(92 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.
A Vanguard Reprocessed Trocar is a previously used device that has been cleaned, inspected, packaged and sterilized by Vanguard Medical Concepts, Inc.
Trocar Cannulae are available in sizes 5-15mm inner diameter and 70-100mm 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 bladed and non-bladed configurations sized 5-15mm. Bladed models are equipped with a safety shield 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-Bladed obturators have either a rounded (blunt) tip or sharply tapered (dilator) tip to allow trocar insertion following a cut down and minimize the risk for internal injury.
Vanguard receives previously used trocars from healthcare facilities; cleans, inspects, tests, packages, labels, and sterilizes the devices; and returns them to a healthcare facility for subsequent use.
This document describes the reprocessing of previously used trocars by Vanguard Medical Concepts, Inc. The submission is for "Vanguard Reprocessed Bladed and Non-Bladed Trocars" (US Surgical/AutoSuture Series). It outlines the device description, technological characteristics, and a conclusion of substantial equivalence to legally marketed predicate devices.
Here's an analysis of the provided text in relation to your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state acceptance criteria in a quantitative format (e.g., "device must achieve X% accuracy"). Instead, it describes a demonstration of equivalence and performance through various validations. The "performance" is implicitly stated as performing "as intended" and being "safe and effective."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device performs as intended | Reaches "Substantial Equivalence" to predicate devices. Validations demonstrate performance. |
| Device is safe and effective | Validations demonstrate safety and effectiveness. |
| Chemical safety (e.g., residual sterilization agents) | Sterilization validation (implied to ensure safety). Cleaning validation. |
| Biocompatibility | Biocompatibility testing. |
| Functionality (e.g., seal integrity, blade retraction, patency) | Performance testing. |
| Sterility Assurance | Sterilization validation. |
| Packaging integrity | Packaging validation. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for performance testing of the reprocessed devices. It broadly mentions "cleaning, test data, biocompatibility testing."
- Sample Size for Test Set: Not explicitly stated.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Given this is a 510(k) for a reprocessed medical device, the testing would likely be a combination of in-house (Vanguard Medical Concepts) laboratory testing and potentially contract lab testing, using the specific devices being reprocessed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This type of information is generally not applicable to a 510(k) submission for reprocessing a medical device like a trocar. The "ground truth" for these devices is typically established through engineering specifications, regulatory standards, and performance characteristics of the original predicate device. Expert panels are not usually used to establish "ground truth" for the functionality of a reprocessed instrument, but rather to evaluate the clinical impact or equivalence. The document does not mention any expert panels.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human judgment is involved in establishing a definitive diagnosis or outcome, for example, in medical imaging studies. For the performance testing of a physical medical device, objective measurements against specifications are used, not human adjudication in this sense.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI algorithms where human readers' performance is compared with and without AI assistance across multiple cases. This submission is for the reprocessing of a surgical instrument.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. A "standalone" performance study refers to the performance of an AI algorithm alone. This submission is for a reprocessed medical device, not an AI algorithm. The device itself is "standalone" in the sense that its functionality is evaluated independently of human surgical skill, but this is a different context than what is meant by "standalone" for AI.
7. The Type of Ground Truth Used
The ground truth used for this type of device (reprocessed trocars) would be:
- Engineering Specifications and Performance Standards: The reprocessed devices must meet the design and performance specifications of the original predicate devices (e.g., seal integrity, blade sharpness, safety shield function, structural integrity).
- Regulatory Standards: Adherence to FDA guidance for reprocessed single-use devices, including sterility, biocompatibility, and cleaning validation.
- Predicate Device Performance: The original predicate devices set the benchmark for acceptable performance.
8. The Sample Size for the Training Set
Not applicable. A "training set" refers to data used to train an AI algorithm. This submission is for a reprocessed medical device, not an AI algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set mentioned in the context of an AI algorithm. The "ground truth" for the processes (cleaning, sterilization, etc.) would be established by validated scientific methods and regulatory requirements for medical device reprocessing.
§ 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.