(245 days)
Single use injection needle is to be used in conjunction with an endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.
Endoscopic Injection Needle consists of Handle, Rod, Needle, Needle holder, Sheath, Catheter, Adapter, Sheath holder, Sheath protection pipe, Tube cap.
The Endoscopic Injection Needle is available in three needle sizes (20 gauges 22 gauge and 25 gauge), five needle lengths (4mm,5mm,8mm and 10mm),five working length(1200mm,1600mm, 1950mm,2000mm, 2300mm). There are 5 series (SN18-05 series, SN18-07 series, SN18-09 series, SN19-05 series and SN19-07 series) total ninety (90) specification injection needles.
The Endoscopic Injection Needle is sterile, single-use device. It is expected to be used in conjunction with an endoscope to perform endoscopic injections into tissue in the GI tract during an endoscopic procedure.
The Endoscopic Injection Needle is designed to pass through the endoscope's forceps to mark the lesions of the digestive tract and use it for injection. Compatibility with endoscopes, working lengths are 1600mm, 1950mm,2000mm, 2300mm, and the minimum working clamp channel is φ 2.8 mm.
The provided text describes the Endoscopic Injection Needle (K213239) and its acceptance criteria, along with a summary of the testing performed to demonstrate its safety and effectiveness.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the successful completion of the tests listed. The "Reported Device Performance" column indicates that the device met these criteria through successful testing.
| Test Item | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Integrity Checks | ||
| Appearance | Integrity, cleanliness, and hygiene | Confirmed to be integrity and cleanliness and hygiene |
| Dimension | Complied with company's requirements | Complied with company's requirements |
| Leakage | No gas leakage | No gas leakage |
| Needle Protection | Needle shall not be exposed when pulling rod back | Needle not exposed when pulling rod back |
| Material/Mechanical Properties | ||
| Resistance to Corrosion | No corrosive marks in immersed part of the needle | No corrosive marks found |
| Stiffness | Needle tube is not easy to deform | Confirmed not easy to deform |
| Resistance to Breakage | Needle tube is not broken during use | Confirmed not broken during use |
| Penetrating Force | Needle tip is sharp (implies sufficient sharpness) | Confirmed needle tip is sharp |
| Connection Strength | All joints are rigid connect | Confirmed all joints are rigid connect |
| Luer Lock Connectors | Meets the requirement of ISO 80369-7 | Meets ISO 80369-7 |
| Functional Testing | ||
| Basic Functional Testing | Successfully inserted and withdrawn into/out of endoscope; stylet passes syringe successfully | Successfully inserted and withdrawn, stylet passes through |
| Chemical/Sterilization Properties | ||
| Chemical Properties | pH, Total content of heavy metals, Potassium permanganate reductive substance, Evaporative residues and Ultraviolet Absorbance meet related requirements | Met related requirements |
| Sterility | Device shall be sterile (SAL: 10-6) | Sterile (by ethylene oxide, SAL: 10-6) |
| EO Residue | ≤10 μg/g | ≤10 μg/g |
| Pyrogen | No pyrogen | No pyrogen |
| Biocompatibility | Conform with ISO10993-1, -4, -5, -10, -11 (Hemolysis, cytotoxicity, sensitization, intracutaneously irritation, acute systemic toxicity, material medicated pyrogenicity) | Verified with ISO 10993 (non-toxic and biocompatible) |
| Shelf Life | Maintain sterility and performance for 2 years | 2-year shelf life established |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the sample size used for each specific bench test item. It generally refers to "bench testing" being performed.
- Data Provenance: The data is from "Summary of non-clinical and performance testing- Bench testing" carried out by Beijing ZKSK Technology Co., Ltd. The tests were performed according to recognized consensus standards and the company's technical requirements. This is retrospective testing performed by the manufacturer on its own device prototypes/production samples. The country of origin for the testing is implied to be China, where the manufacturer is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a physical medical instrument, not an AI/software device that relies on expert interpretation for ground truth in its performance evaluation as described in the context of AI/ML devices. The "ground truth" for the bench tests is based on objective measurements and adherence to engineering and biological standards.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is not an AI/ML device requiring human adjudication for performance evaluation. Adjudication methods are typically relevant for subjective expert assessments or when there are disagreements in interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an Endoscopic Injection Needle, a physical instrument, and its evaluation focuses on bench testing and mechanical/biocompatibility performance, not on AI-assisted human reading.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not applicable. This is not an algorithm or AI device; it's a physical medical instrument. Therefore, the concept of "standalone performance" for an algorithm doesn't apply.
7. The Type of Ground Truth Used
The ground truth for the performance testing is based on objective measurements, adherence to recognized consensus standards (e.g., ISO 7864, ISO 9626, ISO 10993 series, ISO 11607-1, ISO 80369-7), and the manufacturer's internal design requirements and specifications. For biocompatibility, the ground truth is established by the biological responses observed against the criteria in ISO 10993.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set. The device's safety and effectiveness are established through physical and biological testing as described above.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.