(199 days)
The Disposable Endoscope Injection Needle is used for endoscopic injection into gastrointestinal mucosa and submucosa to:
• introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system;
• aid in Endoscopic Mucosal Resection (EMR), Endoscopic Submucosal Dissection (ESD), or polypectomy procedures;
• control non-variceal hemorrhage.
The Disposable Endoscope Injection Needle consists of Sheath, Handle buckle, Handle, Booster tube, Handle end cap, Outer tube, Inner tube, Metal end cap and injection needle tip. It is available in a variety of configurations with varying needle lengths, gauges and working lengths.
The provided text is a 510(k) summary for a medical device called the "Disposable Endoscope Injection Needle." It describes the device, its intended use, comparison to a predicate device, and non-clinical performance data. However, it explicitly states that "No Clinical Study is included in this submission."
Therefore, I cannot provide information about acceptance criteria and a study that proves the device meets clinical performance acceptance criteria, as no such clinical study was conducted or presented in this document. The submission relies solely on non-clinical (bench) testing and substantial equivalence to a predicate device.
Here's what I can extract regarding acceptance criteria and performance based only on the non-clinical data provided:
1. A table of acceptance criteria and the reported device performance:
| Test | Acceptance Criteria (Implied by "passing") | Reported Device Performance |
|---|---|---|
| Appearance | (Implied: Meets visual/design spec) | Passing |
| Dimension | (Implied: Meets dimensional spec) | Passing |
| Performance | (Implied: Meets functional spec) | Passing |
| Connection strength | (Implied: Meets strength spec) | Passing |
| Leakage | (Implied: No leakage) | Passing |
| Cleanliness | (Implied: Meets cleanliness spec) | Passing |
| Compatibility | (Implied: Compatible with endoscopy) | Passing |
| Puncture force | (Implied: Meets force spec) | Passing |
| Corrosion resistance | (Implied: Resists corrosion) | Passing |
| Patency of lumen | (Implied: Lumen is clear/unobstructed) | Passing |
| Durability | (Implied: Durable for intended use) | Passing |
| Stiffness test of needle | (Implied: Meets stiffness spec) | Passing |
| Resistance of needle to breakage | (Implied: Resists breakage) | Passing |
| Positive pressure liquid leakage | (Implied: No leakage under pressure) | Passing |
| Sub-atmospheric pressure air Leakage | (Implied: No air leakage under vacuum) | Passing |
| Stress cracking | (Implied: Resists stress cracking) | Passing |
| Resistance to separation from axial load | (Implied: Resists axial separation) | Passing |
| Resistance to overriding | (Implied: Resists overriding) | Passing |
| Resistance to separation from unscrewing | (Implied: Resists unscrewing separation) | Passing |
| Flow rate | (Implied: Meets flow rate spec) | Passing |
| Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 |
| Sterilization (Ethylene Oxide) | Comply with ISO 11135-1, ISO 10993-7 | Comply with ISO 11135-1, ISO 10993-7 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample sizes used for the non-clinical (bench) tests. The data provenance is implied to be from Yangzhou Fartley Medical Instrument Technology Co., Ltd. in China, where the device is manufactured. These are all prospective bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. These were non-clinical, objective bench tests, not clinical evaluations requiring expert interpretation of results or establishment of ground truth in a medical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as these were objective bench tests, not subjective interpretations requiring adjudication.
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 physical medical instrument (an injection needle), not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the non-clinical tests, the "ground truth" was defined by engineering specifications, industrial standards (like ISO 10993, ISO 11135), and the physical properties required for safe and effective function of such a device.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. 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.