(82 days)
The GLA™ stapler with Tri-Staple™ technology has applications in abdominal and thoracic surgical procedures for resection, transection and creation of anastomosis.
The GIA™ stapler with Tri-Staple™ technology places two triple staggered rows of titanium staples and simultaneously cuts and divides tissue between these two triple rows. The subject GIA™ stapler and cartridges with Tri-Staple™ technology are available in 60 mm staple line length and two staple sizes to accommodate tissue thicknesses: medium/thick and extra thick. Staplers for medium/thick tissue (purple cartridge) deploy three height-progressive rows of 3.0 mm. 3.5 mm and 4.0 mm titanium staples on either side of the tissue cut line. Staplers for extra thick tissue (black cartridge) deploy three height-progressive rows of 4.0 mm, 4.5 mm and 5.0 mm titanium staples on either side of the cut line. Each GIA™ stapler with Tri-Staple™ Technology may be reloaded with a GIA™ Cartridge with Tri-Staple™ Technology up to 7 times for a total of 8 firings per instrument.
The GIA™ Stapler with Tri-Staple™ Technology is manufactured with essentially the same patient contact materials that are utilized within the predicate device (K192720).
The GIA™ stapler with Tri-Staple™ technology has the same principle operation as the predicate device. The GIA™ Stapler with Tri-Staple™ Technology is a manual single-use device. It is provided sterile (ethylene oxide) with a 5-year shelf life, and intended for multiple use during a single procedure, which is the same as the predicate device (K192720).
The document describes a 510(k) premarket notification for the GIA™ Stapler with Tri-Staple™ Technology. A 510(k) submission aims to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, rather than proving that it meets specific, novel acceptance criteria based on extensive clinical studies typical for novel devices.
Therefore, the "acceptance criteria" here refers to demonstrating that the subject device is substantially equivalent to the predicate device in terms of technological characteristics and performance, without raising new questions of safety or effectiveness. The study performed is a series of non-clinical performance tests.
Here's the breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission focused on substantial equivalence, the "acceptance criteria" are implicitly that the subject device performs comparably to the predicate or reference device in specified non-clinical tests. The document doesn't provide explicit pass/fail criteria with numerical thresholds, but rather outlines the types of tests performed to demonstrate comparable performance.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate/Reference) | Reported Device Performance (Summary from Non-Clinical Tests) |
|---|---|
| Performance Test (Bench) | |
| - Visual inspection satisfactory | Performed |
| - IFU walkthrough successful | Performed |
| - Staple formation on test media comparable | Performed |
| - Firing force within acceptable range | Performed |
| - Multi-fire evaluation satisfactory | Performed |
| Performance Test (Ex-Vivo) | |
| - Burst pressure comparable | Performed |
| - Pneumostasis comparable | Performed |
| - Across staple line evaluation comparable | Performed |
| Performance Test (In-Vivo) | |
| - Hemostasis comparable | Performed |
| - Staple formation on tissues comparable | Performed |
| Biocompatibility Tests (per ISO 10993-1 and FDA guidance) | |
| - Cytotoxicity acceptable | Performed |
| - Sensitization acceptable | Performed |
| - Intracutaneous irritation acceptable | Performed |
| - Acute system toxicity acceptable | Performed |
| - Pyrogenicity acceptable | Performed |
| Overall Conclusion | "Based upon the supporting data summarized above, we concluded that the subject device GIA™ Stapler with Tri-Staple™ Technology is substantially equivalent to the legally-marketed device K192720 and does not raise different questions or additional risks of safety and effectiveness than the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes for each of the non-clinical tests (bench, ex-vivo, in-vivo, biocompatibility). It only states that these tests "have been performed." The data provenance is not explicitly mentioned, but the submitter (Covidien) has corporate presence in both China (Leo Chen) and the USA (Katherine Y. Choi, U.S. Agent), suggesting the tests could have been conducted in various locations. Given the nature of these tests, they are inherently prospective experiments designed to evaluate device performance under controlled conditions.
3. 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)
This type of information is not applicable to this submission. "Ground truth" established by experts is typically relevant for diagnostic AI/imaging devices where human interpretation is the benchmark. For a surgical stapler, the "ground truth" is defined by objective physical and biological performance metrics (e.g., burst pressure, staple formation, hemostasis) measured in laboratory or animal settings, not by expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no expert adjudication of results in the context of mechanical device performance testing. The results are based on objective measurements and established test procedures.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable. This type of study is used for evaluating diagnostic devices, particularly those involving human interpretation of medical images (e.g., AI in radiology). The GIA™ Stapler is a surgical instrument, not a diagnostic AI device. The submission explicitly states: "No clinical study is deemed necessary since the substantial equivalence has been sufficiently demonstrated by non-clinical studies."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a manual surgical stapler; it is not an algorithm or an AI product, and therefore does not have a "standalone" algorithmic performance. Its performance is intrinsically tied to its mechanical function and human use in a surgical setting.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As explained in point 3, the concept of "ground truth" in the diagnostic context is not directly applicable. For this device, the "ground truth" for performance evaluation is based on objective measurements from in-vitro (bench), ex-vivo, and in-vivo (animal) studies, such as:
- Physical measurements of staple formation.
- Measured firing force.
- Burst pressure of stapled tissues.
- Assessment of pneumostasis.
- Evaluation of hemostasis.
- Standardized biocompatibility test results.
8. The sample size for the training set
This is not applicable. The GIA™ Stapler is a mechanical surgical device, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
§ 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.