EZ-INTRO PERCUTANEOUS CATHETER SHEATH, EZ-INTRO VESSEL DILATOR

K983940 · Adam Spence Corp. · DYB · Jul 15, 1999 · Cardiovascular

Device Facts

• Record ID: K983940
• Device Name: EZ-INTRO PERCUTANEOUS CATHETER SHEATH, EZ-INTRO VESSEL DILATOR
• Applicant: Adam Spence Corp.
• Product Code: DYB · Cardiovascular
• Decision Date: Jul 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Adam Spence Percutaneous Catheter Introducer is intended to provide a means for percutaneous vascular access while minimizing the back flow of blood during the introduction of cardiovascular devices such as catheters and guide wires.

Device Story

The Adam Spence Percutaneous Catheter Introducer (PCI) is a disposable, single-use device used during diagnostic angiographic procedures. It provides a percutaneous vascular access point for the introduction of cardiovascular devices, such as catheters and guide wires, while incorporating a mechanism to minimize blood backflow. The device is operated by clinicians in a clinical setting. It is available in sizes ranging from 4 to 9 French. The device is designed to facilitate insertion with lower force requirements compared to the predicate, while maintaining structural integrity and preventing tip peelback or leakage during use.

Clinical Evidence

Bench testing only. Performance testing included evaluation of tensile properties, valve/sheath leakage, insertion/withdrawal force, air aspiration, and tip peelback. The device was tested against ANSI MD70.1-1983 and ISO/DIS 11070.2 standards. Biocompatibility was verified per ISO 10993.

Technological Characteristics

Disposable catheter sheath introducer; sizes 4-9 French; Ethylene Oxide gas sterilization; 3-year shelf life. Complies with ANSI MD70.1-1983 (Luer fittings) and ISO/DIS 11070.2 (sterile, single-use intravascular catheter introducers).

Indications for Use

Indicated for patients undergoing diagnostic angiographic procedures requiring percutaneous vascular access for the introduction of cardiovascular devices such as catheters and guide wires.

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

• Daig Corporation Fast-Cath™ Transseptal Catheter Introducer (K964518)

Submission Summary (Full Text)

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K983940

Image /page/0/Picture/1 description: The image shows a date, "JUL 15 1999". The month is July, the day is the 15th, and the year is 1999. The text is written in a simple, sans-serif font and is easily readable. The date is likely a stamp or a handwritten note.

Adam Spence Corporation

1746 Route 34, P.O. Box 1467, Wall, NJ 07719, [phone], Fax, [phone]

## 510(k) SUMMARY

Trade Name: Adam Spence Corp. Percutaneous Catheter Introducer

Common or usual Name: Catheter Sheath Introducer System

Classification Name: Catheter, Introducer, Class II device (per 21 CFR 870.1340)

Equivalent Device: Daig Corporation Fast-Cath™ Transseptal Catheter Introducer, K964518

Contact Name: Carol Rosenbloom

Description and Intended Use: The Adam Spence Corp. Percutaneous Catheter Introducer (PCI) is a disposable device intended for use in diagnostic angiographic procedures. The Adam Spence Percutaneous Catheter Introducer is intended to provide a means for percutaneous vascular access while minimizing the back flow of blood during the introduction of cardiovascular devices such as catheters and guide wires.

Performance Standards:

- Performance standards have not been established under Section 514 of the Food, . Drug and Cosmetic Act.
- ANSI MD70.1-1983. American National Standard for Medical Material Luer Taper ● Fittings - Dimensional Requirements for Luer Lock Fittings
- ISO/DIS 11070.2: Sterile, Single-Use Intravascular Catheter Introducers, Sections 4. . 7, 9, and 10.

Biocompatibility: All appropriate biocompatibility tests have been performed per ISO 10993, Biological Evaluation of Medical Devices (Per General Program Memorandum #G95-1)

Summary of Substantial Equivalence: The Adam Spence Percutaneous Catheter Introducer has the same intended use as other catheter sheath introducers on the market (ie., Daig Fast-Cath™ Hemostasis Introducer.) Additionally, based on the technological characteristics and performance testing the Adam Spence Percutaneous Catheter Introducer is substantially equivalent in its basic design, construction, material, safety, efficacy and intended use to currently marketed catheter sheath introducer systems.

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| SUMMARY OF TECHNOLOGICAL CHARACTERISTICS | | |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| FEATURE | ADAM SPENCE PCI | PREDICATE DEVICE |
| Manufacturer | Adam Spence Corporation | Daig Corporation |
| Sterile Packaging | Sterile and Bulk Packaged | Sterile Pack |
| Sterilization Method | Ethylene Oxide Gas | Ethylene Oxide Gas |
| Shelf Life | 3 Years | 3 Years |
| Available Sizes | 4 though 9 French size | 4 through 9 French size |
| Tensile properties | Exceeds Requirement | Exceeds Requirement |
| Valve/Sheath Leak | No Leakage | 4 Fr. leaked after dilation |
| Insertion/Withdrawal | Substantially Equivalent to Predicate | Acceptable |
| Air Aspiration | Greatly Exceeded Predicate Device | Acceptable |
| Tip Peelback | No Damage or Peelback:<br>Lower average insertion<br>force required to puncture<br>skin than predicate device. | No Damage or Peelback:<br>Higher average insertion<br>force required to puncture<br>skin than ASC PCI. |

Prepared By: Carole A. Lusinaka Date: 4/20/99

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 15 1999

Ms. Carol Rosenbloom Adam Spence Corporation 1746 Route 34 P.O. Box 1467 Wall, NJ 07719

Re: K983940 EZ-Intro™ Percutaneous Catheter Introducer Regulatory Class: II (two) Product Code: 74 DYB Dated: April 16, 1999 Received: April 21, 1999

Dear Ms. Rosenbloom:

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 to 895. A substantially equivalent determination assumes compliance 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, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, 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.

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Page 2 - Ms. Carol Rosenbloom

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 our 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 Also, please note the regulation entitled, [phone]. "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.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,
Thomas 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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

## STATIENTENT OF INDICATIONS FOR USE

The Adam Spence Percutaneous Catheter Introducer is intended to provide a means for The Flain Spence Porcalise while minimizing the back flow of blood during the introduction of cardiovascular devices such as catheters and guide wires.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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| Division of Cardiovascular, Respiratory, and Neurological Devices | |
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| Over-The-Counter Use | |
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