(14 days)
The Fixation Trocar 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 Fixation Trocar may be used with an optical tissue separator or a bladed obturator, and with or without visualization for primary and secondary insertions.
This filing addresses a line extension to the Modular Trocar System approved in K060096. A typical trocar access system consists of a seal, a cannula and an obturator. The obturator is used to place the cannula (with seal attached) through the patient's abdomen, then it's discarded. To function properly, the cannula must not shift from its location in the abdomen as the surgery proceeds. For that reason, many cannulas have structural features that help anchor the cannula in the tissue. These features may range from a textured surface to ridges on the outer diameter of the cannula. The line extension that is the topic of this filing offers trocar models that have an alternate method of anchoring the cannula to abdominal tissue. For descriptive purposes in this document, these trocar models may at times be referred to as "Fixation Trocars". Since the seal and the obturator of the Fixation Trocar are unchanged from the predicate device approved in K060096, this filing primarily addresses the cannula and the features that allow the new anchoring method. A technical description of those features is in "SUMMARY OF TECHNOLOGICAL CHARACTERISTICS" on page 2-2. The Fixation Trocar will be available in cannula diameters ranging from 5mm to 15mm and lengths ranging from 55mm to 150mm. These dimensions match the trocars approved in K060096.
The provided document, K083638, describes a 510(k) premarket notification for a Fixation Trocar, which is a line extension to an existing Modular Trocar System. The primary focus of the new device is an improved anchoring mechanism for the cannula during surgical procedures.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Insertion Force | Not explicitly stated as a defined 'acceptance' value, but implied to be within acceptable surgical usage. | "the force required to insert the trocar cannula and obturator through abdominal tissue." The study determined this force for both the Fixation Trocar and predicate devices. (Specific values not provided in this summary). |
| Post-insertion Migration/Slippage Force | Not explicitly stated as a defined 'acceptance' value, but implied to be sufficient to prevent unintended dislodgement before anchoring. | "the force required to dislodge the trocar cannula from its position in tissue before the anchoring feature is activated." The study determined this force for both the Fixation Trocar and predicate devices. (Specific values not provided in this summary). |
| Retention Force | Not explicitly stated as a defined 'acceptance' value, but the device "performs particularly well in its most important characteristic, retention of the cannula in the patient's abdomen." Competitive performance against predicate is implied as the benchmark. | "the force required to dislodge the cannula from tissue after deployment of the balloon." The study determined this force for both the Fixation Trocar and predicate devices. The CONCLUSION states: "The Fixation Trocar's anchoring feature performs particularly well in its most important characteristic, retention of the cannula in the patient's abdomen." This suggests superior or at least equivalent performance to the predicate. (Specific values not provided in this summary). |
| Removal Force | Not explicitly stated as a defined 'acceptance' value, but implied to be safe and manageable for surgical removal. | "the force required to remove the trocar from tissue after collapse of the balloon." The study determined this force for both the Fixation Trocar and predicate devices. (Specific values not provided in this summary). |
| Overall Safety & Effectiveness | Substantial equivalence to predicate device. | "APPLIED's performance and functional testing demonstrated that the Fixation Trocar is substantially equivalent or superior to its predicate devices and introduces no new safety and effectiveness issues when used as instructed." |
2. Sample Size Used for the Test Set and Data Provenance:
The document states, "These tests were performed on the subject device as well as predicate devices." However, it does not specify the sample size (number of devices, number of trials, or number of tissue samples) for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The tests described are non-clinical, implying they were likely benchtop or ex-vivo tests rather than human clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This document describes non-clinical performance testing of a medical device (trocar). Therefore, the concept of "experts used to establish ground truth" in the context of diagnostic performance (e.g., radiologists interpreting images) is not applicable here. The "ground truth" for the tests mentioned (insertion force, retention force, etc.) would be established through objective physical measurements according to a defined test protocol.
4. Adjudication Method for the Test Set:
Not applicable, as this is non-clinical performance testing, not a study involving human interpretation or subjective assessments that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a non-clinical performance evaluation of a device's physical characteristics, not a study evaluating human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This is a physical medical device, not a software algorithm. The "standalone" performance refers to the device's function directly. The tests described (insertion, retention, etc.) evaluate the device's standalone physical performance characteristics.
7. Type of Ground Truth Used:
The ground truth for the non-clinical tests described would be based on objective physical measurements using calibrated instruments. For example:
- Insertion Force: Measured force (e.g., in Newtons) required to traverse tissue.
- Retention Force: Measured force (e.g., in Newtons) required to dislodge the device from tissue.
- Post-insertion Migration/Slippage Force: Measured force.
- Removal Force: Measured force.
Essentially, the "ground truth" is the empirically measured physical property of the device's interaction with a tissue substitute or actual tissue sample under controlled laboratory conditions, as defined by the "test protocol designed to confirm safety and efficacy."
8. Sample Size for the Training Set:
Not applicable. This is a physical medical device, not a machine learning model, so 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 a physical medical 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.