(88 days)
The CA-Guard Irrigating Cannula is intended to provide an access port to body cavities for endoscopes and endoscopic accessories when intraoperative irrigation or infusion of trocar wound surfaces is desired. The cannula has been tested for compatibility with lidocaine and marcane. Saline and water may also be used as irrigants. The CA-Guard Irrigating Cannula is inherently a needleless system and therefore, minimizes the possibility of "needle sticks" for healthcare workers, in accordance with the Needlestick Safety and Prevention Act of 2000.
The Irrigating Cannula is a non-toxic, sterile, single use, disposable surgical access port. The device is intended to be inserted percutaneously into the peritoneal cavity to provide access for endoscopic instruments. The cannula is intended to replace the cannula that is supplied with the United States Surgical Versaport® 11mm Trocar System.
The proximal end of the cannula is equipped with a female luer connector. The luer communicates with 6 longitudinal grooves on the surface of the inner member of the cannula. The inner member is covered with polyolefin shrink tubing. An array of twenty-four (24) holes deliver infusate to the compromised tissue surfaces of the trocar wound.
This document is a 510(k) premarket notification for an "Irrigating Cannula." This type of submission generally establishes substantial equivalence to a predicate device rather than strictly proving effectiveness against predefined acceptance criteria for a new clinical claim. Therefore, the information provided focuses on demonstrating equivalence through comparison and performance testing, rather than a clinical study with typical acceptance criteria for a diagnostic or AI-driven device.
Based on the provided text, here is an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Biocompatibility: Materials are safe for human contact and show no adverse reactions. | "The materials of construction have been carefully selected for their long history of biocompatibility." (Implied acceptance by using well-established, safe materials). |
| Mechanical Compatibility: Device is physically compatible with the intended existing system (predicate Versaport® Trocar System). | "The CA Guard Irrigating Cannula is designed to be mechanically compatible with all components of the United States Surgical Versaport® 11mm Trocar System using the 5 mm PLUS SEAL." (Implied acceptance by successful physical integration and function with the predicate system). |
| Infusate Compatibility: Device maintains integrity and function when exposed to specified infusates (lidocaine, marcaine, saline, water). | "The cannula has been tested for compatibility with lidocaine and marcane. Saline and water may also be used as irrigants." (Implied acceptance by successful testing with no adverse effects on the device from the infusates). |
| Performance Equivalence: Device performs "as well as or better than" the predicate device in its intended function (providing access, irrigation/infusion via its luer connector and grooves/holes). | "Performance of the device was characterized and compared to that of the predicate utilizing 5 tests." "The tests demonstrated the Irrigating Cannula is substantially equivalent to the cannula manufactured and marketed by the United States Surgical Corporation as part of the Versaport® Trocar System pursuant to 510(k) K954108." "Since the Irrigating Cannula embodies technological characteristics essentially identical to those of the predicate device, we believe the device is safe and effective and that it performs as well as or better than the predicate device." (Implied acceptance by demonstrating equivalent performance in unspecified tests compared to the predicate.) |
| Needlestick Minimization: The design inherently reduces the risk of needlestick injuries for healthcare workers. | "The CA-Guard Irrigating Cannula is inherently a needleless system and therefore, minimizes the possibility of 'needle sticks' for healthcare workers, in accordance with the Needlestick Safety and Prevention Act of 2000." (Design feature that inherently meets this safety objective). |
| Manufacturing Quality: Device is manufactured according to quality system regulations (QSR) and good manufacturing practices (GMP). | "The device has been designed and developed utilizing design control methods in compliance with the QSR. The Irrigating Cannula will be manufactured per specifications and good manufacturing practices that ensure the device is safe and effective for its intended use." (Commitment to QSR/GMP ensures quality and regulatory compliance, implying acceptance of manufacturing process). |
| Technological Equivalence: Device's technological characteristics are comparable to the predicate. | "The Irrigating Cannula was compared to the predicate device using 14 points of comparison and found to be equivalent." (Implied acceptance by a formal comparison finding equivalence on key characteristics). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of human data or a clinical trial. The performance evaluation appears to be based on laboratory or bench testing of the device itself and comparison to the predicate. No information is provided regarding the number of devices tested, the country of origin of data, or whether it was retrospective or prospective, as these are typically not applicable to this type of performance testing for a 510(k) submission of a cannula.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as there was no "test set" involving human data or expert review to establish ground truth in the clinical sense for this device. The evaluation was primarily engineering and materials-based.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as there was no "test set" involving human data or expert review requiring adjudication.
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
This information is not applicable. The device is an "Irrigating Cannula," a physical surgical instrument, not an AI or diagnostic imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's evaluation is not a clinical "ground truth" derived from patient outcomes or expert consensus. Instead, it relies on:
- Predicate device performance: The performance of the legally marketed United States Surgical Versaport® Trocar System (K954108) serves as the benchmark or "ground truth" for equivalence.
- Material properties and established biocompatibility: Existing scientific knowledge and history of use for chosen materials.
- Engineering specifications and functional testing: Device performance against its own design specifications and functional requirements (e.g., fluid flow, mechanical fit).
8. The sample size for the training set
This information is not applicable. The device is a physical surgical instrument, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable. The device is a physical surgical instrument, not an AI model that utilizes a training set with established ground truth.
Summary of the Study (as described in the document):
The "study" for the Irrigating Cannula was a performance characterization and comparison to a legally marketed predicate device (United States Surgical Versaport® Trocar System K954108) for the purpose of demonstrating substantial equivalence under a 510(k) submission.
- Comparison Basis: The new device was compared across "14 points of comparison" for technological characteristics, finding them "essentially identical" or equivalent.
- Performance Testing: "5 tests" were utilized to characterize and compare the performance of the Irrigating Cannula to the predicate device. The specific nature of these tests is not detailed, but they demonstrated substantial equivalence. These likely included tests related to mechanical integrity, fluid flow, and compatibility.
- Infusate Compatibility Testing: The cannula was specifically tested for compatibility with lidocaine and marcaine, finding it suitable for use with these and other common irrigants (saline, water).
- Biocompatibility: Relied on the "long history of biocompatibility" of the selected materials.
- Design & Manufacturing: The device was designed and developed using design control methods compliant with Quality System Regulations (QSR), and will be manufactured per specifications and Good Manufacturing Practices (GMP).
In essence, the "study" was a robust technical and engineering assessment, coupled with a formal comparison to a predicate device, focusing on functional equivalence, material safety, and compatibility rather than clinical efficacy or diagnostic accuracy, which are not relevant for this class of device in a 510(k) context.
§ 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.