(35 days)
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.
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).
This document describes a 510(k) premarket notification for the Edwards eSheath Introducer Set. The review focuses on demonstrating substantial equivalence to previously cleared predicate devices and expanding the indications for use.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative format for each test. Instead, it states that "all results were acceptable" for the design verification and validation tests and that "performance testing has demonstrated that safety and efficacy are not adversely impacted." The tests themselves act as the criteria to be met.
| Test Type | Reported Device Performance |
|---|---|
| Visual Inspection | Successfully completed and acceptable |
| Dimensional Inspection | Successfully completed and acceptable |
| Radiopacity/Visualization | Successfully completed and acceptable |
| Guidewire Compatibility | Successfully completed and acceptable |
| Hemostasis | Successfully completed and acceptable |
| Lubricity and Durability of Sheath | Successfully completed and acceptable |
| Kink Resistance | Successfully completed and acceptable |
| Seam Return After Expansion | Successfully completed and acceptable |
| Bond Strength | Successfully completed and acceptable |
| Device Interaction | Successfully completed and acceptable |
| Hydrophilic Coating Characterization | Successfully completed and acceptable |
| USP Particulate Test | Successfully completed and acceptable |
| Loader Peel Test | Successfully completed and acceptable |
| Material Verification | Successfully completed and acceptable |
| Sterilization Validation | Successfully completed and acceptable |
| Biocompatibility Tests | Successfully completed and acceptable for Cytotoxicity, Hemocompatibility, Systemic Toxicity, Material Mediated Pyrogenicity, Irritation/Intracutaneous Reactivity, Sensitization, Chemical Acceptability, Thrombogenicity |
| Packaging Integrity | Successfully completed and acceptable |
| Shelf Life Verification | Successfully completed and acceptable |
| USP Physico-Chemical Test for Plastic Closures | Successfully completed and acceptable |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes used for each individual test. It mentions that "Performance Testing for the Edwards eSheath Introducer Set (model 914ES and 916ES) was previously provided in Section 14 of 510(k) K152225 and K162184" and "Performance Testing for the Edwards eSheath Introducer Set (model 914ES) indication expansion was previously provided in the FDA PMA140031/S088 and PMA140031/S091." The implication is that the sample sizes were sufficient for the original submissions and remain valid for this expanded indication.
- Data Provenance: The document does not state the country of origin of the data or whether the studies were retrospective or prospective. Given these are premarket submissions for a medical device in the US, the testing would typically be conducted under GLP (Good Laboratory Practice) guidelines and would be considered prospective for the purpose of demonstrating device performance against specific criteria.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable and not provided in the context of this device. The testing described is primarily mechanical, material, and biological performance testing, not diagnostic performance where expert ground truth is typically established (e.g., image interpretation). The "ground truth" for these tests would be the established scientific and engineering standards and methods.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are objective measurements (e.g., dimensions, bond strength, particulate count) or standardized biological evaluations rather than subjective assessments requiring adjudication by multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is not mentioned because this device is an introducer set, not a diagnostic or AI-driven imaging device that would typically involve human readers interpreting cases.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This device is a physical medical device (an introducer set), not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm is not applicable.
7. Type of Ground Truth Used
The "ground truth" for the tests performed can be categorized as:
- Engineering Specifications and Standards: For dimensional, mechanical (bond strength, kink resistance, lubricity, seam return, loader peel), and physical (radiopacity, guidewire compatibility, hemostasis, device interaction) tests.
- USP (United States Pharmacopeia) Standards: For particulate tests and physico-chemical tests for plastic closures.
- ISO/FDA Biocompatibility Guidelines: For biocompatibility tests (cytotoxicity, hemocompatibility, systemic toxicity, pyrogenicity, irritation, sensitization, chemical acceptability, thrombogenicity).
- Sterilization Industry Standards: For sterilization validation.
- Packaging and Shelf Life Standards: For packaging integrity and shelf life verification.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical product, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device.
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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
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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, LLCOne Edwards WayIrvine, 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 Introducer21 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.
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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.
§ 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).