it present any acceptance criteria or studies related to AI/ML performance.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, or AI/MRMC study results, as these concepts are not applicable to the provided device description.
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11 11 1996 Appendices 510(k) Summary of Safety and Effectiveness (App. A) Information supporting claims of substantial equivalence, as defined under the Federal Statement 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. Device The ENDOPATH® EZ-RF Linear Cutter and Coagulation device: description delivers a line of bipolar coagulation . followed by two double-staggered rows of staples . . while simultaneously dividing the tissue. A safety lockout feature is incorporated into the cartridge. The line of bipolar coagulation delivered is approximately 37mm long with a 37mm staple line length, and a cut length of 35mm. A staple retaining cap on the cartridge protects the staples during shipping and transportation. The instrument is reloadable with a universal cartridge and is acceptable for use on tissue which can be compressed to a thickness of 2.0mm or less. The instrument is designed to be reloaded seven times for a maximum of eight firings per instrument. The ENDOPATH® EZ-RF Linear Cutter and Coagulation device is designed to have an integral Indicator Light on the Linear Cutter or an external Indicator Light device. The Linear Cutter connects to an RF electrosurgical generator with an integrated cord from the Linear Cutter to the generator or the external Indicator Light device. The Indicator Light device illuminates when current is flowing above a reference current threshold. Specific generators for use with this instrument include the ERBE ERBOTOM ICC 350 and Valleylab Force 2 electrosurgical generators (see Appendix G). New generators will be added to the labeling as they pass the appropriate qualifications. Any specific instructions/details for use with additional ESG's will also be added to the labeling. Continued on next page
ETHICON ENDO-SURGERY, INC. ENDOPATH® EZ-RF Linear Cutter and Coagulation device
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510(k) Summary of Safety and Effectiveness, Continued
| Intended use | For coagulation, transection, and resection of tissue. |
|---|---|
| Indicationsstatement | The ENDOPATH® EZ-RF Linear Cutter and Coagulation device has applications inopen and minimally invasive surgical procedures for coagulation, transection, andresection of tissue. The bipolar feature is to be used only with the ERBE ERBOTOMICC 350 or the Valleylab Force 2 electrosurgical generators. |
| Technologicalcharacteristics | The technological characteristics of the New Device are the same as the ELC andForceps Predicate Device. |
| Performancedata | Pre-clinical laboratory evaluations were performed to ensure that the device can beused as designed. The studies demonstrated acceptable performance in coagulation,transection, and resection of tissue. |
| Conclusion | Based on the 510(k) summaries and 510(k) statements (21 CFR §807) and theinformation provided herein, we conclude that the New Device is substantiallyequivalent to the ELC and Forceps Predicate Devices under the Federal Food,Drug and Cosmetic Act. |
| Contact | Lorri (Jones) ChavezEthicon Endo-Surgery, Inc.4545 Creek RoadCincinnati, Ohio 45242 |
| Date | April 1, 1996 |
§ 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.