(103 days)
The injection needle is to be used in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.
The injection needle consists of a stainless steel needle attached to plastic tubing and luer lock hub where a standard syringe can be attached for injection of materials through the lumen of the needle into tissue. The minimum required working channel for this proposed product is 2.8mm.
The proposed products are intended for single use, an individual device is packed in a sealed pouch following ETO sterilization. The device is used for local injection via endoscope, with the average contact time of the product and the mucosa of the human digestive tract of less than 1 hour.
The provided document is a 510(k) summary for a medical device (Injection Needle) seeking FDA clearance based on substantial equivalence to a predicate device. It does not contain information about a study proving the device meets specific acceptance criteria in the way an AI/ML medical device would be evaluated. Instead, it focuses on demonstrating equivalence to another marketed device through comparative tables and testing that confirms safety and performance for its intended use.
Therefore, the requested information elements related to AI device evaluation (test sets, ground truth, expert adjudication, MRMC studies, standalone performance, training sets) are not applicable to this document.
However, I can extract the acceptance criteria and performance data that are present, related to the device's technical characteristics and performance based on engineering and biocompatibility testing.
Here's a breakdown of the information that can be extracted from the provided text, and an explanation of why other requested elements are not present:
Acceptance Criteria and Device Performance (Based on Technical Characteristics and General Performance Testing)
| Acceptance Criteria Category | Specific Criteria (Implicit in "Same" or "Similar") | Reported Device Performance (Proposed Device) | Study/Testing that Proves Acceptance (Mentioned) |
|---|---|---|---|
| Regulatory Information | Identical Product Code (FBK) | FBK | 510(k) Submission, Comparative Table |
| Identical Regulation No. (876.1500) | 876.1500 | 510(k) Submission, Comparative Table | |
| Identical Regulatory Class (II) | II | 510(k) Submission, Comparative Table | |
| Sterility | Supplied Sterile | Yes | Sterilization validation testing |
| Individual device packed in sealed pouch | Yes | Sterilization validation testing, Packaging details | |
| EO sterilization | Yes | Sterilization validation testing, Packaging details | |
| Dimensions (Outer Sheath) | Identical Outer Sheath diameter (2.3 mm) | 2.3 mm | Performance testing, Comparative Table |
| Dimensions (Needle Size) | Range of needle gauges (19, 22, 25 gauge) | 19 gauge, 22 gauge, 25 gauge | Performance testing, Comparative Table |
| Dimensions (Needle Length) | Range of needle lengths (4, 5, 6 mm) | 4mm, 5mm, 6mm | Performance testing, Comparative Table |
| Dimensions (Working Length) | Range of working lengths (1800mm, 2000mm, 2300mm) | 1800mm, 2000mm, 2300mm | Performance testing, Comparative Table |
| Materials | Outer Sheath Material (Thermoplastic-PTFE Polymer) | Thermoplastic-PTFE Polymer | Performance testing, Biocompatibility testing, Comparative Table |
| Intended Use | Endoscopic injections in GI tract | "The injection needle is to be used in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract." | Indications for Use statement, Comparative Table |
| Configuration | Needle, inner sheath, outer shell, outer sheath, luer lock | Needle, inner sheath, outer shell, outer sheath and luer lock | Performance testing, Comparative Table |
| Single Use | Single Use Device | Yes | Device description, Comparative Table |
| Biocompatibility | Biocompatible for intended use | (Implied by Biocompatibility testing) | Biocompatibility testing |
| Aging | Stable performance over time | (Implied by Accelerated aging) | Accelerated aging testing |
Information on AI-Specific Study Elements (Not Applicable to this Document):
The provided document is an FDA 510(k) summary for a physical medical device (an injection needle), not an AI/ML-driven diagnostic or treatment device. Therefore, the following information is not present and not applicable to this type of submission:
- Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI algorithm. The device itself undergoes performance and safety testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" established by experts for a physical injection needle in this context.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 does not involve human readers interpreting images with or without AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable. There is no AI model to train.
- How the ground truth for the training set was established: Not applicable.
Summary of Relevant Information from the Document:
- Device: Injection Needle (K150434)
- Manufacturer: Micro-Tech (Nanjing) CO., Ltd.
- Predicate Device: Injectra Injection Needle (K061222)
- Regulatory Pathway: 510(k) for substantial equivalence.
- Testing Performed: Biocompatibility, accelerated aging, performance, and sterilization validation testing. These tests demonstrated that the device is safe and effective for its intended use and supports its substantial equivalence to the predicate device.
- Substantial Equivalence Conclusion: The manufacturer believes the proposed device is substantially equivalent to the predicate device, citing similarities in materials, intended use, function, and overall design. They acknowledge slight differences in needle length and working length, and minor differences in wording for indications for use, but state these differences do not raise new issues of safety or effectiveness.
§ 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.