(27 days)
The MicroCutter XCHANGE™30 is intended for use in multiple open or minimally invasive surgical procedures for the transection, resection, and/or creation of anastomoses in small and large intestine as well as the transection of the appendix.
The MicroCutter XCHANGE™ 30 Stapler is a single patient use stapler that delivers two, double staggered rows of 316L stainless steel staples while simultaneously transecting tissue between staple rows. The MicroCutter XCHANGE™ 30 White Cartridge is available for deployment with the MicroCutter XCHANGE ™ 30 Stapler and delivers a staple (2.8mm) compatible with tissue that can be compressed to 1.0mm. The staple line is approximately 30mm long with a transection length of approximately 27mm.
Here's a breakdown of the acceptance criteria and study information for the MicroCutter XCHANGE™ 30 White Cartridge, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary for the MicroCutter XCHANGE™ 30 White Cartridge (K140170) positions the device as substantially equivalent to the predicate MicroCutter XCHANGE™ 30 Blue Cartridge (K132581). Therefore, the "acceptance criteria" are generally defined by demonstrating equivalence or non-inferiority to the predicate for critical performance parameters.
| Feature / Acceptance Criteria | Reported Device Performance (MicroCutter XCHANGE™ 30 White Cartridge) | Notes / Comparison to Predicate |
|---|---|---|
| Staple Material | Stainless steel (316L) | Same as predicate device. |
| Staple Thickness | 0.19mm | Same as predicate device. |
| Unformed Staple Height | 1.82mm | Predicate: 1.83mm. Very similar. |
| Unformed Staple Primary Tine Length | 1.81mm | Predicate: 3.43mm. This is a significant difference and a primary distinguishing feature of the White Cartridge. |
| Unformed Staple Secondary Tine Length | 0.30mm | Predicate: 0.56mm. Another significant difference. |
| Formed Staple Height | 1.16mm | Predicate: 1.4mm. Consistent with the intended use for thinner tissue. |
| Formed Staple Configuration | D shaped | Same as predicate device. |
| Intended tissue thickness compatibility | Compatible with tissue thickness that can be compressed easily to 1.00mm | Predicate: Compatible with tissue thickness that can be compressed easily to 1.50mm. This is a key functional difference and the ultimate purpose of the White Cartridge. |
| Staple Line Configuration | Two (2), double-staggered rows | Same as predicate device. |
| Staple Line Length | 30mm | Same as predicate device. |
| Number of Staples Per Deployment | 50 (One row of 13 and one row of 12 on either side of transaction line) | Same as predicate device. |
| MRI Compatibility | MR-Conditional | Same as predicate device. |
| Staple Cartridge Insert Material | Vectra A130 Liquid Crystal Polymer (LCP) with no colorant, and Stainless Steel | Predicate: Vectra A130 LCP with VG3010K20 Blue colorant, and Stainless Steel. Key physical change (colorant removal) and functional change (index ridge). |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Toxicity, Hemocompatibility) | Met acceptance criteria in accordance with ISO 10993-1. | Same as predicate device. |
| Packaging | Tyvek and Nylon/LDPE/HDPE coextrusion film Pouch | Same as predicate device. |
| Sterilization | Gamma radiation | Same as predicate device. |
| Sterility Assurance Level | 10^-6 | Same as predicate device. |
| Shelf Life | 12 months | Same as predicate device. |
| Tissue Leak Pressure (Bench) | Non-inferior and substantially equivalent to the predicate Blue Staple Cartridge | Quantitative data not provided, but stated as meeting the criterion of non-inferiority/equivalence. This is a critical functional performance criterion for stapling devices. |
| Staple line pull-apart strength | 11.5 +/- 1.2 lb. | Predicate: 8.2 +/- 0.9 lb. The subject device performed significantly better in this bench test, indicating improved strength for thinner tissue application. This meets or exceeds the implicit acceptance criterion of performing adequately for the intended tissue thickness. |
| Reliability | Demonstrated device performance and strength meets design specification post-gamma sterilization, transit conditioning, environmental conditioning, and accelerated aging. | Implies successful completion of various stress tests to ensure durability and functionality over time and use conditions. |
| Shelf Life Testing | Passed in accordance with ASTM F1980. | Confirms the stated 12-month shelf life. |
| Pre-clinical Evaluation (small intestinal anastomoses in juvenile pigs) | Demonstrated substantial equivalence to the predicate Blue Staple Cartridge. | This is an in-vivo evaluation of the device's functional performance in a relevant biological model. The acceptance criterion is substantial equivalence to the predicate. |
Summary of Studies that Prove the Device Meets Acceptance Criteria:
The device's acceptance is primarily based on a combination of bench testing and a pre-clinical animal study, demonstrating substantial equivalence to the predicate device, especially in its adapted functionality for thinner tissues.
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Bench Testing: The document does not specify the exact sample sizes for each bench test (e.g., reliability, sterility, packaging, pull-apart strength). It typically involves a sufficient number of units to demonstrate statistical significance and consistency, but specific numbers are not disclosed in this summary.
- Animal Study: The document states a "chronic, pre-clinical evaluation of small intestinal anastomoses created in juvenile pigs." The number of animals used is not specified in the summary.
- Data Provenance: Not specified, but generally, such studies are conducted in a controlled laboratory or vivarium setting. It's prospective in nature for the tests conducted.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This device is a medical stapler, not an AI/imaging device requiring expert interpretation of results to establish ground truth in the same way. The "ground truth" for its performance is objective physical and biological measurements (e.g., staple height, pull-part strength, leak pressure, integrity of anastomoses).
- For the animal study, veterinarians and potentially veterinary pathologists would have been involved in assessing the anastomoses and animal health, serving as the "experts" in evaluating the biological outcomes. Their specific number and qualifications are not detailed.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable in the context of this device. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical image interpretation or diagnostic studies where subjective expert opinion is harmonized. Here, the "ground truth" is based on direct measurements and observed biological outcomes.
-
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 device is a mechanical surgical instrument, not an AI-based diagnostic tool or an assist system for human readers.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm. Its performance is evaluated through direct bench and animal testing.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Bench Testing: Mechanical measurements (e.g., length, thickness), material properties, tensile strength (pull-apart), leak pressure. These are objective engineering and physical measurements.
- Animal Study: Biological outcomes, specifically the integrity and healing of "small intestinal anastomoses." This would involve macroscopic and potentially microscopic (pathology) evaluation of the surgical sites and animal health outcomes.
-
The sample size for the training set
- Not applicable. This is a traditional mechanical medical device, not a machine learning or AI-based system that requires a "training set." The design and manufacturing processes are refined through engineering, prototyping, and iterative testing, not through data-driven training algorithms.
-
How the ground truth for the training set was established
- Not applicable, as there is no "training set" in the context of an AI/ML device. The "ground truth" for the device's design and engineering is established through established engineering principles, material science, and prior knowledge from predicate devices and surgical practice.
§ 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.