(181 days)
The SCHNEIDER GUIDER Softip® guiding catheter is designed for the intravascular introduction of interventional devices.
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.
This document describes a 510(k) summary for a medical device, specifically a guiding catheter. It focuses on demonstrating equivalence to predicate devices through in vitro performance tests and biocompatibility, rather than clinical study results involving human performance or diagnostic accuracy. Therefore, many of the requested categories related to human-in-the-loop performance, expert ground truth, and training data for AI models are not applicable.
Here's the information that can be extracted or inferred from the provided text, formatted to address your request as much as possible:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Bond strength comparable to predicate devices | Met (Results indicated equivalence) |
| Flexural rigidity comparable to predicate devices | Met (Results indicated equivalence) |
| Bodystock force delay comparable to predicate devices | Met (Results indicated equivalence) |
| Tip shape recovery comparable to predicate devices | Met (Results indicated equivalence) |
| Introducer resistance comparable to predicate devices | Met (Results indicated equivalence) |
| Inner liner lubricity comparable to predicate devices | Met (Results indicated equivalence) |
| Flow rate comparable to predicate devices | Met (Results indicated equivalence) |
| Pressure injection/leak test comparable to predicate devices | Met (Results indicated equivalence) |
| Output input torque to failure comparable to predicate devices | Met (Results indicated equivalence) |
| Biocompatibility in accordance with ISO 10993-1 recommendations | Met (Materials equivalence demonstrated through biocompatibility testing) |
Note: The document states "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." This implies that the acceptance criteria for each test were to demonstrate equivalence to the predicate devices and that these criteria were met.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any of the in vitro tests.
- Data Provenance: In vitro performance tests. The document does not specify country of origin for the internal testing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The study involved in vitro performance tests comparing the device to predicate devices, not subjective assessments by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No human adjudication was involved in these in vitro performance tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This summary describes the regulatory submission for a physical medical device (guiding catheter), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth: For the in vitro performance tests, the "ground truth" or reference was the performance characteristics of the previously approved predicate devices. For biocompatibility, the ground truth was adherence to ISO 10993-1 recommendations.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device; there is no training set in the context of this submission.
9. How the ground truth for the training set was established
- Not applicable.
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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.
§ 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).