(275 days)
Not Found
No
The device description and performance studies focus on the physical properties and functional performance of a standard catheter introducer sheath, with no mention of AI or ML.
No
The device is an introducer sheath, which facilitates the insertion of other catheters into the venous system. It does not perform a therapeutic function on its own; rather, it is an access tool.
No
The device, a Catheter Introducer Sheath, is described for facilitating access to the venous system or catheter insertion, which are procedural functions rather than diagnostic ones. It does not mention any role in identifying or characterizing diseases or conditions.
No
The device description explicitly states it is made of "flexible and non-flexible polymeric materials" and consists of a "single lumen shaft and a hemostasis valve with a side-arm extension tube," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for accessing the venous system and facilitating catheter insertion. This is a direct medical intervention on a patient's body.
- Device Description: The description details a physical device (sheath, valve, tube) used for accessing blood vessels.
- 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) to provide information for diagnosis, monitoring, or screening. IVDs typically involve reagents, analyzers, or test kits.
This device is a medical device used for a procedural purpose, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Intended Use: Intended to be used to access the venous system and to facilitate catheter insertion and allow access for the administration of fluids and blood sampling.
Indications for Use: The Catheter Introducer Sheath is indicated for use in patients requiring access of the venous system or to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter). It is intended to be used for ≤ 72 hours.
Product codes
DYB
Device Description
Edwards Lifesciences' Catheter Introducer Sheath is an 11 Fr. sterile, non-pyrogenic, single-use introducer made of flexible and non-flexible polymeric materials. It consists of a single lumen shaft and a hemostasis valve with a side-arm extension tube with a female luer and clamp.
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
Functional/Safety Testing: The functional data indicate that the Catheter Introducer Sheath performs in a substantially equivalent manner when compared to the predicate device. The following tests were performed:
Biocompatibility and Sterility: Cytotoxicity, Sensitization, Irritation/Intracutaneous toxicity, Systemic toxicity, Genotoxicity, Haemocompatibility, Muscular toxicity, Subacute/Subchronic toxicity, In Vivo thrombogenicity.
Performance / Shelf Life: Leak Testing (Valve Leak after 72-hour insertion of 7 Fr device, Assembly leak, Valve leak after 6-hour insertion of 9 Fr device, Valve leak after 6-hour insertion of 7 Fr device, Valve leak with no insertion conditioning, Valve leak after multiple insertions, Forward valve leak).
Tensile Testing: Introducer joint tensile, Sideport luer tensile, Sideport tubing to body.
Compatibility and Additional Testing: 9 Fr ballon catheter insertion force, 9 Fr balloon catheter retraction force, Dilator insertion force, Contamination guard connection, Introducer sheath and dilator transition, Valve retention force, Sideport infusion with empty introducer, Sideport infusion post clamping, Sideport infusion with 10 Fr device, Fluoroscopic visibility, Kink testing.
Packaging Testing: All data met acceptance criteria.
Key Metrics
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
Edwards Lifesciences LLC Traditional 510(k) Premarket Notification Catheter Introducer Sheath
510(k) Summary
.. )
| Submitter: | Edwards Lifesciences LLC |
|---|---|
| Contact Person: | Luke Meidell, Regulatory Affairs Associate II |
| 12050 Lone Peak Pkwy | |
| Draper, UT 84020 | |
| Ph - (801) 565-6212 | |
| Fax - (801) 565-6108 | |
| Date Prepared: | March 06, 2014 |
| Trade Name: | Edwards Catheter Introducer Sheath |
| Classification Name: | Introducer, Catheter, Cardiovascular Devices Panel; |
| 21 CFR §870.1340 Product Code DYB, Class II | |
| Predicate Device: | K981909, Baxter Hemostasis Valve Introducer |
Device Description:
Edwards Lifesciences' Catheter Introducer Sheath is an 11 Fr. sterile, non-pyrogenic, single-use introducer made of flexible and non-flexible polymeric materials. It consists of a single lumen shaft and a hemostasis valve with a side-arm extension tube with a female luer and clamp.
Intended Use:
Intended to be used to access the venous system and to facilitate catheter insertion and allow access for the administration of fluids and blood sampling.
Indications for Use:
The Catheter Introducer Sheath is indicated for use in patients requiring access of the venous system or to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter). It is intended to be used for ≤ 72 hours.
Comparative Analysis:
The subject device has the same intended use and technological characteristics (i.e., design, material, chemical composition) as the predicate device. It has been demonstrated that the subject Catheter introducer Sheath is comparable to the predicate
1
device in fundamental scientific technology, material types, principles of operation, and functional performance evaluations. No new issues of safety or efficacy have been raised as a result of the packaging configuration change or the revision of the Indications for Use statement.
Functional/Safety Testing:
The functional data indicate that the Catheter Introducer Sheath performs in a substantially equivalent manner when compared to the predicate device. The following tests were performed:
Biocompatibility and Sterility
Cytotoxicity, Sensitization, Irritation/Intracutaneous toxicity, Systemic toxicity, Genotoxicity, Haemocompatibility, Muscular toxicity, Subacute/Subchronic toxicity, In Vivo thrombogenicity,
Performance / Shelf Life
- Leak Testing .
Valve Leak after 72-hour insertion of 7 Fr device, Assembly leak, Valve leak after 6-hour insertion of 9 Fr device, Valve leak after 6-hour insertion of 7 Fr device, Valve leak with no insertion conditioning, Valve leak after multiple insertions, Forward valve leak.
Tensile Testing .
Introducer joint tensile, Sideport luer tensile, Sideport tubing to body.
Compatibility and Additional Testing .
9 Fr ballon catheter insertion force, 9 Fr balloon catheter retraction force, Dilator insertion force, Contamination guard connection, Introducer sheath and dilator transition, Valve retention force, Sideport infusion with empty introducer, Sideport infusion post clamping, Sideport infusion with 10 Fr device, Fluoroscopic visibility, Kink testing.
Packaging Testing
All data met acceptance criteria.
Conclusion:
The Edwards Catheter Introducer Sheath is substantially equivalent to the cited predicate device.
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 stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 6, 2014
Edwards Lifesciences, LLC. % Luke Meidell Regulatory Affairs Associate III 12050 Lone Peak Pkwy Draper, UT 84020 US
Re: K131627
Trade/Device Name: Catheter Introducer Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: February 12, 2014 Received: February 14, 2014
Dear Mr. Meidell:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Mr. Luke Meidell
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
MA
for
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K131627, page 1 of 1
Edwards Lifesciences LLC Traditional 510(k) Premarket Notification Catheter Introducer Sheath
Indications for Use Statement
510(k) Number (if known): K131627
Device Name: Catheter Introducer Sheath
Indications for Use:
. . . . . . . . . .
The Catheter Introducer Sheath is indicated for use in patients requiring access of the venous system or to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter). It is intended to be used for ≤ 72 hours.
Prescription Use × (Per 21 CFR 801.109)
OR Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Of Device Evaluation (ODE)
MZFDA