The MicroCruiser® Plus Introducer Set is comprised of an .018" diameter guidewire, a guidewire introducer needle, and a coaxial introducer that has a diameter suitable for catheter introduction and placement. The introducer tubing is made from biocompatible polyurethane that has been used extensively in both short and long term catheters. The introducers are provided in the following French sizes: 3 (Inner)/4 (Outer), 3 (Inner)/5 (Outer), and 4 (Inner)/6 (Outer), and in lengths of 10 cm.

AI/ML Overview

This document is a 510(k) summary for the MicroCruiser® Plus Introducer Set. It outlines the device description, indications for use, and a comparison to a predicate device for substantial equivalence. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, I cannot provide the requested information based on this document. The provided text is a regulatory submission for device clearance, not a study report detailing performance metrics and validation.

Summary

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SEP = 5 2001

600 SW 47th Aven iainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662

510(k) SUMMARY
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APPLICANT:	Medical Device Technologies, Inc.3600 SW 47th AvenueGainesville, FL 32608
CONTACT:	Karl SwartzQuality Assurance Manager
TELEPHONE:	(352)338-0440fax (352)338-0662
TRADE NAMES:	MicroCruiser® Plus Introducer Set
COMMON NAME:	Catheter introducers
CLASSIFICATION NAME:	§870.1340-Introducer, Catheter

SUBSTANTIAL EQUIVALENCE:

Company Name	Product Name	510(k) No.
Cook, Inc.	MicroPuncture	Pre-Amendment

DESCRIPTION OF DEVICE:

INDICATIONS FOR USE:

The MicroCruiser® Plus Introducer Set is intended for use in the introduction and placement of guidewires and/or catheters.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 5 2001

Mr. Karl Swartz Medical Device Technologies, Inc. 3600 SW 47th Avenue Gainesville, FL 32608

Re: K011790

MicroCruiser® Plus Introducer Set Regulation Number: 870.1340 Regulatory Class: II (two) Product Code: DYB Dated: June 7, 2001 Received: June 8. 2001

Dear Mr. Swartz:

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 assumptions. Failure to comply with the GMP regulation may result in 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

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Page 2 - Mr. Karl Swartz

have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

James E. Dillard III

mes E. Dillard Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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3600 SW 47th Avenue iainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: MicroCruiser® Plus Introducer Set

Indications for Use:

The MicroCruiser® Plus Introducer Set is intended for use in the introduction and placement of guidewires and/or catheters..

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

Division of Cardiovascular & Respiratory Devices
510(k) Number K011790

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
✓

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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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).