(27 days)
Not Found
No
The summary describes a mechanical device for vascular access and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is used to introduce a guide wire or catheter into the vascular system, which is an interventional or procedural function, not a therapeutic one. It facilitates a medical procedure rather than directly treating a disease or condition.
No
This device is designed to introduce guide wires or catheters into the vascular system, which is an interventional or access function, not a diagnostic one. It does not mention any diagnostic capabilities such as imaging or measurement for disease detection.
No
The device description clearly outlines physical components like needles, guidewires, dilators, and sheaths, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to introduce a guide wire or catheter into the vascular system. This is a procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The components are needles, guidewires, dilators, and sheaths. These are all instruments used for accessing and navigating within the vascular system. They are not reagents, analyzers, or other components typically associated with in vitro diagnostic testing.
- No mention of testing biological samples: The description focuses on the physical introduction of devices into the body, not on analyzing blood, urine, tissue, or other biological samples.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical/interventional tool used directly on the patient.
N/A
Intended Use / Indications for Use
The Stiffer Coaxial Micro-Introducer Kit is indicated for use to introduce up to a 0.038 inch guide wire or catheter into the vascular systems following a small 21 gauge needle stick.
Product codes
DYB
Device Description
The Coaxial Micro-Introducer Kit contains a 21 gauge disposable aspiration and injection needle, a 0.018 inch diameter guidewire, and a coaxial micro-introducer set consisting of a dilator and sheath available in 4F, 4.5F, or 5F.
The modified device contains the same kit configuration as above except that the dilator and sheath are available in 4F or 5F. The inner dilator includes a stainless steel stiffening hypotube. The inner and outer dimensions of the dilator remain the same as the currently marketed Coaxial Micro-Introducer Kit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular systems
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)
Performance Testing: The performance testing for this device included testing to verify that the device functions in a safe and effective manner. The performance testing included the device specifications, functional and dimensional testing of the Stiffer Coaxial Introducer and other testing as applicable to the device. Test results verify that the device performs per specification requirements and is equivalent to the predicate device without creating additional risk to the patient or user.
Biocompatibility Testing: The material in the components used to create the Stiffer Coaxial Micro-Introducer Kit has been demonstrated to be biocompatible through biocompatibility testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUL - 5 2007
510(K) Summary
510(k) Number: K071574
Date Prepared
June 7, 2007
Submitter Information
Submitter's Name/ Address:
Enpath Medical, Inc. 2300 Berkshire Lane North Minneapolis, MN 55441
Establishment Registration: 2183787
Contact Person:
Patrice Stromberg Principal Regulatory Affairs Specialist (763) 951-8181 phone (763) 559-0148 fax pstromberg@enpathmed.com
Device Information
Trade Name: Classification Name: Product Code: Regulation: Panel:
Stiffer Coaxial Micro-Introducer Set Introducer, Catheter DYB Class II, 21 CFR 870.1340 Cardiovascular
Performance Standards
No performance standards applicable tot his product have been developed under Section 514 of the Act.
Predicate Device
Enpath Medical, Inc. Coaxial Micro-Introducer Set (K990705)
.
1
Device Description
The Coaxial Micro-Introducer Kit contains a 21 gauge disposable aspiration and injection needle, a 0.018 inch diameter guidewire, and a coaxial micro-introducer set consisting of a dilator and sheath available in 4F, 4.5F, or 5F.
The modified device contains the same kit configuration as above except that the dilator and sheath are available in 4F or 5F. The inner dilator includes a stainless steel stiffening hypotube. The inner and outer dimensions of the dilator remain the same as the currently marketed Coaxial Micro-Introducer Kit.
Indications for Use
The Stiffer Coaxial Micro-Introducer Kit is indicated for use to introduce up to a 0.038 inch guide wire or catheter into the vascular systems following a small 21 gauge needle stick.
Summary of Non-Clinical Testing
Performance Testing: The performance testing for this device included testing to verify that the device functions in a safe and effective manner. The performance testing included the device specifications, functional and dimensional testing of the Stiffer Coaxial Introducer and other testing as applicable to the device. Test results verify that the device performs per specification requirements and is equivalent to the predicate device without creating additional risk to the patient or user.
Biocompatibility Testing: The material in the components used to create the Stiffer Coaxial Micro-Introducer Kit has been demonstrated to be biocompatible through biocompatibility testing.
Summary of Clinical Testing
No clinical evaluations of this product have been performed.
Statement of Equivalence
Through the data and information presented, Enpath Medical, Inc. considers the Stiffer Coaxial Micro-Introducer Kit to be substantially equivalent to the currently marketed Enpath Medical Inc.'s Coaxial Micro-Introducer Kit based on a comparison of the indications for use and the technological characteristics of the kit components. The testing performed confirms that the Stiffer Coaxial Micro-Introducer Kit will perform as intended.
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 stylized eagle or bird symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 5 2007
Enpath Medical, Inc. c/o Ms. Patrice Stromberg Principal Regulatory Affairs Specialist 2300 Berkshire Lane North Minneapolis, MN 55441
Re: K071574
Stiffer Coaxial Micro-Introducer Set Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer Catheter Regulatory Class: II (two) Product Code: DYB Dated: June 7, 2007 Received: June 8, 2007
Dear Ms. Stromberg:
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. Patrice Stromberg
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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M. S. Hillehem
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 Statement
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Stiffer Coaxial Micro-Introducer Kit
Indications for Use:
+0 The Stiffer Coaxial Micro-Introducer Kit is indicated for use to introduce up a 0.038 inch guide wire or catheter into the vascular systems following a small 21 gauge needle stick.
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 IF NEEDED)
.g. Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number: K071574