(63 days)
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Not Found
No
The summary describes a simple mechanical catheter for contrast delivery and does not mention any computational or image processing capabilities, let alone AI/ML.
No.
The device is used for introducing contrast materials for diagnostic imaging, not for treating a disease or condition.
No.
The device is indicated for "catheterization in the urinary tract or gastrointestinal tract for the introduction of radiopaque contrast materials," which is an interventional or therapeutic procedure, not a diagnostic one. It facilitates the introduction of contrast for imaging, but the device itself does not perform the diagnosis.
No
The device description clearly describes a physical catheter with a lumen, tip, and hub, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for catheterization in the urinary or gastrointestinal tract for the introduction of radiopaque contrast materials. This is a procedure performed in vivo (within the body) for imaging purposes.
- Device Description: The description details a physical catheter used for insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information about a physiological state, health, or disease.
IVDs are specifically designed to perform tests on samples taken from the body. This device is a tool for delivering a substance into the body for imaging, which falls under the category of medical devices used for diagnostic or therapeutic procedures in vivo.
N/A
Intended Use / Indications for Use
The Imager Torque Catheter is indicated for use for catheterization in the urinary tract or gastrointestinal tract for the introduction of radiopaque contrast materials.
Product codes
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Device Description
The Imager Torque Catheter is a single - lumen introduction catheter with a range of tip configurations. The device is flexible catheter with one hole at the tip. A luer lock hub is attached to the proximal end. The catheter is designed to be used with a .038" guidewire if required.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract or gastrointestinal 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
MAR – 4 1997 510(k) Summary Of Safety And Effectiveness
FOI RELEASABLE
| Sponsor: | Boston Scientific Corporation
One Scientific Place
Natick, MA 01760-1537 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Carol J. Holloway
Regulatory Affairs Specialist |
| Submission Date: | December 27, 1996 |
| Description of
Device: | The Imager Torque Catheter is a single - lumen introduction
catheter with a range of tip configurations. The device is flexible
catheter with one hole at the tip. A luer lock hub is attached to the
proximal end. The catheter is designed to be used with a .038"
guidewire if required. |
| Intended Uses: | The Imager Torque Catheter is indicated for use for
catheterization in the urinary tract or gastrointestinal tract for the
introduction of radiopaque contrast materials. |
| Substantial
Equivalence: | The proposed devices are Substantially Equivalent to the predicate
currently marketed devices indicated for use for
catheterization in the cardiovascular system for the introduction
of radiopaque contrast materials and CFR 21 part 878.4200,
Introduction / Drainage Catheter. |