(28 days)
The iDrive™ Ultra powered handle and Endo GIA™ single used with Endo GIA™ single use reloads have applications in abdominal, graecological, pediatric, and thoracic surgery for resection, and creation of anastomosis. It may be used for transection and resection of liver substance, and biliary structures and for transection and resection of pancess.
The iDrive™ Ultra powered handle and Endo GLA™ adapter, when used with Endo GLA™ curved tip single use used to blunt dissect or separate target tissue from other certain tissue.
The iDrive™ Ultra powered handle and Endo GIA™ adapter, when used with the Endo GIA™ Rodial Reload with Tri-Staple™ Technology, has applications in open or minimally invasive general stoominal, gynesologic, pediative and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, it.e. low anterior resection. It may be used for transection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
The Endo GIA™ Extra Long Adapter (EGIAADAPTXL) is a longer version of our currently cleared Endo GIA™ Standard Adapter (EGIAADAPT).
The Endo GIA™ adapter converts the rotary output of the iDrive™ Ultra powered handle to linear motion, enabling compatibility with all Endo GIA™ stapling reloads units.
The iDrive™ Ultra powered handle and Endo GIA™ adapter are multi-patient reusable devices. The devices will deactivate after reaching the end of their service life.
Here's an analysis of the acceptance criteria and study for the device, based on the provided text:
Acceptance Criteria and Device Performance
The provided document describes a Special 510(k) Premarket Notification for a modified medical device. In this context, "acceptance criteria" and "device performance" are primarily focused on demonstrating substantial equivalence to a previously cleared predicate device, rather than establishing de novo performance targets. The criteria for demonstrating substantial equivalence are typically based on showing that the new device performs as safely and effectively as the predicate, especially given that the changes are minor (in this case, an "Extra Long Adapter" for an existing powered stapler system).
Here's a table summarizing the characteristics compared and the stated outcome for performance:
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Endo GIA™ Extra Long Adapter) |
|---|---|---|
| Intended Use (IFU) | Same as predicate device (K121510/K123318) | Same |
| System Component | Indicated for use with iDrive™ Ultra Powered Stapling System | Same |
| Materials | Comprised of materials evaluated in accordance with ISO 10993-1:2009 | Same (No change in materials from previous device). All materials are in accordance with ISO 10993-1. |
| Configuration | Delivers two sets of triple staggered rows of titanium staples, divides tissue via single use reload, initiated by buttons on powered handle. | Same |
| Labeling | Universal adapter IFU | Unchanged (universal adapter IFU) |
| Articulation & Rotation | Function as intended to achieve surgical goals. | Verified successful performance through in-vitro testing. |
| Staple Formation | Consistent and appropriate staple formation. | Verified successful performance through in-vitro testing. |
| Knife Cutting Performance | Effective and safe tissue cutting. | Verified successful performance through in-vitro testing. |
| Lifecycle Reliability | Maintain functionality over its service life. | Verified successful performance through in-vitro testing. |
| Electrical Safety | Compliant with relevant electrical safety standards. | Verified successful performance through testing. |
| Biocompatibility | Biologically safe for patient contact. | Verified successful performance through testing (and stated "All materials are in accordance with ISO 10993-1"). |
The overall acceptance criterion for this 510(k) submission is that the Endo GIA™ Extra Long Adapter is substantially equivalent to the legally marketed predicate device (Endo GIA™ Adapter K121510) and does not raise new questions of safety or effectiveness. The reported device performance, demonstrated through the listed in-vitro tests, aims to prove this substantial equivalence.
Study Information:
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Sample Size Used for the Test Set and Data Provenance:
- The document states "In-vitro testing supports the intended use of this device includes: Articulation and rotation verification, Staple formation verification, Knife cutting performance verification, Lifecycle reliability test."
- No specific sample sizes (e.g., number of staples, number of cycles) are provided for these in-vitro tests.
- The data provenance is not explicitly stated in terms of country of origin, but "in-vitro testing" implies lab-based, benchtop testing rather than human clinical data. It is inherently prospective for the device being tested.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This type of information is generally not applicable to in-vitro performance testing of a mechanical surgical stapler adapter. The "ground truth" for these tests (e.g., proper staple formation, successful cutting) is based on engineering specifications and established performance standards for such devices, not expert consensus interpretation of medical images or patient outcomes.
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Adjudication Method for the Test Set:
- Not applicable as the testing involves objective mechanical and electrical performance verification against engineering specifications, not subjective assessments requiring adjudication.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret data, often with and without AI assistance. This device is a surgical instrument adapter, not a diagnostic tool.
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Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, the described in-vitro testing is a form of standalone performance assessment. The device's mechanical, electrical, and material characteristics are tested independently to ensure they meet engineering specifications and function as intended without a human operator's variable input being part of the performance assessment itself. While a human operates the device, the tests are designed to evaluate the device's inherent functional capabilities.
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Type of Ground Truth Used:
- The "ground truth" for the in-vitro tests (articulation, rotation, staple formation, knife performance, lifecycle, electrical safety, biocompatibility) is based on engineering specifications, established industry standards (like ISO 10993-1), and acceptable performance thresholds for surgical stapling devices. It is not based on expert consensus, pathology, or patient outcomes data in this context.
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Sample Size for the Training Set:
- Not applicable. This device does not use machine learning or AI models that require a "training set" in the conventional sense. The "training" for such devices involves engineering design, prototyping, and iterative testing, not data-driven model training.
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How the Ground Truth for the Training Set Was Established:
- Not applicable for the reasons stated above.
§ 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.