(90 days)
The ECHELON LINEAR™ Cutters have application in gastrointestinal, thoracic, and pediatric surgery for transection, resection, and the creation of anastomoses.
The ECHELON LINEAR™ Cutter delivers two, double-staggered rows of staples while simultaneously dividing the tissue between rows. The instrument has a safety lockout feature that is designed to prevent firing if either no reload or a used reload is installed. An unclamp lockout feature prevents knife exposure by allowing the instrument to open only when the Firing Knob is in the home position. A clamp lockout feature prevents closure of the jaws when the knife is not in the home position. A Staple Retaining Cap on the reload protects the staple leg points during shipping and transportation.
This device may be used on the general population for routine wound closure via stapling.
The 60 mm reload creates a 61 mm staple line and cuts tissue approximately 52 mm beyond the tissue stop.
The 80 mm reload creates an 81 mm staple line and cuts tissue approximately 72 mm beyond the tissue stop.
The 100 mm reload creates a 101 mm staple line and cuts tissue approximately 92 mm beyond the tissue stop.
The instruments are shipped without a reload and must be loaded prior to use. The instrument may be loaded eight times for a maximum of eight firings per instrument during a single procedure.
This document describes the premarket notification (510(k)) for the ECHELON LINEAR™ Cutters, demonstrating its substantial equivalence to a predicate device. As such, the "acceptance criteria" and "device performance" in this context refer to the results of bench and animal testing that demonstrate the new device functions as intended and is safe and effective when compared to existing, legally marketed devices.
It's important to note that this is a 510(k) summary, not a detailed study report. Therefore, some granular details like exact sample sizes for each specific test might not be explicitly stated, but the types of tests and the overall conclusion are provided. The document specifically states that no clinical studies were performed.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission, "acceptance criteria" for performance data typically refers to demonstrating that the new device performs comparably to the predicate device and meets functional requirements (e.g., staple formation, strength, operational forces). The document states that the testing demonstrated substantial equivalence, implying the "acceptance criteria" were met by the "reported device performance."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Bench Testing: | |
| Device Stapling Performance (Formed Staple Height (FSH), Staple Form Quality (SFQ), Staple Line Integrity (SLI)) comparable to predicate. | Performance demonstrated as substantially equivalent to the predicate device. Specific quantitative values for each performance metric are not provided in this summary but would have been demonstrated to be within acceptable ranges or comparable to the predicate. |
| Device Functional Requirements (Force to Close/Clamping Force, Force to Fire, Force to Couple/Decouple Device Halves, Force to Press Clamp Release Button, Human Factor Report) met. | Functional requirements were met. Specific force values or Human Factor report details are not provided in this summary. |
| Product Characterization (Staple line Strength Test) met. | Staple line strength was demonstrated. Specific strength values are not provided. |
| Animal Testing: | |
| Acute Hemostasis achieved. | Acute Hemostasis was successfully evaluated. |
| Appropriate Tissue Healing response observed in Survival Study. | Tissue Healing response was evaluated in survival studies using gastrointestinal and pulmonary models. |
| Biocompatibility: | |
| Biocompatible for intended patient contact profile. | Studies performed and confirmed the device is biocompatible. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Sizes for Test Set (Bench and Animal Testing): The specific sample sizes for each bench test (e.g., number of staples tested for FSH, SFQ, SLI; number of devices for force measurements) and for the animal studies are not explicitly stated in this 510(k) summary. These details would be contained in the full submission, but not in this public summary.
- Data Provenance: Not explicitly stated. For bench and animal testing typically conducted internally or by contract research organizations, the country of origin is usually the manufacturer's location or the location of the testing facility. The data would be considered prospective as it's generated for the purpose of the submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable/not provided in this context. For a device like a surgical stapler, "ground truth" is established through engineering specifications, scientific principles, and established methods for evaluating device performance (e.g., measuring staple dimensions, tensile strength, in-vivo tissue response). There isn't a subjective "expert read" or "adjudication" in the same way there would be for an AI diagnostic algorithm.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. As explained above, for a mechanical device, performance is evaluated against objective, measurable criteria, not subjective expert opinion requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "The premarket submission did not rely on the assessment of clinical performance data to demonstrate device performance and equivalence." This device is not an AI diagnostic tool and does not involve human readers for interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone algorithm study was not done. This device is a mechanical surgical stapler, not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device is based on:
- Engineering specifications and design parameters: For bench testing (e.g., desired staple height, cutting length, force requirements).
- Biomechanical principles: For staple line strength and integrity.
- Physiological outcomes: For animal testing (e.g., hemostasis, tissue healing).
- Comparison to predicate device performance: The core of a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device, implying that the predicate's established safe and effective performance serves as a benchmark for the new device.
8. Sample Size for the Training Set
This information is not applicable/not provided. This is a mechanical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided. As above, there is no "training set" for a mechanical device.
§ 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.