(147 days)
There are no Reference Devices listed in the provided text.
No
The device description and performance studies focus on the physical components and mechanical function of a splittable sheath introducer, with no mention of AI or ML capabilities.
No.
The device is used for introducing other devices (pacing leads and catheters) to the heart and coronary venous system, but it does not directly treat or diagnose a medical condition.
No
Explanation: The device is described as an introducer system for pacing leads and catheters, facilitating their entry into the heart and coronary venous system. Its function is to assist in the delivery of other devices, not to diagnose medical conditions by identifying or measuring pathologies, diseases, or abnormalities.
No
The device description explicitly lists multiple hardware components (splittable sheath introducer, dilator, needle, guide wire, syringe) and describes their physical properties and materials. It also details performance testing related to these physical components.
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 (introducing other devices).
- Device Description: The description details a physical device (sheath introducer, dilator, needle, guide wire, syringe) used for accessing blood vessels and introducing other medical devices. It does not describe a test or assay performed on biological samples in vitro (outside the body).
- Anatomical Site: The anatomical site is the "heart and coronary venous system," which are internal body structures. IVDs typically analyze samples taken from the body, not directly interact with internal organs in this manner.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, providing diagnostic information based on laboratory testing, or any of the typical components or processes associated with IVD devices.
In summary, the Prelude SNAP™ Splittable Sheath Introducer is a medical device used for facilitating procedures within the body, not for performing diagnostic tests on samples outside the body.
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 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 Sheath Introducer system consists of a splittable sheath introducer (with or without side-port), 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 or without a side-port with 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
The Prelude SNAP™ Splittable 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 Sheath Introducer:
- Risk Analysis
- Requirements/Specification Reviews
- . Design Reviews
- Performance Testing (Verification) including but not limited to:
- Dimensional Tests
- Introducer tube outer diameter (OD)
- Introducer tip inner diameter (ID)
- Introducer free length
- Dilator tube outer diameter (OD)
- Dilator tip inner diameter (ID)
- Dilator protrusion from introducer when assembled
- Functional Tests
- Introducer hub break force
- Introducer peel
- Introducer side-port pull force
- Introducer tube to hub joint strength
- Dilator tube to hub joint strength
- Simulated Use Test
- Introducer hemostasis
- Device insertion through introducer valve
- Introducer valve hemostasis (liquid leakage)
- Introducer liquid leakage
- Introducer insertion
- Dilator to introducer engagement
- Dilator luer functionality
- Dilator liquid leakage
- Visual Tests
- Introducer pad printing
- Introducer soft touch pad attachment
- Dimensional Tests
- Sterilization validation
- Biocompatibility Testing
- Cytotoxicity
- Sensitization
- Irritation
- Acute System Toxicity
- Pyrogenicity
- Genotoxicity
- Hemocompatibility
No performance standards have been established under section 514 of the Food, Drug and Cosmetic Act for this device. Performance testing of the Prelude SNAP™ Splittable Sheath Introducer was conducted based on the risk analysis and based on the requirements of the following international standards:
ISO 11070: 1998(E), Sterile, single-use intravascular catheter introducers
ISO 594-2:1998, Conical Fittings with a 6% (Luer) taper for syringes, needles, and certain other medical equipment – Part 2: Lock fittings
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 10993-3: 2003, Biological Evaluation of Medical Devices Part-3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
ISO 10993-4: 2002, Biological Evaluation of Medical Devices Part-4: Selection of Tests for Interactions with Blood, as amended 2006
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
ISO 10993-17: 2002, Biological evaluation of medical devices – Part 17: Methods for the establishment of allowable limits for leachable substances
USP 37-NF 32 : 2014, United States Pharmacopeia 37, National Formulary 32, 2014 Bacterial Endotoxins Test
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
Key Metrics
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 a stylized representation of a human figure in profile, with three overlapping heads suggesting community and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 9, 2015
Merit Medical Systems, Inc. Alina Stubbs Regulatory Affairs Specialist II 65 Great Vallev Parkway Malvern, Pennsylvania 19355
Re: K143255
Trade/Device Name: Prelude Snap Splittable Sheath Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: April 3, 2015 Received: April 6, 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 (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,
Fernande Aguel Fernando Aguel -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K143255
Device Name
Prelude SNAPTM 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)
2 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)
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Attachment 1
3
K143255 510(k) Summary
| General
Provisions | Correspondent Name:
Address:
Telephone Number:
Fax Number:
Contact Person:
Date of Preparation:
Registration Number: | Merit Medical Systems, Inc.
65 Great Valley Parkway
Malvern, PA 19355
(610) 651-5046
(801) 545-4285
Alina Stubbs
April 3, 2015
2529252 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject
Device | Trade Name:
Common/Usual Name:
Classification Name: | Prelude SNAPTM Splittable Sheath
Introducer
Sheath Introducer
Introducer, Catheter (21 CFR §870.1340) |
| Predicate
Device | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | ClassicSheathTM Splittable Hemostatic
Introducer System
Introducer, Catheter (21 CFR §870.1340)
K934901 – Tear-Away Sheath Introducer
Set With Integral Hemostasis Valve
Merit Medical Systems, Inc.
65 Great Valley Parkway
Malvern, PA 19355
(formerly operating as
Thomas Medical Products, Inc.) |
| Classification | Class II
21 CFR §870.1340
FDA Product Code: DYB
Review Panel: Cardiovascular | |
| Intended Use | Prelude SNAPTM Splittable 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 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 Sheath Introducer system consists of a splittable sheath introducer (with or without side-port), 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 Device minimize blood loss and air ingress during use. The introducer is Description available with or without a side-port with 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
| | Technical
Characteristics | Predicate Device
(K934901) | 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 |
| | Dilator outer diameter
(French) | 6F through 12.5F | 6F through 12.5F |
| | Dilator length (in) | 13 cm: 8.95"
and
25 cm: 13.67" | 13 cm: 8.34"
and
25 cm: 13.09" |
| | Dilator tip ID (in) | 0.038" | 0.039" |
| Comparison to
Predicate | 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
45 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 | 12 cc or 10 cc |
| | Device Materials | The materials of
construction are
primarily
polymers with the
exception of the
guide wire and
needle cannula,
which are
stainless steel. | The materials of
construction are
primarily polymers
with the exception
of the guide wire
and needle
cannula, which
are stainless
steel. |
Summary of the technological characteristics of the modified device compared to the predicate devices:
Note: All dimensions are nominal.
6
The Prelude SNAP™ Splittable 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 Sheath Introducer:
- Risk Analysis
- Requirements/Specification Reviews
- . Design Reviews
- Performance Testing (Verification) including but not limited to:
- o Dimensional Tests
- Introducer tube outer diameter (OD) l
- I Introducer tip inner diameter (ID)
- 트 Introducer free length
- Dilator tube outer diameter (OD) ■
- l Dilator tip inner diameter (ID)
- Dilator protrusion from introducer when l assembled
- o Functional Tests
- Introducer hub break force .
- . Introducer peel
- Introducer side-port pull force l
- Introducer tube to hub joint strength
- l Dilator tube to hub joint strength
- o Simulated Use Test
- Introducer hemostasis ■
- I Device insertion through introducer valve
- I Introducer valve hemostasis (liquid leakage)
- l Introducer liquid leakage
- l Introducer insertion
- l Dilator to introducer engagement
- Dilator luer functionality
- . Dilator liquid leakage
- Visual Tests o
- Introducer pad printing ■
- l Introducer soft touch pad attachment
- o Dimensional Tests
- . Sterilization validation
.
- Biocompatibility Testing
- o Cytotoxicity
- Sensitization O
- Irritation O
- Acute System Toxicity O
- Pyrogenicity O
- Genotoxicity O
- Hemocompatibility O
Safety & Performance Tests
7
| No performance standards have been established under section 514 of the Food, Drug and Cosmetic Act for this device. Performance testing of the Prelude SNAP™ Splittable Sheath Introducer was conducted based on the risk analysis and based on the requirements of the following international standards: | |
|---|---|
| International | |
| Standards | ISO 11070: 1998(E), Sterile, single-use intravascular catheter introducers ISO 594-2:1998, Conical Fittings with a 6% (Luer) taper for syringes, needles, and certain other medical equipment – Part 2: Lock fittings 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 10993-3: 2003, Biological Evaluation of Medical Devices Part-3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity ISO 10993-4: 2002, Biological Evaluation of Medical Devices Part-4: Selection of Tests for Interactions with Blood, as amended 2006 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 ISO 10993-17: 2002, Biological evaluation of medical devices – Part 17: Methods for the establishment of allowable limits for leachable substances USP 37-NF 32 : 2014, United States Pharmacopeia 37, National Formulary 32, 2014 Bacterial Endotoxins Test 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 |
8
Merit Medical Systems, Inc. considers the Prelude SNAP™ Splittable Sheath Introducer substantially equivalent to the currently marketed Summary of predicate device (ClassicSheath™ Splittable Hemostatic Introducer Substantial System - K934901). This assessment is based upon analysis of Equivalence similar technological characteristics, bench testing, and indications for use.