(142 days)
The Dilating Tip Obturator is a sterile single use device, intended for use in conjunction with Applied's currently marketed Trocar products to establish a path of entry for endoscopic instruments for use during general, abdominal, gynecological and thoracic minimally invasive procedures or to gain access through tissue planes and/or potential spaces for endoscopic instruments.
The Dilating Tip Obturator is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.
The Dilating Tip Obturator is a sterile single use device, intended for use in conjunction with Applied's currently marketed Trocar products. A standard trocar assembly consists of an obturator, a seal and a cannula system. Traditional obturators use a blade for cutting to establish a path of entry through the several layers of tissue. The Dilating Tip Trocar dilates and separates tissue along its natural fiber lines in its path of entry.
The Dilating Tip Obturator will be available in sizes of 5mm, 11mm and 12mm diameter in lengths ranging from 55mm to 150mm.
The use of the Dilating Tip Obturator, which separates tissue along its natural fibers versus cutting of tissue by traditional bladed trocars is expected to reduce trauma to vessels and the abdominal wall and minimize the risk of organ puncture. Upon removal of the trocar at the end of the procedure the separated tissue is expected to reapproximate, leaving a smaller, linear defect.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Dilating Tip Obturator:
Acceptance Criteria and Device Performance Study for the Dilating Tip Obturator (K012884)
The provided 510(k) summary for the Dilating Tip Obturator (K012884) describes a medical device, not an AI/ML algorithm or software. Therefore, many of the requested elements for AI/ML evaluation (such as sample sizes for test/training sets, data provenance, ground truth establishment by experts, MRMC studies, or standalone algorithm performance) are not applicable to this physical device submission.
The "acceptance criteria" for this type of device typically revolve around demonstrating substantial equivalence to a predicate device through performance and functional testing that shows it raises no new safety or effectiveness issues.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit based on 510(k) submission type) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Device performs its intended functions (e.g., establishing a path of entry, gaining access through tissue planes) effectively. | The device is intended to establish a path of entry for endoscopic instruments or gain access through tissue planes/potential spaces. Performance testing included "tests to verify its reliability during use." |
| Safety Equivalence | Device does not introduce new safety concerns compared to the predicate. | The device is expected to "reduce trauma to vessels and the abdominal wall and minimize the risk of organ puncture" by separating tissue along natural fiber lines, as opposed to cutting. This implies an improvement in safety compared to bladed trocars. |
| Performance Metrics | Insertion Force: Should be within acceptable ranges or comparable to predicate. | Performance testing included "tests to verify the insertion force." The results demonstrated substantial equivalence. |
| Reliability during use | Device maintains integrity and functionality throughout the surgical procedure. | Performance testing included "tests to verify its reliability during use." The results demonstrated substantial equivalence. |
| Substantial Equivalence | All functional and safety aspects are substantially equivalent to the predicate device, or improved, without raising new questions of safety or effectiveness. | "The performance and functional testing demonstrated that the Dilating Tip Obturator is substantially equivalent to its predicate devices and it introduces no new safety and effectiveness issues when used as instructed." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a physical medical device. The "test set" would refer to laboratory or bench testing on the device itself, not a dataset of images or patient information. The document does not specify the number of devices tested for insertion force or reliability. Data provenance (country of origin, retrospective/prospective) is also not applicable to bench testing of a physical device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. Ground truth as typically understood for AI/ML (e.g., disease presence, image annotation) is not relevant here. The ground truth for device performance is typically established through engineering specifications and objective measurements against those specs or against predicate device performance.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on AI/ML ground truth, not for bench testing of a physical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is designed to evaluate the performance of human readers, often with and without AI assistance, on sets of clinical cases. This is not applicable to the evaluation of a physical surgical instrument.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
For this physical device, the "ground truth" would be objective measurements of physical properties and performance characteristics, such as:
- Insertion Force: Measured in units of force (e.g., Newtons) under specified conditions.
- Reliability: Assessed by simulating use conditions and observing for failure, breakage, or loss of function.
- Material Properties: Conformance to material specifications, biocompatibility, sterility.
These are compared against predetermined standards or the performance of the predicate device.
8. The Sample Size for the Training Set
Not applicable. This is a physical device submission; there is no "training set" in the AI/ML sense. Any "training" for the device would refer to manufacturing process controls or operator training, not data used to train an algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable for the same reasons as #8.
§ 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.