(38 days)
The PAJUNK Balloon systems are indicated for patients undergoing laparoscopic surgical procedures requiring a sealed port of access and / or tissue retraction. This is also indicated in patients undergoing laparoscopic surgery requiring a sealed port of access and / or tissue separation in extraperitoneal procedures, such as in hernia repair.
The PAJUNK Obturator is intended for use in establishing a port of access for insertion of endoscopic instruments into the abdominal cavity or extraperitoneal space in abdominal and extraperitoneal surgery.
The PAJUNK® Balloon Systems for dilation facilitate safe and effective dissection of the preperitoneal space under direct view. Orientation during minimal invasive procedures is made easier. Three different shaped balloons are available for either unilateral purposes.
The structural balloon is particularly suitable for preperitoneal access. The design of the balloon simplifies the separation of the peritoneum from the abdominal wall. Additionally it prevents the peritoneal space from collapsing in the case of a loss of gas.
The ring-anchor balloon is also suitable for gastight accessing of the preperitoneal space. The seal is made by inflating the ring-anchor balloon and then advancing and securing the fastening device. Insufflation is performed via the built-in stop cock.
The provided document is a 510(k) Premarket Notification Submission for PAJUNK®'s Balloons and Balloon Systems. This type of submission is for medical devices that are substantially equivalent to a predicate device already on the market, and therefore, it does not typically involve the rigorous performance studies with acceptance criteria, human readers, and ground truth establishment that are common for novel or high-risk devices, especially AI/ML-driven ones.
Instead, the submission focuses on demonstrating substantial equivalence through comparisons to existing predicate devices, bench testing, and validated sterilization processes. Therefore, the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a test set and training set is not present in this document.
The document states: "The comparison of the predicate devices and the subject device in section 12 of this submission as well as the validated sterilization process and the results of the bench testing and bench marking demonstrates that the proposed devices are substantially equivalent to the predicate devices and identical in technical description to devices already cleared for market and therefore demonstrated to be safe and effective. Based on the clinical evaluation, the biocompatibility testing and the bench testing conducted, safety and effectiveness as well as efficacy of PAJUNK® s balloons and balloon systema for dilation and fixation is proven."
This indicates that the "study" demonstrating the device meets "acceptance criteria" (in this context, substantial equivalence to predicate devices and demonstrating safety and effectiveness) relies on:
- Comparison to predicate devices: Establishing that the new device has similar technological characteristics and performs similarly to devices already cleared by the FDA.
- Validated sterilization process: Demonstrating that the sterilization method is effective.
- Bench testing: In-vitro mechanical or functional tests to ensure the device performs as intended (e.g., balloon integrity, inflation/deflation, sealing).
- Biocompatibility testing: To ensure the materials used are safe for contact with the body.
- Clinical evaluation: While not explicitly detailed as a new clinical trial, this likely refers to a review of existing clinical data or literature supporting the function of similar devices.
Without further sections of the submission (e.g., "Section 12"), the specific details of these comparisons and tests, including any numerical acceptance criteria or detailed results, are not available in the provided text.
In summary, the requested information is not applicable to this 510(k) submission document, as it is not a study of an AI/ML device with performance metrics based on data and ground truth as implied by the questions.
§ 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.