(70 days)
The BASX™ Bladeless Trocar has applications in abdominal and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments.
The BASX™ Bladeless Trocar is a sterile single patient use instrument consisting of a radiolucent sleeve in sizes 5mm, 11mm, and 12 mm diameters. The trocar sleeve for the 11 and 12mm devices contains two seals, an outer integrated self-adjusting seal that accommodates instruments ranging from 5mm to 12mm in diameter where indicated and an internal seal. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. The 5mm trocar sleeve accommodates only 5mm instruments. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation.
The provided FDA 510(k) summary for the BASX™ Bladeless Trocar Device indicates that the device's performance was evaluated through bench testing. It explicitly states, "Performance Data Bench testing evaluation was performed to demonstrate that the new device performs as intended." This suggests that physical, mechanical, and/or functional tests were conducted on the device itself, rather than a study involving human or animal subjects or analysis of patient data.
However, the provided document does not detail specific acceptance criteria or report quantitative device performance data from these bench tests. It also lacks information on the other aspects requested in your prompt (sample sizes, ground truth establishment, expert involvement, MRMC studies, or standalone performance).
Therefore, based only on the provided text:
Acceptance Criteria and Study Details for BASX™ Bladeless Trocar Device
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Overall Performance | (Not specified) | "performs as intended" |
| Specific Performance Criteria | (Not specified) | (No specific data provided) |
Notes: The 510(k) summary states that "Bench testing evaluation was performed to demonstrate that the new device performs as intended." However, it does not explicitly list the acceptance criteria or quantitative results for these tests. The determination of "performs as intended" implies that the device met internal design specifications, but these specifications are not detailed in the provided document.
2. Sample Size and Data Provenance for Test Set
- Sample Size: Not specified. The document only mentions "Bench testing evaluation was performed."
- Data Provenance: The nature of bench testing means the data provenance would be from laboratory-controlled experiments on the device itself, rather than human patient data. There is no mention of country of origin for such data or whether it was retrospective or prospective, as these terms typically apply to clinical studies.
3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)
- Number of Experts: Not applicable. Bench testing typically relies on engineers and quality control personnel following pre-defined protocols and objective measurements, rather than expert interpretation for ground truth.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for Test Set
- Adjudication Method: Not applicable. Bench testing involves objective measurements rather than subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. The document describes bench testing, which is a laboratory-based evaluation of the device's physical and functional characteristics, not a clinical study involving human readers or cases.
6. Standalone Performance Study
- Standalone Study: Yes, in the context that "Bench testing evaluation was performed to demonstrate that the new device performs as intended." This testing would be on the algorithm/device itself (although "algorithm" is not relevant here as it's a physical medical device) without human intervention in the performance measurement. However, no specific performance metrics are provided.
7. Type of Ground Truth Used
- Type of Ground Truth: Engineering specifications and objective measurements. For a physical device like a trocar, ground truth would be established by predefined design specifications and performance requirements (e.g., insertion force, seal integrity, gas leakage rate, material strength).
8. Sample Size for Training Set
- Sample Size: Not applicable. This is a physical medical device. The concept of a "training set" typically applies to machine learning algorithms. Design and development were "predicated on use of technology currently used in Ethicon Endo-Surgery trocar devices," implying past experience and data from similar devices informed the design, but not in a formal "training set" sense.
9. How Ground Truth for Training Set Was Established
- Ground Truth Establishment: Not applicable. As above, "training set" is not relevant for this type of device. The design was informed by existing technology, which implies that the performance and safety profiles of those predicate devices served as a baseline of "known good" design principles.
§ 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.