(207 days)
It is to be used in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varices and for submucosal dye marking in the GI tract.
It is a flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform needle functions (e.g., injection) during endoscopy. It is designed with appropriate shape, materials and gauge to function through the working channel of an endoscope. This is a single-use device.
The provided document is a 510(k) summary for the "Endoscopic Injection Needles" (K240675) from Promisemed Hangzhou Meditech Co., Ltd. It focuses on demonstrating substantial equivalence to a predicate device (Single Use Injection Needle, K210917) through non-clinical performance testing.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a formal table of acceptance criteria with specific numerical targets and results in the format requested. Instead, it lists the performance items tested and concludes that the testing "successfully demonstrated essential performance" and that the device "is at least equivalent to the predicate device."
Here's a breakdown of the tested performance items:
| Acceptance Criterion (implicitly met) | Device Performance (reported) |
|---|---|
| Appearance | Tested, results met essential performance. |
| Cleanliness | Tested, results met essential performance. |
| Leakage | Tested, results met essential performance. |
| Puncture force | Tested, results met essential performance. |
| Stiffness | Tested, results met essential performance. |
| Resistance of needle tube to breakage | Tested, results met essential performance. |
| Corrosion resistance of needle tube | Tested, results met essential performance. |
| Particle contamination | Tested, results met essential performance. |
| Flexible properties | Tested, results met essential performance. |
| Flow | Tested, results met essential performance. |
| Compatibility and performance with endoscopes | Tested, results met essential performance. |
| Luer lock hub | Tested, results met essential performance. |
| EO residual | Measured to meet criteria defined in ISO 11135 and AAMI/ANSI/ISO 10993-7:2008(R)2012. |
| ECH residual | Measured to meet criteria defined in ISO 11135 and AAMI/ANSI/ISO 10993-7:2008(R)2012. |
| Shelf-life (3 years) | Validated in accelerated testing per ASTM F1980-16 (2016). Packaging requirements per ISO 11607-1 and ISO 11607-2 were also met. |
| Biocompatibility | Tested by a GLP laboratory following ISO 10993-1:2018; results are qualified (implying compliance with ISO 10993-4, -5, -10, -11, -23, and USP ). |
2. Sample Size Used for the Test Set and Data Provenance:
The document
does not specify the sample sizes
used for each individual non-clinical performance test. It only states that "Performance testing was conducted."
Regarding data provenance, the document indicates that Promisemed Hangzhou Meditech Co., Ltd. is the manufacturer, located in Hangzhou City, China. The biocompatibility testing was conducted by a "third GLP laboratory," but its location is not specified. All tests described are retrospective in the sense that they were conducted for the purpose of this 510(k) submission, likely in a controlled laboratory environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the provided document details non-clinical, benchtop performance testing, not studies involving human subjects or expert assessment of clinical data to establish a "ground truth" as might be done for diagnostic devices. The acceptance criteria for these tests are based on established engineering standards and specifications rather than expert consensus on medical conditions.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as point 3. Benchtop performance tests typically involve objective measurements against predefined specifications, not subjective assessments requiring adjudication among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical test is included in this submission." and "No reference devices were used in this submission." This type of study is relevant for diagnostic imaging devices where human interpretation is involved.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone algorithm performance study was not done. This device is an Endoscopic Injection Needle, a physical medical instrument, not a software algorithm. Therefore, the concept of "standalone algorithm performance" (without human intervention) is not applicable.
7. The Type of Ground Truth Used:
The ground truth for the non-clinical tests described is based on:
- Engineering specifications and design requirements for the device.
- Established national and international standards for medical device testing (e.g., ISO 11135, AAMI/ANSI/ISO 10993-7, ASTM F1980-16, ISO 11607-1, ISO 11607-2, ISO 10993 series, USP ).
- Comparison to the predicate device's performance characteristics to establish substantial equivalence.
8. The Sample Size for the Training Set:
This information is not applicable. As this is a physical medical device and not a machine learning or AI-driven system, there is no "training set." The device's design is based on engineering principles and prior knowledge.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
§ 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.