(108 days)
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No
The description focuses on mechanical and electrical functions (stapling, cutting, bipolar coagulation, safety lockout, indicator light) and does not mention any AI/ML components or capabilities.
No
The device is described as a surgical tool for coagulation, transection, and resection of tissue, which are surgical procedures, not therapeutic treatments.
No
The device is described as a surgical tool for coagulation, transection, and resection of tissue, and its description focuses on its mechanical and electrosurgical functions for performing these procedures. There is no mention of it collecting or analyzing data for diagnostic purposes.
No
The device description clearly details physical components such as staples, a cutting mechanism, a safety lockout feature, a staple retaining cap, and an indicator light, indicating it is a hardware device with electrosurgical functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "coagulation, transection, and resection of tissue" during surgical procedures. This describes a device used on the patient's tissue during surgery, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description details a surgical instrument that cuts, staples, and coagulates tissue. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is purely surgical intervention.
N/A
Intended Use / Indications for Use
Intended use: For coagulation, transection, and resection of tissue.
Indications statement: 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.
Product codes
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Device Description
The ENDOPATH® EZ-RF Linear Cutter and Coagulation device: 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Pre-clinical laboratory evaluations were performed to ensure that the device can be used as designed. The studies demonstrated acceptable performance in coagulation, transection, and resection of tissue.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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.
0
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
1
510(k) Summary of Safety and Effectiveness, Continued
| Intended use | For coagulation, transection, and resection of tissue. |
|---|---|
| Indications | |
| statement | 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. | |
| Technological | |
| characteristics | The technological characteristics of the New Device are the same as the ELC and |
| Forceps Predicate Device. | |
| Performance | |
| data | Pre-clinical laboratory evaluations were performed to ensure that the device can be |
| used 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 the |
| information provided herein, we conclude that the New Device is substantially | |
| equivalent to the ELC and Forceps Predicate Devices under the Federal Food, | |
| Drug and Cosmetic Act. | |
| Contact | Lorri (Jones) Chavez |
| Ethicon Endo-Surgery, Inc. | |
| 4545 Creek Road | |
| Cincinnati, Ohio 45242 | |
| Date | April 1, 1996 |