(163 days)
Wilson disposable injection needle has been designed to be used with an endoscope to perform following therapy:
- Endoscopic sclerotherapy within the esophagus, stomach, duodenum, small intestine, large intestine.
- Endoscopic hemostasis within the esophagus, stomach, duodenum, small intestine, large intestine.
- Endoscopic submucosal injection within esophagus, stomach, duodenum, small intestine, large intestine.
The subjected Disposable Injection Needle is operated together with an endoscope to conduct an endoscopic injection for the treatment of esophageal and gastric varices and submucosal injection in the digestive tract, such as esophagus, stomach, duodenum, small intestine, large intestine.
The subjected device is primarily constituted of handle, tube and needle. The models include PN series, PM series and PM(H) series.
The provided document is a 510(k) premarket notification for a medical device: "Disposable Injection Needle" (PN series, PM series, PM (H) series) by Wilson Instruments (Shanghai) Company Limited. This type of document is a regulatory submission for medical devices, primarily demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a specific study proving the device meets those criteria, as one might find in a clinical trial report or a performance study for AI/software as a medical device (SaMD).
Here's an analysis based on the document's content:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of quantitative acceptance criteria for performance, nor does it present specific device performance results in a measurable, quantifiable way against such criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device through:
- Similar intended use.
- Similar technological characteristics (materials, design, sterilization method).
- Compliance with biocompatibility, sterility, and performance testing in accordance with FDA guidance and international standards.
For medical devices like injection needles, "performance" is often assessed through bench testing for things like needle sharpness, force of injection, material integrity, sterilization effectiveness, and biocompatibility, rather than diagnostic accuracy metrics. The document states that "Test data and report information included in this submission demonstrate that the subjected device is substantially equivalent to the predicate device," but these specific test results are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in the context of data for an AI/SaMD product. It refers to "test data and report information" for biocompatibility, sterility, and performance, which would typically involve physical samples of the device undergoing laboratory testing. The sample sizes for these types of tests are not disclosed in this summary. Data provenance (country of origin, retrospective/prospective) is not applicable in the context of this device and type of submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable to a disposable injection needle. Ground truth, expert consensus, or clinical outcome data are typically relevant for diagnostic or AI devices where there's an interpretation or prediction being made that can be compared against a 'truth'. For an injection needle, the "ground truth" related to its function is derived from engineering specifications and objective physical/chemical tests.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used to resolve discrepancies in expert interpretations in diagnostic studies.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done for this device. This type of study is relevant for diagnostic devices (especially those involving image interpretation by human readers) to assess the impact of AI assistance on human performance. The Disposable Injection Needle is a physical therapeutic/interventional device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone performance study (algorithm only) was not done. This is also specific to AI/SaMD products.
7. The Type of Ground Truth Used:
As noted, the concept of "ground truth" in the diagnostic/AI sense is not applicable. For this physical device, the "truth" is established by:
- Engineering specifications: Meeting defined physical dimensions, material properties, and functional performance (e.g., needle sharpness, strength).
- Biocompatibility testing: Adhering to standards (e.g., ISO 10993) to ensure no adverse biological reactions.
- Sterility testing: Confirming the absence of viable microorganisms per established standards.
- Material safety data: Ensuring components are safe for their intended use.
8. The Sample Size for the Training Set:
This information is not applicable. There is no "training set" for a physical medical device like an injection needle. Training sets are used in machine learning for AI algorithms.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set.
Summary of Acceptance Criteria and Evidence from the Document:
The document states that the device is "substantially equivalent" to the predicate device (Olympus Injector NM-4-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1 cleared via K011484). The "acceptance criteria" can be inferred as meeting the same performance, safety, and effectiveness profiles as the predicate device.
Inferred Acceptance Criteria (not explicitly quantitative in the document):
| Acceptance Criteria Category | Reported Device Performance (Inferred from "Substantial Equivalence") |
|---|---|
| Intended Use | Same as predicate: Endoscopic sclerotherapy, hemostasis, and submucosal injection in the digestive tract. |
| Technological Characteristics | Same as predicate: Product structure (working length, diameter, channel size), materials, EO sterilization method. |
| Biocompatibility | Compliant with FDA guidance and international standards (implied to be equivalent to predicate's compliance). |
| Sterility | Compliant with FDA guidance and international standards (EO sterilization, implied to be equivalent to predicate's compliance). |
| Performance | Compliant with FDA guidance and international standards (implies functional equivalence for injection tasks, such as needle sharpness, force, material integrity, etc., as demonstrated by "test data and report information" not detailed here). |
In conclusion, this 510(k) summary focuses on demonstrating substantial equivalence of a physical medical device (Disposable Injection Needle) to a legally marketed predicate. It does not contain the specific detail about acceptance criteria, study design, and performance metrics typically seen for AI/SaMD or clinical trial reports. The "study" proving the device met the criteria would consist of laboratory tests for biocompatibility, sterility, and various physical performance tests, the details of which are not included in this summary but would have been part of the full 510(k) submission.
§ 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.