(226 days)
The ASD-Tactile™ Suction and Irrigation System is a sterile, single-use device indicated for use in patients undergoing general laparoscopic surgical procedures.
The ASD Tactile Suction and Irrigation System, SI-3000TY and SI-3000TY and SI-3000TYR, is indicated for use in patients undergoing general laparoscopic surgical procedures. It 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. The ASD Tactile Suction and Irrigation System consists of a handpiece equipped with 2 trumpet style valves, a stainless steel probe, and 2 connecting lines of tubing, one 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 handpiece 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, diameter sizes ranging from 2mm to 5mm to pass through without either a loss of pneumoperitoneum or leakage of fluid. A probe is attached to the handpiece via a threaded connector, thus allowing different sized probes to be attached to the handpiece during surgery.
The suction irrigator is a single use disposable device and is sold sterile.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain specific acceptance criteria or quantitative performance data for the ASD-Tactile Suction and Irrigation System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting results from a device performance study against pre-defined criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. | Not specified in the document. The submission claims substantial equivalence based on the device's design, intended use, and components being similar to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical study or a test set with corresponding sample sizes or data provenance (country of origin, retrospective/prospective). The submission relies on a comparison to a predicate device, implying that the safety and effectiveness of the new device are inferred from the predicate's established performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document does not describe a study involving a test set or the establishment of ground truth by experts.
4. Adjudication Method for the Test Set
This information is not applicable as the document does not describe a study involving a test set or an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC comparative effectiveness study is mentioned in the provided text. The submission is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to a predicate device, not on comparative effectiveness with human readers or AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable as the device is a medical instrument (suction irrigator) and not an algorithmic or AI-based diagnostic tool. Therefore, a standalone algorithm performance study would not be relevant.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically used in studies evaluating diagnostic algorithms (e.g., pathology, outcomes data) does not directly apply here. The submission asserts substantial equivalence based on the design, materials, intended use, and technological characteristics of the new device being similar to those of a legally marketed predicate device. The "truth" in this context is the FDA's acceptance of the predicate device's safety and effectiveness.
8. The Sample Size for the Training Set
This information is not applicable as the device is a medical instrument, not an AI or algorithmic system requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above; it is not an AI or algorithmic system.
Summary of the 510(k) Submission:
The provided document is a 510(k) premarket notification for a medical device (ASD-Tactile Suction and Irrigation System). The core approach for obtaining market clearance is to demonstrate substantial equivalence to a previously legally marketed device (predicate device).
- Acceptance Criteria & Performance: Not explicitly stated in a quantitative sense. The "acceptance" by the FDA is based on the argument that the device is substantially equivalent to the predicate, implying similar safety and effectiveness.
- Study Design: No new clinical study or performance study is described in detail within these documents. The submission relies on comparing the new device's characteristics (design, materials, intended use) to the predicate device.
- Ground Truth: The "ground truth" for this type of submission is the established safety and effectiveness of the predicate device, which the new device is claimed to emulate.
Essentially, the document is a regulatory filing, not a research paper detailing a performance study against specific criteria with new data.
§ 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.