(90 days)
The injeTAK Adjustable Tip Needles are intended to be used to deliver a variety of legally marketed drugs into tissues or structures during cystoscopic procedures. They are provided sterile for single use only.
The injeTAK Adjustable Tip Needles (injeTAK Needles) are intended to be used to deliver a variety of legally marketed drugs into tissues of structures during cystoscopic procedures. They are provided sterile for single use only.
The needles will contact the bladder tissue and urine fluid in the patient. The typical injection procedure lasts 10-20 minutes; each injection spot contact lasts approximately 5 seconds but may vary slightly depending on the skill of surgeon.
The models of the injeTAK needles are used with a rigid or flexible cystoscope during cystoscopic procedures and differ in length of the needle dependent upon the type of procedure. The intended use does not vary based on the model number or difference in measurement specifications.
The injeTAK Needle comprises of a needle cannula, contrast mark, needle sheath, handle, needle length dial, hub/luer connector, lock-pin, and a seal ring located inside the handle.
Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:
This document is a 510(k) summary for a medical device called "injeTAK Adjustable Tip Needle (DIS199; DIS201)". The FDA's substantial equivalence determination process for 510(k) clearances typically involves demonstrating that a new device is as safe and effective as a legally marketed predicate device. This often involves non-clinical testing to compare the new device's performance against its design specifications and, by extension, against the predicate.
Given this context, the document primarily focuses on non-clinical testing and comparisons to a predicate device, rather than a clinical study evaluating an AI algorithm or human-in-the-loop performance.
Here's the information extracted and organized based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes various non-clinical tests performed to ensure the device meets its design specifications and performs as intended. Specific, quantifiable acceptance criteria are not explicitly listed in a table format within the provided text, but the general outcome for each test is stated. The "acceptance criteria" are implied by the statement "passed all requirements" or "met the acceptance criteria."
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | "The performed biocompatibility tests show that the injeTAK needles are safe and perform as intended." "The materials of all components... have not changed and stay as exact the same as existing G1 needle that the device biocompatibility will be well maintained for injeTAK G2 versions." |
| Packaging Integrity | "All test results passed and met the acceptance criteria." "The device packaging performance and integrity will be maintained for injeTAK G2." |
| Sterilization Efficacy | "The testing performed confirms that sterilization output requirements were met." |
| Functional & Performance | "The test results passed the acceptance criteria." "Overall performance and results were positive and meet the related specifications." |
| Accelerated Aging/Shelf Life | "The essential functionality and performance of injeTAK G2 version (DIS199 & DIS201) passed all requirements after accelerated aging and are therefore acceptable for the three year shelf life." This implicitly covers flow rate and needle luer leak tests. |
| Critical Dimensions | "The test was intended to verify if the device critical dimensions... meet the design specifications... The test results passed the acceptance criteria." |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for the non-clinical tests conducted (e.g., how many needles were tested for biocompatibility, packaging, or functional performance). It mentions "the product's packaging testing" and "the testing performed," implying a set of samples were used for each test.
Data Provenance: The tests are described as non-clinical and in-house/manufacturer-conducted tests to verify product design specifications. The data is internal to Laborie Medical Technologies Corp.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is an invasive medical instrument (needle) and the evaluation presented is a non-clinical device verification and validation summary, not an AI/software product requiring expert ground truth for interpretation of images or other data. The "ground truth" here is the device's adherence to its engineering specifications and relevant ISO standards.
4. Adjudication method for the test set
Not applicable. This is not a study involving human assessment of data that would require an adjudication method. The "adjudication" in this context would be the internal quality and regulatory review process of the manufacturer.
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
No. This is not an AI-assisted diagnostic or predictive device, and no MRMC study was conducted or is relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This is a hardware device (needle), not an algorithm.
7. The type of ground truth used
The "ground truth" for this medical device's performance evaluation is based on:
- Engineering Design Specifications: The device must meet its predefined critical dimensions, functional parameters (e.g., flow rate, luer leak), and material properties.
- International Standards: Adherence to relevant ISO standards for biocompatibility (e.g., ISO 10993 series), sterilization (e.g., ISO 11135, ISO 11137), and packaging (e.g., ISO 11607).
- Predicate Device Performance: Demonstrating that the new device performs at least as well as the legally marketed predicate device.
8. The sample size for the training set
Not applicable. This is a hardware medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. 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.