(35 days)
PMA140031/S088, PMA140031/S091
No
The summary describes a mechanical introducer set and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is an introducer set, which facilitates the introduction and removal of other devices (heart valves) but does not directly provide a therapeutic effect itself.
No
Explanation: This device, an introducer set, is used to facilitate the introduction and removal of other medical devices (transcatheter heart valves). It does not gather information about a patient's health condition or make a diagnosis.
No
The device description explicitly states it contains physical components like dilators, a sheath, and a loader, and the performance studies detail testing on these physical attributes.
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 and the SAPIEN 3 Ultra transcatheter heart valves." 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 of dilators, a sheath, and a loader aligns with a device used for accessing and navigating within the vascular system, which is an in vivo application.
- Anatomical Site: The specified anatomical site is the "Vascular system," which is an in vivo location.
- Performance Studies: The performance studies listed (e.g., Hemostasis, Lubricity, Kink Resistance, Biocompatibility) are typical for devices used within the body, not for IVDs which would focus on analytical performance with biological samples.
IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or treatment. This device's function is to facilitate the delivery and removal of other devices within the patient's vascular system.
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 and the SAPIEN 3 Ultra transcatheter heart valves.
Product codes
DYB
Device Description
The Edwards eSheath Introducer Set contains two dilators and a sheath with hydrophilic coating, and loader packaged with an Edwards delivery system. It is available with inner sheath diameters of 14 French (model 914ES) and 16 French (model 916ES).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Performance Testing for the Edwards eSheath Introducer Set (model 914ES and 916ES) was previously provided in Section 14 of 510(k) K152225 (submitted 8/7/2015, approved 11/24/2015) and K162184 (submitted 8/4/2016, approved 9/2/2016) remains applicable to the expanded indication.
Performance Testing for the Edwards eSheath Introducer Set (model 914ES) indication expansion was previously provided in the FDA PMA140031/S088 (submitted 5/24/2019, approved 6/4/2019) and PMA140031/S091 (submitted 7/19/2019, approved 8/21/2019); all results were acceptable.
Specifically, the following design verification and design validation testing was successfully completed:
- Visual 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
- Loader Peel Test
- Material Verification
- Sterilization Validation
- Biocompatibility Tests:
- Cytotoxicity
- Hemocompatibility
- Systemic Toxicity
- Material Mediated Pyrogenicity
- Irritation/Intracutaneous Reactivity
- Sensitization
- Chemical Acceptability
- Thrombogenicity
- Packaging Integrity
- Shelf Life Verification
- USP Physico-Chemical Test for Plastic Closures
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Edwards eSheath Introducer Sheath Set (K152225), Edwards eSheath Introducer Sheath Set (K162184)
Reference Device(s)
PMA140031/S088, PMA140031/S091
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
March 9, 2020
Edwards Lifesciences LLC Vilma Arechiga Senior Specialist, Regulatory Affairs One Edwards Way Irvine. California 92614
Re: K200258
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: January 31, 2020 Received: February 3, 2020
Dear Ms. Arechiga:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jaime Raben, Ph.D. Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200258
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 and the SAPIEN 3 Ultra transcatheter heart valves.
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K200258 510(K) Summary
| Submitter: | Edwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92663 |
|--------------------|----------------------------------------------------------------------------------------------------|
| Contact: | Vilma Arechiga Phone: 949-250-3903, Fax: 949-809-7760 |
| Prepared: | January 31, 2020 |
| Trade Name: | Edwards eSheath Introducer Set |
| Common Name: | Catheter, Introducer |
| Classification: | Catheter Introducer
21 CFR 870.1340, Product Code DYB |
| Predicate Devices: | Edwards eSheath Introducer Sheath Set (K152225)
Edwards eSheath Introducer Sheath Set (K162184) |
Device Description:
The Edwards eSheath Introducer Set contains two dilators and a sheath with hydrophilic coating, and loader packaged with an Edwards delivery system.
It is available with inner sheath diameters of 14 French (model 914ES) and 16 French (model 916ES).
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 and the SAPIEN 3 Ultra transcatheter heart valves.
Comparison to Predicate:
The Edwards eSheath Introducer Set (models 914ES and 916ES) is substantially equivalent to the previously 510(k) cleared predicate because they are the same device with the same intended use, only the specific indication has changed to include SAPIEN 3 Ultra, which is already an approved indication for eSheath under the PMA (P140031/S088 and S091).
There is no change to the patient population, warnings, precautions, or contraindications. There are no changes to the eSheath design or manufacturing specifications.
Summary of Non-Clinical Testing:
Performance Testing for the Edwards eSheath Introducer Set (model 914ES and 916ES) was previously provided in Section 14 of 510(k) K152225 (submitted 8/7/2015, approved 11/24/2015) and K162184 (submitted 8/4/2016, approved 9/2/2016) remains applicable to the expanded indication.
4
Performance Testing for the Edwards eSheath Introducer Set (model 914ES) indication expansion was previously provided in the FDA PMA140031/S088 (submitted 5/24/2019, approved 6/4/2019) and PMA140031/S091 (submitted 7/19/2019, approved 8/21/2019); all results were acceptable.
Specifically, the following design verification and design validation testing was successfully completed:
- Visual 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
- . Loader Peel Test
- . Material Verification
- Sterilization Validation
- Biocompatibility Tests:
- · Cytotoxicity
- · Hemocompatibility
- · Systemic Toxicity
- · Material Mediated Pyrogenicity
- · Irritation/Intracutaneous Reactivity
- · Sensitization
- Chemical Acceptability
- · Cytotoxicity
- · Thrombogenicity
- · Packaging Integrity
- · Shelf Life 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. The predicate devices are the same device with the same intended use.