(22 days)
Prelude® Sheath Introducer
Not Found
No
The 510(k) summary describes a standard medical device (sheath introducer) with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML functionality. The description focuses on the physical components and intended use for vascular access.
No.
The device is an introducer sheath that facilitates the introduction of other devices for diagnostic and therapeutic procedures, but it does not perform a therapeutic function itself.
No
The device is described as an introducer to facilitate the percutaneous introduction of various devices for diagnostic and therapeutic procedures, but it is not itself performing a diagnostic function.
No
The device description clearly states it consists of physical components like a sheath introducer, vessel dilator, sideport, extension tubing, 3-way stopcock, hemostasis valve, suture ring, guide wire, needle, and a radiopaque marker tip. These are all hardware components.
Based on the provided information, the Prelude® Sheath Introducer is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing access and facilitating the introduction of devices into veins and/or arteries for diagnostic and therapeutic procedures. This describes a device used in vivo (within the body) for accessing the vascular system.
- Device Description: The description details a physical device (sheath, dilator, stopcock, hemostasis valve) designed for insertion into blood vessels. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) in vitro (outside the body) to provide information for diagnostic purposes.
IVD devices are specifically designed to perform tests on biological samples outside the body to aid in diagnosis, monitoring, or screening. The Prelude® Sheath Introducer's function is to provide access to the vascular system within the body.
N/A
Intended Use / Indications for Use
The Prelude® 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.
Product codes
DRE
Device Description
Merit Medical System's Prelude Sheath Introducer consists of a sheath introducer with compatible vessel dilator that snaps securely into the sheath introducer hub. The sheath is equipped with a sideport attached to a segment of extension tubing terminating in a 3-way stopcock. The sheath hub contains an integral hemostasis valve and suture ring. The device is marketed with and without an appropriately sized guide wire and/or needle. The subject sheath introducers have a radiopaque marker tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
veins and/or arteries
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
Verification and Validation Studies, conducted to demonstrate control of hazards identified in Merit's Clinical Risk Assessment, demonstrate that the modified devices met all of their pre-determined acceptance criteria and acceptably control the identified hazards.
Key Metrics
Not Found
Predicate Device(s)
Prelude® Sheath Introducer
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).
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SECTION 5: 510(k) SUMMARY
NOV 2 0 2007
Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095
K 073035
CONTACT:
Shirley Hyink
October 26, 2007 DATE PREPARED:
TRADE OR PROPRIETARY NAME: Prelude® Sheath Introducer
CLASSIFICATION NAME: Dilator, Vessel, For Percutanious Catheterization (870.1310)
Prelude® Sheath Introducer PREDICATE DEVICES:
DEVICE DESCRIPTION: Merit Medical System's Prelude Sheath Introducer consists of a sheath introducer with compatible vessel dilator that snaps securely into the sheath introducer hub. The sheath is equipped with a sideport attached to a segment of extension tubing terminating in a 3-way stopcock. The sheath hub contains an integral hemostasis valve and suture ring. The device is marketed with and without an appropriately sized guide wire and/or needle. The subject sheath introducers have a radiopaque marker tip.
INTENDED USE: The Prelude 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.
TECHNOLOGICAL COMPARISON : The modified device has the identical intended use and employs the same fundamental technology as the predicate device. A radiopaque marker tip is being added to the distal end of the sheath introducers.
PERFORMANCE TESTING: Verification and Validation Studies, conducted to demonstrate control of hazards identified in Merit's Clinical Risk Assessment, demonstrate that the modified devices met all of their pre-determined acceptance criteria and acceptably control the identified hazards.
SUMMARY OF SUBSTANTIAL EQUIVALENCE
Based on:
- . Merit's conformance with Design Control requirements,
- Analyses of Risks associated with the Modified Device; and .
- Results of Verification and Validation tests identified in the Clinical Risk Assessment, . demonstrating that predetermined acceptance criteria have been met:
the modified devices are as safe and effective as, and perform as well as, or better than, the predicate devices.
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Public Health Service
Image /page/1/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 0 2007
Merit Medical System, Inc. c/o Ms. Shirley Hyink Manager, Regulatory Affairs 1600 West Merit Parkway South Jordan, UT 84095
Re: K073035
Trade/Device Name: Prelude® Sheath Introducer Regulation Number: 21 CFR 870.1310 Regulation Name: Dilator, Vessel for Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: November 6, 2007 Received: November 7, 2007
Dear Ms. Hyink:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
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Page 2 – Ms. Shirley Hyink
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Mcdical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
ina R. Vochner
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4: INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Prelude® Sheath Introducer
Indications for Use:
The Prelude® 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.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Lechner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K073035