(142 days)
The ENDOPATH DEXTRUS Seal Cap Assembly with Accessories and Fixed-Length Access Retractors are indicated for use in procedures where entry of the surgeon's hand may facilitate the procedure, and for extraction of large specimens. The device has application in colorectal, urological, gynecologic, and general surgical procedures. This indication for use includes the specific procedures which fall under these broad categories.
The ENDOPATH DEXTRUS Seal Cap Assembly with Accessories, when used in conjunction with the ENDOPATH DEXTRUS Fixed-Length Access Retractor, is intended to provide extracorporeal extension of pneumoperitoneum and abdominal access for the surgeon during minimally invasive surgery.
The Fixed-Length Access Retractor, when used independently, is also intended to provide wound retraction and protection against wound contamination during minimally invasive and open surgery.
The device is a sterile, single patient use abdominal access system comprised of two separately packaged components:
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Seal Cap Assembly with Accessories
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Fixed-Length Access Retractor
The ENDOPATH DEXTRUS Seal Cap Assembly consists of stationary and rotating rings interconnected by means of an elastomeric material that functions as an irris valve seal with an adjustable aperture. The seal cap assembly is designed to connect with the fixed-length access retractor. The assembled device can maintain peritoneal gas pressure while allowing for insertion of the surgeon's hand or surgical instruments into the abdominal cavity.
The Fixed-Length Access Retractor is available in three sizes to accommodate a wide range of abdominal wall thicknesses. The retractor consists of a top rigid ring and a bottom flexible ring interconnected by means of an elastomeric material. The top rigid ring provides for circumferential wound retraction and is also the connection ring to the seal cap assembly. The bottom flexible ring is inserted into the abdomen for device fixation.
Accessories provided with the ENDOPATH DEXTRUS Seal Cap Assembly include a marking pen, ruler, and forearm wrap. The ruler and marking pen help measure and represent incision length, depending on surgeon glove size. The forearm wrap can be wrapped over the surgeon's glove and gown from the wrist to the upper forearm to facilitate the transition of the surgeon's gown through the iris valve during an extended reach within the abdominal cavity.
The provided 510(k) summary for the Endopath® Dextrus™ Seal Cap Assembly with Accessories and Fixed-Length Access Retractors does not contain the specific details required to complete many sections of your request.
This document is a premarket notification for a medical device and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed clinical study report with acceptance criteria and performance metrics for an AI/algorithm-based device.
Here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Bench testing and preclinical laboratory evaluations were performed to demonstrate that the new device will perform as intended. |
Explanation: The 510(k) summary states that "Bench testing and preclinical laboratory evaluations were performed to demonstrate that the new device will perform as intended." However, it does not provide specific acceptance criteria (e.g., maximum leak rate, force required for insertion, etc.) or quantitative performance results from these tests. These details are typically found in a more comprehensive testing report, not the summary.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: The document refers to "preclinical laboratory evaluations," which implies animal models or simulated environments, and "bench testing." It does not mention human patient data, nor country of origin for any data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The device is a surgical access system, not an AI/diagnostic tool requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for this device would be its physical performance characteristics (e.g., sealing ability, retractor strength) measured via engineering tests.
4. Adjudication method for the test set
Not applicable. This device does not involve subjective interpretations 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
Not applicable. This is not an AI/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device.
7. The type of ground truth used
For mechanical devices, "ground truth" refers to verified performance against engineering specifications or established physical principles. In this case, it would be the objective measurements from bench testing and preclinical laboratory evaluations confirming the device functions as intended (e.g., maintaining pneumoperitoneum, providing wound retraction). No specific "type of ground truth" (like pathology or outcomes data) is mentioned, as it's not relevant for this device.
8. The sample size for the training set
Not applicable. This device does not use an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device does not use an AI model that requires a training set.
Summary of what is present:
- Device Description: Provides a detailed overview of the Endopath® Dextrus™ Seal Cap Assembly with Accessories and Fixed-Length Access Retractors.
- Indications for Use: Clearly states the intended surgical procedures where the device is applicable.
- Technological Characteristics Comparison to Predicate Device: Highlights similarities and key differences (e.g., two-piece design, sterilization method, materials, accessories).
- Performance Data (General Statement): Confirms that bench testing and preclinical laboratory evaluations were performed to show the device performs as intended, but lacks specific details.
To get the details requested in your prompt, one would typically need access to the full 510(k) submission, which would include detailed test reports, protocols, and results. The public 510(k) summary is designed to provide a high-level overview for review and substantial equivalence determination.
§ 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.