(177 days)
These single use, disposable, flexible sheath injection needles are intended to be used for the injection of various types of media through flexible endoscopes.
The Carr-Locke and Articulator Injection Needles are single use, disposable, flexible sheath injection needles that are intended to be used for the injection of various types of media through flexible endoscopes. All the needles have the same general design and consist of a handle luer, a handle hypo tube, a compression spring (except for PN 00711808), a PEEK tube, a spring sheath, a distal hub and an injection needle.
The Carr-Locke and Articulator needles are sterile, disposable devices that are used through the working channel of flexible endoscopes for the purpose of injecting media into the gastrointestinal tract.
The information provided is about the substantial equivalence of the STERIS Articulator and Carr-Locke Injection Needles (K232826) to a predicate device. This document is a 510(k) summary, which focuses on comparing a new device to a legally marketed predicate device to demonstrate that it is as safe and effective. It does not describe a study involving algorithms, AI, or human reader performance.
Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth used, training set sample size, ground truth for training set) are not applicable to this type of device and submission.
However, I can extract the acceptance criteria and device performance from the tables in the "Summary of Nonclinical Tests" section.
Acceptance Criteria and Device Performance
The STERIS Articulator and Carr-Locke Injection Needles (K232826) underwent nonclinical testing to demonstrate substantial equivalence to the predicate device. The following table summarizes the acceptance criteria and reported results:
| Testing Category | Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Functional Testing | Working Length | Meet design requirements | Pass |
| Needle Deployment Length | Meet design requirements | Pass | |
| Needle Handle Luer Compatibility | Meet design requirements | Pass | |
| Luer Compatibility | Meet design requirements | Pass | |
| Needle Deployment Length After Cycles | Meet design requirements | Pass | |
| Device Insertion Force | Meet design requirements | Pass | |
| Device Extraction Force | Meet design requirements | Pass | |
| Pentax Needle Scope Compatibility | Meet design requirements | Pass | |
| Device Catheter Kink Criteria | Meet design requirements | Pass | |
| Ferrule to Needle Tensile Force | Meet design requirements | Pass | |
| PEEK to Needle Tensile Force | Meet design requirements | Pass | |
| Handle Hypo Tube to PEEK Tensile Force | Meet design requirements | Pass | |
| Handle Hypo Tube to Luer Tensile Force | Meet design requirements | Pass | |
| Distal Hub to Spring Sheath Tensile Force | Meet design requirements | Pass | |
| Spring Sheath to Handle | Meet design requirements | Pass | |
| Handle Hypo Tube to Washer Tensile Force | Meet design requirements | Pass | |
| Male Handle to Female Handle Tensile Force | Meet design requirements | Pass | |
| Injection Force Gauge Comparison | Meet design requirements | Pass | |
| Needle Deployment Force & Retraction | Meet design requirements | Pass | |
| Needle Leakage Test | Meet design requirements | Pass | |
| Simulated Use Testing | Endoscope Channel Compatibility | Meet design requirements | Pass |
| Pentax Endoscope Compatibility | Meet design requirements | Pass | |
| Duodenoscope Compatibility | Meet design requirements | Pass | |
| Needle Deployment and Retraction | Meet design requirements | Pass | |
| Needle Deployment Lock | Meet design requirements | Pass | |
| Device Functions in a Straight and Articulated Position | Meet design requirements | Pass | |
| Needle Patency | Meet design requirements | Pass | |
| Duodenoscope Injection Compatibility | Meet design requirements | Pass | |
| Needle Penetration | Meet design requirements | Pass | |
| Leakage Requirement | Meet design requirements | Pass | |
| Device Maintains Structural Integrity | Meet design requirements | Pass |
Study Information (Relevant to this type of device)
- Sample size used for the test set and the data provenance: The document does not specify the exact sample sizes (number of devices or tests performed) for each nonclinical test. It only states that testing was performed. Data provenance is not described as this is a device performance study, not a clinical trial or AI model validation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The tests are engineering/performance evaluations, not clinical diagnoses requiring expert ground truth.
- Adjudication method for the test set: Not applicable for nonclinical device performance tests.
- 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 is not an AI/imaging device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm.
- The type of ground truth used: For these nonclinical tests, the "ground truth" is defined by the "design requirements" which are established engineering and performance specifications for the device.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.