(17 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a vascular introducer sheath, with no mention of AI or ML.
No
The device facilitates the entry of other devices, but it does not directly treat a disease or condition itself.
No
The device is described as an introducer sheath designed to facilitate the entry of interventional devices, and it does not mention any function related to diagnosing diseases or conditions.
No
The device description clearly states it is comprised of physical components (introducer, introducer sheath, head assembly, side port extension) and performance studies focus on physical properties (bond tensile strength, kink resistance, flow rate), indicating it is a hardware device.
Based on the provided information, the Edwards Introducer Sheath is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "facilitate the entry of interventional devices into the human vascular system." This describes a device used in vivo (within the body) for a procedural purpose, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a physical device designed to be inserted into blood vessels. It focuses on mechanical components like sheaths, introducers, valves, and ports for introducing other devices and fluids. This is consistent with an interventional medical device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), reagents, assays, or any other elements typically associated with in vitro diagnostic testing.
Therefore, the Edwards Introducer Sheath is an interventional medical device, not an IVD.
N/A
Intended Use / Indications for Use
The subject device is designed to facilitate the entry of interventional devices into the human vascular system.
The Edwards Introducer Sheath is designed to facilitate the entry of interventional devices into the human vascular system.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The subject device is comprised of an introducer and introducer sheath. The introducer has a tapered soft/flexible tip and is inserted into the introducer sheath, then inserted into the vessel over a guidewire as an assembly. At the proximal end of the sheath the body tubing is connected to a head assembly. The head assembly consists of a housing that contains three hemostasis valves to minimize blood loss. A side port extension with a three-way stopcock allows for the introduction of anticoagulant, as needed. Once the Introducer/Sheath Assembly has been placed within the vessel, the introducer is removed and the sheath is left in place. The sheath provides and maintains a pathway for the introduction of interventional devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human vascular 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)
In vitro performance testing and biocompatibility evaluations were conducted on the subject device as part of an endovascular graft delivery system. Tests specific to the subject device include bond tensile strength. free passage of a guidewire, kink resistance of both the introducer and the sheath, and the flow rate. All testing demonstrated that the subject device met its acceptance criteria.
The subject device is used as part of a system for the deployment of endovascular grafts. The systems are CE marked and commercially available in the European Union. To date, subject devices have been used successfully with few complaints reported.
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
510(k) Summary
A. Submitter Information
Daun Putnam, Regulatory Specialist Edwards Lifesciences One Edwards Way Irvine, CA 92614-5686 Phone Number: (949) 250-2217 Fax Number: (949) 250-3579 Email address: daun putnam(@edwards.com
B. Device Information
-
- Trade Name:
Edwards Introducer Sheath
- Trade Name:
-
- Common or Usual Name:
Catheter Introducer
- Common or Usual Name:
-
- Device Classification and Classification Name:
Class II (DYB, 21 CFR 870.1340 Catheter introducer)
- Device Classification and Classification Name:
-
Predicate Device Identification: 4. Cook® Extra Large Check-Flo® Introducer (K902469) Guidant Ancure® Sheath (K003889)
-
- Device Description:
The subject device is comprised of an introducer and introducer sheath. The introducer has a tapered soft/flexible tip and is inserted into the introducer sheath, then inserted into the vessel over a guidewire as an assembly. At the proximal end of the sheath the body tubing is connected to a head assembly. The head assembly consists of a housing that contains three hemostasis valves
1
to minimize blood loss. A side port extension with a three-way stopcock allows for the introduction of anticoagulant, as needed. Once the Introducer/Sheath Assembly has been placed within the vessel, the introducer is removed and the sheath is left in place. The sheath provides and maintains a pathway for the introduction of interventional devices.
-
- Intended Use:
The subject device is designed to facilitate the entry of interventional devices into the human vascular system.
- Intended Use:
-
- Technological Comparison of Subject Device to Predicate Device:
The physical characteristics, the intended use and the mode of use of the subject device are similar to the predicate devices.
- Technological Comparison of Subject Device to Predicate Device:
-
- Summary of Non-Clinical Tests and Conclusions:
In vitro performance testing and biocompatibility evaluations were conducted on the subject device as part of an endovascular graft delivery system. Tests specific to the subject device include bond tensile strength. free passage of a guidewire, kink resistance of both the introducer and the sheath, and the flow rate. All testing demonstrated that the subject device met its acceptance criteria.
- Summary of Non-Clinical Tests and Conclusions:
-
- Summary of Clinical Tests and Conclusions:
The subject device is used as part of a system for the deployment of endovascular grafts. The systems are CE marked and commercially available in the European Union. To date, subject devices have been used successfully with few complaints reported.
- Summary of Clinical Tests and Conclusions:
2
April 2003 Page 32
10 3
C. Submitter's Signature and Date of Summary Preparation
Darun S. Peterson
Daun Putnam
Regulatory Specialist
x//
Date
్రా
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.
Public Health Service
APR 2 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Edward Lifesciences, LLC Mr. Daun Putman Regulatory Specialist One Edward Way Irvine, CA 92614-5686
Re: K031087
Trade/Device Name: Edward Introducer Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer. Regulatory Class: Class II Product Code: DYB Dated: April 4, 2003 Received: April 10, 2003
Dear Mr. Putman:
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
4
Page 2 - Mr. Daun Putman
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. 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,
Deiter
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Notification Edwards Lifesciences
Indications for Use
510(k) Notification for the Edwards Introducer Sheath Reference:
The Edwards Introducer Sheath is designed to facilitate the entry of interventional devices into the human vascular system.
Prescription Use Only
Da Cei Tel
510(k) Number K031087