(182 days)
The LAGUNA" Softip® diagnostic catheter is designed for delivering radiopaque media to selected sites in the vascular system.
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.
The provided 510(k) summary for the LAGUNA™ Softip® diagnostic catheter does not include information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/ML medical device.
This document describes a traditional medical device (a diagnostic catheter) and its technological characteristics and equivalence to predicate devices through physical tests. It does not involve any AI/ML components, image analysis, or performance metrics like sensitivity, specificity, or AUC that would be associated with AI/ML device studies.
Therefore, I cannot fulfill your request as the required information (acceptance criteria for an AI/ML device, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, etc.) is entirely absent from the provided text.
{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.
§ 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).