(89 days)
The Signia™ small diameter curved tip gray and white reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of vasulature using gray reloads and thin tissue and vasculature using white reloads.
The Signia™ small diameter regular (round) tip white reload has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of thin tissue and the creation of anastomosis.
Signia™ Small Diameter Reloads are 8 mm diameter reloads that shall be utilized for open and minimally invasive surgical procedures for the transection of tissue, specifically vascular and thin tissue structures. They shall be offered with both a curved tip (cleared in predicate submission K191070) and a new reqular (round) tip model. The Signia™ small diameter regular (round) tip white reloads shall be indicated for use in the creation of anastomosis.
The reload is the distal shaft and jaws of the stapler system comprised of a single-use knife. fixed anvil, and the fixed stapler cartridge with two (2) rows of titanium staples on either side of the cut line. The reload is single use only and the cartridges cannot be replaced.
Signia™ Small Diameter Reloads feature a narrow shaft, narrow end-effector, narrow anvil with either a curved tip or regular (round) tip, and multiple articulation angles up to 45 degrees. These features facilitate device access to smaller or tighter surgical spaces (e.g. intercostal) as well as difficult-to-reach vasculature. Signia™ Small Diameter Reloads shall be available in multiple configurations with the following features:
- Open Staple Height: 2.0 mm (grav cartridge) and 2.5 mm (white cartridge) ●
- Cartridge Length: 30 mm and 45 mm .
- Anvil Tip: Curved tip (gray and white) and Regular (Round) tip (white) ●
- Reload Shaft Length: Short (15 cm) and Long (24 cm) ●
- Reload Diameter (upper-shaft to distal end): 8 mm ●
The curved tip on the distal-end of the reload can be used to aid in positioning the reload around target tissue / vessels for subsequent firing. The working length of the Signia™ small diameter reload will fit down an 8mm trocar sleeve or larger, and is compatible with existing Covidien manual and powered stapling handles (see Section 11.10: Compatible Stapling Handles). The short shaft length (15 cm) is recommended for use in open, thoracoscopic or laparoscopic procedures and are compatible with appropriately-sized trocar sleeves, 8 mm or larger. The long shaft length (24 cm) is recommended for use in laparoscopic procedures with appropriately-sized trocar sleeves, 8 mm or larger. The Signia™ Small Diameter Reloads are recommended for use with Covidien compatible short stapler adapters and handles. The reloads contain an intelligence chip, which has the ability to communicate with the Covidien powered Signia™ Stapler handle that has a compatible communications interface.
Through this submission, a new reload model SIGSDL45VT with a regular (round) tip anyil shall be added to the stapling family of Signia™ Small Diameter Reloads as a line extension. Additionally, the indications of Signia™ Small Diameter regular (round) tip white reloads shall be expanded to include creation of anastomosis based on the supporting data provided in this submission.
This document describes the Signia™ Small Diameter Reloads for surgical staplers. The existing curved tip reloads were previously cleared, and this submission (K222641) adds a new regular (round) tip model and expands the indications for the regular (round) tip white reloads to include the creation of anastomosis.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with pass/fail thresholds. Instead, it details a comprehensive suite of performance tests performed to demonstrate substantial equivalence to a predicate device (K191070) and a reference device (K111825) for anastomosis. The fundamental acceptance criterion seems to be that the subject device performs comparably to or better than the predicate/reference devices in relevant performance tests.
Here's a summary of the performance tests conducted, implying "acceptance" if the subject device performs equivalently or acceptably:
| Performance Characteristic/Test | Applicable Reloads | Performance/Outcome (Implied Acceptance) |
|---|---|---|
| Bench Tests (Acute): | Both Curved & Regular (Round) Tip new model | Demonstrated comparable performance to predicate (K191070). |
| Visual inspection | Both Curved & Regular (Round) Tip new model | No issues reported; presumed acceptable. |
| Force to load, rotate, and lock reload | Both Curved & Regular (Round) Tip new model | No issues reported; presumed acceptable. |
| Stapler handle compatibility | Both Curved & Regular (Round) Tip new model | Compatible with existing Covidien manual and powered stapler handles; presumed acceptable. |
| Knife cut | Both Curved & Regular (Round) Tip new model | No issues reported; presumed acceptable. |
| Staple formation in test media | Both Curved & Regular (Round) Tip new model | No issues reported; presumed acceptable. |
| Firing and retraction forces | Both Curved & Regular (Round) Tip new model | No issues reported; presumed acceptable. |
| Communications test with Signia™ Powered Handle | Both Curved & Regular (Round) Tip new model | No issues reported; presumed acceptable. |
| Trocar Insertion/Removal forces | Both Curved & Regular (Round) Tip new model | No issues reported; presumed acceptable. |
| Pneumo-seal leak rate | Both Curved & Regular (Round) Tip new model | No issues reported; presumed acceptable. |
| Worst Case Ex vivo Burst Pressure including Veins | Both Curved & Regular (Round) Tip new model | No issues reported; presumed acceptable. |
| Animal Acute Tests: | Both Curved & Regular (Round) Tip new model | Demonstrated comparable performance to predicate (K191070). |
| Tissue trauma | Both Curved & Regular (Round) Tip new model | No issues reported; presumed acceptable. |
| Grasping trauma | Both Curved & Regular (Round) Tip new model | No issues reported; presumed acceptable. |
| Hemostasis | Both Curved & Regular (Round) Tip new model | No issues reported; presumed acceptable. |
| Staple formation in intended tissue | Both Curved & Regular (Round) Tip new model | No issues reported; presumed acceptable. |
| Chronic Survival Testing in Animal: | Curved Tip Reloads (vs. Control) | Demonstrated substantial equivalence to predicate (K191070) and reference in lobectomy, nephrectomy, splenectomy, and ovariohysterectomy. Implied acceptable long-term performance. |
| Chronic Survival Testing in Animal (Anastomosis): | Regular (Round) Tip Reload (vs. Control) | Demonstrated comparable performance to reference device (K111825) for Jeju-Jejunostomy. Implied acceptable long-term performance. |
| Human Factors / Usability Tests: | General use, labeling, and anastomosis (new model) | Performed per IEC 62366-1 and FDA guidance. No issues reported; presumed acceptable. |
| Biocompatibility Tests: | All models | Performed per ISO 10993-1 and FDA guidance. No issues reported; presumed acceptable. |
| Electrical Safety Tests: | All models | Performed per IEC 60601-1. No issues reported; presumed acceptable. |
| Electromagnetic Compatibility (EMC): | All models | Performed per IEC 60601-1-2. No issues reported; presumed acceptable. |
| Sterilization Assessment: | All models | Performed per ISO 11135. No issues reported; presumed acceptable. |
| Stability / Shelf-life Studies: | All models | No issues reported; presumed acceptable. |
2. Sample size used for the test set and the data provenance
The document provides the following details:
- Bench Tests: The specific sample sizes for each bench test are not provided.
- Animal Acute Tests: The specific sample sizes for these tests are not provided.
- Chronic Survival Testing in Animal:
- Lobectomy (Thorax of Canine): Sample size not specified.
- Nephrectomy, Splenectomy, Ovariohysterectomy (Abdomen of Porcine): Sample size not specified.
- Jeju-Jejunostomy (Small Bowel of Canine): Sample size not specified.
- Provenance: All animal studies (acute and chronic) were conducted as pre-clinical studies by the manufacturer (Covidien). The country of origin for the animal studies is not explicitly stated but is typically conducted at contract research organizations. These are prospective studies given they are conducted to support a new device feature/indication.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the evaluation of the device performance is based on physical and biological measurements in bench and animal studies, not on interpretations by human experts establishing a "ground truth" for a test set in the context of diagnostic AI/imaging.
4. Adjudication method for the test set
This section is not applicable as the evaluation of the device performance is based on physical and biological measurements in bench and animal studies, not on adjudicating expert opinions.
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
No, an MRMC comparative effectiveness study was not done. This device is a surgical stapler, which is a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. The device is a surgical stapler, not an algorithm.
7. The type of ground truth used
The "ground truth" in this context is established through:
- Physical measurements: For bench tests (e.g., staple formation, burst pressure, forces, dimensions).
- In-vivo observations and histological/pathological evaluation: For animal acute and chronic studies (e.g., tissue trauma, hemostasis, staple formation in tissue, long-term healing and integrity of staple lines, anastomosis success). This would involve veterinary pathologists and surgeons assessing outcomes.
- Usability testing: Direct observation and feedback from users (e.g., surgeons).
8. The sample size for the training set
This section is not applicable as this is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable.
§ 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.