The Micro-Stick® 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 Micro-Stick® Set is not intended for use in the coronary or cerebral vasculature.

Device Description

The Micro-Stick® 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 Micro-Stick® Set is packaged sterile.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study proving the device meets them:

No AI/ML device is described in the provided text. The document describes a medical device called the "Micro-Stick® Set," which is an introducer set used for vascular access. The testing performed is in-vitro bench testing to ensure reliable design and performance, not clinical studies involving human readers or AI algorithms.

Therefore, many of the requested sections related to AI/ML device studies (sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this document.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes in-vitro bench testing for the Micro-Stick® Set. It states that the device was tested "to assure reliable design and performance in accordance with ISO standards and/or internal procedures." However, specific numerical acceptance criteria or detailed performance results (e.g., exact force at break in Newtons, precise leakage rates) are not provided in this summary. It only lists the types of tests performed and a general conclusion of conformance.

Acceptance Criterion (Type of Test)	Reported Device Performance
Guidewire Passage	Met requirements (implied)
Air Leakage	Met requirements (implied)
Liquid Leakage	Met requirements (implied)
Force at Break	Met requirements (implied)
Simulated Use	Met requirements (implied)
Biocompatibility (ISO 10993)	Met requirements

Note: The specific numerical or descriptive acceptance levels for these tests are not detailed in the summary. The summary only confirms that the "devices meet the performance criteria of design verification as specified by ISO standards and test protocols."

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in the document. The testing was in-vitro bench testing, so there isn't a "test set" in the context of patient data.
Data Provenance: The testing was "in-vitro" and conducted as "bench performance data." This implies laboratory testing of the physical device components, not involving patient data from a specific country or retrospective/prospective collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not an AI/ML device, and the testing was in-vitro bench testing. No human experts were used to establish ground truth for this type of performance evaluation.

4. Adjudication method for the test set

Not applicable. This is not an AI/ML device, and no human readers/experts were involved in assessing the 'ground truth' of the in-vitro performance.

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

Not applicable. This document does not describe an AI/ML device, nor does it conduct MRMC studies.

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

Not applicable. This document does not describe an AI/ML algorithm.

7. The type of ground truth used

The "ground truth" for the in-vitro tests would be the established ISO standards and internal procedures/specifications for physical device performance (e.g., a specific leakage rate is acceptable, a certain force is required for breakage, a guidewire must pass smoothly). These are engineering and material science metrics, not clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This document does not describe an AI/ML device, and therefore there is no training set mentioned.

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

Not applicable. There is no training set for an AI/ML device described here.

Summary

{0}------------------------------------------------

510(k) SUMMARY

19195

A. Submitter Information:

Submitter:	MEDCOMP®1499 Delp DriveHarleysville, PA-19438-
	JAN - 8 2010
	(215) 256-4201 Telephone
	(215) 256-9191 Fax
Contact:	Susan Pileggi
Date Prepared:	June 26, 2009

B. Device Name: Micro-Stick® Set

Common Name:	Introducer Set
Classification Name:	Catheter Introducer (74 DYB)
C.F.R. Section:	880.1340
Class:	II

C. Predicate Devices:

	K071574: Enpath Medical Inc, Stiffer CoaxialMicro-Introducer Set
	K990705: MedAmicus Inc, MedAmicus CoaxialIntroducer

D. Device Description:

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 Micro-Stick® Set is packaged sterile.

E. Intended Use:

Page 1 of 2 Medcomp Micro-Stick® Set Summary

{1}------------------------------------------------

r. Comparison to Predicate Devices:

The Micro-Stick® Set is substantially equivalent to the predicate devices in terms of intended use, anatomical location, general design, and method of sterilization.

Bench / Performance Data: G.

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

Guidewire Passage .
Air Leakage o
Liquid Leakage o
Force at Break o
o Simulated Use

H. Biocompatibility:

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

Conclusion: l.

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.

Medcomp Micro-Stick® Set Summary

Page 2 of 2

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a symbol. The symbol is a stylized representation of a human figure embracing a three-lined sphere, which is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.

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

MedComp c/o Ms. Susan Pileggi 1499 Delp Drive Harleysville, PA 19438

JAN - 8 2010

Re: K091954

Micro-Stick Set Regulation Number: 21 CFR 880.1340 Regulation Name: Introducer Catheter Regulatory Class: Class H Product Code: DYB Dated: November 24, 2009 Received: November 24, 2009

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 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/tray] 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 (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.

{3}------------------------------------------------

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/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,

R. h. hmer

Bram D. Zuckerman, M.D. Director

Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K091954

Device Name: Micro-Stick® Set

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dma D. V. Lussa

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K091954

4-1

Page 1 of 1

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).