(122 days)
The Mitsubishi Endoscope Introducer Kit is intended to provide an open channel to allow insertion of a small diameter endoscope during laparoscopic choledochoscopy.
The Mitsubishi Endoscope Introducer Kit consists of an internal dilator (with luer fitting to accommodate a hemostasis valve) contained within an external sheath (with attached hemostasis valve and luer fitting). The dilator may be straight or curved and has a lumen to allow passage of a flexible guidewire.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Endoscope Introducer Kit (K955717).
Based on the provided 510(k) summary, the device is an Endoscope Introducer Kit, which is a Class II device. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics.
Therefore, many of the requested details, particularly those related to clinical performance, ground truth, expert adjudication, and sample sizes for training/test sets, are not applicable or not provided in this type of submission.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Study for K955717 Endoscope Introducer Kit
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Acceptance Criterion: Substantial Equivalence to the predicate device, "Candela Introducer Sheath System" (K912443). Key aspects of equivalence include:Same design considerationsSame materials of constructionSame operating principlesSimilar lengths, diameters, and smoothly finished contoursCapabilities for sterilization | The Mitsubishi Endoscope Introducer Kit is reported as substantially equivalent to the Candela Introducer Sheath System. Differences do not raise new questions regarding safety or effectiveness. The device's technological characteristics such as design, materials, operating principles, dimensions, and sterilizability are considered similar to the predicate. |
| (Implicit) Safety & Effectiveness: Does not raise new questions regarding safety or effectiveness. | The submission asserts that no new questions regarding safety or effectiveness are raised. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This 510(k) summary does not describe a clinical performance study with a test set of patient data, as the submission relies on demonstrating substantial equivalence to an already marketed device rather than new clinical data from a prospective or retrospective study. The "test set" in this context would implicitly be an evaluation of the device's physical and functional characteristics against the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. As no clinical "test set" with patient data requiring diagnostic ground truth was used, no experts were involved in establishing such ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. There was no clinical "test set" requiring an adjudication method.
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 physical medical instrument (an introducer kit for endoscopes), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. There was no clinical "ground truth" established as part of this substantial equivalence submission. The "ground truth" for this submission revolves around the characteristics of the predicate device.
8. The sample size for the training set
- Not Applicable. This submission does not describe a machine learning algorithm, and therefore there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an algorithm, this question is not relevant.
Summary of Approach:
The K955717 submission demonstrates substantial equivalence by comparing the technical characteristics, materials, design, operating principles, and intended use of the Mitsubishi Endoscope Introducer Kit to the predicate "Candela Introducer Sheath System" (K912443). The acceptance criterion is met by asserting that these aspects are sufficiently similar and that any differences do not introduce new safety or effectiveness concerns. This regulatory pathway (510(k)) generally relies on this type of comparison rather than extensive new clinical studies testing specific performance metrics.
§ 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.