(56 days)
The DANNIK Laparoscopic Suction Irrigation System is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, and tissue debris from the surgical site
The DANNIK Laparoscopic Suction Irrigation System is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris from the surgical site.
The system consists of a hand piece equipped with two trumpet style valves, a probe and connecting lines of tubing, one set designated to attach to supply of irrigation fluid, and the other designed to attach to an aspiration pump. The valves allow controlled irrigation and aspiration during a surgical procedure.
This device is packaged and sterilized for single use only. Do NOT re-use, reprocess or resterilize. Discard after use with care.
The provided document is a 510(k) summary for the DANNIK Laparoscopic Suction Irrigation System. It outlines the device's characteristics and its substantial equivalence to a predicate device. However, it does not contain acceptance criteria or study details in the format requested for AI/algorithm performance evaluation.
This document describes a medical device (a physical instrument), not an AI/software device. Therefore, many of the requested fields, such as sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types, are not applicable in this context.
Based on the document, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (from predicate device's established performance) | Reported Device Performance (DANNIK Laparoscopic Suction Irrigation System) |
|---|---|
| Functional Equivalence: | |
| - Deliver sterile irrigation fluids. | - Designed to deliver sterile irrigation fluids. |
| - Evacuate blood and tissue debris. | - Designed to evacuate blood and tissue debris. |
| - Controlled irrigation and aspiration. | - Valves allow controlled irrigation and aspiration. |
| Physical Characteristics Equivalence: | |
| - Handpiece design (Trumpet Valve Assembly). | - Trumpet Valve Assembly. (Same as predicate) |
| - Probe Length (e.g., 33cm/330mm). | - 33cm (330mm). (Same as predicate; predicate also offers additional lengths). |
| Safety & Biocompatibility: | |
| - Sterilization (e.g., Ethylene Oxide, ISO 11135-1). | - Ethylene Oxide, ISO 11135-1. |
| - Biocompatibility (e.g., Conforms to ISO 10993). | - Conforms to ISO 10993. |
| Performance Testing: | |
| - Appropriate fluid flow rates (implicitly from predicate). | - Performance studies and bench testing included determining and verifying appropriate fluid flow rates. |
| - Valve seal integrity (implicitly from predicate). | - Performance studies and bench testing included verifying valve seal integrity. |
| Regulatory: | |
| - Prescription use. | - Yes. (Same as predicate) |
2. Sample size used for the test set and the data provenance: Not applicable. This is a physical medical device, not a software or AI product that uses test sets of data. The "test set" here refers to the device itself being tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for a physical device is its manufacturing specifications and performance standards, established through engineering design and testing, not expert consensus on medical images or patient data. The document mentions evaluation by a "Design Engineer."
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used for establishing ground truth in medical imaging or clinical data for AI models.
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: Not applicable. This is a physical surgical tool and does not involve human readers or AI assistance in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. Not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this physical device, the "ground truth" is defined by established engineering and manufacturing standards, and the performance of the predicate device. This is confirmed through bench testing rather than clinical outcomes or pathological analysis.
8. The sample size for the training set: Not applicable. There is no "training set" for a physical device in this context.
9. How the ground truth for the training set was established: Not applicable.
§ 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.