(182 days)
INFINITI™ diagnostic catheter (5 FR), SUPER TORQUEPLUS™ diagnostic catheter (7 FR)
Not Found
No
The description focuses on the physical characteristics and performance of a diagnostic catheter, with no mention of AI or ML.
No.
The device is a diagnostic catheter used for delivering radiopaque media, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "diagnostic catheter."
No
The device description clearly indicates it is a physical catheter, a hardware component, and the performance studies focus on physical properties and tests.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "delivering radiopaque media to selected sites in the vascular system." This is a procedure performed within the body (in vivo) for imaging purposes, not a test performed on samples taken from the body (in vitro).
- Device Description: The description details a catheter designed for physical insertion into the vascular system.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, reagents, or any other typical components of an in vitro diagnostic test.
IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, disease, or congenital abnormality. This device is a tool for delivering a substance for imaging, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The LAGUNA" Softip® diagnostic catheter is designed for delivering radiopaque media to selected sites in the vascular system.
Product codes
Not Found
Device Description
The LAGUNA" diagnostic catheter is manufactured in three French sizes (5 FR, 6 FR and 7. FR) and multiple distal stem configurations and lengths. In addition, within each French size, catheters will be offered with differing handling characteristics to allow flexibility in meeting physician preferences.
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
The following tests were performed on the LAGUNA" Softip® diagnostic catheters and approved predicate device to show equivalence: bond strength tests, flexural rigidity, bodystock force delay, tip shape recovery, flow rate, pressure injection/leak test, output torque, input torque to failure and distal pressure testing.
The results of these tests indicate that the LAGUNA" Softip® diagnostic catheters are equivalent to the previously approved predicate device and is therefore safe for its intended use.
Key Metrics
Not Found
Predicate Device(s)
INFINITI™ diagnostic catheter (5 FR), SUPER TORQUEPLUS™ diagnostic catheter (7 FR)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
Pfizer Hospital Products Group 5905 Nathan Lane Minneapolis, MN 55442 Tel 612 550 5500 Fax 612 550 577 1
Image /page/0/Picture/1 description: The image shows the Pfizer logo. The logo consists of the word "Pfizer" in a stylized font, with the letters overlapping each other. The logo is black and is set against a white background. The logo is simple and recognizable.
OCT 17 1996
510(k) Summary for LAGUNA™ Softip® diagnostic catheter
Date Prepared: April 17, 1996 Sponsor: Schneider (USA) Inc 5905 Nathan Lane Plymouth, MN 55442 Phone: (612)550-5500 Contact: Maria Brittle Sr. Regulatory Affairs Specialist LAGUNA™ Softip® diagnostic catheter Trade/Proprietary Name: Classification: Class II Softip® High Flow diagnostic catheter (5 FR, 7 FR) Equivalent Devices INFINITI™ diagnostic catheter (5 FR) SUPER TORQUEPLUS™ diagnostic catheter (7 FR)
GUIDEZILLA™ Softip® guiding catheters (packaging & sterilization)
Device Description
The LAGUNA" diagnostic catheter is manufactured in three French sizes (5 FR, 6 FR and 7. FR) and multiple distal stem configurations and lengths. In addition, within each French size, catheters will be offered with differing handling characteristics to allow flexibility in meeting physician preferences.
Intended Use
The LAGUNA" Softip® diagnostic catheter is designed for delivering radiopaque media to selected sites in the vascular system.
Technological Characteristics
The following tests were performed on the LAGUNA" Softip® diagnostic catheters and approved predicate device to show equivalence: bond strength tests, flexural rigidity, bodystock force delay, tip shape recovery, flow rate, pressure injection/leak test, output torque, input torque to failure and distal pressure testing.
The results of these tests indicate that the LAGUNA" Softip® diagnostic catheters are equivalent to the previously approved predicate device and is therefore safe for its intended use.