(86 days)
Not Found
No
The device description and intended use focus solely on the mechanical function of an injection needle used with an endoscope. There is no mention of any computational or analytical capabilities, let alone AI or ML.
No
The device is described as an accessory for endoscopes used to deliver injectable materials, not as a standalone therapeutic treatment.
No
Explanation: The device is described as an accessory for endoscopes that delivers injectable materials into tissues. Its function is to facilitate the administration of substances, not to diagnose medical conditions or analyze data to determine the presence or nature of a disease.
No
The device description clearly details physical components such as a stainless steel needle, polycarbonate catheter, and luer lock hub, indicating it is a hardware device.
Based on the provided text, the Martech Endoscopic Injection Needle is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to "provide for delivery of injectable materials into tissues during endoscopic procedures." This describes a device used in vivo (within a living organism) for therapeutic or diagnostic purposes related to the delivery of substances.
- Device Description: The description details a physical needle and catheter designed to be inserted into an endoscope and used to inject materials directly into tissues. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnostic purposes. The provided text does not mention any collection or analysis of bodily specimens.
Therefore, the Martech Endoscopic Injection Needle is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
0
K 960519
MAY - 1 1996
Martech Endoscopic Injection Needle 510(k) Summary
Predicate Devices:
Bard Endoscopic Injection Needle (K933812) and Mill-Rose Endoscopic Injection Needle (K820973)
Intended Use of the Device:
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.
Device Description:
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.