(92 days)
GORE® SEAMGUARD® Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. GORE® SEAMGUARD® Reinforcement can be used for reinforcement of staple lines during hysterectomy, lung resection, liver resection, bladder reconstruction, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, small bowel, and spleen procedures. GORE® SEAMGUARD® Reinforcement is also intended to be used for reinforcement of staple lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.
The subject GORE® SEAMGUARD® Reinforcement device is an assembly of three components: 1) the implantable device, 2) two (2) loading carriers (for anvil & cartridge side of stapling device), and 3) a protective cover. The implantable device consists of three layers - Web, Film, and Adhesive. The Web and Film layers are comprised of synthetic bioabsorbable polyglycolide (PGA) and trimethylene carbonate (TMC). A thin layer of bioabsorbable adhesive is coated onto one surface of the implantable device, and is composed of a synthetic bioabsorbable polylactide and trimethylene copolymer. The adhesive's function is to affix the device onto the surgical stapler for delivery to the implant site. The bioabsorbable copolymers degrade via a combination of hydrolytic and enzymatic pathways. The device is supplied sterile for single use only.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device: GORE® SEAMGUARD® Reinforcement (K131658)
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional/Mechanical Performance (Substantial Equivalence to Predicate) | Bench Study: "Testing of the GORE® SEAMGUARD® Reinforcement consisted of a simulated use performance testing. The tests demonstrated the performance of the subject SEAMGUARD device is substantially equivalent to the predicate SEAMGUARD device." This implies criteria such as: effective affixation to stapler, successful delivery to implant site, structural integrity during stapling, etc. The specific numerical criteria are not detailed in this summary. |
| Biocompatibility | Animal Study: "biocompatibility testing in accordance with ISO 10993-1" "The results of these tests revealed the device is biocompatible for its intended use..." |
| In Vivo Safety and Tissue Response | Animal Study: "...in vivo safety studies. The results of these tests revealed...demonstrated no clinically relevant device-related complications, no adverse tissue response, and histological results comparable to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not explicitly state a numerical sample size for the "simulated use performance testing" (bench study) or the "in vivo safety studies" (animal study). It mentions "testing" and "studies" in plural, implying multiple tests/animals, but no specific numbers are given.
- Data Provenance:
- Bench Study: Not specified, but generally performed in a laboratory setting.
- Animal Study: Animal data (in vivo). The country of origin for the studies is not specified. Both studies are prospective as they were conducted specifically for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not provided in the summary. The evaluations appear to be objective measurements (e.g., performance metrics in bench testing, histological analysis in animal studies) rather than interpretations requiring expert consensus on a subjective ground truth.
4. Adjudication Method for the Test Set:
- Not applicable as the ground truth establishment method (if any) is not specified as requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This device is a medical implant (staple line reinforcement material), not an imaging or diagnostic device that would typically involve human readers interpreting cases. Therefore, an MRMC study is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:
- Not applicable. This device is a passive implant; it does not involve any algorithms or AI to be evaluated for standalone performance.
7. The Type of Ground Truth Used:
- Bench Study: The "ground truth" for the simulated use performance testing would be objective measurements and observations of the device's functional characteristics (e.g., successful loading, secure attachment, integrity after stapling, comparison to predicate device performance specifications).
- Animal Study: The "ground truth" for biocompatibility and in vivo safety studies would be:
- Biocompatibility: Conformance to ISO 10993-1 standards, which involve specific tests for cytotoxicity, sensitization, irritation, etc.
- In Vivo Safety: Histological analysis of tissue response (e.g., inflammation, foreign body reaction) and clinical observation of device-related complications in animal models. The comparison was made to the predicate device's expected tissue response.
8. The Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As above, no training set is involved for this type of medical 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.