(24 days)
The ENDOPATH® Dilating Tip Trocar has application in thoracic, gynecologic and general surgical procedures to establish a path of entry for endoscopic instruments.
The ENDOPATH® Dilating Tip Trocar in sizes ranging from 5mm to 12mm in diameter is a sterile, single patient use instrument consisting of a sharp flat bladed tip and a spring-loaded shield. The shield is designed to cover the flat bladed tip to protect internal organs once the abdominal or thoracic cavity has been entered. The trocar sleeve contains an outer gasket and internal flapper valve with a seal to minimize gas leakage when instruments are inserted or removed in that trocar. There is a stopcock valve for gas insufflation and a desufflation lever for gas evacuation.
Here's an analysis of the provided text regarding the ENDOPATH® Dilating Tip Trocar, focusing on acceptance criteria and supporting studies:
Based on the provided "510(k) Summary of Safety and Effectiveness" and the FDA's clearance letter, the details regarding acceptance criteria and the study are extremely limited. It appears this device underwent a premarket notification (510(k)) pathway, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than extensive clinical efficacy studies with predefined acceptance criteria.
Here's what can be extracted and what information is not present in the document based on your request:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined in terms of specific metrics or thresholds. The document states the device must "perform as intended." | "All testing demonstrated satisfactory performance." |
Observation: The document does not provide a quantifiable or measurable acceptance criterion (e.g., "puncture force must be less than X N," "seal integrity must maintain X psi for Y minutes," or "tip deployment success rate must be > Z%"). Instead, it uses a general statement of satisfactory performance.
Study Details
2. Sample sized used for the test set and the data provenance:
- Test set sample size: Not specified.
- Data provenance: Not specified, but "Bench testing" is mentioned, implying laboratory or in-vitro testing. No country of origin is mentioned for the data, nor is it specified as retrospective or prospective (which would typically apply to clinical data, not bench testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not applicable. For bench testing, ground truth is typically established by engineering specifications, calibration standards, or direct measurement by qualified technical personnel, not clinical experts.
- Qualifications of experts: Not applicable as per the above.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical studies, not for bench testing where objective measurements are typically taken.
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:
- MRMC study: No. This is a surgical device, not an imaging AI device, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone study: Not applicable. This refers to AI algorithm performance. The device is a physical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of ground truth: Implied to be based on engineering specifications and objective measurements during "Bench testing." The document does not specify particular metrics but suggests the device was tested against its intended functional performance.
8. The sample size for the training set:
- Training set sample size: Not applicable. There is no mention of machine learning or an algorithm that would require a training set. This is a physical medical device.
9. How the ground truth for the training set was established:
- Ground truth establishment for training set: Not applicable, as there is no training set for this type of device.
Summary of Study Findings
The document states: "Performance Data: Bench testing was performed to ensure that the device performs as intended. All testing demonstrated satisfactory performance."
This indicates that internal bench tests were conducted, and the results were deemed acceptable by the manufacturer (Ethicon Endo-Surgery, Inc.) for the purpose of demonstrating substantial equivalence for 510(k) clearance. However, the specific details, methodologies, results, and acceptance criteria of these bench tests are not disclosed in the provided 510(k) summary. The FDA's clearance letter confirms their review of this information and determination of substantial equivalence.
§ 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.