(46 days)
The Uroplasty Rigid Endoscopic Needle is an accessory to currently marketed endoscopes allowing delivery of injectable material into tissues during an endoscopic procedure. The Uroplasty Rigid Endoscopic Needle may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials. The type of material to be injected will be dependent on the nature of the endoscopic procedure. Possible injectable materials include: tissue bulking agents; sclerosing agents; local anesthetics; saline; or contrast media.
The Uroplasty Rigid Endoscopic Needle is an accessory for endoscopes with a working channel inner diameter of 5 French or larger. The Rigid Endoscopic Needle is supplied sterile and is intended for single use only. The 5 French stainless steel cannula is 380 to 500 mm long with an 18-gauge tip (10 mm in length) and a metal luer lock connector; the needle also has a protective polyethylene sheath.
Here's a breakdown of the acceptance criteria and study information for the Uroplasty Rigid Endoscopic Needle, based on the provided document:
This document is a marketing submission (510(k)) for a medical device. These submissions generally aim to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies like those for novel high-risk devices.
Based on the provided information, the "study" described is a declaration of substantial equivalence to a predicate device rather than a performance study with acceptance criteria in the typical sense of a diagnostic or therapeutic accuracy study.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate device (Advanced UroScience Injection Needle K982890) | The Uroplasty Rigid Endoscopic Needle is "technologically the same" as the predicate device, having "similar intended uses and principles of action." In instances where they differ, "no concerns about safety or effectiveness are raised." The device "allows delivery of injectable materials into tissues during an endoscopic procedure, thereby achieving its intended use." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission relies on substantial equivalence to a predicate device, not on a new performance study with a test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable.
4. Adjudication Method for the Test Set
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a comparative effectiveness study involving human readers and AI.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. The device is a physical medical instrument, not an algorithm.
7. Type of Ground Truth Used
Not applicable. The "ground truth" here is the established performance and safety profile of the predicate device, K982890, as determined by its prior clearance. The submission argues that the new device shares those characteristics.
8. Sample Size for the Training Set
Not applicable. There is no training set mentioned, as this is not an AI/algorithm-based device.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of the Device's "Acceptance Criteria" Met by the "Study":
The acceptance criteria for the Uroplasty Rigid Endoscopic Needle, within the context of this 510(k) submission, is to demonstrate Substantial Equivalence to a legally marketed predicate device (Advanced UroScience Injection Needle, K982890).
The "study" that proves the device meets this acceptance criteria is the comparison provided in Section 8: 510(k) Summary under "Technological Characteristics" and "Performance."
- Technological Characteristics: The submission explicitly states, "The new and predicate devices are technologically the same; they are both rigid endoscopic needles intended to be accessories for standard endoscopes for the use of administering injectable materials. Both devices have similar intended uses and principles of action; they are both supplied sterile and are for single use only." It further notes, "In the few instances where the devices differ, no concerns about safety or effectiveness are raised."
- Performance: The document states, "The Uroplasty Rigid Endoscopic Needle allows delivery of injectable materials into tissues during an endoscopic procedure, thereby achieving its intended use." This implies its performance is aligned with its intended use, which is consistent with the predicate device.
- Conclusion: The submission explicitly concludes, "The subject device, the Uroplasty Rigid Endoscopic Needle, is substantially equivalent to the previously cleared endoscopic needle by Advance UroScience (K982890)."
The FDA's decision letter (K051905) confirms that the FDA reviewed the submission and "determined the device is substantially equivalent...". This FDA determination is the ultimate "proof" in the regulatory sense that the "acceptance criteria" of substantial equivalence were met.
§ 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.