(66 days)
Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.
Trocars and cannulae are designed to establish a port of entry for endoscopic instruments used during minimally invasive surgery.
The Trocar Cannula is available with a threaded sleeve with a 5mm inner diameter and 100mm length. The Cannula is equipped with a sealing system for maintenance of pneumoperitoneum during insertion and withdrawal of instruments and with a luer stopcock port for insufflation and desufflation of the operative cavity.
Trocar Obturator is available in bladeless configuration sized 5 mm.. Bladeless optical obturators are equipped with a clear tip and a video laparoscopy channel to allow trocar insertion under direct visual quidance and minimize the risk for internal injury
The reprocessed device has the same intended use as the original device and does not incorporate new technology or design changes.
The provided text is a 510(k) premarket notification for reprocessed trocars. It details the device, its intended use, and substantial equivalence to a predicate device. However, it does not contain the specific acceptance criteria, device performance data, study design, or validation results needed to answer your request fully.
The document states that a previous 510(k) (K062497) included information for trocars limited to one reprocessing cycle, and this current 510(k) (K100080) "includes data to demonstrate that the Trocars, models B5LT and CB5LT, can undergo two (2) reprocessing cycles without changing the safety and effectiveness of the device." This implies a study was conducted, but the details of that study are not present in the provided excerpts.
To address your request, I will indicate where the information would typically be found in a complete submission or what is inferred from the available text.
Here's a breakdown of the requested information based on the provided text and general 510(k) content expectations:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance (Not provided in excerpt) |
|---|---|
| Maintain safety and effectiveness after two reprocessing cycles (compared to predicate or new device). | Specific performance metrics (e.g., integrity, sealing, penetration force, material properties) and their quantitative results are not detailed in the provided excerpt. |
| Meet same intended use and performance specifications as the original device. | No specific performance data is presented. |
Explanation: The document explicitly states: "This 510(k) includes data to demonstrate that the Trocars, models B5LT and CB5LT, can undergo two (2) reprocessing cycles without changing the safety and effectiveness of the device." This sets the acceptance criteria at maintaining safety and effectiveness. However, the specific metrics and the actual performance results demonstrating this are not included in the provided pages.
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 provided in the excerpt. A complete 510(k) submission for reprocessing validation would typically include specific numbers of devices tested.
- Data Provenance: Not stated in the excerpt. It would usually be prospective testing of reprocessed devices.
- Country of Origin: Not specified for the data itself, but the applicant (Ascent Healthcare Solutions) is located in Phoenix, Arizona, USA, and the manufacturing site is in Lakeland, FL, USA.
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)
- Not applicable/Not mentioned. This type of information (expert review for ground truth) is more common for diagnostic imaging AI submissions. For a reprocessed medical device, the "ground truth" is typically established through direct physical, mechanical, and functional testing of the device itself against established specifications, rather than expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not mentioned. Adjudication methods are typically used in clinical or image-based studies where expert consensus is required for ground truth determination. Device performance testing for reprocessing generally involves objective measurements.
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 a submission for a reprocessed surgical device, not an AI or diagnostic imaging device that would typically involve an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is for a physical medical device, not an algorithm. The performance being evaluated is that of the reprocessed trocar itself. The "standalone performance" here would effectively be the results of the physical and functional tests on the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this type of device validation would be established through:
- Validated test methods: Objective measurements of physical, mechanical, and functional properties (e.g., integrity, sealing, penetration force, material strength, sterility, biocompatibility) according to pre-defined specifications and industry standards.
- Comparison to original device specifications: Ensuring the reprocessed device performs identically to the new, predicate device.
- Safety and effectiveness demonstration: Ensuring no compromise in patient safety or clinical effectiveness due to reprocessing.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning submission with a "training set." The validation involves direct testing of the reprocessed devices.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" in this 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.