(32 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 barb 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).
INSORB™ Absorbable Staples are 5 mm in length, 0.8 mm thick, 3.5 mm wide overall, and have barb 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).
The provided K033602 510(k) summary does not contain the acceptance criteria or a study demonstrating that the device meets such criteria in the traditional sense of performance metrics against predefined thresholds.
This 510(k) submission is for a modified version of an already cleared device (K024117). The modification is solely related to the method of sterilization (Gamma Radiation). Therefore, the focus of this submission is on demonstrating that the new sterilization method does not alter the fundamental characteristics or safety and effectiveness of the device, rather than proving a new set of performance criteria for the device itself.
Based on the provided text, here's what can be inferred or stated about the study and acceptance:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as performance metrics. The underlying acceptance criterion for a 510(k) of this nature is substantial equivalence to the predicate device. This means demonstrating that the change in sterilization method does not introduce new questions of safety or effectiveness and that the device remains as safe and effective as the predicate.
- Reported Device Performance: Not reported in terms of specific numerical performance data (e.g., tensile strength, absorption rates) in this document. The "performance" demonstrated is that the device, with the new sterilization method, is deemed substantially equivalent to the predicate.
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable / Not Provided: The summary does not describe a clinical or performance study with a "test set" as would be used for a new device's primary efficacy or safety claims. The focus is on the sterilization process. Information on the testing done for the sterilization validation itself (e.g., sterility testing, biocompatibility after sterilization) is not detailed in this 510(k) summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable / Not Provided: There is no indication of experts establishing a "ground truth" for a test set. This type of evaluation is not relevant for a sterilization change submission.
4. Adjudication Method for the Test Set:
- Not Applicable / Not Provided: No adjudication method is mentioned as there is no described test set requiring expert review or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No: An MRMC study is typically used for diagnostic devices involving human interpretation of results. This device is a surgical staple, and such a study is not relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No: This is not an AI/algorithm-based device.
7. Type of Ground Truth Used:
- Not Applicable: For a sterilization change, the "ground truth" would relate to the validation of the sterilization process itself (e.g., demonstrating sterility assurance level, material compatibility post-sterilization), rather than expert consensus on clinical outcomes or pathology. This information is not detailed in the summary.
8. Sample Size for the Training Set:
- Not Applicable / Not Provided: There is no "training set" as this is not a machine learning or diagnostic device that requires such data.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable / Not Provided: Not relevant for this type of device.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" that proves the device meets the acceptance criteria is the demonstration of substantial equivalence to its predicate device (K024117). The single key difference, as stated, is the method of sterilization (Gamma Radiation).
The implication is that Incisive Surgical provided data to the FDA to demonstrate:
- Effectiveness of Gamma Sterilization: That the chosen Gamma radiation dose achieves the required sterility assurance level (SAL). This typically involves bioburden testing, dose mapping, and validation studies according to standards like ANSI/AAMI/ISO 11137.
- Material Compatibility/Integrity: That the Gamma sterilization process does not adversely affect the physical properties, chemical composition, biocompatibility, or performance (e.g., strength, absorption profile) of the INSORB™ Absorbable Staple material. This would involve comparing pre- and post-sterilization testing of critical device characteristics.
- Packaging Integrity: That the packaging maintains its integrity and barrier properties after exposure to Gamma radiation.
The acceptance criteria for this submission, though not explicitly listed as numerical targets, would have been that:
- The device, post-Gamma sterilization, remains sterile (meeting SAL requirements).
- The device's functional performance and safety characteristics remain unchanged compared to the predicate device.
- The device continues to meet its intended use for subcuticular closure of skin.
The conclusion of the 510(k) summary explicitly states: "The modified INSORB Absorbable Staple described in this submission is substantially equivalent to the predicate device." This statement, along with the FDA's clearance letter ("We have reviewed your Section 510(k) premarket notification... and have determined that this device is substantially equivalent..."), confirms that Incisive Surgical successfully demonstrated these points to the FDA's satisfaction for the change in sterilization method.
§ 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.