(170 days)
The Bladeless Trocar, Bladed Trocar, and Hasson Trocar have application in a variety of laparoscopic procedures to provide a port of entry for laparoscopic instruments.
The Disposable Surgical Trocar is composed of two parts, one obturator and one guide tube (cannula). The obturator of the Bladeless Trocar is plastic allowing the surgeon to dilate between tissues. The obturator of Bladed Trocar is made of PC and a small blade made of stainless steel, which is released when the surgeon presses the trocar to help with cutting. The Disposable Surgical Trocar Kit, bladed or bladeless, has one obturator and two cannulas or two obturators and four cannulas. The device is for single use only. This device is sterilized with ethylene oxide and has a shelf life of 3 years.
This is an FDA 510(k) summary for a medical device called "Bladeless Trocar; Bladed Trocar; Hasson Trocar." The document describes the device, its intended use, and compares it to a legally marketed predicate device (K141594).
However, your request asks for "acceptance criteria and the study that proves the device meets the acceptance criteria" specifically in the context of an AI/ML medical device submission. The provided document is for a mechanical surgical instrument (trocar) and does not involve AI/ML. Therefore, the requested information categories concerning AI/ML performance (e.g., sample size for test set, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this submission.
The document states:
"The subject device trocar models (Bladeless Trocar, Hasson Trocar) are manufactured by the same company that manufactures those of the predicate device (Unimicro) and are identical to those cleared under K141594. As such, performance testing is not required."
This statement indicates that the regulatory acceptance is based on the substantial equivalence to a predicate device, specifically because the new device is identical and manufactured by the same company as the predicate. Therefore, no new performance studies were conducted or required to demonstrate that the device meets acceptance criteria.
To specifically address the prompts given the available information:
-
A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Substantial Equivalence to predicate device K141594. The key criteria are identical design, materials, manufacturing process, and intended use to a previously cleared device.
- Reported Device Performance: Not applicable, as performance testing was explicitly stated as "not required" due to the identical nature to the predicate device. The performance is assumed to be equivalent to the predicate device.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable as no performance study was conducted.
-
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 as no performance study was conducted.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no performance study was conducted.
-
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 non-AI device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a non-AI device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable as no performance study was conducted. Regulatory acceptance is based on substantial equivalence to the predicate device.
-
The sample size for the training set
- Not applicable. This is a non-AI device.
-
How the ground truth for the training set was established
- Not applicable. This is a non-AI 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.