(151 days)
No
The summary describes a mechanical device for introducing other devices into blood vessels and does not mention any computational or analytical capabilities that would suggest AI/ML.
No
The device is described as an introducer sheath for interventional and diagnostic devices, facilitating access to the vasculature rather than directly treating a condition.
No
The device is described as an introducer sheath for interventional and diagnostic devices, facilitating access but not performing diagnostic functions itself.
No
The device description explicitly details physical components (coil reinforced shaft, hemostasis valve, dilator) and performance studies involve manual testing, biocompatibility, and sterilization, all indicative of a hardware medical device.
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 of interventional and diagnostic devices into the peripheral (and coronary) vasculature." This describes a device used within the body for accessing blood vessels, not for testing samples outside the body.
- Device Description: The description details a physical device with a shaft, valve, side port, stopcock, and dilator. These are components of a medical device used for access and delivery, not for performing diagnostic tests on biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely procedural – facilitating access to the vasculature.
N/A
Intended Use / Indications for Use
The Prelude Guide Sheath Introducer is indicated to be used for the introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DYB, DRE
Device Description
The Prelude Guide Sheath Introducer is a sterile, disposable device consisting of a (a) a coil reinforced shaft with an atraumatic tip and the distal end: (b) a hemostasis valve with a side port and color-coded stopcock; and (c) a tapered tip dilator with snap-fit hub at the proximal end.
(a) Shaft. The coil reinforced, multi-layer polymer shaft contains a tapered tip at the distal end. A continuous inner PTFE tube forms the core of the shaft and provides a circular working lumen through which devices can be passed. A single, full length Pebax tube creates the outer cover of the shaft. A stainless-steel flat wire coil is fused between the two polymer tubes along the entire length of the shaft. Hydrophilic coating is applied on the distal 35cm of the shaft. A radiopaque marker made of platinum iridium is embedded 5mm from the distal end of the shaft. At the proximal end of the shaft, a female, winged luer hub is over-molded onto the shaft to support handling and to provide for the connection of the hemostasis valve. This hub is color coded to match the French size of the device.
(b) Hemostasis valve. A removable hemostasis valve is thread onto the luer hub at the proximal end of the shaft. Inside the valve housing, a lubricated, silicone slit disc provides a seal around devices passed through the sheath, thereby preventing blood leakage through the valve. Just distal of the valve housing is connected to a side port leading to a threeway stopcock valve. The sideport is used for flushing the introducer sheath. At the proximal end of the valve housing, the color-coded housing cap provides a snap fit connection the hub of the dilator.
(c) Dilator. The dilator made of a polypropylene blend with Pebax and Barium sulphate (4F) or polypropylene blend with Bismuth Oxychloride (5-8F) contains a full-length round lumen to allow placement over guidewire. The distal end of the dilator is configured as a tapered tip that extends about 2 cm beyond the end of the sheath when the dilator is fully inserted through the sheath. An integral, color coded luer hub that is over-molded onto the proximal end the dilator supports handling of the dilator and provides a snap fit connection to the valve housing cap at the proximal end of the sheath introducer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral (and coronary) vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Nonclinical performance data demonstrates that the Prelude Guide Sheath 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.
The results of the testing demonstrated that the subject Prelude Guide Sheath met the predetermined acceptance criteria applicable to the performance of the device.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side, there is a symbol representing the Department of Health & Human Services - USA. To the right, there is a blue square with the letters 'FDA' in white. Next to the blue square, the words 'U.S. FOOD & DRUG' are written in blue, with 'ADMINISTRATION' written in a smaller font size below.
October 4, 2021
Merit Medical Systems, Inc. David Thomas Principal Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, Utah 84095
Re: K211405
Trade/Device Name: Prelude Guide Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB, DRE Dated: August 31, 2021 Received: September 1, 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
1
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,
Finn Donaldson Assistant Director (Acting) DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211405
Device Name Prelude® Guide Sheath
Indications for Use (Describe)
The Prelude Guide Sheath Introducer is indicated to be used for the introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.
| 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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3
510(k) Summary
K211405
Prelude Guide Sheath
| General
Provisions | Submitter Name:
Address:
Telephone Number:
Fax Number:
Contact Person:
Date of Preparation:
Registration Number: | Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095
(801) 316-4956
(801) 208-3365
David Thomas
August 31, 2021
1721504 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject
Device | Trade Name:
Common/Usual Name:
Classification Name: | Prelude® Guide Sheath
Sheath Introducer
Catheter Introducer |
| Predicate
Device | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer:
Manufacturer: | DuraSheath Introducer Sheath System
Catheter Introducer
K181463 (Predicate)
Contract Medical International
K091329 (Reference Device) – Pinnacle
Destination Peripheral Guiding Sheath
Terumo Medical Corp |
| Classification | Class II
21 CFR § 870.1340
FDA Product Code: DYB, DRE
Review Panel: Cardiovascular | |
4
Indications for Use
The Prelude Guide Sheath Introducer is indicated to be used for the introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.
A. Device Description
The Prelude Guide Sheath Introducer is a sterile, disposable device consisting of a (a) a coil reinforced shaft with an atraumatic tip and the distal end: (b) a hemostasis valve with a side port and color-coded stopcock; and (c) a tapered tip dilator with snap-fit hub at the proximal end.
(a) Shaft. The coil reinforced, multi-layer polymer shaft contains a tapered tip at the distal end. A continuous inner PTFE tube forms the core of the shaft and provides a circular working lumen through which devices can be passed. A single, full length Pebax tube creates the outer cover of the shaft. A stainless-steel flat wire coil is fused between the two polymer tubes along the entire length of the shaft. Hydrophilic coating is applied on the distal 35cm of the shaft. A radiopaque marker made of platinum iridium is embedded 5mm from the distal end of the shaft. At the proximal end of the shaft, a female, winged luer hub is over-molded onto the shaft to support handling and to provide for the connection of the hemostasis valve. This hub is color coded to match the French size of the device.
(b) Hemostasis valve. A removable hemostasis valve is thread onto the luer hub at the proximal end of the shaft. Inside the valve housing, a lubricated, silicone slit disc provides a seal around devices passed through the sheath, thereby preventing blood leakage through the valve. Just distal of the valve housing is connected to a side port leading to a threeway stopcock valve. The sideport is used for flushing the introducer sheath. At the proximal end of the valve housing, the color-coded housing cap provides a snap fit connection the hub of the dilator.
(c) Dilator. The dilator made of a polypropylene blend with Pebax and Barium sulphate (4F) or polypropylene blend with Bismuth Oxychloride (5-8F) contains a full-length round lumen to allow placement over guidewire. The distal end of the dilator is configured as a tapered tip that extends about 2 cm beyond the end of the sheath when the dilator is fully inserted through the sheath. An integral, color coded luer hub that is over-molded onto the proximal end the dilator supports handling of the dilator and provides a snap fit connection to the valve housing cap at the proximal end of the sheath introducer.
5
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 0.035 inches for 4 French and up to 0.038 inches for 5 French through 8 French models. Guide wire is not part of the device. 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 Prelude Guide Sheath consists of twenty-nine (29) models of different sizes (4 French, 5 French, 6 French, 7 French and 8 French) and effective lengths (45cm, 65cm and 90 cm).
D. Comparison of Technological Characteristics with the Predicate Devices
With regard to the design, device features, method of sterilization, and mode of operation, the Prelude Guide Sheath does not differ from the predicate devices. Materials used to manufacture the Prelude Guide Sheath are identical to that used in the legally marketed predicate device, or very similar to those contained in the legally marketed reference device.
Technological characteristics of the subject device do not differ from the predicate device and differ only with respect to materials for selected components and the choice of lubricious coating on the sheath from a hydrophobic coating to a hydrophilic coating which is similar to the reference device. Both the Pebax used for the outer layer and the hydrophilic coating applied to the distal end of the Prelude Guide Sheath are commonly used in medical devices, including introducer sheaths and catheters. There are no differences in the material and technological characteristics between the subject device and the predicate device.
E. Performance Tests
Nonclinical performance data demonstrates that the Prelude Guide Sheath 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. ●
6
The list of tests performed to support determination of substantial equivalence is provided in the table below.
| Testing Performed | ||
|---|---|---|
| No, | Verification/Validation Test | Applicable Standard(s) |
| 1 | Insertion Force/Tip Insertion | |
| Peel Back | Internal Requirement | |
| 2 | Peak Tensile Force Shaft/Hub & | |
| Tip | ISO 10555-1:2013 | |
| ISO 10555-3:2013 | ||
| ISO 11070:2014 | ||
| 3 | Visual (Extraneous/Surface | |
| Defects) | ISO 11070:2014 | |
| 4 | Sheath Stiffness | Internal Requirement |
| 5 | Sheath Kink | Tested through Validation |
| 6 | Radiopacity marker band & tip | ISO 11070:2014, ASTM F640-12 |
| ISO 10555-1:2013 | ||
| 7 | Hydrophilic coating durability & | |
| coverage/coating length | Internal Requirement | |
| 8 | Hydrophilic Coating Lubricity | Tested through Validation |
| 9 | Coating integrity test (particulate | |
| evaluation) | ASTM F1877-16 | |
| Class II Special Controls Guidance for | ||
| Certain Percutaneous Transluminal | ||
| Coronary Angioplasty (PTCA) Catheters | ||
| 10 | Corrosion resistance | ISO 11070:2014 |
| 11 | Sheath assembly leak | ISO 11070:2014 |
| 12 | Hydrogen Peroxide Resistance | ISO 10555-1:2013 |
| ISO 10555-3:2013 | ||
| 13 | Radiopacity Dilator | ISO 11070:2014 |
| ISO 10555-1:2013 | ||
| 14 | Dilator tip fracture | Internal Requirement |
| 15 | Dilator-to-Hub Tensile | ISO 10555-1:2013 |
| 16 | Sheath tip to dilator taper length | Internal Requirement |
| 17 | Dilator Stiffness & Hub Snap | |
| Force | No Standard-Tested through Validation | |
| 18 | Dilator Insertion/Removal from Sheath | No Standard - Testing through Validation |
| 19 | Dimensional tests for OD & ID of sheath & dilator | ISO 11070:2014 |
| 20 | Curve shape & visual for sheath & dilator | Internal Requirement |
| 21 | Curve Retention | No standard - Testing through Validation |
| 22 | Sheath Effective Length | ISO 10555-1:2013 |
| 23 | Luer Design Tests | ISO 11070:2014 |
| ISO 594-1: 1986 | ||
| ISO 594-2:1998 | ||
| 24 | Hemostasis Valve Leakage | 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 | |
| Cytotoxicity Testing | ||
| Sensitization | ||
| Irritation | ||
| Acute Systemic Toxicity | ||
| Pyrogenicity | ||
| Hemocompatibility | ||
| • ASTM Hemolysis Study – Direct Contact and Extract Method: Phosphate Buffered Saline Extraction | 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 | ||
| ο | Complement Activation | |
| (SC5b-9 only) Assay | ||
| Thrombogenicity Study – In-vitro | ||
| Blood Loop Assay, Partial | ||
| Thromboplastin Time (PTT) | ||
| 28 | Chemical Characterization – | |
| Particulate Analysis | ASTM F1877-16 |
7
8
F. Conclusions
The results of the testing demonstrated that the subject Prelude Guide Sheath 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 Prelude Guide Sheath raises no new questions of safety and effectiveness compared to the predicate device and is substantially equivalent to the predicate device, DuraSheath Introducer Sheath System K181463 manufactured by Contract Medical International.