(86 days)
The Martech Endoscopic Injection Needle is indicated for use as an accessory for currently marketed endoscopes to provide for delivery of injectable materials into tissues during endoscopic procedures.
As with currently marketed endoscopic injection needles, the Martech Endoscopic Injection Needle may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials which have received approval for use by the FDA. The type of material to be injected will be dependent on the nature of the endoscopic procedure, but such materials may include for example: delivery of collagen during cystoscopic procedures; delivery of sclerosing agents during esophagoscopic and gastroscopic procedures; delivery of local anesthetics during cystoscopic procedures; or delivery of saline or contrast media during colonoscopic procedures.
The Martech Endoscopic Injection Needle fits within various endoscopes with working channels having a 5 French or larger inner diameter and extends beyond the proximal end of the endoscope. The Endoscopic Injection Needle is sterile, disposable and nonpyrogenic. It consists of a non-coring, 23 gauge stainless steel needle attached to a flexibe, 5 French polycarbonate catheter with luer lock hub. The luer lock hubs are designed to meet the "American National Standard for Medical Material, Luer Taper Fittings and Performance' (ANSI/HIMA MD70. i-1983). Moreover, these luer lock hubs are designed to accommodate standard syringes. To allow for smooth passage of the device through the endoscope's instrument channel, the transition between the needle and catheter assembly is tapered.
The Endoscopic Injection Needle will be provided in a variety of lengths, up to 200 cm, in order to accommodate for different length instrument channels. The needle length will be specified on the device's unit label. In general, the shorter needles with shorter endoscopes such as bronchoscopes and the longer needles may be used with longer endoscopes such as flexible gastroscopes and colonoscopes.
This is a 510(k) summary for a medical device (Martech Endoscopic Injection Needle), not a study analyzing AI/algorithm performance. Therefore, most of the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc. related to AI or algorithm performance) is not applicable and cannot be extracted from this document.
The document describes the device, its intended use, and claims substantial equivalence to predicate devices (Bard Endoscopic Injection Needle and Mill-Rose Endoscopic Injection Needle).
Here's what can be extracted based on the nature of the document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria for the device itself (not an AI/algorithm): The document implies performance criteria related to its physical characteristics and functionality. These are not explicitly stated in a quantitative table but are inferred from the description and comparison to predicate devices.
- Fits within various endoscopes with working channels having a 5 French or larger inner diameter.
- Extends beyond the proximal end of the endoscope.
- Sterile.
- Disposable.
- Nonpyrogenic.
- Non-coring, 23 gauge stainless steel needle.
- Flexible, 5 French polycarbonate catheter with luer lock hub.
- Luer lock hubs meet "American National Standard for Medical Material, Luer Taper Fittings and Performance' (ANSI/HIMA MD70. i-1983).
- Luer lock hubs accommodate standard syringes.
- Tapered transition between needle and catheter assembly for smooth passage.
- Available in various lengths up to 200 cm.
- Reported Device Performance (as implied by the 510(k) summary): The document asserts that the device meets these implied criteria by claiming substantial equivalence to predicate devices that have already demonstrated safety and effectiveness for these functions. The 510(k) process relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. There are no specific quantitative performance metrics reported in this summary that would typically be found in an algorithm performance study (e.g., sensitivity, specificity, accuracy).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This is not an AI/algorithm performance study. The 510(k) summary does not detail a "test set" in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. This is not an AI/algorithm performance study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This is not an AI/algorithm performance study.
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. This is not an AI/algorithm performance study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/algorithm performance study; it's a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the context of an algorithm. The "ground truth" for this device's safety and effectiveness is established through adherence to standards (ANSI/HIMA MD70. i-1983) and comparison to predicate devices for which safe and effective use has already been demonstrated in clinical practice.
8. The sample size for the training set
- Not applicable. This is not an AI/algorithm development.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/algorithm development.
§ 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.