(89 days)
Manually operated surgical device intended for making incisions into the patient's body to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures.
Manually operated surgical device intended for creating a surgical space by dissecting layers of connective tissue along natural planes to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures.
Manually operated surgical device intended for providing a well anchored and gas tight instrument channel to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures.
The Pajunk Trocars together with the Trocar Sleeves, the Pajunk Balloon Systems and the according accessories are manually operated surgical devices used by physicians for making incisions into the patient's body to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures.
The Paiunk Trocar Sleeves are rigid tubes placed with the help of Trocars or Obturators into the patient's body to allow insertion of endoscopes and endoscopic accessories.
The trocars are used together with the trocar sleeves for puncture of the patient's body. The trocar is then removed to allow insertion of endoscopes and endoscopic accessories.
The Pajunk Safety-Trocar features a sharp, beveled tip that is covered by an inside, spring loaded, blunt obturator (Veress-concept). During puncture, the obturator is pushed into the shaft against the force of the spring and thus releases the cutting tip which can now penetrate the skin layers. As soon as the abdominal space is reached, the blunt obturator is moved forward by the spring, covers the cutting tip and prevents injuries in the abdomen.
The PAJUNK distension balloon system is indicated for laparoscopic procedures specially in extraperitoneal surgery, where dissection of tissue in the extraperitoneal space under direct view is essential.
The PAJUNK structural balloon system is indicated for laparoscopic procedures specially in extraperitoneal surgery, where a solid anchored and gas-tight entry port with an instrument channel together with a mechanical support of the extraperitoneal work space is needed. The inflation of the balloon causes a continuing dissection and anchoring in the extraperitoneal work space.
The PAJUNK Ring-Anchor balloon system is indicated for laparoscopic procedures specially in extraperitoneal surgery, where a solid anchored and gas-tight entry port with an instrument channel is needed.
The disposable valve top is used with the Pajunk trocar sleeves and provides the same intended use. The valve is used instead of the trap door valve. The top is made out of polymer instead out of chromated brass. The metal tube is reusable and identical to the ones of the Paiunk trocar sleeves. The advantage is the easier cleaning, sterilization and assembling procedure.
The Pajunk fixable slide cones with or without a fixation thread and with suture holders on both sides have been designed for first puncture technique according to Hasson in laparoscopic applications.
The reducer sleeve is inserted into the actually used trocar sleeve to reduce the diameter for improved quide and gas-tight insertion of endoscopic surgical instruments with outer diameters smaller than the nominal inner diameter of the trocar sleeve.
If the actually applied trocar sleeve does not provide sufficient space for needed endoscopes and endoscopic accessories or endoscopic surgical instrument it can be replaced with a larger trocar sleeve.
The trocar stop with fixation thread is used to fixate the insertion of the trocar sleeve. The trocar sleeve is fixed by hand with a screw.
This document is a 510(k) Summary of Safety and Effectiveness for Pajunk GmbH's Trocars, Trocar Sleeves, Distension System, and Anchoring System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the way a clinical trial might.
Therefore, many of the requested categories for describing a study proving acceptance criteria cannot be directly extracted from this type of regulatory submission. This document primarily asserts that the new devices are substantially equivalent to existing, legally marketed predicate devices, meaning they have similar features, intended uses, and do not raise new issues of safety or effectiveness.
Here's an analysis based on the provided text, highlighting where information is available and where it is not:
1. A table of acceptance criteria and the reported device performance
This document does not present a table of specific acceptance criteria (e.g., performance metrics like penetration force, sealing integrity, or specific clinical outcomes) nor does it report detailed device performance data against such criteria. The "acceptance criteria" here is met through the demonstration of substantial equivalence to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (similar intended use, technology, principles of operation, and no new safety/effectiveness issues) | "The minor differences between the Paiunk Trocar and Trocar Sleeves, Distension System, the Anchoring System and accessories and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This submission relies on an equivalency claim rather than new clinical data from a dedicated test set. The data provenance would be a comparison to existing predicate devices already on the market.
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)
Not applicable. Ground truth, in the context of device performance, would typically be established through clinical observation or objective measurements. This document does not describe such a process for a new clinical trial. The "ground truth" for substantial equivalence is the safety and effectiveness profile of the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication in the clinical study sense 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
Not applicable. This device is a surgical tool, not an AI diagnostic/interpretive system. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-only device. It is a manually operated surgical device used by physicians.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the regulatory submission is based on the established safety and effectiveness of the predicate devices already on the market. The submission asserts that the new device has "similar basic features and intended uses" to these predicates and "raise no new issues of safety and effectiveness."
8. The sample size for the training set
Not applicable. There is no concept of a "training set" in the context of this 510(k) submission for a surgical instrument.
9. How the ground truth for the training set was established
Not applicable. See point 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.