(48 days)
This device intends to provide pinpoint suction and irrigation to the surgical site during laparoscopic procedures. It is to be used in conjunction with a legally-marketed irrigation pump, irrigant bag or bottle, legally-marketed suction source, and a laparoscopic probe.
For USE INDICATED DEVICE THIS FOR PATIENTS ELIGIBLE VIA GENERAL LAPAROSCOPIC TREATMENT SURGICAL PROCEDURES
This device consists of the following parts already connected to each other:
- Main Body to control suction and irrigation. A pool suction tip may be connected to the body
- 10 ft Twin tubing to allow for suction and irrigation. The blue color tube allows for irrigation and the clean color tube allows for suction.
A "Y" connector connects the blue tube to two branch tubes (clear color, 12" each). Each branch ends with spike with guard, allowing connection to saline bags. Also, each branch includes a clamp intended to avoid back-flow to the disconnected branch. Clamps may not be used if both branches are simultaneously connected.
An adapter at the end of the other clear color tube allows connection to a suction machine.
The provided K994256 submission is for a Suction Irrigation Trumpet Valve Set, which is a Class II medical device. This type of submission relies on demonstrating substantial equivalence to existing, legally marketed predicate devices rather than testing against specific performance acceptance criteria in the way a novel diagnostic algorithm might.
Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically applied to diagnostic AI devices with quantifiable performance metrics (like sensitivity, specificity, AUC) is not directly applicable here. Instead, the "acceptance criteria" for a 510(k) submission like this revolve around demonstrating that the new device is as safe and effective as its predicate.
Here's how to interpret the request in the context of this device:
1. Table of "Acceptance Criteria" and Reported Device Performance
For this device, the "acceptance criteria" are the characteristics of the predicate device (Trump-It II and Magnum 250), and the "reported device performance" is the claim of equivalence for each of those characteristics.
| Characteristic ("Acceptance Criteria" from Predicate) | Reported Device Performance (Claim for New Device) |
|---|---|
| Indications for use | Equivalent |
| Target population | Equivalent |
| Design | Equivalent |
| Materials | Equivalent |
| Performance | Equivalent |
| Sterility | Similar |
| Biocompatibility | Equivalent |
| Mechanical safety | Equivalent |
| Chemical safety | Equivalent |
| Anatomical sites | Equivalent |
| Human factors | Equivalent |
| Energy used and/or delivered | Equivalent |
| Compatibility with environment and other devices | Equivalent |
| Where used | Equivalent |
| Standards met | Equivalent |
| Electrical safety | Equivalent (not applicable) |
| Thermal safety | Equivalent (not applicable) |
| Radiation safety | Equivalent (not applicable) |
2. Sample size used for the test set and the data provenance
- Not applicable. This submission doesn't involve a "test set" or data provenance in the context of evaluating a diagnostic algorithm. It's about demonstrating equivalence to a predicate device. The assessment is based on comparing design, materials, intended use, etc., rather than performance on a clinical dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "test set" requiring expert ground truth for this type of device submission. The "ground truth" or standard for comparison is the established safety and effectiveness of the predicate device, which is based on its prior regulatory clearance and market history.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no "test set" and therefore no adjudication method required.
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 instrument (suction irrigation set), not an AI diagnostic tool that assists human readers. Therefore, MRMC studies and AI effect sizes are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a manual surgical tool, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this 510(k) submission is the established safety and effectiveness profile of the predicate devices (Trump-It II and Magnum 250), as determined by their prior FDA clearance. The new device demonstrates "equivalence" by showing it shares the same fundamental scientific technology and intended use without raising new questions of safety or effectiveness.
8. The sample size for the training set
- Not applicable. This device is hardware and does not utilize a training set in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for this type of device.
§ 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.