(14 days)
The Modular Trocar System is a sterile, single-use device, intended for use in conjunction with APPLIED's currently marketed trocar products to establish a path of entry for endoscopic instruments for use during general, abdominal. gynecological and thoracic minimally invasive procedures or to gain access through tissue planes and/or potential spaces for endoscopic instruments. The Modular Trocar System may be used with an optical separator or a bladed obturator, and may be used with or without visualization for primary and secondary insertions.
A typical trocar access system consists of a seal, a cannula and an obturator. This filing applies to a change to the access system approved in K060096. The change involves offering the option of a second obturator design. The optional obturator has a cutting blade covered by a retractable shield. De-activation of the shield is accomplished by moving a switch on the obturator handle. The design concept and materials of the optional obturator are similar to those approved in APPLIED's Disposable Surgical Trocar 510(k) K943489. The method of de-activation of the shield is similar to the method used in the Ethicon Bladed Shielded system approved in K971475.
This document describes the Kii Shielded Access System (Modular Trocar System), a medical device for use in minimally invasive surgical procedures. The 510(k) summary (K072674) details the device's intended use and design, emphasizing the addition of a new obturator design with a cutting blade covered by a retractable shield. The submission focuses on demonstrating substantial equivalence to predicate devices, particularly concerning insertion forces.
Acceptance Criteria and Reported Device Performance for K072674: Kii Shielded Access System
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Insertion Force | Demonstrated substantial equivalence to the predicate device (K943489). |
| Shield Mechanism Reliability | Performance and functional testing demonstrated equivalence to predicate devices. |
| Shield Deployment Time | Performance and functional testing demonstrated equivalence to predicate devices. |
| Locking Mechanism Structural Strength Test | Performance and functional testing demonstrated equivalence to predicate devices. |
Study Details:
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Sample Size used for the test set and the data provenance:
The document does not specify the exact sample size for each performance test. It states that "These tests were performed on the subject device as well as predicate devices," implying a comparison was made. Given the nature of mechanical testing for a medical device, the sample size would likely be a statistically relevant number of units to ensure reliability and repeatability for each test (e.g., typically several units for each test for robust statistical analysis), but this is not explicitly stated. The data provenance is internal to Applied Medical Resources Corporation. There is no mention of country of origin of data or whether it was retrospective or prospective, though performance testing for 510(k) submissions is typically prospective, controlled testing in a laboratory setting. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. For this type of mechanical device testing, "ground truth" is established by direct measurement of physical properties (e.g., force, time, strength) against engineering specifications and comparison to predicate device performance, not by expert consensus or interpretation of images. The tests are objective and quantitative. -
Adjudication method for the test set:
Not applicable. As noted above, the tests are objective measurements of physical properties, not subjective assessments requiring adjudication. -
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 mechanical surgical access device, not an AI or imaging diagnostic device. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a mechanical surgical access device, not an AI or software algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the performance tests mentioned (Insertion Force, Shield Mechanism Reliability, Shield Deployment Time, Locking Mechanism Structural Strength Test), the "ground truth" is based on objective, quantitative measurements of physical properties and performance against established engineering specifications and comparison to the predicate devices. The acceptable range for these measurements is typically defined by engineering standards and the performance of currently marketed, legally predicate devices. -
The sample size for the training set:
Not applicable. This device does not use an AI component, and therefore, there is no "training set." -
How the ground truth for the training set was established:
Not applicable. There is no training set for this mechanical 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.