(88 days)
The Biodesign Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. The Reinforcement may be used for buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomy, pneumoreduction) and other incisions and excisions of the lung and bronchus. The Staple Line Reinforcement can be used for the reinforcement of the gastric staple line during bariatric surgical procedures, and for reinforcement of staple lines during small bowel, mesentery, colon and colorectal procedures. The Staple Line Reinforcement may be used with anastomotic staplers or with non-anastomotic staplers.
The subject device consists of a thin multi-layer strip of SIS, pre-coated with a ready-to-use contact adhesive that eliminates the need for a separate adhesive (hydrogel), or activation of the adhesive through rehydration to affix the device to surgical stapler jaws. The single-use implant device is provided to the point of use with a protective liner covering the adhesive which has been assembled onto a foam carrier which is suspended in an alignment tray sized for the jaws of a surgical stapler. The completed device, liner, carrier, and alignment tray unit is then sealed in a foil pouch with an integrated humidity control feature and terminally E-beam sterilized. In order to accommodate a variety of commercially available surgical staplers the device is available in configurations measuring from 0.05mm to 0.6mm in thickness, and in nominal (unfolded) device lengths ranging from 76 mm to 176 mm in length and up to 12 mm wide. Upon implantation, the Biodesign® Staple Line Reinforcement device will provide mechanical reinforcement of the staple line by buttressing the soft tissue and preventing the surgical staples from tearing through the affected tissue. In addition, the Biodesign® Staple Line Reinforcement device will incorporate (remodel) into the body over time such that no graft material is left behind.
This document is a 510(k) summary for the Biodesign® Staple Line Reinforcement device. It describes the device, its intended use, and compares it to a legally marketed predicate device (K170945) to demonstrate substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes performance data in terms of "Product verification testing" and "Staple line leakage testing" but does not explicitly state numerical acceptance criteria for these tests. Instead, it describes general findings.
| Acceptance Criteria (Inferred from Performance Data) | Reported Device Performance |
|---|---|
| Mechanical performance of the subject device for its intended use. | Product verification testing was performed on SHS (presumably "shelf-stable") conditioned sterilized finished devices to evaluate the mechanical performance of the subject device for its intended use. (Implied: met performance expectations, but no specific metrics provided). |
| Adequate staple line buttressing for use as a prosthesis for surgical repair of soft tissue deficiencies. | Staple line leakage testing confirms that the Biodesign® Staple Line Reinforcement provides adequate staple line buttressing for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. (Implied: met performance expectations regarding leakage, but no specific leakage rates or thresholds provided). |
| Adequate packaging system to support a 6-month shelf life claim. | Non-clinical bench testing was performed on representative SHS conditioned packaging system samples to confirm that the packaging system is adequate to support a 6-month shelf life claim. Testing at additional timepoints is ongoing and the product shelf life will be extended as stability and package system integrity data justifies. (Successfully supports 6-month claim, with ongoing testing for longer periods). |
| Biocompatibility according to ISO 10993 standards for biological evaluation and specific tests (genotoxicity, cytotoxicity, irritation, systemic toxicity, implantation effects). | Biocompatibility test data for the subject device has been submitted in support of the substantial equivalence under the ISO 10993 regime, specifically addressing: Part 1, Part 3, Part 5, Part 6, Part 10, Part 11. (Implied: met biocompatibility requirements for these tests, no specific results are detailed). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide specific sample sizes for the "Product verification testing" or "Staple line leakage testing". It states "representative SHS conditioned sterilized finished devices" and "representative SHS conditioned packaging system samples" were used.
The data provenance is not explicitly stated in terms of country of origin. The testing appears to be non-clinical bench testing conducted by the manufacturer, Cook Biotech Incorporated, which is a U.S.-based company (West Lafayette, IN). All tests mentioned are retrospective (bench tests performed on the device).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable. The device is a physical medical device (surgical mesh), and its performance is evaluated through objective physical and biological tests (mechanical performance, leakage, biocompatibility). There is no "ground truth" derived from expert interpretation of images or clinical data in the context of diagnostic accuracy.
4. Adjudication Method for the Test Set:
This information is not applicable for the reasons stated above (physical device testing, not expert-based assessment).
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:
This information is not applicable. The device is a surgical mesh for physical reinforcement, not an AI-assisted diagnostic or clinical decision support tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable. The device is a physical product, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance claims of this device is based on objective scientific and engineering measurements in benchtop and laboratory settings:
- Mechanical performance: Measured physical properties and behaviors under simulated surgical conditions.
- Staple line leakage: Measured leakage rates or other objective indicators of buttressing effectiveness.
- Biocompatibility: Results from standardized ISO 10993 in vitro and in vivo biological tests.
- Packaging and shelf life: Measured integrity of packaging and stability of the product over time under defined conditions.
8. The Sample Size for the Training Set:
This information is not applicable because the device is a physical medical device and does not involve AI or machine learning that requires training data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable, as there is no training set for this device.
§ 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.