(109 days)
No
The device description and performance studies focus on the mechanical and material properties of a vascular introducer sheath and introducers. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
No.
This device is an introducer set, which is an accessory used to facilitate the introduction and removal of other therapeutic devices (specifically, the Edwards SAPIEN 3 Transcatheter Heart Valve). It does not directly provide therapy itself.
No
The device is an introducer set designed to facilitate the insertion and removal of other medical devices (transcatheter heart valves and their delivery systems) into the vasculature. Its function is mechanical and procedural, not diagnostic.
No
The device description clearly outlines physical components (sheath, introducers, seals, housing, stopcock, etc.) made of various materials, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "introduction and removal of devices used with the Edwards SAPIEN 3 Transcatheter Heart Valve." This describes a device used in vivo (within the body) to facilitate a medical procedure.
- Device Description: The description details a physical device (sheath and introducers) designed to be inserted into the vascular system. It talks about materials, dimensions, features for insertion and hemostasis, and compatibility with other medical devices.
- Anatomical Site: The anatomical site is the "Vascular system," which is within the body.
- Performance Studies: The performance studies focus on physical and functional characteristics of the device itself (e.g., radiopacity, hemostasis, durability, biocompatibility) and its interaction with other devices, not on analyzing biological samples.
In Vitro Diagnostic (IVD) devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological samples.
N/A
Intended Use / Indications for Use
The Edwards eSheath Introducer Set is indicated for the introduction and removal of devices used with the Edwards SAPIEN 3 Transcatheter Heart Valve.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The Edwards eSheath Introducer Set consists of a sheath and 2 introducers. It is available with inner sheath diameters of 14 French (model 914ES) and 16 French (model 916ES). The 14 French introducer set is used to facilitate introduction of the 23mm and 26mm SAPIEN 3 THV and Commander Delivery System into the vasculature, and the 16 French introducer set is used to facilitate introduction of the 29mm SAPIEN 3 THV and Commander Delivery System into the vasculature.
The sheath shaft is comprised of 2 layers of material (HDPE/TecoFlex coextruded outer layer and PTFE liner). The outer and inner layer are folded, creating a seam which allows the distal region of the sheath to temporarily expand in diameter when a device is inserted. A tapered strain relief at the proximal end of the sheath shaft helps provide hemostasis when the sheath is inserted.
A radiopaque marker on the distal end indicates the location of the sheath tip in the body and a hydrophilic coating on the sheath tubing exterior facilitates introduction into the vessel. The sheath tubing mates with a housing, which holds three seals (valves) to provide hemostasis: a duckbill seal, a disc seal, and a cross slit seal. The housing also includes flushport tubing and a stopcock to allow for flushing of the sheath.
Two introducers are provided to aid in the introduction of the target vessel, and can also be used for dilation of the vessel prior to sheath insertion. The introducers are radiopaque and feature a tapered tip and guidewire lumen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Non-clinical testing was completed to demonstrate that the performance characteristics of the Edwards eSheath Introducer Set are equivalent to the predicates, and to verify that design requirements are satisfied. Specifically, the following design verification and validation testing was successfully completed:
- . Visual Surface Inspection
- Dimensional Inspection .
- . Radiopacity/Visualization
- Guidewire Compatibility
- . Hemostasis
- . Lubricity and Durability of the Sheath
- Kink Resistance ●
- Seam Return After Expansion
- Bond Strength ●
- . Device Interaction
- Hydrophilic Coating Characterization .
- . USP Particulate Test
- . Sterilization Validation
- Biocompatibility Tests: .
- . Cytotoxicity
- Hemocompatibility ■
- I Systemic Toxicity
- I Material Mediated Pyrogenicity
- I Irritation/Intracutaneous Reactivity
- Sensitization I
- 트 Chemical Acceptability
- Thrombogenicity
- Packaging Integrity
- Shelf Life Verification ●
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.
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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus-like symbol with three figures in profile, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol in a circular fashion. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 24, 2015
Edwards Lifesciences Karen Reynolds Regulatory Affairs Associate III 1 Edwards Way Irvine, California 92614-5686
Re: K152225
Trade/Device Name: Edwards eSheath Introducer Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: October 26, 2015 Received: October 27, 2015
Dear Karen Reynolds:
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.
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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Industry and Consumer Education 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 yours.
M.R. Hilleman
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152225
Device Name Edwards eSheath Introducer Set
Indications for Use (Describe)
The Edwards eSheath Introducer Set is indicated for the introduction and removal of devices used with the Edwards SAPIEN 3 Transcatheter Heart Valve.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
510(K) Summary
| Submitter: | Edwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92663 |
|-----------------------|--------------------------------------------------------------------------------------------------------------|
| Contact: | Karen Reynolds Phone: 949-250-2500, Fax: 949-756-4408 |
| Prepared: | August 5, 2015 |
| Trade Name: | Edwards eSheath Introducer Set |
| Common Name: | Catheter, Introducer |
| Classification: | Catheter Introducer
21 CFR 870.1340, Product Code DYB |
| Predicate
Devices: | RetroFlex 3 Introducer Sheath Set (K093877)
Solopath Balloon Expandable Transfemoral Introducer (K100819) |
Device Description:
The Edwards eSheath Introducer Set consists of a sheath and 2 introducers. It is available with inner sheath diameters of 14 French (model 914ES) and 16 French (model 916ES). The 14 French introducer set is used to facilitate introduction of the 23mm and 26mm SAPIEN 3 THV and Commander Delivery System into the vasculature, and the 16 French introducer set is used to facilitate introduction of the 29mm SAPIEN 3 THV and Commander Delivery System into the vasculature.
The sheath shaft is comprised of 2 layers of material (HDPE/TecoFlex coextruded outer layer and PTFE liner). The outer and inner layer are folded, creating a seam which allows the distal region of the sheath to temporarily expand in diameter when a device is inserted. A tapered strain relief at the proximal end of the sheath shaft helps provide hemostasis when the sheath is inserted.
A radiopaque marker on the distal end indicates the location of the sheath tip in the body and a hydrophilic coating on the sheath tubing exterior facilitates introduction into the vessel. The sheath tubing mates with a housing, which holds three seals (valves) to provide hemostasis: a duckbill seal, a disc seal, and a cross slit seal. The housing also includes flushport tubing and a stopcock to allow for flushing of the sheath.
Two introducers are provided to aid in the introduction of the target vessel, and can also be used for dilation of the vessel prior to sheath insertion. The introducers are radiopaque and feature a tapered tip and guidewire lumen.
Intended Use:
Entry of interventional devices into the vascular system
4
Indication:
The Edwards eSheath Introducer Set is indicated for the introduction and removal of devices used with the Edwards SAPIEN 3 Transcatheter Heart Valve.
Comparison to Predicate:
The Edwards eSheath Introducer Set (models 914ES) is substantially equivalent in function, performance, and design to the RetroFlex 3 Introducer Sheath Set (K093877), Solopath Balloon Expandable Transfemoral Introducer (K100819), and Cook Medical Check-Flo Performer Extra Large Introducer (K142829). The Edwards eSheath and the Solopath Introducer have an expandable shaft. The Edwards eSheath is expanded in the vasculature by the device that is passed through the inner diameter and the Solopath Introducer is expanded in the vasculature via inflation. The eSheath device compatibility testing was completed using the Edwards SAPIEN 3 Transcatheter Heart Valve and Commander delivery system (commercially available per PMA P140031). The RetroFlex 3 Introducer Sheath Set (K093877) has the same proximal end (housing, hemostasis control, and flush tube) and introducer as the Edwards eSheath but does not include the expansion feature.
Summary of Non-Clinical Testing:
Non-clinical testing was completed to demonstrate that the performance characteristics of the Edwards eSheath Introducer Set are equivalent to the predicates, and to verify that design requirements are satisfied. Specifically, the following design verification and validation testing was successfully completed:
- . Visual Surface Inspection
- Dimensional Inspection .
- . Radiopacity/Visualization
- Guidewire Compatibility
- . Hemostasis
- . Lubricity and Durability of the Sheath
- Kink Resistance ●
- Seam Return After Expansion
- Bond Strength ●
- . Device Interaction
- Hydrophilic Coating Characterization .
- . USP Particulate Test
- . Sterilization Validation
- Biocompatibility Tests: .
- . Cytotoxicity
- Hemocompatibility ■
- I Systemic Toxicity
- I Material Mediated Pyrogenicity
- I Irritation/Intracutaneous Reactivity
- Sensitization I
- 트 Chemical Acceptability
- Thrombogenicity
- Packaging Integrity
- Shelf Life Verification ●
Conclusion:
Based upon device testing and descriptive characteristics, the Edwards eSheath Introducer Set is substantially equivalent to the predicate device and performance testing has demonstrated that safety and efficacy are not adversely impacted.