(29 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of an introducer sheath and associated components, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is an introducer set used to facilitate the insertion and removal of other devices, specifically the Edwards SAPIEN 3 Transcatheter Heart Valve, into the vasculature. It does not provide therapeutic treatment itself.
No
Explanation: The device description states its purpose is for the "introduction and removal of devices" and "to facilitate introduction" of other medical devices. This indicates a role in access and delivery, not in diagnosing conditions.
No
The device description clearly outlines physical components (sheath, dilators, loader) made of materials like HDPE, TecoFlex, and PTFE, and describes their physical functions and testing. There is no mention of software.
Based on the provided text, 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) for a surgical procedure, not a device used in vitro (outside the body) to examine specimens from the body.
- Device Description: The description details a physical device (sheath, dilators, loader) designed to be inserted into the human vasculature. This is consistent with an invasive medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the Edwards eSheath Introducer Set is a medical device used for a surgical procedure, not an IVD.
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
DYB
Device Description
The Edwards eSheath Introducer Set consists of a sheath and two dilators packaged together, and one loader packaged with the Commander delivery system. The Edwards eSheath Introducer Set is available in two sizes: model 914ES (14F inner diameter) and model 916ES (16F inner diameter). The 14F eSheath introducer set is used to facilitate introduction of the 20mm, 23mm and 26mm SAPIEN 3 THV and Commander Delivery System into the vasculature, and the 16F eSheath 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. The sheath shaft exterior includes a hydrophilic coating to facilitate introduction into the target vessel. The distal end of the shaft features a radiopaque marker, and the shaft mates proximally with a housing that contains three valves (seals) to provide hemostasis, an extension tube for flushing, and suture holes on the exterior.
Two dilators are provided to aid in the introduction of the sheath into the target vessel, and can also be used for dilation of the vessel prior to sheath insertion. The dilators are radiopaque and feature a tapered tip and guidewire lumen.
The loader features a disc valve within the loader cap assembly to help maintain hemostasis, and a scored perforation on the loader tube allowing the loader tubing to be "peeled away" and removed to utilize the full working length of the inserted device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human vasculature
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:
- Loader Peel Test
- Bond Strength Test
- Biocompatibility Tests:
- Cytotoxicity
- Sensitization
- Irritation/Intracutaneous Toxicity
- Systemic Toxicity
- Hemocompatibility
- Material Verification
- USP Physico-Chemical Test for Plastic Closures
- Sterilization Validation
- Packaging Integrity
- Shelf Life Verification
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Edwards eSheath Introducer Set (K152225)
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
Image /page/0/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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 2, 2016
Edwards Lifesciences LLC Yi Gao Specialist, Regulatory Affairs One Edwards Way Irvine, California 92614
Re: K162184
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: August 3, 2016 Received: August 4, 2016
Dear Yi Gao:
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 devicerelated 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" (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 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,
Brian D. Pullin -S
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) K162184
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)
| Prescription Use (Part 21 CFR 201 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 201 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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K162184 510(K) Summary
| Submitter: | Edwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92663 |
|-------------------|------------------------------------------------------------------|
| Contact: | Yi Gao
Phone: 949-250-2500
Fax: 949-756-4408 |
| Prepared: | August 30, 2016 |
| Trade Name: | Edwards eSheath Introducer Set |
| Common Name: | Catheter, Introducer |
| Classification: | Catheter Introducer
21 CFR 870.1340, Product Code DYB |
| Predicate Device: | Edwards eSheath Introducer Set (K152225) |
Device Description:
The Edwards eSheath Introducer Set consists of a sheath and two dilators packaged together, and one loader packaged with the Commander delivery system. The Edwards eSheath Introducer Set is available in two sizes: model 914ES (14F inner diameter) and model 916ES (16F inner diameter). The 14F eSheath introducer set is used to facilitate introduction of the 20mm, 23mm and 26mm SAPIEN 3 THV and Commander Delivery System into the vasculature, and the 16F eSheath 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. The sheath shaft exterior includes a hydrophilic coating to facilitate introduction into the target vessel. The distal end of the shaft features a radiopaque marker, and the shaft mates proximally with a housing that contains three valves (seals) to provide hemostasis, an extension tube for flushing, and suture holes on the exterior.
Two dilators are provided to aid in the introduction of the sheath into the target vessel, and can also be used for dilation of the vessel prior to sheath insertion. The dilators are radiopaque and feature a tapered tip and guidewire lumen.
The loader features a disc valve within the loader cap assembly to help maintain hemostasis, and a scored perforation on the loader tube allowing the loader tubing to be "peeled away" and removed to utilize the full working length of the inserted device.
4
Intended Use:
Entry of interventional devices into the vascular system
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:
A table comparing the proposed device to the predicate devices is provided below.
| Predicate Device | Subject Device | |
|---|---|---|
| Edwards eSheath Introducer Set | Edwards eSheath Introducer Set | |
| (with Loader) | ||
| Manufacturer | Edwards Lifesciences | Identical |
| 510(k) | K152225 | K162184 |
| Device Classification | Class II, DYB | |
| (21 CFR 870.1340) | ||
| Catheter Introducer | Identical | |
| Intended Use | Entry of interventional devices into the | |
| vascular system | Identical | |
| Indication 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. | Identical | |
| Target Population | Patients requiring vascular intervention | |
| with the SAPIEN 3 Transcatheter Heart | ||
| Valve | Identical | |
| Anatomical Sites | Human vasculature | Identical |
| Model Numbers | 914ES, 916ES | Identical |
| Sizes available (French) | 14F, 16F inner diameter | Identical |
| Package Contents | 1- Sheath | |
| 2- Introducer (dilator) | 1 - Sheath | |
| 2 - Dilators | ||
| 1 - Loader (packaged with the | ||
| Commander delivery system) | ||
| Working Length | 36.5 cm | Identical |
| Guidewire Compatibility | 0.035" guidewire | Identical |
| Radiopaque elements | Sheath, Dilators | Identical |
| Sheath | ||
| Hemostasis Control | 3 hemostasis seals | Identical |
| Expansion Mechanism | Expandable seam | Identical |
| Hydrophilic coating | Sheath, Dilators | Identical |
| Sterilization Method / | ||
| Re-use | Ethylene Oxide | |
| Single use only | Identical | |
| Sterility Assurance | ||
| Level | 10-6 or better | Identical |
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
5
requirements are satisfied. Specifically, the following design verification and validation testing was successfully completed:
- Loader Peel Test ●
- Bond Strength Test
- Biocompatibility Tests: ●
- Cytotoxicity ၊
- Sensitization ।
- -Irritation/Intracutaneous Toxicity
- Systemic Toxicity -
- Hemocompatibility -
- Material Verification -
- -USP Physico-Chemical Test for Plastic Closures
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.
- . Sterilization Validation
- Packaging Integrity
- Shelf Life Verification .