(135 days)
Reprocessed trocars are intended to provide a pathway for entry of instruments during minimally invasive surgery, with particular applications in abdominal, gynecological, urological, and thoracic procedures.
Vanguard Reprocessed Trocar is a previously used device that has been cleaned, inspected, packaged and sterilized by Vanguard Medical Concepts, Inc.
Trocar Cannulae is available with smooth or threaded sleeve in sizes 5-15mm inner diameter and 5-15cm length. Cannulae are equipped with a pressure seal for maintenance of pneumopertineum during insertion and withdrawal of instruments. Some models are equipped with a luer stopcock port for insufflation and desufflation of the operative cavity. Some models are provided with stability anchors inserted over the cannula sleeve to help seal the incision site and maintain cavity pressure.
Trocar Obturator is available in shielded and non-shielded configurations sized 5-15mm. Models equipped with a safety shield are designed to expose the blade during insertion but to retract over the tip once the operative cavity has been penetrated, so as to reduce the risk for vascular or visceral injury. Non-shielded optical obturators are equipped with a clear tip and an 11-12mm video laparoscopy channel to allow trocar insertion under direct visual guidance and minimize the risk for internal injury.
The provided text describes a 510(k) summary for Vanguard Reprocessed Dilating Tip and Blunt Trocars. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report with specific performance metrics for the reprocessed device. Therefore, much of the requested information regarding detailed study design, statistical analysis, and clinician-based performance metrics is not available within this document.
Here's an attempt to answer based on the provided text, highlighting what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. It generally claims that "cleaning, sterilization, packaging validations, and performance and biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Cleaning effectiveness | Not quantitatively stated. Implied as "successfully cleaned." |
| Sterilization effectiveness | Not quantitatively stated. Implied as "successfully sterilized." |
| Packaging integrity | Not quantitatively stated. Implied as "successfully packaged." |
| Performance (functional) | Not quantitatively stated. Implied as performing "as intended," and that "reprocessed trocars possess identical technological characteristics" to OEM devices. |
| Biocompatibility | Not quantitatively stated. Implied as "biocompatible." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of evaluating algorithm performance or diagnostic accuracy. It refers to "cleaning, sterilization, packaging validations, and performance and biocompatibility testing" as the basis for demonstrating safety and effectiveness.
- Sample Size: Not specified for each type of testing.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It's likely these were laboratory or bench tests conducted by Vanguard Medical Concepts, Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since this is a reprocessed medical device approval, not an AI/diagnostic software approval, the concept of "ground truth" derived from experts in a clinical diagnostic context does not apply in the same way. The ground truth for the reprocessed device's safety and effectiveness would be established through:
* Bench testing: Measuring physical properties, functional performance against specifications.
* Sterilization validation: Demonstrating sterility.
* Biocompatibility testing: Ensuring material safety.
No "experts" in the sense of clinicians establishing ground truth for diagnostic accuracy are mentioned or relevant here.
4. Adjudication Method for the Test Set
Not applicable, as this is not a diagnostic study requiring expert adjudication of clinical findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size
No MRMC comparative effectiveness study was done, as this is a device reprocessing approval for physical instruments, not a diagnostic AI or imaging interpretation system requiring human-in-the-loop performance evaluation.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
As this concerns a reprocessed physical device, the "ground truth" refers to established engineering standards, material science specifications, and regulatory requirements for sterility and biocompatibility.
- Engineering Specifications: Functional performance validated against the original equipment manufacturer's (OEM) device specifications.
- Sterility Assessment: Meeting established sterility assurance levels (e.g., 10^-6).
- Biocompatibility Standards: Adherence to ISO 10993 or similar standards.
- Cleaning Efficacy Standards: Demonstrating removal of organic and inorganic contaminants to acceptable levels.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device.
§ 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.