(130 days)
ECHELON ENDOPATH Staple Line Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. ECHELON ENDOPATH Staple Line Reinforcement can be used for reinforcement of staple lines during lung resection and bariatric surgical procedures. The device can also be used for reinforcement of staple lines during gastric, small bowel, and colorectal procedures.
Echelon Endopath Staple Line Reinforcement is a staple line reinforcement, also known as a buttress, for use in the surgical environment for the purpose of reinforcing a staple line.
The Subject Device of this 510(k) is the same as the Predicate Device with a modification to the labeling to include the addition of the Intuitive Surgical SureForm™ 60 mm Blue, Green and Black Reloads and SureForm™ 60 mm Stapler 510(k) Cleared K173721 as compatible devices. The Predicate Device is compatible with the Echelon Flex™ 60 mm Powered Plus Articulating Endoscopic Linear Cutters with Echelon Endopath 60 mm Endoscopic Linear Cutter Reloads with Gripping Surface Technology, (510k cleared K202665, K183435). There are no design or manufacturing changes associated with this submission.
The Subject Device is to be used with surgical stapling devices. Surgical stapling devices place staggered rows of staples with a reinforcement material, and simultaneously divide the tissue and the reinforcement material between the stapled rows. The Subject Device is an absorbable staple line reinforcement material which is secured to both the stapler anvil and reload with a synthetic attachment material. The product consists of an applicator which includes the implantable device, one for each of the upper and lower stapler jaws. The implantable material consists of 3 materials: the Vicryl material, the Polydioxanone film and the attachment adhesive material. Echelon Endopath Staple Line Reinforcement is an implanted material which works as an adjunct to surgical staples after transection, to provide support to soft tissue during the healing process. There are no modifications to the predicate device; and the materials of the Subject Device and Predicate Device are the same. Each unit is packaged sterile in separate pouch.
The provided information is for the ECHELON ENDOPATH Staple Line Reinforcement device. This submission is a 510(k) premarket notification, indicating that the device is claiming substantial equivalence to a predicate device, rather than presenting novel clinical study data for a new device. The "study" mentioned mainly refers to bench testing for compatibility.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| All bench studies passed the criteria for success. | |
| Device Compatibility with Stapler and Reloads (including Intuitive Surgical SureForm™ 60 mm Blue, Green, and Black Reloads and SureForm™ 60 mm Stapler) | Passed |
| Staple Form Quality | Passed |
| Staple Line Integrity | Passed |
| Manipulation of device on tissue | Passed |
| Buttress security on Surgical Stapler and Reload | Passed |
| Release Force | Passed |
| Shear Force | Passed |
| Usability Testing | Passed |
Note: The document states "All bench studies passed the criteria for success," but it does not explicitly list the specific numerical acceptance criteria (e.g., a minimum force in Newtons for shear force) for each test. Instead, it confirms that the device met whatever criteria were predefined for these tests.
2. Sample Size Used for the Test Set and Data Provenance
The document only mentions "bench testing." It does not specify sample sizes for individual tests. The data provenance is laboratory/bench testing, not human or animal data. Therefore, details like country of origin for data or retrospective/prospective do not apply in the context of this bench study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This was a bench study, not an expert-driven clinical evaluation. The "ground truth" would be the engineering specifications and performance thresholds set for the device's mechanical properties, not expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. This was a bench study with objective measurements, not a test involving human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This device is a mechanical staple line reinforcement, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a passive mechanical component, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the bench testing would be established by the engineering and design specifications for the device's mechanical properties and compatibility requirements with the staplers. This typically involves objective physical measurements and established test methods, not expert consensus, pathology, or outcomes data in the traditional sense of a clinical study.
8. The Sample Size for the Training Set
Not applicable. There is no information in the document about a "training set" as this is a mechanical device, not an AI or machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.