COAXIAL INTRODUCER SET

K101399 · Martech Medical Products · DYB · Jun 17, 2010 · Cardiovascular

Device Facts

• Record ID: K101399
• Device Name: COAXIAL INTRODUCER SET
• Applicant: Martech Medical Products
• Product Code: DYB · Cardiovascular
• Decision Date: Jun 17, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Coaxial Introducer Set is indicated for percutaneous introduction of up to a 0.038 inch guidewire or catheter into the vascular system following a small 21 gauge needle stick. The Coaxial Introducer Set is not intended for use in the coronary or cerebral vasculature.

Device Story

Coaxial Introducer Set facilitates vascular access by providing a channel for guidewire or catheter placement. Device consists of inner dilator within slightly shorter outer sheath; kit includes 21 gauge introducer needle, .018" guidewire, and 4F or 5F coaxial introducer (standard or stiff versions). Used by clinicians to dilate initial entry point; provides path for larger devices. Operates via mechanical insertion into vascular system. Benefits patient by enabling minimally invasive access to vasculature while minimizing trauma from initial needle stick. Not for coronary or cerebral use.

Clinical Evidence

Bench testing only. In-vitro testing performed per ISO standards and internal procedures, including guidewire passage, air leakage, liquid leakage, force at break, and simulated use. Biocompatibility testing meets ISO 10993 requirements.

Technological Characteristics

Coaxial design with inner dilator and outer sheath. Available in 4F or 5F sizes, standard or stiff configurations. Includes 21 gauge needle and .018" guidewire. Materials meet ISO 10993 biocompatibility standards. Sterilized configuration.

Indications for Use

Indicated for percutaneous introduction of up to 0.038 inch guidewire or catheter into vascular system following 21 gauge needle stick. Contraindicated for use in coronary or cerebral vasculature.

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

• Medcomp, Micro-Stick Set (K091954)

Submission Summary (Full Text)

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K1.01399

JUN 1 7 2010

# 510(k) SUMMARY

#### Submitter Information: A.

Submitter:

Contact:

Date Prepared:

MARTECH MEDICAL PRODUCTS 1500 Delp Drive Harleysville, PA 19438 [phone] Telephone [phone] Fax Susan Pileggi May 17, 2010

Coaxial Introducer Set B. Device Name:

> Common Name: Classification Name: C.F.R. Section: Class:

Introducer Set Catheter Introducer (74 DYB) 880.1340

K091954: Medcomp, Micro-Stick Set Predicate Devices:

II

#### D. Device Description:

C.

The Coaxial Introducer Set is designed to provide dilation of the initial entry point and provide a channel for attaining vascular access. The coaxial introducer consists of an inner dilator within a slightly shorter outer sheath.

The kit contains a 21 gauge introducer needle, a .018" diameter guidewire, and a 4F or 5F coaxial introducer. The coaxial introducer is offered in a standard and stiff version.

The Coaxial Introducer Set is provided in sterile and non-sterile configurations.

#### E. Intended Use:

The Coaxial Introducer Set is indicated for percutaneous introduction of up to a 0.038 inch guidewire or catheter into the vascular system following a small 21 gauge needle stick. The Coaxial Introducer Set is not intended for use in the coronary or cerebral vasculature.

#### F. Comparison to Predicate Devices:

The Coaxial Introducer Set is substantially equivalent to the predicate devices in terms of intended use, anatomical location, general design, and method of sterilization.

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#### G. Bench / Performance Data:

The following in-vitro testing was performed on the Coaxial Introducer Set to assure reliable design and performance in accordance with ISO standards and/or internal procedures.

- Guidewire Passage ●
- . Air Leakage
- � Liquid Leakage
- Force at Break .
- Simulated Use .

#### H. Biocompatibility:

Results for all biocompatibility testing demonstrate the materials used meet the requirements of ISO 10993.

### I. Conclusion:

The proposed devices meet the performance criteria of design verification as specified by ISO standards and test protocols. The proposed device has the same intended use, operation and function as the predicates. There are no differences that raise new issues of safety and effectiveness. The proposed devices are substantially equivalent to the legally marketed predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three thick, curved lines.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 1 7 2010

Martech Medical c/o Ms. Susan Pileggi Regulatory Specialist 1500 Delp Drive Harleysville, PA 19438

Re: K101399

Trade/Device Name: Coaxial Introducer Set Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer Catheter Regulatory Class: Class II (two) Product Code: DYB Dated: May 17, 2010 Received: May 26, 2010

Dear Ms. Pileggi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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### Page 2 - Ms. Susan Pileggi

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutiFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Duna R. Vichner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): Kjol 399

Device Name: Coaxial Introducer Set

Indications for Use:

The Coaxial Introducer Set is indicated for percutaneous introduction of up to a 0.038 inch guidewire or catheter into the vascular system following a small 21 gauge needle stick. The Coaxial Introducer Set is not intended for use in the coronary or cerebral vasculature.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Viclun

(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular Devices

510(k) Number_K10739