(67 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical performance of a sheath introducer system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an introducer system for pacing leads and catheters, not a system that provides therapy itself.
No
This device is described as an introducer system for inserting leads and catheters; it does not perform diagnostic functions but facilitates the introduction of other devices.
No
The device description clearly outlines multiple physical components including a splittable sheath introducer, dilator, needle, guide wire, and syringe, all made of physical materials. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "introduction of various types of pacing leads and catheters to the heart and coronary venous system." This describes a device used in vivo (within the body) for a procedural purpose.
- Device Description: The description details a physical device (sheath introducer, dilator, needle, guidewire, syringe) used to facilitate the insertion of other devices into the body. It does not describe a test or assay performed on biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical/interventional tool used to access a specific anatomical site.
N/A
Intended Use / Indications for Use
For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
Product codes
DYB
Device Description
Prelude SNAP™ Splittable Hydrophilic Sheath Introducer is a splittable hemostatic introducer system that is intended for the introduction of various types of pacing leads and catheters. The Prelude SNAP™ Splittable Hydrophilic Sheath Introducer system consists of a splittable sheath introducer lubricated with hydrophilic coating, dilator, 18g introducer needle, guide wire, and a syringe. The device is provided sterile and intended for single use only. It is for use in hospitals or healthcare facilities.
The splittable sheath introducer contains a hemostasis valve to minimize blood loss and air ingress during use. The introducer is available with a side-port and three-way stopcock that provides means for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The splittable sheath introducer is available in two lengths: 13cm and 25cm. The dilator is designed to conform to the inner diameter of the introducer and has a tapered tip.
The materials of construction are primarily polymers with the exception of the guide wire and needle cannula which are stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart and coronary venous system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals or healthcare facilities
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)
The Prelude SNAP™ Splittable Hydrophilic Sheath Introducer has been thoroughly tested through verification of product specifications and user requirements. The following quality assurance measures were applied during the development of the Prelude SNAP™ Splittable Hydrophilic Sheath Introducer:
- Risk Analysis
- Requirements/Specification Reviews ●
- Design Reviews ●
- Performance Testing-Bench ●
- Introducer Sheath Insertion O
- O Introducer Sheath Outer Diameter (O.D.)
- Introducer Sheath Tip Inner Diameter (I.D.) o
- Introducer Sheath Peel Force o
- Simulated Use Introducer Insertion (Kink and O Flexibility)
- Introducer Sheath Coating Length O
- Introducer Sheath Coating Adherence o
- Introducer Sheath Coating Lubricity/Durability O
- Particulate Testing O
- Sterilization Validation
- Biocompatibility Testing .
- o Cytotoxicity
No performance standards have been established under section 514 of the Food, Drug and Cosmetic Act for this device. When applicable, performance testing of the Prelude SNAP™ Splittable Hydrophilic Sheath Introducer was conducted based on the risk analysis and based on the requirements of the following international standards:
ISO 11070:1998E 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 AAMI TIR28:2009, Product adoption and process equivalence for ethylene oxide sterilization ISO 10993-1: 2009, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing within a risk management process, ISO 10993-7: 2008, Biological Evaluation of Medical Devices Part-7 Ethylene Oxide Sterilization Residuals USP 37-NF 32 , United States Pharmacopeia 37, National Formulary 32, 2014 Bacterial Endotoxins Test USP 37-NF 32 , United States Pharmacopeia 37, National Formulary 32, Pyrogen Test. 2014 AAMI/ANSI ST72:2011, Bacterial Endotoxins - Test methods, routine monitoring, and alternatives to batch testing ASTM D4169-09, Standard Practice for Performance Testing of Shipping Containers and Systems ISO 11607-1: 2009, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems ISO 14971:2012, Medical devices - Application of risk management to medical devices The results of the testing demonstrated that the subject Prelude SNAP™ Splittable Hydrophilic Sheath Introducer met the predetermined acceptance criteria of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines beneath them. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 30, 2015
Merit Medical Systems, Inc. Alina Stubbs Regulatory Affairs Specialist II 65 Great Valley Parkway Malvern, Pennsylvania 19355
Re: K152381
Trade/Device Name: Prelude SNAPTM Splittable Hydrophilic Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 30, 2015 Received: October 1, 2015
Dear Alina Stubbs:
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 of medical devicerelated 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
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
M.A. Hillebrand
for
for Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K152381
Prelude SNAP™ Splittable Hydrophilic Sheath Introducer Premarket Notification 510(k)
Merit Medical Systems, Inc.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
| 510(k) Number (if known) | |
|---|---|
| K152231 |
Device Name
Prelude SNAPTM Hydrophilic Splittable Sheath Introducer
Indications for Use (Describe)
For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
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."
FORM FDA 3881 (1/14)
Page 1 of 1
3
K152381 510(k) Summary
| General
Provisions | Submitter Name:
Address:
Telephone Number:
Fax Number:
Contact Person:
Date of Preparation:
Registration Number: | Merit Medical Systems, Inc.
65 Great Valley Parkway
Malvern, PA 19335
(610) 651-5046
(801) 545-4285
Alina Stubbs
October 27, 2015
2529252 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Trade Name:
Common/Usual Name:
Classification Name: | Prelude SNAP™ Splittable Hydrophilic Sheath
Introducer
Sheath Introducer
Introducer, Catheter (21 CFR §870.1340) |
| Predicate
Device | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | Prelude SNAP™ Splittable Sheath Introducer
Introducer, Catheter (21 CFR §870.1340)
K143255 - Prelude SNAP™ Splittable Sheath
Introducer
Merit Medical Systems, Inc. |
| Classification | | Class II
21 CFR § 870.1340
FDA Product Code: DYB
Review Panel: Cardiovascular |
| Intended Use | | Prelude SNAP™ Splittable Hydrophilic Sheath Introducer is indicated
"For the introduction of various types of pacing leads and catheters to
the heart and coronary venous system". |
4
| | Prelude SNAP™™ Splittable Hydrophilic Sheath Introducer is a splittable
hemostatic introducer system that is intended for the introduction of
various types of pacing leads and catheters. The Prelude SNAP™™
Splittable Hydrophilic Sheath Introducer system consists of a splittable
sheath introducer lubricated with hydrophilic coating, dilator, 18g
introducer needle, guide wire, and a syringe. The device is provided
sterile and intended for single use only. It is for use in hospitals or
healthcare facilities. | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Device
Description | The splittable sheath introducer contains a hemostasis valve to
minimize blood loss and air ingress during use. The introducer is
available with a side-port and three-way stopcock that provides means
for air or blood aspiration, fluid infusion, blood sampling, and pressure
monitoring. The splittable sheath introducer is available in two lengths:
13cm and 25cm. The dilator is designed to conform to the inner
diameter of the introducer and has a tapered tip. | |
| | The materials of construction are primarily polymers with the exception
of the guide wire and needle cannula which are stainless steel. | |
5
Summary of the technological characteristics of the modified device compared to the predicate device:
| | Technical Characteristics | Predicate Device
(K143255) | Subject Device |
|--|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|
| | Device Dimensions (nominal) | | |
| | Sheath introducer inner diameter (French) | 6F through 12.5F | 6F through 12.5F |
| | Sheath introducer length (cm) | 13 & 25 cm | 13 & 25 cm |
| | Sheath Introducer sideport and stopcock | Available with and without sideport and stopcock. | Available with sideport and stopcock only. |
| | Dilator outer diameter (French) | 6F through 12.5F | 6F through 12.5F |
| | Dilator length (in) | 13 cm: 8.34"
and
25 cm: 13.09" | 13 cm: 8.34"
and
25 cm: 13.09" |
| | Dilator tip ID (in) | 0.039" | 0.039" |
| | Introducer needle length (cm) | 7 cm | 7 cm |
| | Introducer needle outer diameter (gage) | 18 g | 18 g |
| | Guide wire length & diameter (in. x cm) | 13 cm: 0.038" x 50 cm J-Tip
and
25 cm: 0.038" x 80 cm J-Tip | 13 cm: 0.038" x 50 cm J-Tip
and
25 cm: 0.038" x 80 cm J-Tip |
| | Syringe volume (cc) | 12 cc or 10 cc | 12 cc or 10 cc |
| | Device Materials | | |
| | Sheath Lubricant | Silicone Dispersion | Hydrophilic Coating |
| | All other materials of the Prelude SNAP™ Splittable Hydrophilic Sheath Introducer are identical to the predicate device. | | |
Note: All dimensions are nominal.
6
The Prelude SNAP™ Splittable Hydrophilic Sheath Introducer has been thoroughly tested through verification of product specifications and user requirements. The following quality assurance measures were applied during the development of the Prelude SNAP™ Splittable Hydrophilic Sheath Introducer:
- Risk Analysis
- Requirements/Specification Reviews ●
- Design Reviews ●
- Performance Testing-Bench ●
- Introducer Sheath Insertion O
- O Introducer Sheath Outer Diameter (O.D.)
- Introducer Sheath Tip Inner Diameter (I.D.) o
- Introducer Sheath Peel Force o
- Simulated Use Introducer Insertion (Kink and O Flexibility)
- Introducer Sheath Coating Length O
- Introducer Sheath Coating Adherence o
- Introducer Sheath Coating Lubricity/Durability O
- Particulate Testing O
- Sterilization Validation
- Biocompatibility Testing .
- o Cytotoxicity
Safety & Performance Tests
7
| Safety &
Performance
Tests
(continued) | No performance standards have been established under section 514 of
the Food, Drug and Cosmetic Act for this device. When applicable,
performance testing of the Prelude SNAP™ Splittable Hydrophilic
Sheath Introducer was conducted based on the risk analysis and based
on the requirements of the following international standards:
ISO 11070:1998E 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 AAMI TIR28:2009, Product adoption and process equivalence
for ethylene oxide sterilization ISO 10993-1: 2009, Biological Evaluation of Medical Devices
Part-1: Evaluation and Testing within a risk management
process, ISO 10993-7: 2008, Biological Evaluation of Medical Devices
Part-7 Ethylene Oxide Sterilization Residuals USP 37-NF 32 , United States Pharmacopeia 37, National
Formulary 32, 2014 Bacterial Endotoxins Test USP 37-NF 32 , United States Pharmacopeia 37,
National Formulary 32, Pyrogen Test. 2014 AAMI/ANSI ST72:2011, Bacterial Endotoxins - Test methods,
routine monitoring, and alternatives to batch testing ASTM D4169-09, Standard Practice for Performance Testing of
Shipping Containers and Systems ISO 11607-1: 2009, Packaging for terminally sterilized medical
devices - Part 1: Requirements for materials, sterile barrier
systems and packaging systems ISO 14971:2012, Medical devices - Application of risk
management to medical devices The results of the testing demonstrated that the subject Prelude
SNAP™ Splittable Hydrophilic Sheath Introducer met the
predetermined acceptance criteria of the device. |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of
Substantial
Equivalence | Based on the indications for use, design, safety and performance
testing, the subject Prelude SNAP™ Splittable Hydrophilic Sheath
Introducer meets the requirements that are considered essential for its
intended use and is substantially equivalent to the predicate device, the
Prelude SNAP™ Splittable Sheath Introducer - K143255, manufactured
by Merit Medical Systems, Inc. |