(69 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical performance of a sheath introducer, with no mention of AI or ML capabilities.
No.
The device is intended to provide access for other devices used in diagnostic and therapeutic procedures, but it is not itself a therapeutic device.
No
Explanation: The "Intended Use / Indications for Use" section states that the device 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." This indicates the device is an accessory used to facilitate diagnostic procedures, rather than being a diagnostic device itself.
No
The device description clearly outlines physical components such as a sheath introducer, dilator, hub, valve, suture ring, tubing, sidearm, stopcock, guide wire, and needles, indicating it is 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 clearly states that the device is used to "provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries". This describes a device used in vivo (within the body) for procedural access, not a device used in vitro (outside the body) to examine specimens like blood or tissue for diagnostic purposes.
- Device Description: The description details components like a sheath introducer, dilator, hemostasis valve, and sidearm, all of which are consistent with a device used for vascular access during medical procedures. There is no mention of reagents, assays, or other components typically associated with IVD devices.
- Anatomical Site: The device is intended for use in "veins and/or arteries", which are anatomical structures within the body. IVD devices typically analyze samples taken from the body.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, performing diagnostic tests, or providing diagnostic information based on the analysis of specimens.
In summary, the Merit Prelude IDeal Hydrophilic Sheath Introducer is a medical device used for vascular access during procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Merit Prelude IDeal Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guide wires.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The 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 Prelude Ideal Hydrophilic Sheath Introducer is available in 7cm. 11cm, 16cm and 23cm lengths, (French sizes 4F, 5F, 6F and 7F) and is designed to accept 0.018", 0.021" and 0.025" diameter guide wires. The Prelude Ideal Hydrophilic Sheath Introducer is marketed with any of the following components, depending on the product configuration: guide wire, metal access needle, access needle with inner metal needle and outer plastic cannula and BowTie™ guide wire insertion device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
veins and/or arteries, including but not limited to the radial artery
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 of the subject 7F Prelude IDeal Hydrophilic Sheath Introducer was conducted based on the risk analysis and based on the requirements of the following international standard:
- ISO 11070:1998, Sterile, single-use intravascular catheter introducers
- ISO 11135:2014, Sterilization of health care products – Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 10993-1:2009, Biological Evaluation of Medical Devices Part ● 1: Evaluation and Testing within a risk management process, and FDA quidance Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995
- ISO 10993-3:2014, Biological Evaluation of Medical Devices Part ● 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
- ISO 10993-4:2002 (Amd.1:2006), Biological evaluation of medical ● devices - Part 4: Selection of tests for interactions with blood
- ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- ISO 10993-7:2008. Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- ISO 10993-10:2010. Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization
- ISO 10993-11:2006, Biological evaluation of medical devices -Part 11: Tests for systemic toxicity
- ASTM F756-17, Standard practice for assessment of hemolytic properties of materials
- United States Pharmacopeia 40, National Formulary 35, 2017 Pyrogen Test
The following tests were performed to demonstrate there were no unacceptable risks associated with the changes made to the device:
Performance Testing - Bench
- Suture Ring Rotation
- 90º Tip Bend Test/Conditioning
- Tensile Tip to Shaft
- Sheath Assembly Leak, 300kPa
- Tensile Hub to Sidearm (4F only)
- Tensile - Valve Cap to Hub
- Tensile Suture Ring to Strain Relief
- Dilatory Drag through Sheath Tip and Valve
- Sheath Effective Length
- Kink Dual Pivot
- Stiffness, Force of Deflection
- Sidewall Compression
- Tip Insertion Force (with coating activation)
- Coating Lubricity and Durability
- Sheath Bend Radius
- Radiopacity of Shaft and Tip
- Hydrophilic Coating Uniformity, Coverage Length
- Tensile - Hub to Shaft
- Sheath Tip Ball Gauge Drag
- Sheath Shaft Inner Diameter
- Sheath Shaft Outer Diameter
- Tensile Shaft
- Torque Shaft to Hub
- Corrosion Resistance
Particulate Evaluation
Validation Testing
- Outer Surface
- Stiffness with Dilator
- Catheter Insertion and Exchange
- Sheath Stiffness without Dilator
Biocompatibility
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Pyrogenicity
- Genotoxicity
- Hemolysis
- Thrombogenicity
- Complement Activation
- Chemical Characterization
Key Results: The results of the testing demonstrated that the subject Prelude IDeal Hydrophilic Sheath Introducer 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.
Not Found
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
February 15, 2018
Merit Medical Systems, Inc. David Thomas Principal Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, Utah 84095
Re: K173750
Trade/Device Name: Prelude IDeal Hydrophilic Sheath Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: January 15, 2018 Received: January 16, 2018
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. The general controls provisions of the Act include requirements for annual registration. Iisting 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 of medical device-related 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
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Kenneth J. Cavanaugh -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) K173750
Device Name Prelude IDeal Hydrophilic Sheath Introducer
Indications for Use (Describe)
The Merit Prelude IDeal Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guide wires.
| 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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3
510(k) Summary - K173750
Submitter Name: Merit Medical Systems, Inc. Address: 1600 West Merit Parkway South Jordan, UT 84095 General Telephone Number: (801) 316-4956 Provisions Fax Number: (801) 253-6982 Contact Person: David Thomas Date of Preparation: January 15, 2018 Registration Number: 1721504 Prelude IDeal™ Hydrophilic Sheath Introducer Trade Name: Common/Usual Name: Sheath Introducer Classification Name: Catheter Introducer Subject Device Requlatory Class: Product Code: DYB 870.1340 21 CFR §: Review Panel: Cardiovascular PreludeEASE™ Hydrophilic Sheath Introducer Trade Name: Classification Name: Sheath Introducer Predicate Premarket Notification: K140543 (Primary Predicate Device) Device K150257 (Secondary Predicate Device) Manufacturer: Merit Medical Systems, Inc. This predicate has not been subject to a design-related recall. The 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. Device Description The Prelude Ideal Hydrophilic Sheath Introducer is available in 7cm. 11cm, 16cm and 23cm lengths, (French sizes 4F, 5F, 6F and 7F) and is designed to accept 0.018", 0.021" and 0.025" diameter guide wires. The Prelude Ideal Hydrophilic Sheath Introducer is marketed with any of the following components, depending on the product configuration:
guide wire, metal access needle, access needle with inner metal needle and outer plastic cannula and BowTie™ guide wire insertion device.
ਹ
4
| Indications for
Use | The Merit Prelude IDeal Hydrophilic Sheath Introducer is intended to
provide access and facilitate the percutaneous introduction of various
devices into veins and/or arteries, including but not limited to the radial
artery, while maintaining hemostasis for a variety of diagnostic and
therapeutic procedures.
The access needle with inner metal needle and outer plastic cannula is
used to gain access to the vein or artery for placement of guide wires. |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to
Predicate
Device | The technological characteristics of the subject Prelude Ideal
Hydrophilic Sheath Introducer are substantially equivalent to those of
the predicate 4F through 7F PreludeEASE 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 in the materials used for the
sheath that allow for a thinner wall sheath than the predicate devices
and the colorants used on the strain relief, sheath cap and stopcock
handle. |
5
No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the subject 7F Prelude IDeal Hydrophilic Sheath Introducer was conducted based on the risk analysis and based on the requirements of the following international standard:
- . ISO 11070:1998, Sterile, single-use intravascular catheter introducers
- . ISO 11135:2014, Sterilization of health care products – Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 10993-1:2009, Biological Evaluation of Medical Devices Part ● 1: Evaluation and Testing within a risk management process, and FDA quidance Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995
- ISO 10993-3:2014, Biological Evaluation of Medical Devices Part ● 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
- ISO 10993-4:2002 (Amd.1:2006), Biological evaluation of medical ● devices - Part 4: Selection of tests for interactions with blood
Performance Tests
●
- ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- . ISO 10993-7:2008. Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- ISO 10993-10:2010. Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization
- . ISO 10993-11:2006, Biological evaluation of medical devices -Part 11: Tests for systemic toxicity
- . ASTM F756-17, Standard practice for assessment of hemolytic properties of materials
- . United States Pharmacopeia 40, National Formulary 35, 2017 Pyrogen Test
The following tests were performed to demonstrate there were no unacceptable risks associated with the changes made to the device:
Performance Testing - Bench
- Suture Ring Rotation
- 90º Tip Bend Test/Conditioning ●
- Tensile Tip to Shaft ●
- Sheath Assembly Leak, 300kPa
- Tensile Hub to Sidearm (4F only) ●
- . Tensile - Valve Cap to Hub
6
- Tensile Suture Ring to Strain Relief .
- Dilatory Drag through Sheath Tip and Valve .
- Sheath Effective Length ●
- Kink Dual Pivot ●
- Stiffness, Force of Deflection
- Sidewall Compression ●
- Tip Insertion Force (with coating activation) ●
- Coating Lubricity and Durability
- Sheath Bend Radius ●
- Radiopacity of Shaft and Tip
- Hydrophilic Coating Uniformity, Coverage Length ●
- Tensile - Hub to Shaft
- Sheath Tip Ball Gauge Drag
- Sheath Shaft Inner Diameter ●
- Sheath Shaft Outer Diameter ●
- Tensile Shaft ●
- Torque Shaft to Hub ●
- Corrosion Resistance .
Performance Tests cont.
Particulate Evaluation .
Validation Testing
- Outer Surface
- Stiffness with Dilator .
- Catheter Insertion and Exchange ●
- . Sheath Stiffness without Dilator
Biocompatibility
- Cytotoxicity
- Sensitization ●
- Irritation ●
- Acute Systemic Toxicity ●
- Pyrogenicity ●
- Genotoxicity ●
- Hemolysis ●
- Thrombogenicity
- Complement Activation ●
- Chemical Characterization ●
7
| | The results of the testing demonstrated that the subject Prelude IDeal
Hydrophilic Sheath Introducer met the predetermined acceptance
criteria applicable to the performance of the device. |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of
Substantial
Equivalence | Based on the indications for use, design, and performance testing, the
subject Prelude IDeal Hydrophilic Sheath Introducer raises no new
questions of safety or effectiveness compared to the predicate device
and is substantially equivalent to the predicate device, the
PreludeEASE Hydrophilic Sheath Introducer, K140543 and K150257,
manufactured by Merit Medical Systems, Inc. |