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510(k) Data Aggregation
(86 days)
Reprocessed Covidien Trocar
The Reprocessed Covidien Trocars are indicated for use in a variety of gynecologic, general, thoracic, and urologic endoscopic procedures to create and maintain a port of entry.
A trocar is a sterile device used in a variety of endoscopic procedures to establish and maintain a port of entry for surgical tools. Trocars consists of three primary components; the cannula which allows access into the abdominal cavity during the procedure; the seal, located at the top of the cannula allows instruments to pass through the cannula while preventing loss of pneumoperitoneum when instruments are inserted and withdrawn from the obturator, which is a mechanism that allows the cannula to penetrate the abdomen. There are also various configurations of diameter and length, but all models have the same basic design, materials, and technological characteristics.
This document describes the premarket notification for a Reprocessed Covidien Trocar (K172093). The study contained within this document evaluates the performance of the reprocessed device compared to the original equipment manufacturer (OEM) device.
Here's an analysis of the provided information according to your criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical targets for each parameter. Instead, the performance testing aims to demonstrate equivalence to the new OEM device. Therefore, the "acceptance criteria" here implicitly means "performance equivalent to the new OEM device."
| Performance Test Category | Specific Test | Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|---|---|
| Functional Testing | Seal Drag | Equivalent to new OEM device | Side-by-side testing of reprocessed devices to an identical new OEM device was performed, indicating satisfactory functional performance. (Specific numerical results not provided) |
| Seal Leakage | Equivalent to new OEM device | Side-by-side testing of reprocessed devices to an identical new OEM device was performed, indicating satisfactory functional performance. (Specific numerical results not provided) | |
| Insertion, Fixation, & Removal Force | Equivalent to new OEM device | Side-by-side testing of reprocessed devices to an identical new OEM device was performed, indicating satisfactory functional performance. (Specific numerical results not provided) | |
| Cleaning Validation | Residual Protein and Hemoglobin | As clean as a new OEM device | Cleaning validation performed to ensure reprocessing steps thoroughly cleaned and sanitized devices to be as clean as a new OEM device. (Specific numerical thresholds or results not provided) |
| Visual Inspection | As clean as a new OEM device | Cleaning validation performed to ensure reprocessing steps thoroughly cleaned and sanitized devices to be as clean as a new OEM device. (Specific observational results not provided) | |
| Cleaning Performance Qualification | As clean as a new OEM device | Cleaning validation performed to ensure reprocessing steps thoroughly cleaned and sanitized devices to be as clean as a new OEM device. (Specific results not provided) | |
| Product Stability | Shelf Life Testing (1-year Accelerated Aging) | Maintained performance after aging | 1-year Accelerated Aging was performed. (Specific stability results not provided) |
| Sterilization & Packaging | EtO Sterilization Testing | Sterilized effectively | EtO Sterilization Testing was performed. (Specific results not provided) |
| Simulated Shipment Testing | Maintained integrity after shipment | Simulated Shipment Testing was performed. (Specific results not provided) | |
| Biocompatibility Testing | Cytotoxicity | Biocompatible | Testing was performed. (Specific results not provided) |
| Irritation and Sensitization | Biocompatible | Testing was performed. (Specific results not provided) | |
| Acute Systemic | Biocompatible | Testing was performed. (Specific results not provided) | |
| EtO Residuals Testing | Below acceptable limits | Testing was performed. (Specific results not provided) | |
| Material Mediated Pyrogenicity | Non-pyrogenic | Testing was performed. (Specific results not provided) |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not specify the exact sample size for the "test set" (i.e., how many reprocessed trocars were tested against how many new OEM trocars for each performance test). It only states that "side-by-side testing of the reprocessed devices to an identical new OEM device" was performed.
- Data Provenance: The data is based on benchtop performance testing conducted by ReNovo, Inc. It is prospective testing designed to demonstrate the performance of their reprocessed devices. The country of origin of the data is not explicitly stated but is implied to be where ReNovo, Inc. conducted its testing (USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This study does not involve human readers or interpretation of medical images/data where expert ground truth establishment would be required. The evaluation is based on objective physical and chemical testing.
4. Adjudication Method for the Test Set
Not applicable. There is no adjudication method described as this is not a study involving subjective interpretation or consensus. The performance tests are objective laboratory measurements.
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 is a study on the reprocessing of a physical medical device (trocar), not an AI imaging or diagnostic algorithm. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is not an algorithm or AI device. The "standalone" performance refers to the reprocessed device itself, which was evaluated through benchtop testing.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this study is essentially the performance and characteristics of a new, legally marketed OEM Covidien Trocar. The reprocessed device's performance is compared against this established benchmark.
8. The Sample Size for the Training Set
Not applicable. This is not an AI or machine learning study, so there is no concept of a "training set" in this context. The study focuses on evaluating the reprocessing process and the final reprocessed product.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device evaluation.
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