(26 days)
Not Found
No
The document describes a mechanical introducer device and does not mention any AI or ML components or functionalities.
No
The device is an introducer for implanting catheters and pacemaker leads, not a therapeutic device itself.
No
Explanation: The device is described as an introducer for implanting catheters and pacemaker leads, which are interventional procedures, not diagnostic ones. Its purpose is to facilitate the placement of other medical devices, not to diagnose a condition.
No
The device description clearly describes a physical, tubular-shaped device with integrated handles and a "tear-away" feature, which are hardware components. The summary also mentions packaging configurations that include physical items like needles, syringes, and guidewires.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for "implanting catheters and pacemaker leads into the venous system." This is an in vivo procedure, meaning it is performed within a living organism.
- Device Description: The description details a physical device used to facilitate the insertion of other medical devices into the body. This aligns with an in vivo application.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with or implant devices into the body.
N/A
Intended Use / Indications for Use
The MedAmicus FlowGuard™ Peelable Introducer is indicated for use in the percutaneous insertion of pacing leads or catheters in the venous system.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
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.
6
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 _______________________________________________________________________________________________________________________________________________________