(77 days)
Not Found
No
The device description and performance studies focus on the physical components and material properties of a sheath introducer, with no mention of AI, ML, image processing, or data-driven algorithms.
No.
The device facilitates the introduction of other devices for diagnostic and therapeutic procedures, but it does not itself perform a therapeutic function.
No
The "Intended Use / Indications for Use" states that the device is intended to "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 that the device itself is an accessory used during diagnostic procedures by introducing other diagnostic devices, but it does not perform a diagnostic function itself.
No
The device description clearly outlines physical components like a sheath introducer, vessel dilator, side arm, stopcock, hemostasis valve, suture ring, radiopaque marker tip, and optional guide wire. This indicates a hardware-based medical device, not a software-only one.
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 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 living body).
- Device Description: The description details a physical device designed for insertion into blood vessels, including a sheath, dilator, stopcock, and hemostasis valve. These are components of an invasive medical device, not a device used to examine samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (like blood, urine, or tissue) in vitro (in a test tube or lab setting) to provide diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the body to diagnose diseases or conditions. This device is designed to facilitate procedures performed directly on the patient's circulatory system.
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
The 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 side arm terminating in a 3-way stopcock. The sheath hub contains an integral hemostasis valve and a suture ring. The subject sheath introducer has a radiopaque marker tip. The device is marketed with and without an appropriately sized guide wire.
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
Performance testing of the subject Prelude® 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 ANSI/AAMI/ISO 11135-1:2007, Sterilization of health care products - 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 guidance Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995 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 interaction with blood ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2002 (Amd. 1:2006), Biological evaluation of medical devices – Part 10: Tests for irritation and delayed type hypersensitivity 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 F756-08:2008, Standard Practice for Assessment of Hemolytic Properties of Materials United States Pharmacopeia 33, National Formulary 28, 2010 Pyrogen Test. Test results demonstrated that the subject Prelude® Sheath Introducer met the pre-determined acceptance criteria applicable to the safety and efficacy of the device.
Key Metrics
Not Found
Predicate Device(s)
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).
0
·
| Section 5 | JUN 07 2013 | ||
|---|---|---|---|
| 510(k) Summary | |||
| General | |||
| Provisions | Submitter Name: | Merit Medical Systems, Inc. | |
| Address: | 1600 West Merit Parkway | ||
| South Jordan, UT 84095 | |||
| Telephone Number: | (801) 208-4196 | ||
| Fax Number: | |||
| Contact Person: | |||
| Date of Preparation: | |||
| Registration Number: | (801) 253-6932 | ||
| Michaela Rivkowich | |||
| March 19, 2013 | |||
| 1721504 | |||
| Subject | |||
| Device | Trade Name: | Prelude® Sheath Introducer | |
| Common/Usual Name: | Vessel Dilator for Percutaneous Catheterization | ||
| Classification Name: | Vessel Dilator for Percutaneous Catheterization | ||
| Predicate | |||
| Device | Trade Name: | Prelude® Sheath Introducer | |
| Classification Name: | Vessel Dilator for Percutaneous Catheterization | ||
| Premarket Notification: | |||
| Manufacturer: | K073035 | ||
| Merit Medical Systems, Inc. | |||
| Classification | Class II | ||
| 21 CFR § 870.1310 | |||
| FDA Product Code: DRE | |||
| Review Panel: Cardiovascular | |||
| 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. | |||
| Device | |||
| Description | The 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 side arm terminating in a 3-way | |||
| stopcock. The sheath hub contains an integral hemostasis valve and a | |||
| suture ring. The subject sheath introducer has a radiopaque marker tip. | |||
| The device is marketed with and without an appropriately sized guide | |||
| wire. |
.
1
| Comparison to
Predicate
| Device | The subject device has the same technological characteristics (i.e., as the predicate device). The only change that was made was to the radiopaque marker tip material. |
|---|---|
| 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 Prelude® 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 ANSI/AAMI/ISO 11135-1:2007, Sterilization of health care products - 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 guidance Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995 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 interaction with blood ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2002 (Amd. 1:2006), Biological evaluation of medical devices – Part 10: Tests for irritation and delayed type hypersensitivity 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 F756-08:2008, Standard Practice for Assessment of Hemolytic Properties of Materials United States Pharmacopeia 33, National Formulary 28, 2010 Pyrogen Test The following is a list of all significant testing that was successfully completed: |
A 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
2
Design Verification
- . Tortuous path test
- t Force at break
- . Radiopacity
- Tip insertion/peel back ●
- . Dilator drag
- Stiffness �
Biocompatibility
- . Cytotoxicity
- . Sensitization
- Irritation .
- Acute Systemic Toxicity .
- ◆ Pyrogenicity
- Genotoxicity .
- ◆ Hemolysis
- Thrombogenicity .
- Complement Activation �
- Chemical Characterization .
The results of the testing demonstrated that the subject Prelude® Sheath Introducer met the pre-determined acceptance criteria applicable to the safety and efficacy of the device.
Summary of Substantial Equivalence
Based on the indications for use, design, safety and performance testing, the subject Prelude® Sheath Introducer meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device, the Prelude® Sheath Introducer, manufactured by Merit Medical Systems, Inc.
Safety & Performance Tests cont.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized depiction of an eagle. The eagle is composed of three parallel, curved lines that suggest the bird's wings and body, conveying a sense of motion and flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 7, 2013
Merit Medical Systems, Inc. C/O Michaela Rivkowich Principal Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, UT 84095
Re: K130791
Trade/Device Name: Prelude® Sheath Introducer Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator for Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: May 9, 2013 Received: May 10, 2013
Dear Ms. Michaela 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 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.
4
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 vours.
Z. Z.
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure.
5
Section 4
Indications for Use
510(k) Number:
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 × (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)