(181 days)
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No
The summary describes a physical guiding catheter and its performance characteristics, with no mention of software, algorithms, or AI/ML terms.
No
The device is a guiding catheter used for the intravascular introduction of interventional devices, not for therapeutic intervention itself. It is an accessory to therapies, not a therapeutic device.
No
The device is described as a guiding catheter designed for the "intravascular introduction of interventional devices," which indicates a therapeutic or interventional purpose, not a diagnostic one. There is no mention of it being used to detect, identify, or monitor a medical condition.
No
The device description clearly states it is a guiding catheter, which is a physical medical device, and the performance studies describe physical tests on the catheter.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "intravascular introduction of interventional devices." This describes a device used within the body for a procedural purpose, not for testing samples outside the body to diagnose a condition.
- Device Description: The description focuses on the physical characteristics and function of a catheter used for guiding other devices within blood vessels.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
- Performance Studies: The performance studies described are related to the physical and mechanical properties of the catheter (bond strength, flexibility, flow rate, etc.), which are relevant to its function as a guiding device, not as a diagnostic test.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The SCHNEIDER GUIDER Softip® guiding catheter is designed for the intravascular introduction of interventional devices.
Product codes
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Device Description
The SCHNEIDER GUIDER guiding catheter is manufactured in five French sizes (6 through 10 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The following invitro performance tests were conducted with the SCHNEIDER GUIDER Softip® guiding catheters and approved predicate devices to show equivalence: bond strength tests, flexural rigidity, bodystock force delay, tip shape recovery, introducer resistance, inner liner ubricity, flow rate, pressure injection/leak test, output input torque to failure. Materials equilvalence was demonstrated through biocompatibility testing following ISO 10993-1 recommendations.
The results of these tests indicated that the SCHNEIDER GUIDER Softip® guiding catheters are equivalent to the previously approved predicate devices and are, therefore, safe for the intended use.
Key Metrics
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Predicate Device(s)
Petite brite tip® guding catheter (6 FR), Vista brite tip™guiding catheter (10 FR), TRIGUIDE® guiding catheter (10 FR), DVI guiding catheter (10 FR), SOLID-7 guiding catheter (packaging only)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.1240 Flow-directed catheter.
(a)
Identification. A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.(b)
Classification. Class II (performance standards).
0
NOV 1 9 1996
Image /page/0/Picture/1 description: The image shows the Pfizer logo. The logo consists of the word "Pfizer" in a bold, sans-serif font, set against a solid black oval background. The word "Pfizer" is white, creating a strong contrast with the black background.
Image /page/0/Picture/2 description: The image shows the letterhead for Schneider (USA) Inc, a subsidiary of Pfizer Hospital Products Group. The address is 5905 Nathan Lane, Minneapolis, MN 55442. The phone number is 612-550-5500 and the fax number is 612-550-5771. The letterhead also includes the number K961999.
Image /page/0/Picture/3 description: The image shows the word "SCHNEIDER" in a bold, sans-serif font. To the left of the word is a stylized symbol that resembles three horizontal bars stacked on top of each other, with rounded ends. The text and symbol are both in black, creating a strong contrast against the white background.
510(k) Summary for SCHNEIDER GUIDER Softip® guiding catheter
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92. The assigned 510(k) number is 15901999
| Date Prepared: | May 21, 1996 |
|---|---|
| Sponsor: | Schneider (USA) Inc |
| 5905 Nathan Lane | |
| Plymouth, MN 55442 | |
| Phone: (612)550-5500 | |
| Contact: | Maria Brittle |
| Sr. Regulatory Affairs Specialist | |
| Trade/Proprietary Name: | SCHNEIDER GUIDER Softip® guiding catheters |
| Classification: | Class II |
| Equivalent Devices | Petite brite tip® guding catheter (6 FR) |
| Vista brite tip™guiding catheter (10 FR) | |
| TRIGUIDE® guiding catheter (10 FR) | |
| DVI guiding catheter (10 FR) | |
| SOLID-7 guiding catheter (packaging only) |
Device Description
The SCHNEIDER GUIDER guiding catheter is manufactured in five French sizes (6 through 10 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 SCHNEIDER GUIDER Softip® guiding catheter is designed for the intravascular introduction of interventional devices.
Technological Characteristics
The following invitro performance tests were conducted with the SCHNEIDER GUIDER Softip® guiding catheters and approved predicate devices to show equivalence: bond strength tests, flexural rigidity, bodystock force delay, tip shape recovery, introducer resistance, inner liner ubricity, flow rate, pressure injection/leak test, output input torque to failure. Materials equilvalence was demonstrated through biocompatibility testing following ISO 10993-1 recommendations.
The results of these tests indicated that the SCHNEIDER GUIDER Softip® guiding catheters are equivalent to the previously approved predicate devices and are, therefore, safe for the intended use.