(182 days)
The 9F Prelude IDeal Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
The 9F Prelude IDeal Hydrophilic Sheath Introducer consists of a sheath introducer with compatible vessel dilator that snaps securely into the sheath introducer hub. The sheath hub contains an integral hemostasis valve. A rotating suture ring is affixed to the sheath hub. The sheath tubing is coated with a hydrophilic coating and incorporates a stainless steel braid. A sidearm is affixed to the sheath hub and has a 3-way stopcock at its proximal end. The 9F Prelude Ideal Hydrophilic Sheath Introducer is available in 11cm and 23cm lengths, (French size 9F) and is designed to accept 0.038" diameter guide wires. The 9F Prelude Ideal Hydrophilic Sheath Introducer is marketed with the following components: quide wire, metal access needle, quide wire insertion device.
This document describes the 510(k) summary for the 9F Prelude IDeal Hydrophilic Sheath Introducer, a medical device. It does not contain information about an AI/ML powered device, therefore, the requested information elements (1-9) which are related to AI/ML device studies and ground truth establishment are not applicable.
The document focuses on demonstrating the substantial equivalence of the 9F Prelude IDeal Hydrophilic Sheath Introducer to its predicate device (K173750 and K142829) through performance testing.
Here's the relevant information about the non-clinical performance and testing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists performance tests conducted, referencing applicable international and internal standards. It generally states that the device "met the predetermined acceptance criteria applicable to the performance of the device." However, specific numerical acceptance criteria and the exact reported device performance values are not provided in this summary. The table below outlines the tests performed:
| Verification/Validation Test | Applicable Standard(s) | Reported Device Performance |
|---|---|---|
| Insertion Force/Tip Insertion Peel Back | Internal Requirement | Met predetermined acceptance criteria |
| Peak Tensile Force Shaft/Hub, Sidearm & Tip | ISO 10555-1:2013, ISO 10555-3:2013, ISO 11070:2014 | Met predetermined acceptance criteria |
| Cap Tensile | Internal Requirement | Met predetermined acceptance criteria |
| Visual (Extraneous/Surface Defects) | ISO 11070:2014 | Met predetermined acceptance criteria |
| Sheath Tip Ball Gauge Drag | Internal Requirement | Met predetermined acceptance criteria |
| Sheath Stiffness | Internal Requirement | Met predetermined acceptance criteria |
| Sheath Kink | Internal Requirement | Met predetermined acceptance criteria |
| Sidewall Compression | Internal Requirement | Met predetermined acceptance criteria |
| Radiopacity marker band & tip | ISO 11070:2014, ASTM F640-12, ISO 10555-1:2013 | Met predetermined acceptance criteria |
| Hydrophilic coating durability & coverage/coating length | Internal Requirement | Met predetermined acceptance criteria |
| Hydrophilic Coating Lubricity | Internal Requirement | Met predetermined acceptance criteria |
| Coating integrity test (particulate evaluation) | ASTM F1877-16, Class II Special Controls Guidance for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters | Met predetermined acceptance criteria |
| Corrosion resistance | ISO 11070:2014 | Met predetermined acceptance criteria |
| Sheath assembly leak | ISO 11070:2014 | Met predetermined acceptance criteria |
| Dilator-to-Hub Tensile | ISO 10555-1:2013 | Met predetermined acceptance criteria |
| Tip Bend Test | Internal Requirement | Met predetermined acceptance criteria |
| Dilator Stiffness & Hub Snap Force | No Standard - Tested through Validation | Met predetermined acceptance criteria |
| Dilator Insertion/Removal from Sheath | No Standard - Testing through Validation | Met predetermined acceptance criteria |
| Dimensional tests for OD & ID of sheath & dilator | ISO 11070:2014 | Met predetermined acceptance criteria |
| Stiffness of introducer through tortuous path/ guidewire & catheter compatibility | Tested through validation | Met predetermined acceptance criteria |
| Dilator Ink Adhesion | Internal Requirement | Met predetermined acceptance criteria |
| Sheath Effective Length | ISO 10555-1:2013 | Met predetermined acceptance criteria |
| Suture Ring Tensile/Rotation | ISO 11070:2014 | Met predetermined acceptance criteria |
| Dilator Drag through Sheath Valve & Tip | Internal Requirement | Met predetermined acceptance criteria |
| Torque, Sheath Bend Radius | No specification requirement | Met predetermined acceptance criteria |
| Hemostasis Valve Leakage/dislodgement | ISO 11070:2014 | Met predetermined acceptance criteria |
| EO Sterilization Validation | ISO 11135:2014, ISO 10993-7:2008, AAMI TIR28:2016 | Met predetermined acceptance criteria |
| Package Integrity Testing | ISO 11607-1:2019, ISO 11607-2:2019, ASTM D4169-16 | Met predetermined acceptance criteria |
| Biocompatibility Testing | ISO 10993-1:2009, ISO 10993-4: 2017, ISO 10993-5:2009, ISO 10993-6:2009, ISO 10993-7:2008, ISO 10993-10:2010, ISO 10993-11:2017, ISO 10993-12:2012 | Met predetermined acceptance criteria |
| Chemical Characterization - Particulate Analysis | ASTM F1877-16 | Met predetermined acceptance criteria |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided document for each specific test.
- Data Provenance: The tests are "Nonclinical performance data" and internal validation tests. The provenance is internal to the manufacturer, Merit Medical Systems, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is a non-clinical device filing, and expert adjudication for ground truth (as in a clinical study or AI/ML model evaluation) is not applicable or described. The tests are based on engineering and material science standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for non-clinical performance testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by meeting the requirements of recognized international and internal engineering, material, and sterility standards (e.g., ISO, ASTM). These standards define objective, measurable criteria for device functionality and safety.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML powered device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML powered device.
Summary of Conclusions from the Document:
The 9F Prelude IDeal Hydrophilic Sheath Introducer demonstrated substantial equivalence to its predicate devices by meeting predetermined acceptance criteria in nonclinical performance tests. These tests included manual testing against international standards, coating adhesion and particulate testing, transportation integrity, biocompatibility, sterilization validation, and accelerated aging. The differences from the predicate (larger diameter, different hemostasis valve, colorants, tubing material, removal of compression sleeve, and dilator material change) and minor changes in indications for use (exclusion for radial artery use and specific access needle) were deemed not to raise new questions of safety or effectiveness.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 7, 2022
Merit Medical Systems David Thomas Principal Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, Utah 84095
Re: K212152
Trade/Device Name: Prelude IDeal 9F Hydrophilic Sheath Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: December 3, 2021 Received: December 6, 2021
Dear David Thomas:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (QS) 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,
Misti Malone Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212152
Device Name
Prelude IDeal 9F Hydrophilic Sheath Introducer
Indications for Use (Describe)
The 9F Prelude IDeal Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------- |
|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
K212152
9F Prelude IDeal Hydrophilic Sheath Introducer
| GeneralProvisions | Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Date of Preparation:Registration Number: | Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(801) 316-4956(801) 208-3365David ThomasDecember 3, 20211721504 |
|---|---|---|
| SubjectDevice | Trade Name:Common/Usual Name:Classification Name:Regulatory Class:Product Code:21 CFR §:Review Panel: | 9F Prelude IDeal™ Hydrophilic Sheath IntroducerSheath IntroducerCatheter IntroducerIIDYB870.1340Cardiovascular |
| PredicateDevice | Trade Name:Classification Name:Premarket Notification:Manufacturer: | 9F Prelude IDeal™ Hydrophilic Sheath IntroducerCatheter IntroducerK173750Merit Medical Systems, Inc. |
| ReferenceDevice | Tradename:Classification Name:Premarket Notification:Manufacturer: | Flexor Check-Flo IntroducersSheath IntroducerK142829Cook Incorporated |
Class II Classification 21 CFR § 870.1340 FDA Product Code: DYB, DRE Review Panel: Cardiovascular
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The 9F Prelude IDeal Hydrophilic Sheath Introducer is intended to Indications provide access and facilitate the percutaneous introduction of various for Use devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures
A. Device Description
The 9F Prelude IDeal Hydrophilic Sheath Introducer consists of a sheath introducer with compatible vessel dilator that snaps securely into the sheath introducer hub. The sheath hub contains an integral hemostasis valve. A rotating suture ring is affixed to the sheath hub. The sheath tubing is coated with a hydrophilic coating and incorporates a stainless steel braid. A sidearm is affixed to the sheath hub and has a 3-way stopcock at its proximal end.
The 9F Prelude Ideal Hydrophilic Sheath Introducer is available in 11cm and 23cm lengths, (French size 9F) and is designed to accept 0.038" diameter guide wires.
The 9F Prelude Ideal Hydrophilic Sheath Introducer is marketed with the following components: quide wire, metal access needle, quide wire insertion device.
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B. Operation and Compatibility
After removal from the sterile pouch packaging using aseptic techniques, the device is placed into the vasculature. Prior to use, the introducer sheath and dilator are flushed with heparinized solution. The dilator is then inserted completely into the introducer sheath and locked into place through the snap fit connection at the housing of the hemostasis valve. The dilator-sheath-combination is then passed as one unit over a guide wire with a maximum size of up to 0.038 inches. Once the introducer sheath is fully placed in the patient, the guide wire and dilator are removed and compatible catheters and instruments can be inserted through the introducer sheath.
C. Device Models
The 9F Prelude IDeal™ Hydrophilic Sheath Introducer consists of two (2) models of different effective lengths (11cm and 23cm).
D. Comparison of Technological Characteristics with the Predicate Devices
The technological characteristics of the subject 9F Prelude Ideal Hydrophilic Sheath Introducer are substantially equivalent to those of the predicate 4F through 7F Prelude Ideal Hydrophilic Sheath Introducer. The subject device has the same basic design as the predicate device in that it consists of sheath tubing, hub, sidearm and stopcock and is provided with a vessel dilator. The difference between the subject and the predicate devices is the diameter of the sheath and dilator, the larger hemostasis valve and the colorants used on the strain relief, sheath cap, dilator hub and stopcock handle. There have also been changes to the currently marketed Prelude IDeal product lines that have also been included with this new 9F size that include 1) the sidearm tubing which changed the tubing material from Carbothane to Tecothane, 2) the removal of the compression sleeve, and 3) the change in dilator material from a homopolymer polypropylene to a copolymer polypropylene.
The indications for use for the 9F Prelude IDeal Hydrophilic Sheath Introducer is the same as the predicate Prelude IDeal Hydrophilic Sheath Introducer with the exemption of the following:
The indications for the 9F Prelude IDeal does not include a statement "including but not limited to the radial artery" since this larger size catheter is considered too large for safe use in the radial artery. The indication is the same as other Prelude Sheath introducers that include up to an 8F size such as the Prelude Sheath Introducer cleared under K070159 that are also not used for radial access.
The indications also does not include the statement "The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guidewires" since this type of access needle is not included with the 9F size.
These changes are not critical to the intended surgical use of the product which can still be safely and effectively used for access to other peripheral veins or arteries.
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E. Performance Tests
Nonclinical performance data demonstrates that the 9F Prelude IDeal™ 9F Hydrophilic Sheath Introducer consists is substantially equivalent to the predicate. The following performance data from the non-clinical tests were provided to support the substantial equivalence determination:
- Manual testing, including tests required under relevant international standards, . coating adhesion and particulate testing, transportation integrity testing, performed to verify the validate the design.
- . Biocompatibility Risk Assessment (BRA) and biocompatibility device testing to demonstrate compatibility.
- . Sterilization information to confirm sterility of the device upon exposure to the selected sterilization cycle.
- . Accelerated aging testing to confirm product performance at end of shelf life.
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The list of tests performed to support determination of substantial equivalence is provided in the table below.
| No, | Verification/Validation Test | Applicable Standard(s) |
|---|---|---|
| 1 | Insertion Force/Tip InsertionPeel Back | Internal Requirement |
| 2 | Peak Tensile Force Shaft/Hub,Sidearm & Tip | ISO 10555-1:2013ISO 10555-3:2013ISO 11070:2014 |
| Cap Tensile | Internal Requirement | |
| 3 | Visual (Extraneous/SurfaceDefects) | ISO 11070:2014 |
| Sheath Tip Ball Gauge Drag | Internal Requirement | |
| 4 | Sheath Stiffness | Internal Requirement |
| 5 | Sheath Kink | Internal Requirement |
| Sidewall Compression | Internal Requirement | |
| 6 | Radiopacity marker band & tip | ISO 11070:2014, ASTM F640-12ISO 10555-1:2013 |
| 7 | Hydrophilic coating durability &coverage/coating length | Internal Requirement |
| 8 | Hydrophilic Coating Lubricity | Internal Requirement |
| 9 | Coating integrity test (particulateevaluation) | ASTM F1877-16Class II Special Controls Guidance forCertain Percutaneous TransluminalCoronary Angioplasty (PTCA) Catheters |
| 10 | Corrosion resistance | ISO 11070:2014 |
| 11 | Sheath assembly leak | ISO 11070:2014 |
| 15 | Dilator-to-Hub Tensile | ISO 10555-1:2013 |
| 16 | Tip Bend Test | Internal Requirement |
| 17 | Dilator Stiffness & Hub SnapForce | No Standard-Tested through Validation |
| 18 | Dilator Insertion/Removal fromSheath | No Standard - Testing through Validation |
| 19 | Dimensional tests for OD & ID ofsheath & dilator | ISO 11070:2014 |
| Stiffness of introducer throughtortuous path/ guidewire &catheter compatibility, | Tested through validation | |
| 20 | Dilator Ink Adhesion | Internal Requirement |
| 22 | Sheath Effective Length | ISO 10555-1:2013 |
| Suture Ring Tensile/Rotation | ISO 11070:2014 | |
| Dilator Drag through Sheath Valve& Tip | Internal Requirement | |
| Torque, Sheath Bend Radius, | No specification requirement | |
| 24 | Hemostasis ValveLeakage/dislodgement | ISO 11070:2014 |
| 25 | EO Sterilization Validation | ISO 11135:2014 |
| ISO 10993-7:2008 | ||
| AAMI TIR28:2016 | ||
| 26 | Package Integrity Testing | ISO 11607-1:2019 |
| ISO 11607-2:2019 | ||
| ASTM D4169-16 | ||
| 27 | Biocompatibility Testing | ISO 10993-1:2009 |
| Cytotoxicity Testing | ISO 10993-4: 2017 | |
| Sensitization | ISO 10993-5:2009 | |
| Irritation | ISO 10993-6:2009 | |
| Acute Systemic Toxicity | ISO 10993-7:2008 | |
| Pyrogenicity | ISO 10993-10:2010 | |
| Hemocompatibility | ISO 10993-11:2017 | |
| ISO 10993-12:2012 | ||
| ASTM Hemolysis Study – Direct Contact and Extract Method: Phosphate Buffered Saline Extraction | ||
| Complement Activation (SC5b-9 only) Assay | ||
| Thrombogenicity Study – In-vitro Blood Loop Assay, Partial Thromboplastin Time (PTT) | ||
| Heparinized Blood Platelet and Leukocyte Count Assay | ||
| 28 | Chemical | ASTM F1877-16 |
| Characterization - | ||
| Particulate Analysis |
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F. Conclusions
The results of the testing demonstrated that the subject 9F Prelude IDeal™ Hydrophilic Sheath Introducer met the predetermined acceptance criteria applicable to the performance of the device.
Based on the indications for use, design, safety and performance testing, the subject 9F Prelude IDeal™ 9F Hydrophilic Sheath Introducer raises no new questions of safety and effectiveness compared to the predicate device and is substantially equivalent to the predicate device, Prelude IDeal™ Hydrophilic Sheath Introducer manufactured by Merit Medical Systems, Inc. (K171750).
§ 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).