(226 days)
Not Found
No
The device description and performance studies focus on the physical and mechanical properties of a sheath introducer, with no mention of AI or ML capabilities.
No.
The device is intended to facilitate the introduction of other devices used in diagnostic or therapeutic procedures, but it does not perform a therapeutic function itself.
No.
The device is intended to provide access and facilitate the introduction of other devices for diagnostic or therapeutic procedures, but it is not itself a diagnostic device; it is an introducer sheath.
No
The device description clearly outlines a physical medical device consisting of a sheath introducer, dilator, access needle, and various accessories like guide wires, syringes, and scalpels. The performance studies also focus on physical characteristics and biocompatibility, not software validation.
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... while maintaining hemostasis for a variety of diagnostic or therapeutic procedures." This describes a device used in vivo (within the body) to facilitate other procedures, not a device used in vitro (outside the body) to examine specimens from the body.
- Device Description: The description details components like a sheath introducer, dilator, sidearm, stopcock, hemostasis valve, and access needle. These are all components of a device used for vascular access and introduction of other devices into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological specimens (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
Therefore, the Merit PreludeEASE™ Hydrophilic Sheath Introducer is a medical device used for vascular access and introduction, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Merit PreludeEASE™ 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 or 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 PreludeEASE™ Hydrophilic Sheath Introducer consists of a sheath introducer with compatible vessel dilator that snaps securely into the sheath introducer hub. The sheath is coated with a hydrophilic coating and is equipped with a sidearm terminating in a 3-way stopcock. The sheath hub contains an integral hemostasis valve and suture ring. The access needle with inner metal needle and outer plastic cannula is an accessory device which is used to gain access to the vein or artery for placement of guide wires.
The PreludeEASE 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, syringe, scalpel 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 PreludeEASE 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 11135-1:2007, Sterilization of health care products – Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ISO 11607-1:2010, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems ASTM D4169-09, Standard Practice for performance Testing of Shipping Containers and Systems ISO 2233:2000, Packaging – Complete, filled transport packages and unit loads – Conditioning for testing ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, and FDA guidance Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995 ANSI/AAMI/ISO 10993-3:2003, 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 F756-08, Standard practice for assessment of hemolytic properties of materials United States Pharmacopeia 35, National Formulary 30, 2012 Pyrogen Test
Performance Testing-Bench
- Surface
- Radiodetectability
- Size Designation
- Sheath Introducer Assembly Leak
- Sheath Introducer Hemostasis Valve 5.8 psi Leak
- Sheath Introducer Tubing Pull (Force at Break)
- Sheath Introducer Hub to Tubing Pull (Force at Break)
- Dilator Hub to Tubing Pull (Force at Break)
- Sheath / Dilator Tip Peel Back
- Hemostasis Valve Dislodgement
- Hemostasis Valve Vacuum
- Hemostasis Valve Low Pressure with Dilator Dwell
- Sidearm to Sheath Hub Pull (Force at Break)
- Sheath Hub to Cap Pull (Force at Break)
- Sheath Introducer Stiffness and Flex Modulus
- Sheath Introducer Kink Resistance
- Suture Ring Pull Test
- Dilator Stiffness and Flex Modulus
- Hydrophilic Coating Lubricity
- Hydrophilic Coating Coverage/Adherence and Length
- Two-Part Access Needle Metal Cannula to Hub Pull
- Two-Part Access Needle Plastic Cannula to Hub Pull
- Two-Part Access Needle Insertion and Withdrawal Test
- Particulate Evaluation
- Kink Resistance
- Torque Strength
- Packaging Testing
- Scalpel Flex Test
Biocompatibility
- Cytotoxicity
- Sensitization
- Intracutaneous Injection
- Acute Systemic Toxicity
- Pyrogenicity
- Genotoxicity
- Hemolysis
- Thrombogenicity
- Complement Activation
- Chemical Characterization
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/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other. The faces are facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 16, 2014
Merit Medical Systems, Inc. Ms. Michaela Rivkowich Principal Regulatory Affairs Specialist 1600 West Merit Pkwv. South Jordan, Utah 84095
Re: K140543
Trade/Device Name: PreludeEase Hydrophilic Sheath Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 3, 2014 Received: September 4, 2014
Dear Ms. Rivkowich,
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, 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Melissa A. Torres -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) K140543
Device Name PreludeEASE Hydrophilic Sheath Introducer
Indications for Use (Describe)
The Merit PreludeEASE 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| 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) 208-4196
(801) 253-6932
Michaela Rivkowich
October 16, 2014
1721504 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject
Device | Trade Name:
Common/Usual Name:
Classification Name: | PreludeEASE™ Hydrophilic Sheath Introducer
Sheath Introducer
Catheter Introducer |
| Predicate
Device | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | Prelude® PSI Sheath Introducer
Vessel Dilator for Percutaneous
Catheterization
K070159
Merit Medical Systems, Inc. |
| Predicate
Device | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | Glidesheath
Catheter Introducer
K102008
Terumo Medical Corporation |
| Classification | Class II
21 CFR § 870.1340
FDA Product Code: DYB
Review Panel: Cardiovascular | |
| Intended Use | The Merit PreludeEASE™ 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 or
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. | |
| Device
Description | The PreludeEASE™ Hydrophilic Sheath Introducer consists of a sheath
introducer with compatible vessel dilator that snaps securely into the
sheath introducer hub. The sheath is coated with a hydrophilic coating
and is equipped with a sidearm terminating in a 3-way stopcock. The
sheath hub contains an integral hemostasis valve and suture ring. The
access needle with inner metal needle and outer plastic cannula is an
accessory device which is used to gain access to the vein or artery for
placement of guide wires. | |
| | The PreludeEASE 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, syringe, scalpel and BowTie™ guide wire
insertion device. | |
| Comparison
to Predicate
Device | The technological characteristics of the subject PreludeEASE
Hydrophilic Sheath Introducer are substantially equivalent to those of
the predicate devices. The subject device has the same basic design
as the predicate devices in that it consists of a sheath tubing, hub,
sidearm and stopcock and is provided with a vessel dilator. The main
difference is in the device materials. Just as the predicate devices, the
PreludeEASE is provided with kit components typically used to obtain
vascular access. | |
| Safety &
Performance
Tests | No performance standards have been established under Section 514 of
the Food, Drug and Cosmetic Act for these devices. Performance
testing of the subject PreludeEASE 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 11135-1:2007, Sterilization of health care products – Ethylene
oxide - Part 1: Requirements for development, validation and
routine control of a sterilization process for medical devices ISO 11607-1:2010, Packaging for terminally sterilized medical
devices Part 1: Requirements for materials, sterile barrier systems
and packaging systems ASTM D4169-09, Standard Practice for performance Testing of
Shipping Containers and Systems ISO 2233:2000, Packaging – Complete, filled transport packages
and unit loads – Conditioning for testing ISO 10993-1:2009, Biological Evaluation of Medical Devices Part
1: Evaluation and Testing within a risk management process, and
FDA guidance Required Biocompatibility Training and Toxicology
Profiles for Evaluation of Medical Devices, May 1, 1995 ANSI/AAMI/ISO 10993-3:2003, 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 F756-08, Standard practice for assessment of hemolytic
properties of materials United States Pharmacopeia 35, National Formulary 30, 2012
Pyrogen Test | |
4
5
6
Performance Testing-Bench
- Surface
- Radiodetectability ●
- Size Designation ●
- Sheath Introducer Assembly Leak ●
- Sheath Introducer Hemostasis Valve 5.8 psi Leak ●
- Sheath Introducer Tubing Pull (Force at Break) ●
- Sheath Introducer Hub to Tubing Pull (Force at Break) ●
- Dilator Hub to Tubing Pull (Force at Break)
- Sheath / Dilator Tip Peel Back
- Hemostasis Valve Dislodgement
- Hemostasis Valve Vacuum
- Hemostasis Valve Low Pressure with Dilator Dwell ●
- Sidearm to Sheath Hub Pull (Force at Break)
- Sheath Hub to Cap Pull (Force at Break) ●
- Sheath Introducer Stiffness and Flex Modulus ●
- Sheath Introducer Kink Resistance
- Suture Ring Pull Test
- Dilator Stiffness and Flex Modulus
- Hydrophilic Coating Lubricity
- Hydrophilic Coating Coverage/Adherence and Length
- Two-Part Access Needle Metal Cannula to Hub Pull ●
- Two-Part Access Needle Plastic Cannula to Hub Pull
- Two-Part Access Needle Insertion and Withdrawal Test
- Particulate Evaluation ●
- . Kink Resistance
- Torque Strength .
- Packaging Testing ●
- Scalpel Flex Test ●
Biocompatibility
- Cytotoxicity ●
- Sensitization ●
- Intracutaneous Injection ●
- Acute Systemic Toxicity
- Pyrogenicity ●
- Genotoxicity ●
- Hemolysis ●
- Thrombogenicity ●
- Complement Activation ●
- Chemical Characterization ●
Safety & Performance Tests cont.
7
| Summary of
Substantial
Equivalence | Based on the indications for use, design, safety and performance
testing. the subject PreludeEASE Hydrophilic Sheath Introducer meets
the requirements that are considered essential for its intended use and
is substantially equivalent to the predicate devices, the Prelude PSI
Sheath Introducer, K070159 and the Glidesheath, K102008. |
| ------------------------------------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|