(84 days)
The ENDOPATH® Ultra-Retractor and Vessel Dissector are intended for use in dissecting and retracting in all types of surgical procedures requiring dissection and retraction of tissue.
The ENDOPATH™ Ultra-Retractor has application for the creation and maintenance of an operative cavity in the extraperitoneal spaces such as the retroperitoneal, preperitoneal, and subcutaneous areas. The device may be used in all types of surgical procedures, requiring dissection and retraction of tissue.
The Vessel Dissector has application for use in the blunt dissection of tubular structures such as veins, arteries, nerves, and ducts. The device may also be used in all types of surgical procedures requiring dissection of tissue.
The ENDOPATH® Ultra-Retractor consists of a handle, a wide shaft, and a transparent blunt tip dissector (two instruments are available with a variation in the tip size). The blunt tip dissects tissue and creates a cavity that allows instrument passage. The wide shaft maintains the space created by the transparent tip. The tip is transparent to allow visualization during insertion, tunneling, and dissection. Also, the device is provided with a luer lock, located on the handle, for the attachment of suction or gas, such as CO2, nitrogen, or air, as an aid for the removal of mist or smoke when used in combination with electrosurgery or ultrasonic devices and/or clearing the endoscope lens.
The instrument is compatible with a rigid endoscope that has maximum diameter of 5.5mm and is 290mm to 300mm in length.
This document is a 510(k) summary for the ENDOPATH® Ultra-Retractor and Vessel Dissector. It does not contain the level of detail typically found in a study description that would allow for a comprehensive answer to all parts of your request. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed outcomes from a large-scale clinical study with specific performance metrics and ground truth establishment.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device can be used as designed and is safe and effective. | "Pre-clinical laboratory evaluations were performed to ensure that the device can be used as designed. The studies demonstrated acceptable performance to the Predicate Device." |
| Substantial equivalence to predicate device. | "Based on the 510(k) summaries and 510(k) statements (21 CFR §807) and the information provided herein, we conclude that the New Device is substantially equivalent to the Predicate Device under the Federal Food, Drug and Cosmetic Act." |
| Compatibility with rigid endoscope | "The instrument is compatible with a rigid endoscope that has maximum diameter of 5.5mm and is 290mm to 300mm in length." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document only mentions "Pre-clinical laboratory evaluations." These are likely benchtop tests or potentially animal studies, not human clinical trials with a defined test set sample size.
- Data Provenance: Not specified. Given it's pre-clinical lab evaluation, it would likely be internal testing data, not country-specific patient data.
- Retrospective/Prospective: Not specified, but "Pre-clinical laboratory evaluations" often imply prospective testing designed to evaluate specific aspects of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not provided. Pre-clinical evaluations typically rely on engineering specifications, design verification, and internal expert judgment regarding mechanical and functional performance, rather than a formal "ground truth" established by external medical experts in the way clinical studies do.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/not specified. Adjudication methods are typically used in clinical studies where interpretation of results (e.g., image readings) by multiple human experts is involved. Pre-clinical lab evaluations generally do not involve this process.
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
- No, an MRMC comparative effectiveness study was not done. This document predates widespread AI in medical devices and focuses on mechanical and functional equivalence for a surgical instrument. An MRMC study is relevant for diagnostic imaging AI algorithms, not for surgical retractors.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not an AI/algorithm-based device. It is a physical surgical instrument. Therefore, a standalone algorithm performance study is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The document refers to "pre-clinical laboratory evaluations." For a surgical instrument like this, the "ground truth" would likely be adherence to engineering specifications, successful performance of intended functions (e.g., retraction strength, dissection ability, ability to maintain space), material compatibility, and sterile barrier integrity. This would be verified through a combination of physical and mechanical testing, not expert consensus on medical images or pathology.
8. The sample size for the training set
- Not applicable. This device does not use a training set as it is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this 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.