(34 days)
The Endo GIA™ Reload has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
The subject device and the predicate device both are a linear or articulating reload that is attached to a stapler handle. The reload contains staples, a cutting blade, and an anvil which to form the staples. Once the reload is attached to the stapler handle, the trigger on the handle is manually squeezed once to close the anvil in order to clamp the tissue. Once the anvil is fully closed, it securely retains the tissue until it is opened. To fire either the subject or predicate device, a safety must be physically and intentionally disengaged after full clamp-up. Once the safety has been disengaged, the trigger can be squeezed additional times to fire the staples and advance the cutting blade. The number of firing squeezes will increase the cartridge length. The subject and predicate Endo GIA™ reloads are sterilized via ethylene oxide, have 45mm or 60mm staple cartridge lengths, 3.5mm or 4.8mms titanium staples, single use and disposable devices. The subject device contains two modifications compared to predicate, the addition suture slots and blunt blades within the anvil and cartridge of the reload. These two minor modifications are the only differences between the subject device and the predicate device. The addition of the suture slots and blunt blades are the result of refurbishment of components from a previously cleared device (K080898). The suture slots within the previously cleared device (K080898) secured suture on the anvil and cartridge to hold reinforcement material. The blunt blades would cut the suture in order to deploy the reinforcement material when the reload is fired. The subject device is refurbished by removing the sutures and tissue reinforcement material.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Endo GIA™ Reload device, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| In vitro staple formation | Demonstrated |
| Insertion/Removal force | Demonstrated |
| In vivo tissue firing for tissue trauma, knife cut, and staple formation | Demonstrated |
| In vivo tissue trauma abrasion | Demonstrated |
| Cytotoxicity Test | Demonstrated |
| ETO Residual Testing (ISO 10993-7:2008) | Demonstrated |
| IR analysis | Demonstrated |
| Passivation (rust and corrosion) meeting ASTM A967 | Demonstrated |
Note: The document states, "The result of these tests demonstrates that the proposed device Endo GIA™ Reload is substantially equivalent to the predicate device." While it doesn't provide specific quantitative results for each criterion, the overall statement indicates successful performance against the set criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the "in vitro" or "in vivo" performance tests. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The studies listed are engineering/performance tests (e.g., staple formation, force, cytotoxicity), not clinical studies requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. The performance tests are quantitative or qualitative assessments of device mechanics and biocompatibility, not requiring an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or reported in this 510(k) submission. This device is a surgical stapler reload and its performance is evaluated through engineering and in vivo animal studies, not through human reader interpretation of images.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
Not applicable. The Endo GIA™ Reload is a physical medical device, not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for the performance tests would be defined by the pre-established engineering specifications, material standards, and biological responses expected from a safe and effective stapling device. For example:
- Staple formation: Visual and microscopic inspection against defined staple geometries.
- Insertion/Removal force: Measurement against specified force limits.
- Tissue trauma, knife cut, staple formation (in vivo): Histopathological evaluation of tissue samples, gross observation of staple lines and cutting performance in animal models.
- Biocompatibility tests (Cytotoxicity, ETO Residual, Passivation): Adherence to ISO and ASTM standards and guidelines.
8. Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. Its development and testing rely on engineering design, material science, and pre-clinical validation.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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.