(160 days)
Not Found
No
The device description focuses on mechanical safety features and material composition, with no mention of AI or ML.
No
The device is an introducer used to facilitate the placement of other medical devices, such as catheters and pacemaker leads, into the venous system. It does not directly treat a medical condition. Its primary function is to minimize needle stick injuries during the introduction process, which is a safety feature, not a therapeutic action.
No
The device is an introducer designed to facilitate the insertion of other devices (like catheters or pacemaker leads) into the venous system and to minimize needle stick injuries. It does not gather information about the patient's health status or diagnose conditions.
No
The device description clearly details physical components made of materials like PTFE, polypropylene, HDPE, polycarbonate, and stainless steel, indicating it is a hardware device.
Based on the provided information, the Enpath Safety Introducer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "introduce catheters, pacemaker leads and similar devices into the venous system." This is a direct intervention on the patient's body for therapeutic or diagnostic purposes (introducing devices), not for examining specimens in vitro (outside the body).
- Device Description: The description details a physical device designed for insertion into the venous system, with features to prevent needle stick injuries. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or any other biological specimen. There are no reagents, assays, or analytical procedures described.
In summary, the Enpath Safety Introducer is a medical device used for accessing the venous system, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
The Enpath Safety Introducer is intended to minimize needle stick injuries when used to introduce catheters, pacemaker leads and similar devices into the venous system
Product codes
74 DYB
Device Description
The Enpath Safety Introducer is designed to minimize needle stick injuries when used to introduce catheters, pacemaker leads and similar devices into the venous system. Sheath needles consisting of a peelable sheath over a needle, or peelable micro-introducers using the Seldinger Technique, are common methods for placing such devices. This Safety Introducer device combines various attributes of both the needle and the micro-introducer with the inclusion of a safety feature. The Safety Introducer allows for a one-step process of accessing the body. The Safety Introducer includes a safety shield which is spring-loaded in position during the ready-to-use state. After gaining vessel access, the needle subassembly is undocked from the introducer sheath and removed, leaving the sheath in the vessel for Removing the introducer sheath during standard practice passively catheter placement. advances (activates) the safety shield that locks in place. The safety shield covers the sharp of the needle bevel to protect patients and healthcare workers from accidental needle sticks.
The sheath body is constructed of PTFE and is filled with bismuth trioxide as a radiopacifier. The sheath handles, made of polypropylene resin, are overmolded onto the PTFE sheath tubing. The dilator is made of HDPE (high density polyethylene) and has a hub made of HDPE resin overmolded onto the dilator shaft. The front bub and the luer components are both molded of Polycarbonate resin. The needle and spring are stainless steel. The swivel luer cap and needle cover are both made of Polypropylene. UV cured adhesive is used during the assembly to hold the needle to the luer. The final assembly is coated with silicone lubricant from the tip of the needle to the handles of the sheath to reduce insertion force.
Sizes of the assembly range from 3.5 FR to 7FR. The needle is 21gauge for all French sizes, and the materials and construction are the same for all French sizes. The Safety Introducer will be packaged and EtO sterilized for one time use in a Tyvek pouch. The packaging configuration may include sterile kit containing a stainless steel guidewire or a bulk, nonsterile configuration.
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
A Risk Analysis for the Safety Introducer was performed per Enpath Medical, Inc internal procedure, WI42020, Hazard Analysis, FMEA and Risk Analysis. This document is modeled closely after European Standard ISO 14971: 2000 Medical Devices - Application of Management to Medical Devices
The performance testing for this device included testing to verify that the device safety function performed effectively. Additional testing verified that the device performed per specification requirements.
Key Metrics
Not Found
Predicate Device(s)
TFX Medical Safety Needle with Introducer, K000665
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
NOV 3 0 2004
IV. 510(k) Summary
Submitter
Enpath Medical Incorporated 15301 Highway 55 West Minneapolis, MN 55447 Main: 763-15301 Fax: 763-559-0148 email: www.enpathmed.com
Date Prepared
June 18, 2004
Trade Name
Enpath Safety Introducer
Common Name
Catheter Introducer
Predicate Device
TFX Medical Safety Needle with Introducer, K000665
Device Description
The Enpath Safety Introducer is designed to minimize needle stick injuries when used to introduce catheters, pacemaker leads and similar devices into the venous system. Sheath needles consisting of a peelable sheath over a needle, or peelable micro-introducers using the Seldinger Technique, are common methods for placing such devices. This Safety Introducer device combines various attributes of both the needle and the micro-introducer with the inclusion of a safety feature. The Safety Introducer allows for a one-step process of accessing the body. The Safety Introducer includes a safety shield which is spring-loaded in position during the ready-to-use state. After gaining vessel access, the needle subassembly is undocked from the introducer sheath and removed, leaving the sheath in the vessel for Removing the introducer sheath during standard practice passively catheter placement. advances (activates) the safety shield that locks in place. The safety shield covers the sharp of the needle bevel to protect patients and healthcare workers from accidental needle sticks.
The sheath body is constructed of PTFE and is filled with bismuth trioxide as a radiopacifier. The sheath handles, made of polypropylene resin, are overmolded onto the PTFE sheath tubing. The dilator is made of HDPE (high density polyethylene) and has a hub made of HDPE resin overmolded onto the dilator shaft. The front bub and the luer components are both molded of Polycarbonate resin. The needle and spring are stainless steel. The swivel luer cap and needle cover are both made of Polypropylene. UV cured adhesive is used during the assembly to hold the needle to the luer. The final assembly is coated with silicone lubricant from the tip of the needle to the handles of the sheath to reduce insertion force.
Sizes of the assembly range from 3.5 FR to 7FR. The needle is 21gauge for all French sizes, and the materials and construction are the same for all French sizes. The Safety Introducer will be packaged and EtO sterilized for one time use in a Tyvek pouch. The packaging configuration may include sterile kit containing a stainless steel guidewire or a bulk, nonsterile configuration.
1
Intended Use
The Enpath Safety Introducer is intended to minimize needle stick injuries when used to introduce catheters, pacemaker leads and similar devices into the venous system
Technological Characteristics
The device is technologically equivalent to other safety needle and introducer products.
Summary of Studies
A Risk Analysis for the Safety Introducer was performed per Enpath Medical, Inc internal procedure, WI42020, Hazard Analysis, FMEA and Risk Analysis. This document is modeled closely after European Standard ISO 14971: 2000 Medical Devices - Application of Management to Medical Devices
The performance testing for this device included testing to verify that the device safety function performed effectively. Additional testing verified that the device performed per specification requirements.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 overlapping, curved shapes, possibly representing human figures or abstract forms. The logo is rendered in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 3 0 2004
Ms. Karyl D. Haskell Quality Assurance and Regulatory Affairs Manager Enpath Medical Incorporated -- Delivery Systems Division 15301 Highway 55 West Minneapolis, MN 55477
Re: K041708 Enpath Safety Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: 74 DYB Dated: October 20, 2004 Received: October 21, 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 I ou may a 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. Karyl D. 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 (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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
puma D. lochner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
V. Indications for Use
Indications for Use
510(k) Number (if known):___Not Assigned Ko41708
Device Name: Enpath Safety Introducer
Indications For Use: The Enpath Safety Introducer is intended to minimize needle stick injuries when used to introduce catheters, pacemaker leads and similar devices into the venous system
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Duna R. La hner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number Ko4) Jo 8