PERCUGLIDE

K960917 · Scientific Device Manufacturer, LLC · DRE · Jul 2, 1996 · Cardiovascular

Device Facts

• Record ID: K960917
• Device Name: PERCUGLIDE
• Applicant: Scientific Device Manufacturer, LLC
• Product Code: DRE · Cardiovascular
• Decision Date: Jul 2, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1310
• Device Class: Class 2

Intended Use

These devices are intended for use in percutaneous introduction of various catheters and/or guidewires into the vasculature.

Device Story

Percutaneous catheter introducer set; includes dilator (4-13 Fr, 100-340mm), tapered sheath (FEP or Pebax), 18ga needle, and guidewire. Hemostasis valve with silicone seal optional. Used by clinicians for vascular access. Facilitates catheter/guidewire insertion into vasculature. Packaged in vacuum-formed trays or Tyvek pouches; sterilized via ethylene oxide.

Clinical Evidence

No clinical data. Biocompatibility testing per ISO 10993-1 is underway for externally communicating (circulating blood) device.

Technological Characteristics

Materials: FEP, Pebax, silicone. Sizes: 4 Fr to 13 Fr; lengths: 100mm to 340mm. Components: dilator, tapered sheath, 18ga needle, guidewire. Sterilization: Ethylene oxide.

Indications for Use

Indicated for patients requiring percutaneous vascular access for the introduction of catheters and/or guidewires.

Regulatory Classification

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.

Predicate Devices

• Arrow International introducer sets
• Cordis Corporation introducer sets
• Cook Incorporated introducer sets

Submission Summary (Full Text)

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sdm

K960917

scientific device manufacturer, inc.

999 Andersen Drive, Suite 110

San Rafael, California 94901

Phone [phone] Fax [phone]

JUL 3 1996

# SUMMARY OF SAFETY AND EFFECTIVENESS

Percutaneous Catheter Introducer. Set

510(k) Premarket Notification

**Trade Name:** SDM Percuglide

**Generic Name:** Percutaneous Catheter Introducer/Set

**Manufacturer:** Scientific Device Manufacturer, LLC
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.

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## 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. Ball
Vice President Regulatory Affairs and Quality Assurance