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510(k) Data Aggregation
(700 days)
The Mediclose™ System is a single-use indicated for approximation of tissues and percutaneous suturing of port-site fascia wounds following laparoscopic surgery.
The Mediclose™ System is an Automatic Trocar Closure (ATC) device supplied with one or more Mediclose™ Adaptors, supplied sterile for single use. The combination of the Mediclose™ Device and one Mediclose™ Adaptor results in a minimally invasive surgical system which aids surgeons in closing trocar wounds following a laparoscopic procedure. In laparoscopic surgery, trocars are used to gain access to the body in a minimally invasive way. This means that these procedures are performed through incisions of approximately 12 mm, compared to traditional open surgery which needs a large wound across the abdomen. The Mediclose™ Device is available in one size and configuration, designed for single-handed use, to which each of three Mediclose™ Adaptors can be fitted, at the user's option, depending on the make/model of trocar being used. The Mediclose™ System is intended to pass a suture through the soft-tissue laver (fascia) of a trocar wound after laparoscopic surgery. This is done with the end-goal of closing the trocar-induced wound by pulling needles through the fascia and subsequently closing the wound. The Mediclose™ System has two items: The Mediclose™ Device, which incorporates the suture and needle set; The Mediclose™ Adaptor, three color-coded models are available separately from the Mediclose™ . Device which are compatible with a specific brand/model of 12 mm trocar sleeves that are legally cleared for marketing in the USA, viz: Ethicon EndoPath Covidien VersaOne Applied Medical Kii The Mediclose™ Device also contains a needle-suture set manufactured by Assut Europe composed of two straight cylindrical needles attached to Glicofil Lac, a braided, coated, violet PGLA absorbable suture. The suture and needles are mounted into the device at the time of manufacture, making it ready to use upon opening the packaging.
The provided FDA 510(k) summary for the Mediclose™ System focuses on non-clinical testing for substantial equivalence, rather than a study proving performance against clinical acceptance criteria. The device is a suturing device, and the evaluation is primarily based on mechanical and biocompatibility tests.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents extensive non-clinical testing with acceptance criteria. No clinical performance acceptance criteria are mentioned as no clinical studies were submitted. The table below summarizes the non-clinical acceptance criteria and reported results.
| Test Purpose | Acceptance Criteria | Result |
|---|---|---|
| Sterilization Validation | Sterile after half ETO cycle | Pass |
| Shelf Life Validation: | ||
| a) Transportation test | Packaging is fully functional and undamaged | Pass |
| b) Sterile pack seal integrity | No dye penetration | Pass |
| c) Sterile pack seal strength | >1.5 N/15mm | Pass |
| d) Suture needle/thread strength | Average >14.7 N; Single result >4.41 N | Pass |
| e) Suture knot pull strength | Average >38.2 N | Pass |
| Biocompatibility: | ||
| a) Cytotoxicity | ≥70% of the control mean % viability | Pass |
| b) Sensitization | Positive response in <10% of tests animals | Pass |
| c) Intracutaneous Reactivity | [Test article mean] - [Control mean] ≥ 1.0 | Pass |
| d) Acute systemic toxicity | Absence of toxic reaction after 72 hours | Pass |
| e) Material mediated Rabbit pyrogen | Temperature rise >0.5 degC | Pass |
| f) LAL bacterial endotoxicity | <0.5 EU/ml | Pass |
| Mechanical tests: | ||
| a) Mediclose joint tensile tests | >15 N | Pass |
| b) Mediclose folding part to handle tensile | >30 N | Pass |
| c) Mediclose folding part to handle compression | >30 N | Pass |
| d) Needle retention force | >15 N <30 N | Pass |
| e) Mediclose assembly tensile | >30 N | Pass |
| f) Adaptor security tensile | >30 N | Pass |
| g) Operating button spring resistance | <23.3 N | Pass |
| h) Device passage through trocar sleeve | Unrestricted passage | Pass |
| Performance tests in porcine model with pneumoperitoneum | No functional failures | Pass |
| Performance tests in human fascia model | No functional failures | Pass |
2. Sample size used for the test set and the data provenance
The sample sizes for these non-clinical tests are listed in the table above under the "Standard" column. They range from 1 sample to 44 Mediclose units, 35 guinea pigs, 3 white rabbits, or 10 male mice depending on the specific test.
The data provenance is not explicitly stated in terms of country of origin but is from internal test protocols and generally accepted international standards (ISO, ASTM, USP, EP). The tests are all described as non-clinical testing, implying a prospective testing approach conducted with the manufactured devices and biological models.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. For these non-clinical tests, the "ground truth" is established by the specified standards (e.g., ISO, ASTM) and measured quantitatively, rather than by expert consensus. There are no human "readers" or human expert interpretations involved in determining the outcome of these mechanical or biological tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, the tests are objective, quantitative measurements against predefined criteria from established standards or internal protocols, not subjective interpretations requiring adjudication.
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
Not applicable. This device is a surgical tool, not an AI-assisted diagnostic or imaging device. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual surgical tool, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests is based on:
- Quantitative measurements: Mechanical strength, physical dimensions, chemical properties, and biological reactions as defined by international standards (ISO, ASTM, USP, EP) and internal test protocols.
- Absence of functional failures: Observed during performance tests in porcine and human fascia models.
8. The sample size for the training set
Not applicable. This device is a physical medical device, not a machine learning algorithm, so there is no training set in the typical sense. The device's design is likely based on iterative engineering and testing rather than data-driven machine learning training.
9. How the ground truth for the training set was established
Not applicable, for the same reasons as point 8.
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