The MedAnicus FlowGuard™ Peelable Introducer is a small diameter tubular shaped device with integrated proximal handles. The FlowGuard™ 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 "teat-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 FlowGuard 100 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™ Peelable Introducers.

AI/ML Overview

This document describes the MedAmicus FlowGuard™ Peelable Introducer, a medical device used for the percutaneous insertion of pacing leads or catheters into the venous system. The submission is a 510(k) premarket notification for a modified packaging configuration of an already approved device.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety & Effectiveness not affected by new packaging configurations	A packaging validation will be completed to ensure this. This validation is summarized in Section X of the submission and is based on a Risk Analysis per EN1441:1998.

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

The document does not specify a separate "test set" in the context of clinical performance evaluation for the device itself. The primary study mentioned is a "packaging validation."

Sample Size: Not explicitly stated for the packaging validation.
Data Provenance: The study is described as an internal packaging validation based on a risk analysis. No country of origin for data is mentioned, nor is it specified if it's retrospective or prospective, though a validation is typically prospective for new configurations.

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

Not applicable. The study described is a packaging validation and risk analysis, not a clinical study involving experts establishing ground truth for device performance in patients.

4. Adjudication Method for the Test Set

Not applicable, as there is no clinical test set requiring adjudication mentioned in the provided text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study was not done. The document focuses on a packaging change and its validation, not a multi-reader evaluation of clinical performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical medical introducer, not an algorithm or AI system.

7. Type of Ground Truth Used

For the packaging validation, the "ground truth" would be the established safety and effectiveness parameters of the original device, against which the new packaging's impact is assessed through risk analysis and testing (e.g., sterility, package integrity, material compatibility).

8. Sample Size for the Training Set

Not applicable. This submission is for a physical medical device, not an AI or machine learning algorithm that requires a "training set."

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

Not applicable, as there is no training set for an algorithm.

Summary of the Study Discussed:

The primary "study" mentioned is a packaging validation. The purpose of this validation is to ensure that changing the device's packaging configurations (individually pouched and bulk non-sterile, in addition to the original convenience kit) does not negatively affect the safety and effectiveness of the MedAmicus FlowGuard™ Peelable Introducer.

Methodology: The validation will be completed based on a Risk Analysis, following internal procedures compliant with European Standard EN1441:1998 Medical Devices - Risk Analysis. This risk analysis involved comparing the risks associated with the new packaging configurations against the currently approved convenience kit packaging.
Outcome: The document states that the packaging validation will be completed and summarized in Section X of the submission, confirming that "no effect on the safety and effectiveness of the device" is expected.

The FDA's letter (K030905) indicates that the device was found to be substantially equivalent to legally marketed predicate devices. This determination was based on the information provided, including the intention to complete the packaging validation as described.

Summary

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MedAmicus, Inc.

Confidential

510(k) Summary V.

Submitter

APR - 9 2003

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

Date Prepared

March 20, 2003

Trade Name MedAmicus FlowGuard™ Peelable Introducer

Common Name

Catheter Introducer

Predicate Device MedAmicus Valved Peelable Introducer K021004

Device Description

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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 modified packaging of this device is technologically equivalent to the currently approved device.

Summary of Studies

Design Verification of the device is not required as there are no design modifications to the device. A packaging validation will be completed for the individually pouched, sterile introducers to ensure that there is no effect on the safety and effectiveness of the device. This validation will be 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 packaging configurations with the currently approved convenience kit packaging. This validation is summarized in Section X of this submission.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three abstract human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 9 2003

Mr. Karyl Haskell Quality Assuarance and Regulatory Affairs Manager MedAmicus, Incorporated 15301 Highway 55 West Minneapolis, MN 55447

K030905 Re:

Trade/Device Name: MedAmicus FlowGuard™ Peelable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer. Regulatory Class: Class II Product Code: DYB Dated: March 21, 2003 Received: March 24, 2003

Dear Mr. 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.

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

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Page 2 - Mr. Karyl Haskell

forth in the quality systems (OS) 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. 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 Part 807.97) you may obtain. 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,

KOBATU

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

Enclosure

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MedAmicus, Inc.

Confidential

Indications for Use VI.

510(k) Number (if known): Not Assigned

Device Name: MedAmicus FlowGuard™ Peelable Introducer

Indications for Use: The MedAmicus FlowGuard™ Peelable Introducer indicated for use in the percutaneous insertion of pacing leads or catheters in the venous system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X OR Over-The-Counter Use
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K030965

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).