(118 days)
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No
The device description focuses on physical components and materials for percutaneous introduction of catheters and guidewires, with no mention of AI or ML capabilities.
No
This device is an introducer, designed for the percutaneous introduction of other catheters and guidewires into the vasculature. Its primary function is to facilitate access for therapeutic devices, rather than performing a therapeutic function itself.
No
The device is intended for percutaneous introduction of catheters and guidewires into the vasculature for interventional/therapeutic purposes, not for diagnosing medical conditions.
No
The device description clearly details physical components such as dilators, sheaths, needles, guidewires, and packaging, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in percutaneous introduction of various catheters and/or guidewires into the vasculature." This describes a device used in vivo (within the body) for a medical procedure.
- Device Description: The description details components like dilators, sheaths, needles, and guidewires, which are all instruments used for accessing and navigating within the body's vascular system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body, not to be inserted into the body for procedural purposes.
N/A
Intended Use / Indications for Use
These devices are intended for use in percutaneous introduction of various catheters and/or guidewires into the vasculature.
Product codes
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Device Description
The various SDM Percutaneous Catheter Introducer/Set range in dilator tubing sized from 4 Fr to 13 Fr and in dilator lengths from 100mm to 340mm. Sheaths paired with the dilators are tapered and close fitting to facilitate maximum ease of insertion. The sheaths are offered in both FEP and Pebax depending on customer preference. The sheath hemostasis valve contains a silicone seal and is offered both with a sideport and plain. An 18ga needle and guidewire of appropriate size will also be included with each set. Dilator luers are marked with a numeral and sheath caps are colored coded to indicate french size. These sets will be packaged in semi-rigid vacuum formed trays containing a heat-sealed, ethylene oxide permeable lids.
A more economical, reduced version of the set will also be offered containing just a dilator and sheath without hemostasis valve packaged in a Tyvek/Poly chevron pouch
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows a graphic with the letters "sdm" in the center of a circle. The circle is surrounded by an oval shape. The letters are in lowercase and appear to be in a simple, sans-serif font.
scientific device man
999 Andersen Drive, Suite 110 San Rafael, California 94901 Phone 415-454-9370 Fax 415-454-9380
3 1996 JUL
SUMMARY OF SAFETY AND EFFECTIVENESS
Percutaneous Catheter Introducer , Set
510(k) Premarket Notification
SDM Percuglide Trade Name:
Percutaneous Catheter Introducer/Set Generic Name:
Scientific Device Manufacturer, LLC Manufacturer: 999 Andersen Drive, Suite 110 San Rafael, CA 94901 Establishment Registration Number: TBD
Classification:
In preparation of this Premarket Notification, it was determined that devices of this generic type have been previously classified as Class II devices. No performance standards have yet been established for these products.
Product Description:
The various SDM Percutaneous Catheter Introducer/Set range in dilator tubing sized from 4 Fr to 13 Fr and in dilator lengths from 100mm to 340mm. Sheaths paired with the dilators are tapered and close fitting to facilitate maximum ease of insertion. The sheaths are offered in both FEP and Pebax depending on customer preference. The sheath hemostasis valve contains a silicone seal and is offered both with a sideport and plain. An 18ga needle and guidewire of appropriate size will also be included with each set. Dilator luers are marked with a numeral and sheath caps are colored coded to indicate french size. These sets will be packaged in semi-rigid vacuum formed trays containing a heat-sealed, ethylene oxide permeable lids.
A more economical, reduced version of the set will also be offered containing just a dilator and sheath without hemostasis valve packaged in a Tyvek/Poly chevron pouch
Intended Use:
These devices are intended for use in percutaneous introduction of various catheters and/or guidewires into the vasculature.
1
Rationale for Substantial Equivalence:
Scientific Device Manufacturer's Percutaneous Catheter Introducer/Sets are substantially equivalent to currently marketed introducer sets with regard to intended use, materials, dimensions and mechanical properties. Dimensions, materials, and functionality have been chosen to match commonly accepted industry standards and to replicate several of the predicate devices, including those made by Arrow International, Cordis Corporation and Cook Incorporated. No significant changes or modifications were made from those predicate devices. SDM, LLC, therefore posits that its devices are equivalent in safety and effectiveness to those devices.
Biocompatibility Evaluation:
Materials used in Scientific Device Manufacturer's Percutaneous Catheter Introducer/Sets were chosen to be generically the same as those present in the substantially equivalent devices. Testing is currently underway by SDM for this externally communicating device (circulating blood) to show this device to be biocompatible per the requirement of ISO Standard 10993, Part I. This data will be provided to the office of Device Evaluation prior to completion of review.
Summary:
Based upon the product description and its intended use as outlined in this summary, the Scientific Device Manufacturer's Percutaneous Catheter Introducer/Kits are substantially equivalent to other vascular access kits currently in use.
Richard C. Bell
Richard C. Ball Vice President Regulatory Affairs and Quality Assurance