The McdAmicus FlowGuard™ Peelable Introducer is a small diameter tubular shaped device with integrated proximal handles. The FlowGuard 100 Peelable Introducer is designed to provide a relatively atraumatic method for implanting catheters and pacemaker leads into the venous system. The FlowGuard™ Peelable Introducer has a "tear-away" feature common to the predicate devices. This feature allows the user to remove the introducer without removing the inserted catheter or pacing lead. The MedAmicus FlowGuard" Peelable Introducer is packaged in three configurations: 1) a convenience kit containing a MedAmicus FlowGuard11M Peelable Introducer, a thin-wall needle, a disposable syringe, and a flexible guidewire, packaged in a tray and a sealed pouch. 2) individually pouched, sterile MedAmicus FlowGuard™ Peelable Introducer and 3) bulk, nonsterile MedAmicus FlowGuard™ Peclable Introducers.

AI/ML Overview

This document describes a 510(k) premarket notification for the MedAmicus FlowGuard™ Peelable Introducer (K040150). This submission is for a material revision to the sheath handle of an already approved device (K030905). Due to the nature of this submission being for a minor change to an existing device, the studies conducted are primarily focused on verifying that the material change does not negatively impact the device's performance or safety.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission mentions "Design Verification of the device has been completed to verify the changes to the device." This implies various internal tests were conducted against pre-defined acceptance criteria. However, the specific quantitative acceptance criteria and the detailed results of these tests are not provided in the given text.

The text states: "Shelf Life testing, using accelerated aging, has been completed to verify that the new material will yield consistent handle integrity." This indicates an acceptance criterion related to handle integrity over time, but the specific metrics are not given.

Acceptance Criteria (Implied)	Reported Device Performance
Consistent handle integrity over shelf life	"Shelf Life testing, using accelerated aging, has been completed to verify that the new material will yield consistent handle integrity."
No adverse impact from new material on device functionality	"Design Verification of the device has been completed to verify the changes to the device."
(Specific performance metrics derived from a Risk Analysis per EN1441:1998)	(Details not provided in the text)

2. Sample Size Used for the Test Set and Data Provenance

The text does not specify the sample sizes used for the design verification or shelf-life testing. The data provenance is internal to MedAmicus, and the nature of the studies (design verification, shelf-life testing) suggests a prospective approach to test the modified device. There is no mention of country of origin for the data beyond the manufacturer's location in Minneapolis, MN, USA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as the studies described are engineering design verification and shelf-life tests, not clinical or diagnostic studies requiring expert-established ground truth. Device performance in these contexts is typically evaluated against engineering specifications and material properties, not subjective expert assessment.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or imaging devices to assess the impact of AI on human reader performance, which is not relevant for a catheter introducer with a material change.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm only) performance study was not done. This device is a physical medical instrument, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth for the design verification and shelf-life testing would be engineering specifications, material properties, and established performance benchmarks for the predicate device. These are objectively measurable criteria, not expert consensus, pathology, or outcomes data, which are typically associated with diagnostic or therapeutic efficacy studies.

8. The Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" as this device is not an AI/ML algorithm requiring training data. The studies performed are for a physical device.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8.

Summary

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

K040150

V. 510(k) Summary

Submitter

MedAmicus, Incorporated 15301 Highway 55 West Minneapolis, MN 55447 Main: 763-15301 763-559-0148 Fax: email: www.medamicus.com

Date Prepared

January 22, 2004

Trade Name MedAmicus FlowGuard™ Peclable Introducer

Common Name

Catheter Introducer

Predicate Device

MedAmicus FlowGuard TM Peelable Introducer 510(k) K030905.

Device Description

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

Confidential

Intended Use

There are no changes to the Intended Use of the device from the currently approved device.

The MedAmics FlowGuard™ Peelable Introducer is indicated for use in the percutaneous insertion of pacing leads or catheters in the venous system.

Technological Characteristics

The material revision to the sheath handle material is technologically equivalent to the currently approved device. The method of use is not revised as a result of the material change.

Summary of Studies

Design Verification of the device has been completed to verify the changes to the device. These validations were completed based on a Risk Analysis per internal procedures that are compliant with European Standard EN1441: 1998 Medical Devices -- Risk Analysis. This Risk Analysis was completed by comparing the risks associated with the new material sheath handle compared to the currently approved device. Shelf Life testing, using accelerated aging, has been completed to verify that the new material will yield consistent handle integrity. The validations are summarized in Section X of this submission.

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

Image /page/2/Picture/2 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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three wavy lines or a caduceus without the snake, representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 2004

MedAmicus Incorporated c/o Ms. Kary Haskell Quality Assurance and Regulatory Affairs Manager 15301 Hwy, 55 West Minneapolis, MN 55447

Re: K040150

MedAmicus FlowGuard Peelable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: January 22, 2004 Received: January 23, 2004

Dear Ms. Haskell:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

Page 2 - Ms. Kary Haskell

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); 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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Name R. Holmes

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

Enclosure

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

Indications for Use

510(k) Number (if known):__K040150

Device Name: __ MedAmicus FlowGuard™ Peelable Introducer

Indications For Use: The MedAmicus FlowGuard Peelable Introducer in indicated for indications i or ooc. This modifines pacing leads or catheters in the venous system.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dung R. Voelker

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

/ision Sign-Off) ്. Jision of Cardiovascular Devices

510(k) Number ŁO4 D150 _______________________________________________________________________________________________________________________________________________________

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).