(126 days)
The TC Endo Port has applications in abdominal, thoracic, laparoscopic and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments.
TC Endoport trocars are sterile single patient use instruments consisting of a sleeve and obturator in sizes ranging from 5-12 mm in diameter. The TC Endoport obturator is made from plastic, and has a dilator tip which gently moves aside any internal viscera that may be adjacent to the abdominal or thoracic wall. The trocar sleeve contains two seals, an outer annular seal that accommodates instruments from 5-12 mm in diameter, and an internal seal. Together these seals minimize gas or fluid leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve, or valved luer are provided with standard luer lock fittings, to provide for gas insufflation, desufflation, or infusion and aspiration of fluids.
The provided document describes the acceptance criteria and performance of the "TC Endo Port" device, a surgical trocar. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Exposure | All samples must be capable of withstanding a 2X sterilization cycle. | Implied to meet the criteria, as no failures are reported and the conclusion states "No new questions of safety or effectiveness were raised during the performance testing of the device." The device is also mentioned to be "EtO gas-permeable sterile." |
| Simulated Implant | All samples must be capable of being implanted in simulated conditions using the instructions for use. Insertion forces must be equal to or less than predicate device. | Implied to meet the criteria, as no failures are reported and the conclusion states "No new questions of safety or effectiveness were raised during the performance testing of the device." |
| Valve Tool Pass Verification | Must pass the range of recommended tools through the valve without damaging the valve or causing the loss of more than 10ml of fluid. | Implied to meet the criteria, as no failures are reported and the conclusion states "No new questions of safety or effectiveness were raised during the performance testing of the device." |
| Valve Cyclic Test | Must pass the maximum sized tool through the valve ten times without damaging the valve or causing the loss of more than 10ml of fluid. | Implied to meet the criteria, as no failures are reported and the conclusion states "No new questions of safety or effectiveness were raised during the performance testing of the device." |
| Valve Pressure Withstand | Must withstand a fluid pressure of 450mmHg without leaking. | Implied to meet the criteria, as no failures are reported and the conclusion states "No new questions of safety or effectiveness were raised during the performance testing of the device." |
| Balloon Diameter Verification | Profile of balloons must be within 15%-25% of expected values from design. | Implied to meet the criteria, as no failures are reported and the conclusion states "No new questions of safety or effectiveness were raised during the performance testing of the device." |
| Balloon Volume Loss | Balloons cannot lose more than 0.5ml over one hour. | Implied to meet the criteria, as no failures are reported and the conclusion states "No new questions of safety or effectiveness were raised during the performance testing of the device." |
| Balloon Inflation/Deflation Time | Balloons must inflate and deflate in under 15 seconds. | Implied to meet the criteria, as no failures are reported and the conclusion states "No new questions of safety or effectiveness were raised during the performance testing of the device." |
| Balloon Cyclic Test | Balloons and inflation lumens must withstand 40 inflation/deflation cycles to 1 atm without failure. | Implied to meet the criteria, as no failures are reported and the conclusion states "No new questions of safety or effectiveness were raised during the performance testing of the device." |
| Balloon Minimum Burst Strength | Balloon should withstand 2X SF over 1 atm. | Implied to meet the criteria, as no failures are reported and the conclusion states "No new questions of safety or effectiveness were raised during the performance testing of the device." |
| Cannula to Hub Strength | Material interface should resist a tensile force of up to 3.4 lb (15 N). | Implied to meet the criteria, as no failures are reported and the conclusion states "No new questions of safety or effectiveness were raised during the performance testing of the device." |
| Inflation Lumen to Hub Strength | Material interface should resist a tensile force of up to 3.4 lb (15 N). | Implied to meet the criteria, as no failures are reported and the conclusion states "No new questions of safety or effectiveness were raised during the performance testing of the device." |
| Valve Body to Cannula Strength | Material interface should resist a tensile force of up to 3.4 lb (15 N). | Implied to meet the criteria, as no failures are reported and the conclusion states "No new questions of safety or effectiveness were raised during the performance testing of the device." |
| Dilator Insertion/Removal Force | Material interface should resist a tensile force of up to 3.4 lb (15 N). | Implied to meet the criteria, as no failures are reported and the conclusion states "No new questions of safety or effectiveness were raised during the performance testing of the device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- For "Sterilization Exposure" test: "All" samples.
- For "Simulated Implant" test: 30 new devices + 1 Predicate device.
- For all other listed tests: 30 samples each.
- Data Provenance: The document does not specify the origin (e.g., country) of the data, nor does it explicitly state if the study was retrospective or prospective. Given that these are non-clinical, in-vitro performance tests for a new device, they are inherently prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The tests described are non-clinical performance evaluations of the device's physical properties and functionality, not diagnostic or clinical assessments requiring expert human interpretation for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation of data where consensus is needed to establish ground truth. The tests performed for this device are objective measurements of physical and functional properties.
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, a Multi Reader Multi Case comparative effectiveness study was not done. The document explicitly states: "No clinical tests were conducted as part of this products development." This device is a surgical instrument, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is an endoscope and accessories, a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology, expert consensus) does not directly apply here. For these non-clinical performance tests, "ground truth" is defined by the objective physical and functional parameters measured against pre-defined engineering specifications and direct comparison to a predicate device. For example, "withstanding a 2X sterilization cycle" or "not losing more than 10ml of fluid" are the objective criteria that act as the standard.
8. The Sample Size for the Training Set
This information is not provided and is not applicable. This is a physical medical device being evaluated through non-clinical performance testing against a predicate, not an AI/ML algorithm that requires a training set.
9. How the 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.