FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Disposable Sclerotherapy Needle device consists of: Luer connector, handle, molding metal tube, Inner sheath connection limit tube, Fixing sleeve, Outer sheath, Inner sheath, connection tube, metal cap, needle. EO Sterilization and use for single use only. The material expected to come into contact with the patient is SUS304 、SUS303、PP/PE.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device, the "Disposable Sclerotherapy Needle." This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device's efficacy through extensive clinical trials as would be required for a novel device.

Therefore, the acceptance criteria and study detailed in this document are not for an AI/ML powered device, nor do they involve complex aspects like:

AI/ML model performance metrics: There are no metrics like sensitivity, specificity, AUC, etc.
Test set and training set details: No data sets, their provenance, or sample sizes related to AI are mentioned because there is no AI component.
Expert ground truth establishment: No expert consensus readings or adjudication methods are discussed because there is no AI algorithm to evaluate.
MRMC studies: No human reader studies are conducted because the device is a physical instrument, not an AI diagnostic tool.
Standalone algorithm performance: There's no algorithm to perform standalone.

Instead, the document focuses on bench testing and biocompatibility evaluations for a physical medical instrument.

Here's a breakdown of the relevant information provided, adapted to the context of a physical medical device:

Acceptance Criteria and Device Performance (for a physical medical device)

The document implicitly defines "acceptance criteria" by stating compliance with relevant international standards and successful completion of bench tests. The "performance" is demonstrated by the passing results of these tests and the determination of substantial equivalence.

Acceptance Criteria Category	Specific Criteria (from standards/tests)	Reported Device Performance/Findings
Biocompatibility	Compliance with ISO 10993 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing" and ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals". Ensure materials in contact with patient are safe.	"The proposed device meets the requirements of ISO 10993..." and "The results show the device is safe in the aspect of biocompatibility evaluation." The materials expected to come into contact with the patient (SUS304, SUS303, PP, or PE) were evaluated.
Sterilization	Compliance with ISO 11135-1 "Sterilization of Health Care products Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices." Ensure effective sterilization and minimal residuals.	"The proposed device meets the requirements of ... ISO 11135-1..." The device is single-use, EO sterilized.
Physical Properties	Bench tests performed on "Appearance" and "Physical properties." Implicitly, these tests would cover aspects relevant to the device's function and integrity, such as needle sharpness, sheath integrity, handle functionality, Luer connector fit, and overall structural soundness. (Specific numerical criteria for these are not detailed in the summary, which is common for 510(k) summaries).	"The following bench tests were performed on Disposable Sclerotherapy Needle: Appearance, Physical properties. The results of all testing were passing." This indicates that the device met all internal specifications for its physical characteristics and appearance.
Functional Equivalence	Demonstration that the proposed device is substantially equivalent to the predicate device (K171454) in terms of indications for use, configuration, sheath diameter, needle size, working length, packaging, materials, and principle of operation. Minor differences should not raise new questions of safety or effectiveness.	The document provides a detailed comparison table (Section 5.6) highlighting similarities and minor differences. It concludes: "The differences between the proposed device and the predicate devices do not raise any questions regarding its safety and effectiveness." And ultimately: "...Hangzhou AGS Medtech Co., Ltd has demonstrated that proposed device Disposable Sclerotherapy Needle is substantially equivalent to Boston Scientific Corporation's Injection Therapy Needle Catheter, K171454."

Study Details (for a physical medical device)

1. Sample Size for the Test Set and Data Provenance:

Test Set: The document states that "bench tests were performed." While "sample size" for specific physical properties is not explicitly quantified (e.g., "N=X needles tested"), it refers to the number of units tested to ensure properties like appearance and physical integrity. For medical devices, this is typically a statistically relevant sample from a production batch, not a "data set" in the computational sense.
Data Provenance: Not applicable in the context of "data provenance" for AI models. The testing was conducted by the manufacturer, Hangzhou AGS MedTech CO., Ltd, in China (as per their address). It is implied these are results from prospective testing specifically conducted for this 510(k) submission, not retrospective data.

2. Number of Experts Used to Establish Ground Truth and Qualifications:

This question is not applicable to this submission. The "ground truth" for a physical device like a sclerotherapy needle is established by established engineering specifications, material standards, and functional performance benchmarks (e.g., a needle must be sharp enough to penetrate tissue without bending, the Luer connector must fit). There are no human "experts" establishing a "ground truth" in the way a radiologist establishes disease presence for AI training. The adherence to international standards and passing bench tests are the "truth."

3. Adjudication Method for the Test Set:

Not applicable. There is no "adjudication" in the sense of reconciling divergent expert opinions, as there are no expert readings of images or data. Bench tests yield objective, measurable results (pass/fail, within specified tolerances).

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, not performed, and not applicable. This is a physical medical device, not an AI assistant. MRMC studies are designed to compare the diagnostic performance of human readers with and without AI assistance. This device does not have an AI component.

5. Standalone Performance:

Not applicable in the AI sense. There isn't an "algorithm" to perform standalone. The closest equivalent would be the "bench tests" performed on the device itself, which demonstrated its standalone physical properties and compliance with standards.

6. Type of Ground Truth Used:

The "ground truth" for this device's performance is based on:
- Engineering Specifications and Design Requirements: The device must meet its predetermined design and functional requirements.
- International Standards: Adherence to ISO standards (ISO 10993, ISO 11135-1, ISO 10993-7) for biocompatibility and sterilization.
- Bench Test Results: Objective measurements of physical properties (e.g., appearance, integrity, mechanical characteristics).
- Comparison to Predicate Device: The predicate device itself serves as a benchmark for substantial equivalence, implying its safe and effective performance in the past.

7. Sample Size for the Training Set:

Not applicable. This device does not have an AI/ML component, therefore there is no "training set."

8. How the Ground Truth for the Training Set Was Established:

Not applicable. Since there is no training set for an AI model, there is no ground truth to be established in this context.

Summary

Regulation Number and Section

§ 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.