EMCEE INTRODUCER SHEATH, DILATOR, OBTURATOR, INTRODUCER SET

K980504 · Schneider/Namic · DYB · Aug 7, 1998 · Cardiovascular

Device Facts

• Record ID: K980504
• Device Name: EMCEE INTRODUCER SHEATH, DILATOR, OBTURATOR, INTRODUCER SET
• Applicant: Schneider/Namic
• Product Code: DYB · Cardiovascular
• Decision Date: Aug 7, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Emcee™ Introducer Set is intended for use in facilitating the percutaneous introduction of catheters, interventional devices, and temporary pacing leads into the vasculature (including the radial artery).

Device Story

Emcee Introducer Set facilitates percutaneous vascular access for catheters, interventional devices, and temporary pacing leads. System components include percutaneous introducer sheath with hemostatic gasket, sideport extension with stopcock, dilator, and optional guidewire/obturator. Physician inserts guidewire into vessel; sheath/dilator assembly backloaded over guidewire; dilator supports sheath entry; dilator removed once sheath positioned. Obturator supports sheath tubing while in vivo. Lubricious coating applied to components for smooth insertion/removal. Used in clinical settings by physicians for vascular access procedures. Output is established vascular access path for subsequent interventional device delivery. Benefits include simplified, controlled access to vasculature, including radial artery.

Clinical Evidence

Bench testing only. Biocompatibility testing conducted in accordance with ISO 10993-1 (1992)E. No clinical data presented.

Technological Characteristics

Components include plastic sheath, dilator, and obturator with lubricious coating. Features insert-molded hemostatic hub, cap, and sideport with stopcock. Dilators accommodate guidewire diameters .018", .025", .032", .035", and .038". Biocompatible materials per ISO 10993-1. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients requiring percutaneous vascular access for catheters, interventional devices, or temporary pacing leads, including radial artery access.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• MORSE® Hemostatic Catheter Introducer Set (K915078)
• Epic™ Introducer Sheath (K960310)
• Cook CHECK-FLO® Performer™ Introducer (K895044)
• Arrow Radial Artery Catheterization Set (K810675)
• Cordis Avanti™ Transradial Sheath Kit (K962746)

Submission Summary (Full Text)

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AUG - 7 1998

K980504

# IX. 510(K) SUMMARY

| Manufacturer: | SCHNEIDER/NAMIC<br>Glens Falls, New York 12801 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Karin L. Smith<br>Regulatory Affairs Specialist |
| | Telephone Number: [phone]<br>Facsimile Number: [phone] |
| Date Prepared: | May 22, 1998 |
| Trade Name: | Emcee Introducer Set |
| Common Name: | Catheter Introducer |
| Classification Name: | Introducer, Catheter |
| Predicate Devices: | MORSE® Hemostatic Catheter Introducer Set (K915078)<br>Epic™ Introducer Sheath (K960310)<br>Cook CHECK-FLO® Performer™ Introducer (K895044)<br>Arrow Radial Artery Catheterization Set (K810675)<br>Cordis Avanti™ Transradial Sheath Kit (K962746) |

#### Product Description:

The Emcee™ Introducer Set is comprised of a percutaneous introducer sheath and dilator. The set may also contain a guidewire and/or an obturator.

The Emcee™ Introducer Sheath is comprised of an insert molded hemostatic sheath hub and cap design which encapsulates a hemostatic gasket system. The hub also incorporates a sideport extension line with an attached stopcock. The tubing portion of the sheath is percutaneously introduced into the patient's vasculature. The sideport extension is used for purposes of blood access maintenance and fluid administration.

Subsequent to the physician gaining access to the patient's vasculature, a guidewire is inserted into the blood vessel. The Sheath/Dilator combination may be backloaded over the Guidewire to direct the device into the lumen of the vessel. Once the Sheath/Dilator assembly is in place, the dilator and Mini Guidewire (if used) are removed.

Emcee™ Introducer Set

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## IX. 510(K) Summary (Continued)

The Emcee™ Dilator is a tapered plastic tube with an integral luer hub which is inserted into the Emcee™ Introducer Sheath. The Dilator is longer than the Sheath and with its tapered distal tip, serves to facilitate and support the entry of the Sheath into the patient's vasculature. Once the Emcee™ Introducer Sheath is in place, the Dilator is removed. The Emcee™ Introducer Set will be offered with dilators to accommodate the following guidewire diameters: .018", .025", .032", .035", and .038". Other sizes of dilators will also be provided to address physician preferences.

The Emcee™ Obturator is a plastic tube with an integral luer hub which is inserted into the Emcee™ Introducer Sheath. The Obturator is approximately the same length as the Sheath and is intended to support the tubing portion of the Sheath while the device remains In Vivo.

Components of the Emcee™ Introducer Set have a lubricious coating for a smooth entrance and removal from the vasculature.

#### Intended Use:

The Emcee™ Introducer Set is intended for use in facilitating the percutaneous introduction of catheters, interventional devices and temporary pacing leads into the vasculature. Included in this indication are procedures using the radial artery as an access site.

### Comparison to Predicate Device:

The Emcee™ Introducer Set design and indications are substantially equivalent to the predicate devices. The manufacturing process, packaging, and sterilization for the Emcee™ Introducer Set mirrors that of SCHNEIDER/NAMIC's currently marketed device.

#### Performance Testing:

The new Emcee™ Introducer Set has been subjected to non-clinical performance testing to provide data supporting its safety and effectiveness for its intended uses.

### Biocompatibility:

Emcee™ Introducer Sets were subjected to biocompatibility testing having its basis in International Standards Organization (ISO) 10993-1 (1992)E "Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests". The Emcee™ Introducer Set is considered to be biocompatible.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized representation of a human figure in profile, composed of three overlapping silhouettes. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG - 7 1998

Ms. Karin L. Smith Regulatory Affairs Specialist Schneider/Namic Pruyn's Island Glens Falls, NY 12801

Re: K980504 Emcee Introducer Set Trade Name: Requlatory Class: II Product Code: DYB May 22, 1998 Dated: Received: May 26, 1998

Ms. Smith: Dear

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800

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#### Page 2 - Ms. Karin L. Smith

A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Tinas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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II. Premarket Notification Required Information (Continued)

INDICATIONS FOR USE

Page 1 of 1

510(k) Number K980504

Device Name: Emcee™ Introducer Set

Indications For Use:

17-2-242-2019-03-20

Intended for use in facilitating the percutaneous introduction of catheters, interventional devices, and temporary pacing leads into the vasculature (including the radial artery).

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluations (ODE)

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Division of Cardiovascular, Respiratory,

Division of Cardiovas and Neurological Dev 510(k) Num

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use_