(114 days)
The Weck Reusable Obturator is indicated for use with appropriate disposable Weck Vista cannulas in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.
The Weck® Reusable Obturator is used to establish penetration into the abdominal cavity during laparoscopic surgical procedures. When used with the appropriate corresponding disposable cannula, the system creates a port of entry into the patient, facilitating the access of various diameter devices, while maintaining insufflation at the surgical site. The obturator is positioned into the peritoneum as a guide to the corresponding cannula during minimally invasive surgical procedures, and then is removed in order to provide a pathway for the insertion and removal of various sized surgical devices. The Weck® Reusable Obturator is intended to be used by trained physicians.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate obturators for performance | Achieved; comparative test results demonstrate substantial equivalence. |
| Seamless interchangeability with predicate obturators | Achieved; comparative test results demonstrate seamless interchangeability. |
| Compliance with ISO 10993-1 for patient-contacting materials | Achieved; all patient-contacting materials are in compliance. |
| Appropriate cleaning and sterilization instructions for reusable devices | IFU updates integrated according to ISO 17664:2004 to ensure appropriate cleaning and sterilization. |
| Introduction of no new issues of safety and effectiveness | Achieved; modifications do not introduce any new issues. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the traditional sense of a clinical or observational study with human subjects or a defined dataset. Instead, the evaluation was based on bench testing.
- Sample Size: Not explicitly stated as a number of devices or data points, but rather refers to "bench testing" which implies a series of tests conducted on the device.
- Data Provenance: The data originates from internal "bench testing" performed by Teleflex Medical, Inc. The document does not specify country of origin for the data or if it was retrospective or prospective, though bench testing is inherently prospective in its execution for the purpose of verifying performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided. The testing performed was bench testing to verify performance characteristics and substantial equivalence, not a clinical study requiring expert assessment for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Bench testing does not typically involve an adjudication method as would be used in clinical trials with multiple expert readers. The evaluation was based on objective measurements and comparisons against predicate devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or performed. The study described is a bench test comparison of a reusable device against disposable predicate devices to demonstrate substantial equivalence, not a study involving human readers or comparative effectiveness in a clinical setting.
6. Standalone Performance Study
Yes, a standalone performance evaluation was conducted in the form of "bench testing." This testing was performed on the device itself to verify its performance characteristics and compare them to predicate devices, without human intervention as part of the primary performance measurement.
7. Type of Ground Truth Used
The "ground truth" for this device evaluation was established through objective performance metrics and specifications derived from the predicate devices, as determined through their own clearance processes. The Weck® Reusable Obturator was tested to verify that its performance was "substantially equivalent" and "seamlessly interchangeable" with these established predicate devices.
8. Sample Size for the Training Set
This information is not applicable and not provided. The device being evaluated is a physical medical device (an obturator), not an AI algorithm or software. Therefore, there is no "training set" in the context of machine learning.
9. How Ground Truth for the Training Set Was Established
This information is 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.