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 Description

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.

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.

AI/ML Overview

The provided text describes the AngioXpand Introducer Catheter and its substantial equivalence claim to a predicate device but does not contain information about specific acceptance criteria, study details, or performance metrics beyond a general statement of equivalency. Therefore, much of the requested information cannot be extracted directly from the provided text.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified in the document. The document states that the device has been "tested in accordance with applicable standards" and "Data has been provided to demonstrate that product performance and safety are substantially equivalent to current legally marketed devices."	The device performance is deemed "substantially equivalent" to the predicate device, the BD Introsyte Precision Introducer Catheter (K020834), based on comparison of device features, materials, intended use, and performance. No specific performance metrics are provided.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only broadly mentions "testing" and "data provided."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This type of information is usually relevant for studies involving human interpretation or clinical endpoints, which are not detailed here. The study focuses on material properties, design, and intended use as compared to a predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not specified. The document does not describe a process involving expert adjudication for a test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not a study involving AI or human reader interpretation. The device is a physical introducer catheter.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is not an algorithm or AI-based device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not explicitly stated for specific performance criteria. The "ground truth" for demonstrating substantial equivalence appears to be based on established performance characteristics and safety profiles of the predicate device and relevant industry standards for introducer catheters.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary of Study (Based on available information):

The provided text indicates that A.B. Korkor Medical, Inc. conducted a study to demonstrate the substantial equivalence of the AngioXpand Introducer Catheter to a legally marketed predicate device, the BD Introsyte Precision Introducer Catheter (K020834). This study involved a comparison of device features, materials, intended use, and performance. While specific test results or quantitative performance metrics are not detailed, the FDA's 510(k) clearance (K092097) confirms that the device was deemed substantially equivalent for its stated indications for use. The nature of the device (an introducer catheter) suggests that the "testing in accordance with applicable standards" likely included mechanical, material, and biocompatibility testing to ensure safety and functionality comparable to the predicate device. However, the document does not provide the specifics of these tests or their results.

Summary

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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 BlackMedical Murray, Inc.400 North Rand RoadNorth Barrington, IL 60010
	MAY - 6 2010
Telephone:	(847) 620-7990
Fax:	(847) 620-7995
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:

: _ _;

DYB

Cardiovascular

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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

-- j

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 (800) 638-2041 or (301) 796-7100 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

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).