(57 days)
Suction Irrigation is indicated for general purpose use as suction/irrigation device to facilitate lavage during laparoscopic surgery and general surgery. The device functions to aid flushing blood and tissue debris from the surgical site.
The suction irrigation set, consists of a hand piece equipped with two trumpet style valves, a probe, and connecting lines of tubing, one set designed to attach to a 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. The suction irrigation set is designed to deliver-sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood. tissue debris, and smoke from the surgical site while the hand piece of the suction irrigator is designed to allow instruments to be introduced through the suction irrigation probe to reach the operative site. The instrument adapter is adjustable to allow a variety of instruments and diameters. It is a single use, disposable device and is sold sterile.
The provided text describes a 510(k) summary for the "Disposable Suction Irrigation" device by Taiwan Surgical Corporation. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves specific acceptance criteria for a novel device. Therefore, a direct mapping to all requested points is not fully possible as the nature of the submission is different from a typical de novo study evaluating a new device's performance against predefined metrics.
However, based on the information provided, I can extract and infer some details:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate device and relevant standards. The "performance" here refers to the device meeting these criteria, often by being "same" as the predicate or passing specific tests.
| Acceptance Criteria Category | Specific Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Design/Specification | Design Description | Same as Predicate device |
| Length of steel tube (350mm/470mm) | Matches Predicate (350mm/470mm), but elsewhere stated as 330mm/450mm for subject device, implying a range is acceptable. | |
| OD of steel tube (5mm) | Same as Predicate | |
| PVC soft tube (2900mm) | Same as Predicate | |
| Functional Performance | Anti-vacuity test | Passed. "TWSC is the best; the second is Unimax." (Implies better than predicate) |
| Anti-flat tube test | Passed. "No flat tube situation under 400-760 mmHg suction pressure." | |
| Handle button pressure test | Passed. "The capability is correspond with product specification." (Implies meeting spec despite being "worse" than something unstated) | |
| Biocompatibility | Cytotoxicity Test | Passed (following ISO 10993) |
| Intracutaneous test | Passed (following ISO 10993) | |
| Maximization sensitization test | Passed (following ISO 10993) | |
| Pyrogen test | Passed (following ISO 10993) | |
| Sterilization | Sterilization Dose (25kGy) | Passed, met ISO 11137-2:2012 VD max25 for SAL of 10-9 |
| Safety and Effectiveness | Same intended use as predicate | Same as Predicate |
| Same basic technology as predicate | Same as Predicate | |
| Achieves same effectiveness | Concluded to achieve same effectiveness as predicate | |
| Achieves same safety | Concluded to achieve same safety as predicate |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state sample sizes for tests. It details "bench report" findings, meaning the testing was likely conducted in a lab setting. The provenance of the data is from Taiwan Surgical Corporation's internal testing as part of their 510(k) submission. The type of data is prospective as it involves tests specifically conducted for this submission, not retrospective analysis of past data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. For a device like this, the "ground truth" often relates to meeting engineering specifications or established biological safety standards, which are typically assessed by qualified technicians or engineers, rather than clinical experts like radiologists for image-based diagnostics.
4. Adjudication Method for the Test Set
This information is not provided. Adjudication methods are typically relevant for clinical studies where expert consensus is needed to resolve discrepancies, which does not appear to be the primary focus of this type of submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data. The "Disposable Suction Irrigation" is a surgical tool, and its effectiveness is determined by its functional performance and safety, not by human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical surgical tool and not an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily based on:
- Engineering Specifications: Meeting predefined physical dimensions, pressure tolerances, and functional requirements.
- Established Standards: Adherence to international standards like ISO 10993 for biocompatibility and ISO 11137-2:2012 for sterilization.
- Predicate Device Comparison: The predicate device (UNIMAX MEDICAL SYSTEM INC., K103509) serves as a benchmark for comparison, implying its established safety and effectiveness forms part of the "ground truth" for demonstrating substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable. "Training set" refers to data used to train AI models. This device is a physical product, not an AI/software device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as 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.