(234 days)
Not Found
Not Found
No
The summary describes a physical device (cannula) used for injecting contrast media and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a diagnostic tool used to inject contrast media to identify blockages, not to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states, "ERCP is a diagnostic procedure for suspected biliary tract obstruction," and "The ERCP cannula serves as the pathway by which contrast media is injected for the purpose of identifying the reason for blockage." This clearly indicates the device's role in diagnosis.
No
The device description clearly states it is a physical cannula used for injecting contrast media, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The description clearly states the device is an "ERCP cannula" used to inject "contrast media" into the "biliary tract" for diagnostic imaging. This is an in vivo procedure, meaning it is performed within the living body.
- Lack of Sample Analysis: The device facilitates the injection of a substance for imaging; it does not analyze a sample taken from the body.
Therefore, the device described is a medical device used for an in vivo diagnostic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ERCP is a diagnostic procedure for suspected biliary tract obstruction such as strictures or stones. The ERCP cannula serves as the pathway by which contrast media is injected for the purpose of identifying the reason for blockage. Patients with diagnosed biliary tract calculi or strictures can then be treated with an assortment of therapeutic modalities.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The ERCP cannula serves as the pathway by which contrast media is injected for the purpose of identifying the reason for blockage.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary tract
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)
The Summary of Safety and Effectiveness on the endoscopic procedure for bile duct pathology and the ERCP cannulas used reflects data available and presented at the time the submission was prepared, but, caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
K96 3051
SECTION II SUMMARY AND CERTIFICATION
ENDOSCOPIC RETROGRADE CHOLANGOPANCREATOGRAPHY (ERCP) SUMMARY
The Summary of Safety and Effectiveness on the endoscopic procedure for bile duct pathology and the ERCP cannulas used reflects data available and presented at the time the submission was prepared, but, caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth.
Procedure/Product Overview
ERCP is a diagnostic procedure for suspected biliary tract obstruction such as strictures or stones. The ERCP cannula serves as the pathway by which contrast media is injected for the purpose of identifying the reason for blockage. Patients with diagnosed biliary tract calculi or strictures can then be treated with an assortment of therapeutic modalities.
Contraindications for ERCP Procedure
ERCP is contraindicated in patients with/or:
- Acute pancreatitis, unless clinical situation necessitates 1) procedure
- Recent myocardial infarction, unless surgical intervention is 2) required
-
- Presence of barium in the GI tract
-
- Pregnancy
-
- Severe pulmonary disease
- ୧) Allergy to contrast media
-
- Uncooperative or unable to tolerate procedure
The physician will determine patient's appropriateness for the procedure.
Manufacturing Overview
U.S.E. manufactured and tested the product to performance specifications based on predicate and/or substantially equivalent devices.
U.S.E. manufacturing processes and procedures are based on good manufacturing practices. Quality assurance methods and procedures based on MIL-STD-9858 are utilized to assure conformance to design specifications.
Materials used in the manufacturing process are certified to standards appropriate for their use.
3