A.B. KORKOR MEDICAL SKINNYSAFE INTRODUCER SHEATH

K092097 · A.B. Korkor Medical, Inc. · DYB · May 6, 2010 · Cardiovascular

Device Facts

• Record ID: K092097
• Device Name: A.B. KORKOR MEDICAL SKINNYSAFE INTRODUCER SHEATH
• Applicant: A.B. Korkor Medical, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: May 6, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The AngioXpand Introducer Catheter is intended to facilitate placement of other devices such as guidewires or catheters through the skin into the vascular system.

Device Story

The AngioXpand Introducer Catheter is a disposable device consisting of a needle and catheter. It is used by clinicians to facilitate vascular access. The device utilizes a catheter-over-needle design. During cannulation, the system allows the use of a smaller initial needle size than the final catheter size; an appropriately sized guidewire or dilator is used to expand the introducer's tip, enabling the passage of the desired catheter or guidewire into the blood vessel. This mechanism reduces the range of needle sizes required for patient cannulation, potentially minimizing trauma associated with larger gauge introducers.

Clinical Evidence

Bench testing only. Data provided demonstrates that product performance and safety are substantially equivalent to current legally marketed devices.

Technological Characteristics

Disposable catheter-over-needle system. Components include a needle and catheter. Operates via mechanical expansion of the introducer tip using a guidewire or dilator. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients requiring vascular access to facilitate the placement of guidewires or catheters through the skin into the vascular system.

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

• BD Introsyte Precision Introducer Catheter (K020834)

Submission Summary (Full Text)

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#### 510(k) Summary

A.B. Korkor Medical, Inc. AngioXpand Introducer Catheter

This 510(k) summary of the safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92

| The assigned 510(k) number is: | K092097 |
|--------------------------------|-----------------------------------------------------------------------------------------|
| Contact Person: | Andy Black<br>Medical Murray, Inc.<br>400 North Rand Road<br>North Barrington, IL 60010 |
| | MAY - 6 2010 |
| Telephone: | [phone] |
| Fax: | [phone] |
| Date Prepared: | April 9, 2010 |

Device Name and Classification

| Classification Name: | Introducer, Catheter |
|------------------------|--------------------------------|
| Common/Usual Name: | Introducer Catheter |
| Proprietary Name: | AngioXpand Introducer Catheter |
| Device Classification: | Class II |
| Regulation Number | 21 CFR Ref. § 870.1340 |

#### Device Description

Panel:

Product Code:

: _ _;

The AngioXpand Introducer Catheter is a medical device composed of a disposable needle and catheter. The device is equivalent in intended use to current legally marketed introducer catheter devices, and utilizes the same catheter-over-needle form as other legally marketed devices.

DYB

Cardiovascular

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The AngioXpand Introducer Catheter decreases the range of introducing needle sizes required during patient cannulation. The system is expected to provide a patient the benefit realized by decreasing the size of the introducing needle required of larger gauge introducers.

An appropriate sized guidewire or dilator becomes the means of expanding the introducer's tip, allowing passage of a catheter or guidewire into the blood vessel. This action permits the initial size of the needle to be smaller than the desired placed catheter size.

## Substantial Equivalence Claim

Based on comparison of device features, materials, intended use and performance, the A.B. Korkor Medical, Inc. AngioXpand Introducer Catheter is shown to be substantially equivalent to the commercially available predicate device BD Introsyte Precision Introducer Catheter approved by the FDA under 510k number K020834.

## Indications for Use

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The AngioXpand Introducer Catheter is intended to facilitate placement of other devices such as guidewires or catheters through the skin into the vascular system.

#### Summary of Testing

The AngioXpand Introducer Catheter has been tested in accordance with applicable standards.

Data has been provided to demonstrate that product performance and safety are substantially equivalent to current legally marketed devices.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling the perimeter, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. In the center of the seal is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

MAY - 6 2010

A. B. Korkor Medical, Inc c/o Mr. Mark Job 1394 25th St. NW Buffalo, MN 55313

Re: K092097

Trade/Device Name: AngioXpand® Introducer Catheter Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: April 9, 2010 Received: April 12, 2010

Dear Mr. Job:

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 individe 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. However, we remind you that device labeling must be truthful and not misleding,

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.

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 modical

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Page 2 - Mr. Mark Job

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/AboutFDA/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,

WMS

Bram 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: _______________________________________________________________________________________________________________________________________________________________

Device Name: A.B. Korkor Medical AngioXpand Introducer Catheter

Indications for Use:

The AngioXpand Introducer Catheter is intended to facilitate placement of other devices such as guidewires or catheters through the skin into the vascular system.

| Prescription Use _X_ | AND/OR | Over The-Counter Use_ |
|--------------------------------------------------------------------------|---------|------------------------|
| (Part 21 CFR 801 Subpart D) | | (21 CFR 801 Subpart C) |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | | |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
| (Division Sign-Off) | | |
| Division of Cardiovascular Devices | | |
| 510(k) Number | K092097 | |