(130 days)
The Echelon Contour™ Curved Cutter with Reload is intended for transection in colorectal surgical procedures.
The Echelon Contour™ Curved Cutter Stapler with reload is a multifire, single patient use device with a curved head that cuts and staples. The device will provide ligation of colorectal structures when permanent ligation is required.
The device delivers four staggered rows of titanium staples, with a knife between the second and third row of staples, and staples and creates a 40 mm curved transection. The device is designed with a feature which prevents closing if a used reload is in the instrument.
Another feature is provided to prevent firing unless the closure trigger is latched in the closed position. A retaining pin holds tissue in place and can be positioned either manually or by squeezing the closure trigger.
The instrument is preloaded with a either a blue or green reload. The instrument may be further loaded for a maximum of six firings per instrument during a single procedure.
Each reload includes a knife blade with two staggered rows of staples on each side, an anvil, a yellow cutting washer, a retaining pin, and a staple retainer.
The provided text describes a 510(k) premarket notification for the "Echelon Contour™ Curved Cutter Stapler with Reload." This device is a surgical stapler, and the supporting documentation focuses on demonstrating its substantial equivalence to a legally marketed predicate device.
The study presented is not for an AI/ML medical device, but rather a traditional medical device (a surgical stapler). Therefore, many of the requested criteria related to AI/ML device studies (such as sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance of an algorithm, etc.) are not applicable to this submission.
The document primarily details bench testing, biocompatibility testing, accelerated aging stability, sterilization, and animal studies to demonstrate substantial equivalence to a predicate device. It explicitly states: "Clinical Studies: This submission does not include data from Clinical Studies."
Here's an attempt to fill out the table and answer the questions based only on the provided text, noting where information is not applicable or not provided.
Acceptance Criteria and Device Performance for Echelon Contour™ Curved Cutter Stapler with Reload
1. Table of Acceptance Criteria and Reported Device Performance (as derived from the text):
| Acceptance Criteria Category | Specific Test/Study | Reported Device Performance |
|---|---|---|
| Bench Testing | Leak Onset Pressure Equivalency | "The new device was shown to have equivalent performance to the predicate device" |
| Formed Staple Height (FSH) Equivalency | "The new device was shown to have equivalent performance to the predicate device" | |
| Staple Line Integrity and Staple Form Quality Equivalency | "The new device was shown to have equivalent performance to the predicate device" | |
| Force to Close | "The new device was shown to have equivalent performance to the predicate device" | |
| Force to Fire | "The new device was shown to have equivalent performance to the predicate device" | |
| Handle Performance Characterization | "The new device was shown to have equivalent performance to the predicate device" | |
| Biocompatibility | ISO Cytotoxicity | "No findings of toxicological concern" |
| ISO Sensitization | "No findings of toxicological concern" | |
| ISO Irritation (Intracutaneous Reactivity) | "No findings of toxicological concern" | |
| ISO Acute Systemic Toxicity | "No findings of toxicological concern" | |
| USP Material Mediated Pyrogenicity | "No findings of toxicological concern" | |
| Stability | Accelerated Aging Stability | "Device performance was maintained for the proposed shelf life." |
| Sterilization | Pyrogen testing | "Minimal to no risk for the staples with respect to the presence of endotoxins." |
| Animal Study | Hemostasis study | "The new device was shown to have equivalent performance to the predicate device" |
| Survival study | "The new device was shown to have equivalent performance to the predicate device" | |
| MR Safety | Non-clinical testing | "Staples in the device are MR conditional." |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for each bench test or animal study. The overall approach is to show "equivalence" to a predicate device, rather than derive absolute performance metrics from a large sample.
- Data Provenance: Not specified in terms of country of origin. The studies are described as "non-clinical data" and "animal study" conducted in accordance with FDA's Good Laboratory Practice Standard (21 CFR 58). It's a regulatory submission for a physical device, not an AI model, so "retrospective or prospective" doesn't directly apply in the usual sense of human clinical data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a medical device (stapler) submission, not an AI/ML device that requires human expert annotation for ground truth. Performance is assessed through physical measurements, chemical tests, and animal models.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 refer to human experts reviewing and agreeing on ground truth in studies involving subjective interpretation (e.g., image analysis for AI). This device relies on objective measurements in bench and animal studies to demonstrate equivalence.
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:
- Not Applicable. This is not an AI/ML device, nor is it a study involving human readers or comparative effectiveness in diagnosing or interpreting medical images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This category applies to AI algorithms. This submission is for a physical surgical stapler.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the bench tests: "Ground truth" is established by standard engineering and mechanical test methodologies (e.g., force measurements, physical dimensions of staples, pressure leakage tests).
- For biocompatibility: Adherence to ISO standards and toxicology findings.
- For animal studies: Physiological outcomes (hemostasis, survival) in animal models compared to the predicate device.
- No "expert consensus," "pathology," or "outcomes data" in the typical clinical study sense described for ground truth.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established:
- Not Applicable. As above, no training set for an AI/ML model.
§ 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.