(155 days)
Not Found
No
The summary describes a standard sheath introducer with no mention of AI or ML capabilities.
No.
Explanation: The device is an introducer sheath, which facilitates the introduction of other devices for diagnostic and therapeutic procedures. It does not perform a therapeutic function itself.
No
The device is described as a sheath introducer intended to provide access and facilitate the percutaneous introduction of other devices. While it can be used in procedures that are diagnostic, the device itself does not perform a diagnostic function (e.g., measuring, analyzing, or interpreting physiological data to diagnose a condition). Its role is purely procedural.
No
The device description clearly outlines physical components such as a sheath introducer, vessel dilator, sideport, extension tubing, 3-way stopcock, hemostasis valve, suture ring, guide wire, and access needle. These are all hardware components, indicating it is not a software-only device.
Based on the provided information, the Merit 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 involves direct interaction with the patient's circulatory system.
- Device Description: The description details a physical device (sheath, dilator, stopcock, valve) designed for insertion into the body.
- 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) in vitro (outside the body) to provide information for diagnostic purposes.
IVD devices are used to perform tests on samples taken from the body to diagnose diseases or conditions. The Merit Prelude™ Sheath Introducer is a medical device used in vivo (within the body) for procedural access.
N/A
Intended Use / Indications for Use
The Merit 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 (comma separated list FDA assigned to the subject device)
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 access needle.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and Validation Studies, as identified in the Clinical Risk Assessment, were completed and demonstrated that the modified devices met all of their pre-determined acceptance criteria.
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
§ 870.1310 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).
0
Merit Medical Systems, Inc. Merit Prelude™ Sheath Introducer Special [510(k)] PREMARKET NOTIFICATION CONFIDENTIAL
Attachment 4
JUN 2 1 2007
510(k) Summary
SAFETY AND EFFECTIVENESS SUMMARY
This information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Submitted by Name/Address: | Merit Medical Systems, Inc
1600 West Merit Parkway
South Jordan, Utah 84095 |
|------------------------------------|---------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 1721504 |
| Primary Contact Person: | Jerrie Hendrickson
Regulatory Affairs Specialist II |
| Telephone: | (801) 208-4119 |
| Fax: | (801) 253-6918 |
| Email: | jhendri@merit.com |
| Alternate Contact Person: | Stephanie A. Erskine
Vice President Corporate Regulatory Affairs |
| Telephone: | (801) 208-4349 |
| Fax: | (801) 253-6967 |
| Email: | serskine@merit.com |
| Date Summary Prepared: | January 16, 2007 |
| Trade Name: | Prelude™ Sheath Introducer |
| Common Name: | Vessel Dilator for Percutaneous Catheterization |
| Classification Name | Vessel Dilator for Percutaneous Catheterization,
Class II, Product Code DRE (per 21 CFR
870.1310) |
| Predicate Device | Prelude™ Sheath Introducer (K050962), manufactured by Merit
Medical Systems, Inc. |
1
Merit Medical Systems, Inc. Merit Prelude™ Sheath Introducer Special [510(k)] PREMARKET NOTIFICATION CONFIDENTIAL
| 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 access needle. |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Merit 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. |
| Technology Comparison | The modified device has the identical intended use and employs
the same fundamental technology as the predicate device.
Additional sizes have been added, minor changes in materials
have been made, and the configuration of the dilator tip has
been modified to accept smaller size guide wires. In addition,
some kits containing the Prelude™ are now marketed with
appropriately sized guide wires and access needles. |
| Performance Testing | Verification and Validation Studies, as identified in the Clinical
Risk Assessment, were completed and demonstrated that the
modified devices met all of their pre-determined acceptance
criteria. |
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 Risk Analyses . 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.
2
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with its wings forming three distinct, curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 1 2007
Ms. Jerrie Hendrickson Regulatory Affairs Specialist Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095
Re: K070159
Trade/Device Name: Prelude™ Sheath Introducer Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator for Percutaneous Catherization Regulatory Class: Class II Product Code: DRE Dated: May 21, 2007 Received: May 23, 2007
Dear Ms. Hendrickson:
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.
3
Page 2 - Ms. Jerrie Hendrickson
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 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.
Dma R. bohner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
pg. 141 1 KD 10154
Merit Medical Systems, Inc. Merit Prelude™ Sheath Introducer Special [510(k)] PREMARKET NOTIFICATION CONFIDENTIAL
Attachment 2
Indications for Use Statement
510(k) Number (if known):
Device Name:
Merit Prelude™ Sheath Introducer
Indications for Use:
The Merit 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 901 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart O)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. de Jesus
Division Sign-Off) (Division of Cardiovascular Devices
510(k) Number K070159