(144 days)
The ETHICON™ 4000 Staplers and ETHICON™ 3D Reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement materials.
The ETHICON™ 4000 Stapler and ETHICON™ 3D Reloads are sterile, singlepatient-use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. Together, the ETHICON™ 4000 60 mm Staplers and ETHICONTM 3D Reloads deliver 3D staples in the first, second, fifth and sixth rows of staples. The third and fourth rows (nearest the knife) maintain the traditional 2D B-formed staples.
ETHICON™ 4000 60 mm Staplers have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. The Subject stapler device is available in three different shaft lengths - Compact, Standard and Long. The shaft can rotate freely in both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site. The device is packaged with a primary lithium Battery Pack that must be installed prior to use. There is embedded software to articulate and initiate firing of the device.
The instruments are packaged without a reload and must be loaded prior to use. The instrument may be reloaded for a maximum of 12 firings during a single procedure. A Staple Retaining Cap on the reload protects the staple leg points during shipping and transportation. The instruments' lockout feature is designed to prevent a used or improperly installed reload from being re-fired or an instrument from being fired without a reload.
The staples are permanent implants that provide tissue closure and apposition from the time of implant through the critical phases of healing. The staples remain in place for the patient's lifetime, unless in the opinion of the treating physician, they require removal.
The Subject stapler and reloads will not be compatible with previous ECHELON™ staplers and reloads. This is a new platform that will work with 3D reloads only.
This 510(k) summary is for the ETHICON™ 4000 60mm Staplers and ETHICON™ 3D 60mm Reloads. It focuses on non-clinical testing to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list a table of acceptance criteria with corresponding performance metrics for the reasons stated below. Instead, it indicates that the devices either met or improved upon the predicate devices' performance, or passed functional requirements.
| Test Type | Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|---|
| Staple Performance Bench Testing | Equivalent to or improved compared to predicate devices | Performed staple performance equivalence bench testing compared to the predicate, and performed at least equivalently or showed improved performance. |
| Device Functional Performance | Met functional requirements of the subject device features | Performed device functional performance bench testing and passed the functional requirements. |
| Staple Line Strength | Demonstrated characteristics comparable to predicate devices | Performed staple line strength product characterization of Subject and Predicate devices, implying comparable strength or meeting specified criteria, though specific metrics are not provided. |
| Biocompatibility | Compliant with ISO 10993-1 | Biocompatibility evaluation was performed according to ISO 10993-1. |
| Hemostasis Performance | Acceptable hemostasis performance in pre-clinical models (details not provided) | Pre-clinical data including hemostasis performance was collected in abdominal and thoracic procedures. Result deemed acceptable to demonstrate substantial equivalence, though specific metrics and acceptance levels are not given. |
| Tissue Healing Response | Acceptable tissue healing response in pre-clinical models (details not provided) | Pre-clinical data including tissue healing response was collected in abdominal and thoracic procedures. Result deemed acceptable to demonstrate substantial equivalence, though specific metrics and acceptance levels are not given. |
| Human Factors | Met human factors engineering requirements (details not provided) | Human Factors testing report was included. |
| 3D Staple Design Safety/Efficacy | Safe and effective staple formation with the 3D staple design, as demonstrated by testing vs. reference devices and meeting acceptance criteria. | The same stapling performance tests were conducted on the Subject and reference devices (with 3D staple design), and all met their respective acceptance criteria. This demonstrates safe and effective staple formation with the 3D staple design. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for the test sets used in the non-clinical studies (e.g., staple performance, functional performance, staple line strength, hemostasis, tissue healing).
The data provenance is from non-clinical studies, which implies laboratory or animal testing rather than human subject data. Pre-clinical data for hemostasis and tissue healing response were conducted in "Abdominal and Thoracic procedures," indicating animal models.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the evaluation relies on non-clinical (bench and pre-clinical animal) testing and not on expert interpretation of human clinical data or images. Ground truth, in this context, would be established by objective measurements and scientific protocols.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation relies on non-clinical testing, not subjective assessments that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study was not done. This device is a surgical stapler and reload system, not an AI-assisted diagnostic or interpretive device that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a surgical stapler, which is a physical medical instrument, not an algorithm or software-only device.
7. The type of ground truth used
The ground truth for the non-clinical tests would be established through:
- Objective Measurements: For staple performance, functional performance, and staple line strength, measurements of physical properties (e.g., staple formation, closure force, staple line integrity, burst pressure) would serve as ground truth, compared against pre-defined engineering specifications or predicate performance.
- Histopathology/Pathology and Physiological Measurements: For hemostasis and tissue healing response in pre-clinical animal studies, ground truth would be established through direct observation, macroscopic assessment, histological examination (pathology), and physiological measurements relevant to bleeding control and tissue repair.
- Compliance with Standards: For biocompatibility, ground truth is compliance with the requirements of ISO 10993-1.
8. The sample size for the training set
This information is not applicable. The device is a physical surgical instrument, not an AI/ML algorithm that requires a "training set." The development process would involve extensive engineering design, prototyping, and iterative testing, but not a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.