(13 days)
suction/irrigation
Systems for irrigation and aspiration of rinsing liquid in the operating area.
Oenchal modular multifunction suction/irrigation system with pistol handle, maintenance i he Fajant modular many different adaptable tubes and lockable instrument channel for iree & way varro, marry af rinsing liquid in the laparoscopic operating area. The instrument imgation and aspliation of this instruments are inserted and closes when they are channel adomatioally opene would the instrument channel can be opened manually by removed. Allemativery "are xample to remove a hook-type instrument or a biopsy. The prossing a pachbutter.inted/ assembled for cleaning without any tools needed.
Modular Turve fiction handles with trumpet valves or maintenance-free 2-way valves The T ajurit Suchon inigation hardison her in the dismounted without any tools. Each handle can be used with any tube having a M8x1 mm connector; i.e. all handles of the series 1298-XX-00 are completely interchangeable.
The Pajunk adaptable suction/irrigation tubes with connector M8x1 mm can be used with any handle having a M8x1 mm connector. Adaptable suction/irrigation tubes with large LuerLock connector female can be used with any handles of series 1295-XX-00.
Modular multifunction suction/irrigation system with pistol handle, maintenance-free 2-way walve, many different adaptable tubes and lockable instrument channel Ø 5mm for irrigation valve, many direront adaptable the laparoscopic operating area. The instrument channel automatically opens when instruments are inserted and closes when they are removed. automativally the closure of the instrument channel can be opened manually by pressing a Akerhutton for example to repove a hook-type instrument or a biopsy. The system can be dismounted/assembled for feaning without any tools need
This is a 510(k) premarket notification for a medical device, not a study report. Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and sample sizes for a performance study is not present in the provided text.
The document describes the device, its indications for use, and confirms that the FDA has found it substantially equivalent to legally marketed predicate devices. It does not contain a study demonstrating how the device meets specific acceptance criteria based on performance metrics.
Here's an attempt to answer the questions based on the available information, noting what cannot be extracted:
1. A table of acceptance criteria and the reported device performance
This information is not available in the provided document. The 510(k) submission is about demonstrating substantial equivalence to a predicate device, not typically about reporting specific performance metrics against pre-defined acceptance criteria in the format of a clinical or technical study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available. The document focuses on the description of the device itself and its equivalence to other devices, not on a performance study with a test set.
3. 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)
This information is not available. No test set or ground truth establishment process is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available. No test set or adjudication process is described.
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
This information is not available. The device is a "modular valve handles for adaptable tubes" and an "adaptable suction/irrigation system." It is a surgical instrument, not an AI-assisted diagnostic tool, so an MRMC study or AI-related effectiveness is irrelevant and not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not available and is not applicable. The device is a physical surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not available. No ground truth for performance evaluation is mentioned.
8. The sample size for the training set
This information is not available. The document is not about a machine learning or AI device that would require a training set.
9. How the ground truth for the training set was established
This information is not available. Not applicable to this type of device.
Summary of what is present:
- Indications for Use: "suction/irrigation Systems for irrigation and aspiration of rinsing liquid in the operating area."
- Device Description: Modular valve handles, adaptable suction/irrigation tubes, and a modular multifunction suction/irrigation system with a pistol handle, 2-way valve, and lockable instrument channel.
- Regulatory Classification: Class II, Product Code GCJ, Regulation Number 876.1500.
- Outcome: The FDA found the device "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed.
This document serves as an FDA clearance letter based on substantial equivalence, which is a different type of submission than a detailed performance study with defined acceptance criteria and experimental results.
§ 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.