(195 days)
Not Found
No
The device description focuses on the physical characteristics and mechanical function of a guidewire and its extension, with no mention of AI or ML capabilities.
No
The device, a guidewire, is intended to facilitate the placement of catheters for PTCA and PTA procedures, not to directly treat or prevent a disease or condition itself. It is an accessory device assisting in a therapeutic procedure.
No
The device is a guidewire intended to facilitate the placement of a catheter through a blood vessel for therapeutic procedures (PTCA and PTA), not for diagnosis.
No
The device description clearly describes a physical guidewire and its components, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Braun Guidewire Function: The description clearly states the Braun Guidewire is intended to be used inside a blood vessel to guide a catheter during procedures like PTCA and PTA. This is an in vivo (within the living body) application.
The device description and intended use are consistent with a medical device used for interventional procedures within the body, not for laboratory testing of specimens.
N/A
Intended Use / Indications for Use
The Braun Guidewire is intended to fit inside a catheter for the catheter through a blood ressel. These catheters may be used for PTCA and PTA procedures. These guidewires are not intended for use for cerebral,reproductive,or nuerological procedures.
Product codes
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Device Description
The Braun Guidewire is a steerable, shapeable guidewire. The guidewire is available in a variety of diameters, stiffnesses, and lengths. Certain sizes are extendible to exchange lengths.
Extendible guidewires have an attachment at the proximal end of the guidewire which is adanted to receive a Braun Guidewire extension wire. Extending the guides exchange of intravascular devices while maintaining distal guidewire position. The extension is removable and permits the guidewire to be returned to its original length and functionality.
Extension Wire Device Description: The Braun Guidewire extension wire is available in sizes compatible with Braun Guidewire extendible guidewires. The distal end of the extension is adapted to engage the proximal end of the guidewire enabling exchange of intravascular devices while maintaining distal guidewire position. The extension is removable and permits the guidewire to be returned to its original length and functionality.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K852123, K852354, K854830, K861574, K861765, K862360, K864585, K872220, K874202, K874776, K881787, K881897, K884262, K884895, K902755, K905502, K913328, K913631, K915723, K925381, K934602, K942066, K950156, K884198, K922912, K914032, K924009, K933466
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
ОСТ 1998
SUMMARY OF SAFETY AND EFFECTIVENESS II.
| Applicant Name & Address: | B. Braun Medical Inc., Cardiovascular Division
824 Twelfth Avenue
Bethlehem, Pa 18018 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mark Alsberge, Regulatory Affairs Manager |
| Date Prepared: | June 21, 1996 |
| Common or Usual Name: | B. Braun Guidewires |
| Device Classification Name: | Wire, Guide, Catheter |
| Substantial Equivalence: | ACS Guidewires-- K852123, K852354, K854830, K861574, K861765, K862360, K864585,
K872220, K874202, K874776, K881787, K881897, K884262, K884895, K902755, K905502,
K913328, K913631, K915723, K925381, K934602, K942066 / or K950156
Target Guidewires--K884198, K922912 / or K914032
USCI Guidewires--K924009 / or K933466 |
Guidewire Description: The Braun Guidewire is a steerable, shapeable guidewire. The guidewire is available in a variety of diameters, stiffnesses, and lengths. Certain sizes are extendible to exchange lengths.
Extendible guidewires have an attachment at the proximal end of the guidewire which is adanted to receive a Braun Guidewire extension wire. Extending the guides exchange of intravascular devices while maintaining distal guidewire position. The extension is removable and permits the guidewire to be returned to its original length and functionality.
Extension Wire Device Description: The Braun Guidewire extension wire is available in sizes compatible with Braun Guidewire extendible guidewires. The distal end of the extension is adapted to engage the proximal end of the guidewire enabling exchange of intravascular devices while maintaining distal guidewire position. The extension is removable and permits the guidewire to be returned to its original length and functionality.
Statement of Intended Use:
The Braun Guidewire is intended to fit inside a catheter for the catheter through a blood ressel. These catheters may be used for PTCA and PTA procedures. These guidewires are not intended for use for cerebral,reproductive,or nuerological procedures.