(90 days)
The BLUNTPORT™ Blunt Trocar with Threaded Anchor is intended for use in a variety of gynecologic, general, thoracic, and urologic endoscopic procedures to create and maintain a port of entry.
The Bluntport™ with Threaded Anchor 5mm-12mm is a sterile. single use device used for abdominal access during laparoscopic procedures. The device consists of a cannula assembly, blunttipped obturator component and an anchoring assembly. The cannula assembly accommodates various size laparoscopic devices ranging from 5mm to 12mm in diameter while still maintaining pneumoperitoneum. The anchoring device provides stability of the cannula at the access site.
The provided document is a 510(k) summary for the Covidien Bluntport™ Blunt Trocar with Threaded Anchor 5mm-12mm. It outlines the device description, intended use, and a comparison with a predicate device. However, it does not provide detailed acceptance criteria and specific performance results in a quantifiable manner from a study.
The document states that "Design verification studies were conducted to demonstrate that the Bluntport™ with Threaded Anchor 5mm-12mm is safe and effective and performs as intended." It then lists the types of tests performed. For this type of device (a surgical trocar), the "acceptance criteria" are typically related to the functional performance of the device (e.g., maintaining pneumoperitoneum, anchoring strength, biocompatibility), and the "study" would involve testing the device against these performance requirements.
Based on the provided text, I can infer the general categories of acceptance criteria and the types of studies conducted, but I cannot give specific numerical acceptance thresholds or the detailed performance data that would "prove" the device meets them. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with specific statistical outcomes.
Here's an attempt to structure the information based on what is available and what is typically expected for such devices, while acknowledging the limitations of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Expected Performance (Inferred) | Reported Device Performance (as stated in document) |
|---|---|---|
| Pneumoperitoneum Leak Rate | Device should prevent significant gas leakage during use to maintain surgical cavity inflation. | Studies conducted for "pneumoperitoneum leak rate" (details not provided, but implies satisfactory performance). |
| Anchoring Strength | Device should remain securely anchored at the access site without dislodgement during procedures. | Studies conducted for "anchoring strength" (details not provided, but implies satisfactory performance). |
| Anchor Position Adjustment | The anchoring mechanism should allow for appropriate and secure adjustment as intended. | Studies conducted for "anchor position adjustment" (details not provided, but implies satisfactory performance). |
| Biocompatibility (Cytotoxicity) | Device materials should not cause cytotoxic reactions. | Studies conducted for "cytotoxicity" (implies passing standard biocompatibility tests). |
| Biocompatibility (Sensitization) | Device materials should not cause sensitization (allergic reactions). | Studies conducted for "sensitization" (implies passing standard biocompatibility tests). |
| Biocompatibility (Intracutaneous Irritation) | Device materials should not cause significant skin irritation upon contact. | Studies conducted for "intracutaneous irritation" (implies passing standard biocompatibility tests). |
| Biocompatibility (Acute Systemic Toxicity) | Device materials should not cause acute systemic toxic effects. | Studies conducted for "acute systemic toxicity" (implies passing standard biocompatibility tests). |
| Overall Safety & Effectiveness | The device should be safe and effective for its intended use and comparable to predicate device. | "Design verification studies were conducted to demonstrate that the Bluntport™... is safe and effective and performs as intended." |
| Substantial Equivalence | The device should be substantially equivalent to the predicate device and not introduce new risks. | "The result of these tests demonstrate that the Bluntport™... is substantially equivalent to the predicate device and does not introduce additional risk to the patient." |
Limitations: The document only lists the types of tests performed. It does not provide specific numerical acceptance criteria (e.g., "leak rate less than X mL/min") or the quantitative results of these tests. The statement "implies satisfactory performance" is an interpretation based on the conclusion that the device is safe, effective, and substantially equivalent.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for any of the listed tests (pneumoperitoneum leak rate, anchoring strength, etc.).
The data provenance is not explicitly stated (e.g., country of origin). The studies appear to be retrospective in the sense that they are design verification studies performed by the manufacturer, rather than prospective clinical trials.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
For a device like a surgical trocar, "ground truth" and "experts" as typically understood in diagnostic AI/image analysis studies are not directly applicable in the same way. The performance of the device (e.g., leak rate, anchoring strength) is typically measured using engineering and biological testing methods against established standards or internal specifications, not by expert consensus on clinical findings. Therefore, this information is not provided and is likely not relevant in the context of this device's verification.
4. Adjudication Method for the Test Set
As explained above, "adjudication method" is not applicable here, as these are technical performance and biocompatibility tests rather than assessments requiring human interpretation of data for ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is designed for evaluating diagnostic devices or AI algorithms where human readers interpret medical data. This type of study is not applicable to a surgical tool like a trocar, and therefore, no such study or its effect size is mentioned.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This question refers to the performance of an AI algorithm independent of human interaction. The Covidien Bluntport™ Blunt Trocar is a physical surgical device, not an AI algorithm. Therefore, a standalone performance study in this context is not applicable.
7. Type of Ground Truth Used
The "ground truth" for the performance tests (e.g., pneumatic leak rate, anchoring strength) would be objective physical measurements obtained through standardized engineering and laboratory testing protocols. For biocompatibility, the ground truth would be established by the results of standardized biological assays (e.g., cell viability, immune response indicators) interpreted against established ISO standards (ISO 10993-1).
8. Sample Size for the Training Set
Not Applicable. The device is a physical surgical tool, not an AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set for a physical surgical device, this question is not relevant.
§ 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.