(198 days)
The Reprocessed Reloadable AutoSuture GIA staplers are intended to be used in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and anastomosis. In addition the AutoSuture ENDO GIA Staplers may be used for transection of liver lissue, hepatic vasculature and biliary structures.
SterilMed's reprocessed AutoSuture GIA Endoscopic Stapler places two triple staggered rows of titanium staples and the blade, contained in the reload, simultaneously divides the tissue between the two rows. These devices allow for a maximum of 8 reloads in a single surgical procedure. The OEM has specified that the subject staplers may be fired up to 25 times in a single surgical procedure. SterilMed has lowered the number of firings allowed to 8 based upon clinical input, the procedures these devices are used for and the maximum allowable firings for similar devices of other manufactures. Note: Only the stapler is the subject of this submission, the implantable staple and the staple cartridge are not reprocessed and therefore are not included.
The provided document describes a 510(k) premarket notification for Reprocessed AutoSuture GIA Endoscopic Staplers. This is a submission for a reprocessed medical device, not a novel AI/software-as-a-medical-device (SaMD) product. Therefore, the information requested in the prompt, such as AI model performance, sample sizes for training/test sets, expert adjudication, MRMC studies, and ground truth establishment, is not applicable to this type of submission.
The acceptance criteria and supporting study for a reprocessed device primarily focus on demonstrating that the reprocessed device performs substantially equivalently to the original (predicate) device and that the reprocessing methods (cleaning, sterilization, functional testing) are validated and effective.
Here's an interpretation based on the provided document:
Acceptance Criteria and Device Performance for Reprocessed AutoSuture GIA Endoscopic Staplers
| Acceptance Criteria Category | Description | Reported Device Performance |
|---|---|---|
| Functional Characteristics | The reprocessed staplers must demonstrate appropriate functional characteristics, performing in a manner substantially equivalent to the original, new AutoSuture GIA Endoscopic Stapler. This includes: | Representative samples of reprocessed staplers are confirmed to meet the functional performance of the predicate device (AutoSuture GIA Endoscopic Stapler K061095). Specific metrics are not detailed but would typically include: |
| Cleaning Validation | The reprocessing methods must effectively clean the used devices to remove biological contaminants and particulates. | Process validation testing was performed to validate the cleaning procedures. The specific metrics for cleanliness (e.g., residual protein, hemoglobin, TOC) and the acceptance limits would have been established and met during this validation. |
| Sterilization Validation | The reprocessing methods must effectively sterilize the cleaned devices, rendering them free of viable microorganisms. | Process validation testing was performed to validate the sterilization procedures. This typically involves demonstrating a sterility assurance level (SAL) of 10^-6 or better for a terminal sterilization process, using biological indicators and validated cycles. |
| Packaging Validation | The packaging used for the reprocessed devices must maintain sterility and product integrity until the point of use. | Process validation testing was performed to validate device packaging. This typically involves accelerated and real-time aging studies, as well as package integrity tests (e.g., peel strength, burst tests). |
| Manufacturing Process Control | The manufacturing process for reprocessing must include robust controls to ensure consistent quality and performance of all produced devices. | The manufacturing process includes visual and validated functional testing of all products produced. This implies a quality management system with in-process and final product inspections and tests to ensure conformity to specifications. |
| Maximum Firings Allowed | The reprocessed device must be safe for use for a specified maximum number of firings within a single surgical procedure. The OEM allows up to 25 firings for new devices. SterilMed aimed to lower this number based on clinical input and comparison with similar devices, demonstrating safety for the proposed use. | SterilMed lowered the number of firings allowed to 8 based on clinical input, procedures used, and maximum allowable firings for similar devices of other manufacturers. This implies testing was conducted to support the safety and efficacy of the device for at least 8 firings after reprocessing. |
| Material Equivalence | The reprocessed device, post-reprocessing, must maintain material properties that are substantially equivalent to the predicate device and suitable for its intended use. (Not explicitly stated as an "acceptance criteria" but implied by substantial equivalence claim). | The conclusion of substantial equivalence is based on the devices' similarities in functional design (principle of operation), materials, indications for use, and methods of construction. This suggests that materials are not significantly degraded or altered by the reprocessing such that they compromise safety or performance. |
| Indications for Use | The reprocessed device must be suitable for the same indications for use as the predicate device. | The reprocessed reloadable AutoSuture GIA staplers are intended for use in abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection of tissue and anastomosis. Additionally, the AutoSuture ENDO GIA Staplers may be used for transection of liver tissue, hepatic vasculature, and biliary structures, which aligns with the typical indications for the new predicate device. |
Regarding the AI/SaMD specific questions from the prompt:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, this is a reprocessed physical device. Testing would involve a sample of reprocessed devices from the production line, not a data test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Clinical input informed the "8 firings" decision, but this isn't ground truth for an algorithm.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a reprocessed device, "ground truth" would relate to objective measurements of functionality, safety (e.g., sterility, cleanliness, burst strength for staple lines), and material integrity compared to the new device specifications and regulatory standards. It doesn't involve clinical "ground truth" in the diagnostic sense.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) submission demonstrates substantial equivalence for a reprocessed stapler through bench testing and process validation for cleaning, sterilization, packaging, and functional performance, rather than clinical studies or AI algorithm validation.
§ 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.