(270 days)
Sclerotherapy & Endoscopic Needles are endoscopic accessories intended to introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system or to inject liquid to aid in polypectomy procedures.
Sclerotherapy & Endoscopic Needles are endoscopic accessories intended to introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system or to inject liquid to aid in polypectomy procedures.
Sclerotherapy & Endoscopic Needles (see schematic representation in Figure 1) are made of a flexible catheter with an inner tube connected to the needle at the distal end and a handle with a piston and a luer-lock connection at the proximal end.
All devices of this family group are packed in a medical grade paper pouch and sterilized by ETO. The sterile devices are distributed in carton boxes along with an Instruction for Use.
There are 4 variations of the Sclerotherapy & Endoscopic Needles with different catheter lengths and diameters and different needle lengths and diameters (see Table 1).
The device is used through an endoscope to inject different types of sclerosing agents, vasoconstrictors, or other solutions into selected sites of the digestive system to control actual or potential bleeding. It can be also used to inject liquid into the mucosa to aid in polypectomy procedures.
These procedures can last from 15 minutes. Furthermore, this device comes in contact with the digestive system mucosa.
There are no accessories for this kind of devices.
This document describes the G-Flex Europe SPRL's Sclerotherapy & Endoscopic Needles, which are endoscopic accessories intended to introduce sclerosing agents or other solutions into the digestive system. The 510(k) submission, K222006, establishes substantial equivalence to the Boston Scientific Interject Injection Therapy Needle Catheter (K171454).
Here's an analysis of the acceptance criteria and supporting studies based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical targets for clinical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. The "acceptance criteria" are implied to be that the device performs comparably to the predicate and meets design specifications and relevant standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional / Mechanical Performance: Device meets design specifications for dimensions, mechanical integrity, controllability, permeability, and smoothness. | Bench testing (dimensions verification, visual inspection, mechanical evaluation, controllability, permeability, and smoothness) demonstrated that the device meets the design specifications. |
| Biocompatibility: Device is safe for intended contact with human tissue. | Biocompatibility tests were conducted in accordance with the ISO 10993 series. Test results confirmed the device is biocompatible for the stated intended use. |
| Sterility: Device reliably achieves a specified sterility assurance level (SAL). | Validation of ethylene oxide sterilization was conducted following the half-cycle method I, in accordance with ISO 11135-1:2014 and ISO 11138-2:2009, to meet a minimum SAL of 10^-6. |
| Shelf-life: Device maintains its performance and safety over its declared shelf-life. | 3-year accelerated and 2-year real-time aging validations were performed. These demonstrated that dimensions, mechanical resistance, controllability, permeability, thoroughness, bio-property, and sterility were not affected during the stated shelf-life. A 3-year real-time aging validation is ongoing. Packaging and shelf-life studies conform to ISO 11607-1:2019, ASTM F1980-16, and ASTM D4169-16. |
| Equivalence to Predicate Device: Device has similar technological characteristics and intended use to the predicate. | A detailed comparison table (Section 6) highlights similarities in regulatory information, clinical condition, intended use/indications for use, contraindications, site of use, duration of contact, patient population, design, conditions of use, environment of use, materials, and sterilization methods. Minor differences in dimensions and wording of indications/contraindications were assessed as not impacting clinical application. |
2. Sample sized used for the test set and the data provenance
The document explicitly states: "No clinical testing was performed to support the medical device as the indications for use are equivalent to the predicate device." Therefore, there is no clinical "test set" in the context of human data. The performance evaluations were based on non-clinical bench testing, biocompatibility testing, sterility validation, and shelf-life studies. The "sample sizes" for these non-clinical tests are not detailed in the summary, nor is the "data provenance" (country of origin), as it pertains to laboratory and manufacturing data rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Given that no clinical testing was performed and no "test set" of patient data was used, this information is not applicable.
4. Adjudication method for the test set
Not applicable, as no clinical test set was used.
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. The device is a physical endoscopic accessory, not an AI-assisted diagnostic or treatment system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical endoscopic accessory, not an algorithm.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" was established by:
- Design Specifications: For bench testing, comparing physical and mechanical characteristics to engineering and design requirements.
- International Standards: For biocompatibility (ISO 10993 series), sterility (ISO 11135-1:2014, ISO 11138-2:2009), packaging (ISO 11607-1:2019), and aging (ASTM F1980-16, ASTM D4169-16). Compliance with these standards serves as the ground truth for safety and performance in their respective domains.
- Predicate Device Characteristics: For the substantial equivalence comparison, the characteristics and established safety/effectiveness of the predicate device (Boston Scientific Interject Injection Therapy Needle Catheter, K171454) served as the "ground truth" baseline.
8. The sample size for the training set
Not applicable, as this device does not involve machine learning or AI models with a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this 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.