(70 days)
The Advanced UroScience Injection needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissues during an endoscopic procedure.
The Advanced UroScience Injection Needle consists of a stainless steel needle attached to a plastic luer lock hub. Needle length ranges up to 200 cm to accommodate the length of the endoscope channel and gauge ranges from 14 to 25. The needle length and gauge will be identified on the label. The luer lock hub, which is molded onto the needle, is designed to accommodate a standard syringe. The Advanced UroScience Injection Needle is intended for use as an accessory for currently marketed endoscopes and provides delivery of injectable materials during an endoscopic procedure. The type of material to be injected is dependent on the nature of the procedure, but may include delivery of collagen during cystoscopic procedures, sclerosing agents during esophagoscopic and gastroscopic procedures, local anesthetics during cystoscopic or laryngoscopic procedures, or saline or contrast media during colonoscopic procedures. The Advanced UroScience Injection Needle is provided sterile and is intended for single use only.
The provided text details a 510(k) summary for the Advanced UroScience Injection Needle. This type of submission is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This process does not typically involve studies that define and meet specific acceptance criteria in the same way a new device with novel technology would.
Therefore, many of the requested elements for acceptance criteria and study design are not applicable to this type of regulatory submission. The primary "study" involved is a comparison to a predicate device to establish substantial equivalence.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: For a 510(k) submission like this, the "acceptance criteria" revolve around demonstrating substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device has the same intended use and similar technological characteristics, or that any differences do not raise new questions of safety and effectiveness. The specific criteria are thus a qualitative comparison rather than quantitative performance metrics.
- Reported Device Performance: The document does not report specific quantitative performance data for the Advanced UroScience Injection Needle. Instead, it describes its design and intended use, asserting its similarity to predicate devices.
| Acceptance Criteria (for 510(k) Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Same as predicate device | "The Advanced UroScience Injection Needle is intended for use as an accessory for currently marketed endoscopes and provides delivery of injectable materials during an endoscopic procedure." (Same as predicate devices implicitly, as determined by FDA's substantial equivalence finding) |
| Technological Characteristics: Similar to predicate devices (materials, design, function) | "The Advanced UroScience Injection Needle consists of a stainless steel needle attached to a plastic luer lock hub. Needle length ranges up to 200 cm... gauge ranges from 14 to 25." "consists of a stainless steel needle and luer lock connector hub where a standard syringe can be attached for injection of materials through the lumen of the needle into tissue." (Asserted to be similar to predicate devices K843719 and K960519) |
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable. This document is a 510(k) summary, not a report of a performance study with a test set of data. The "test" for a 510(k) is the comparison to the predicate device based on design, materials, manufacturing methods, and indications for use.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No such "test set" or ground truth establishment by experts for performance evaluation is described in this 510(k) summary. The "ground truth" here is the regulatory acceptance of the predicate devices.
4. Adjudication Method for the Test Set
- Not applicable. There is no described "test set" and thus no adjudication method mentioned. The decision on substantial equivalence is made by the FDA reviewer.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This type of study is not relevant to a 510(k) submission for this device. An MRMC study would typically be for diagnostic imaging devices or algorithms where human reader performance is being evaluated.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This device is a physical medical instrument (an injection needle), not an algorithm or software. Therefore, the concept of "standalone performance" in this context is not applicable.
7. The Type of Ground Truth Used
- The "ground truth" in a 510(k) submission like this is primarily regulatory precedent and engineering principles. The device is deemed safe and effective because it is substantially equivalent to devices already on the market (the predicate devices K843719 and K960519) that have a history of safe and effective use. There's no specific clinical outcomes or pathology data for this device within this submission that establishes a "ground truth" of its performance.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" for this type of device.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set, this question is not relevant.
§ 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.