(30 days)
Synthetic absorbable INSORB™ staples are intended for use in abdominal, thoracic, gynecologic, orthopedic, plastic and reconstructive surgery for the subcuticular closure of skin where an absorbable tissue fastener is desired for temporary tissue approximation.
INSORB™ Absorbable Staples are 5 mm in length, 0.8 mm thick, 3.5 mm wide overall, and have cleat tips that are 0.7 mm apart. They are used in conjunction with a manual surgical stapler from Incisive (Note: Incisive's manual surgical stapler is a Class I exempt device pursuant to 21 CFR 878.4800 and is not the subject of this submission).
This 510(k) summary (K061784) describes a special 510(k) submission for the INSORB™ Absorbable Staple which primarily focuses on changes to the manufacturing process, sterilization, packaging, and shelf-life, rather than new performance studies with specific acceptance criteria related to a new-to-market device. Therefore, a direct comparison of the device's numerical performance against explicit acceptance criteria in a table format, as you might find for a diagnostic AI device, is not fully applicable here.
However, based on the information provided, we can infer some "acceptance criteria" through the lens of substantial equivalence and identify the "studies" (or rather, validations/tests) that demonstrate these criteria were met for the modified device.
Here's an attempt to structure the information based on your request, interpreting "acceptance criteria" and "study" within the context of a Special 510(k) for manufacturing changes:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Changes) | Reported Device Performance (Demonstrated by Validation) |
|---|---|
| Sterility Assurance Level (SAL): Achieves 10-6 SAL. | Sterilization Validation changed from VDmax to Method 1 to allow implementation of a 10-6 SAL validated gamma dose at less than 25kGy. This indicates successful validation of the new sterilization method to meet the required SAL. |
| Moisture Protection: Maintains device integrity and performance. | Packaging includes a desiccant, which indicates a measure to control moisture, implying successful packaging validation to ensure the device's stability. |
| Staple Strength (Post-Exposure): Increased by 50% compared to predicate.* | Strength specifications for the staple following exposure to 37°C buffered saline for 7 days and 21 days have been increased 50% to accommodate the STRONGER staple fabricated by the refinements in the micromolding process. This implies testing was done to verify the increased strength compared to the predicate, demonstrating this performance gain. |
| Shelf Life: Extended to 2 years. | Shelf Life extended to 2 years. This would have been supported by shelf-life testing (e.g., accelerated aging and real-time aging studies) to demonstrate that the device maintains its characteristics (including strength, sterility, and functionality) over the extended period under specified storage conditions, especially considering the packaging change with a desiccant and lower gamma dose. The document implicitly confirms successful completion of such studies to justify the extension. |
| Biocompatibility: Remains safe for intended use. | Although not explicitly stated as a change, as a Special 510(k) for a previously cleared device, it's assumed that the materials and their biocompatibility profile remain acceptable or were re-evaluated if material changes were implicit in the micromolding process. The overall conclusion of "substantial equivalence" implies continued biocompatibility. |
| Functionality/Performance (General): Performs as intended. | The changes (micromolding refinement, lower gamma dose, desiccant) are described as improvements leading to a "STRONGER staple." The substantial equivalence determination confirms that the modified device continues to meet the intended use and performs safely and effectively. This would typically be supported by functional testing. |
Note: The 50% increase in strength is presented as an outcome of the combined changes rather than a pre-defined acceptance criterion in isolation. However, for a Special 510(k), demonstrating that changes lead to an improved or at least equivalent safety and effectiveness profile is key.
Details of the "Studies" (Validations/Tests) and Other Information:
Given that this is a Special 510(k) focused on manufacturing and packaging changes for an already cleared device, the information provided is less about clinical performance studies and more about engineering validations.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided text. For engineering and sterilization validations, sample sizes are typically determined statistically based on the type of test (e.g., destructive vs. non-destructive, variability of the parameter). These details would be in the full submission, not the summary.
- Data Provenance: The studies are related to the manufacturing, sterilization, and packaging of the device by Incisive Surgical, located in Plymouth, MN, USA. Therefore, the data would originate from their internal testing and validation processes. It is retrospective in the sense that the testing was performed, and then the results were submitted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This question is not applicable to this type of submission. The "ground truth" for manufacturing and sterilization validations is based on established engineering principles, international standards (e.g., for sterilization), and regulatory requirements, not human expert consensus on device performance in a diagnostic or clinical setting. Internal technical experts (e.g., engineers, microbiologists, quality assurance personnel) would design and oversee these validations.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies involving interpretation of medical data (e.g., images) by multiple experts. For manufacturing validations, results are typically evaluated against pre-defined specifications and statistical criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC study was not done. This type of study is relevant for evaluating the impact of a diagnostic device (often AI-assisted) on human reader performance, which is not the subject of this 510(k).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone performance study was not done. This device is a surgical staple, not an algorithm or a diagnostic tool.
7. The Type of Ground Truth Used
- The "ground truth" for these validations is engineering specifications, regulatory standards, and pre-defined performance targets. For example:
- Sterilization: Regulatory requirement for SAL (e.g., 10^-6).
- Strength: Mechanical specifications determined through product design and comparative testing to the predicate.
- Shelf-life: Stability parameters (e.g., physical integrity, sterility) maintained over time according to pre-established specifications.
8. The Sample Size for the Training Set
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this device.
§ 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.