(86 days)
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instruments to pass through the cannula while preventing loss of pneumoperitoneum when instruments are inserted and withdrawn from the obturator, which is a mechanism that allows the cannula to penetrate the abdomen.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.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.