(34 days)
KNS
None
No
The summary describes a mechanical device for injecting contrast and does not mention any AI/ML components or functions.
No
The device is used to cannulate and inject contrast media for diagnostic imaging (cholangiogram) of the biliary duct system, not to treat a disease or condition.
Yes
The device is used to inject contrast media and perform fluoroscopy or x-ray to obtain a cholangiogram of the biliary duct system, which is a diagnostic imaging procedure to visualize the bile ducts.
No
The device description clearly describes a physical medical device (a triple lumen ERCP cannula) and its hardware components and functionality. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- TandemRX Function: The TandemRX is a cannula used to directly inject contrast media into the biliary duct system within the body (in vivo) for imaging purposes (cholangiogram). It is a surgical/interventional device, not a diagnostic test performed on a sample.
The description clearly outlines its use for a procedure involving direct interaction with the patient's internal anatomy and the injection of a substance for imaging, which is not the function of an IVD.
N/A
Intended Use / Indications for Use
The TandemRX is indicated for use to cannulate and inject contrast media to obtain a cholangiogram of the biliary duct system. The contrast media is injected through the cannula and fluoroscopy or x-ray is performed to obtain the cholangiogram.
Product codes
KNS
Device Description
The Microvasive TandemRX is a triple lumen ERCP cannula capable of accepting an .035" guidewire in one open channel while simultaneously injecting contrast media through the other two lumens. The two lumens are joined at the proximal end so that injection of contrast medium can be accomplished through a single injection port. The open channel allows for the quick exchange of a guidewire completely isolated from injection agents. No stylet is necessary for scope passage. The TandemRX may be placed with or without the aid of a guidewire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy or x-ray
Anatomical Site
biliary duct system
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
Laboratory testing regarding characteristics was performed on TandemRX to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluid-contact materials of the TandemRX with satisfactory results.
Key Metrics
Not Found
Predicate Device(s)
Microvasive Tandem XL Cannula
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 97 0054
SECTION 9 510(K) SUMMARY
FEB | 0 1997
FOI RELEASABLE
Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification "...adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation chooses to submit a summary of information respecting safety and effectiveness.
| DATE: | January 6, 1997 | |
|---|---|---|
| COMMON/USUAL NAMES: | Injection Cannula | |
| TRADE/PROPRIETARY NAME: | Unknown at this Time | |
| CLASSIFICATION NAME & | ||
| DEVICE CLASSIFICATION: | Class I | |
| Name | Number 21 CFR Ref. | |
| Cannula, Injection 79 FGY | KNS | |
| DEVICE PANEL/BRANCH: | Gastroenterology-Urology (GU) | |
| Gastro-Renal (GRDB) | ||
| OWNER/OPERATOR: | Boston Scientific Corporation | |
| One Boston Scientific Place | ||
| Natick, MA 01760 | ||
| CONTACT PERSON: | Lisa M. Quaglia, Senior Regulatory Affairs Specialist |
DESCRIPTION
The Microvasive TandemRX is a triple lumen ERCP cannula capable of accepting an .035" guidewire in one open channel while simultaneously injecting contrast media through the other two lumens. The two lumens are joined at the proximal end so that injection of contrast medium can be accomplished through a single injection port. The open channel allows for the quick exchange of a guidewire completely isolated from injection agents. No stylet is necessary for scope passage. The TandemRX may be placed with or without the aid of a guidewire.
1
INDICATIONS FOR USE
The TandemRX is indicated for use to cannulate and inject contrast media to obtain a cholangiogram of the biliary duct system. The contrast media is injected through the cannula and fluoroscopy or x-ray is performed to obtain the cholangiogram.
DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES
Boston Scientific Corporation believes that the TandemRX is substantially equivalent to the currently-marketed Microvasive Tandem XL Cannula. The major components of the TandemRX are the shaft, hub, guidewire introducer, and the outer sheath. A thorough comparison of the descriptive characteristics between the TandemRX and the predicate device shows equivalence.
PERFORMANCE CHARACTERISTICS
Laboratory testing regarding characteristics was performed on TandemRX to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluidcontact materials of the TandemRX with satisfactory results.
CONCLUSION
Boston Scientific Corporation believes that TandemRX is substantially equivalent to the currently-marketed Microvasive Tandem XL. The Modified TandemRX is equivalent in its indications for use, while being very similar in design and materials. In addition, Boston Scientific Corporation has presented laboratory testing and biocompatibility information. The information presented provides assurance that the TandemRX will meet the minimum requirements that are considered acceptable for its intended use.