(60 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the physical characteristics and functional performance of a splittable sheath introducer, with no mention of AI or ML capabilities.
No
This device is an introducer system used to facilitate the insertion of other devices (like pacing/defibrillator leads or catheters) into the venous vasculature, rather than directly providing therapy itself. Its function is to create a path and maintain access, not to treat a condition.
No
Explanation: The device is an introducer system for inserting leads and catheters, not for diagnosing conditions.
No
The device description clearly details a physical, splittable sheath introducer system made of materials like silicone, with various sizes and lengths, and includes accessory components like needles, syringes, and guide wires. This is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the introduction of leads and catheters into the venous vasculature. This is a direct medical intervention on a patient's body.
- Device Description: The device is a physical tool (sheath introducer) used to facilitate the placement of other medical devices within the body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information. IVDs are designed to perform tests on samples taken from the body to diagnose conditions.
The device is clearly a medical device used for a therapeutic or procedural purpose, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The introduction of various types of pacing/defibrillator leads and catheters into the venous vasculature.
Product codes
DYB
Device Description
The Prelude Pursuit™ Splittable Sheath Introducer is a splittable introducer system indicated for the introduction of various types of pacing/defibrillator leads and catheters into the venous vasculature. The "splittable” function allows the introducer to be withdrawn over a diagnostic/therapeutic catheter (e.g. peripherally inserted central catheter, totally implantable venous access device/port, dialysis, drainage, hemodynamic line, etc.) or pacing/defibrillator lead and from the vessel while maintaining said device in place. The product is available in 16 French sizes, from 5 F through 16 F, and in two different lengths, 13 cm and 25 cm. It is packaged either as a kit with optional accessory components (introducer needle, syringe, guide wire), or as a stand-alone (sheath-dilator) set. The device is provided sterile and intended for single use only. It is for use in hospitals or healthcare facilities. The splittable sheath introducer is lubricated with a silicone dispersion and its hub has a threaded locking mechanism for dilator engagement. The dilator is designed to conform to the inner diameter of the introducer and has a tapered tip for ease of insertion.
Prelude Pursuit™ Splittable Sheath Introducer kit consists of:
One (1) Splittable Sheath Introducer
One (1) Dilator
One (1) .038" x 50 cm or .038" x 80 cm guidewire (depending on the introducer length)
One (1) 18 G introducer needle
One (1) 12 cc or 10 cc syringe
Prelude Pursuit™ Splittable Sheath Introducer stand-alone set consists of:
One (1) Splittable Sheath Introducer
One (1) Dilator
The materials of construction are primarily polymers except for the optional guide wire and introducer 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
venous vasculature
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)
Performance testing of the Prelude Pursuit™ Splittable Sheath Introducer was conducted based on the risk analysis and based on the requirements of various international standards. The testing included:
Dimensional Tests: Introducer sheath tube outer diameter (OD), Introducer tip inner diameter (ID), Introducer free length, Dilator tube outer diameter (OD), Delay tip inner diameter (ID), Dilator protrusion from introducer when assembled.
Functional Tests: Introducer hub break force, Introducer sheath peel force, Introducer tube to hub joint strength, Dilator tube to hub joint strength, Mating dilator ISO 594-2 compliance.
Simulated Use Test: Introducer sheath / dilator insertion - synthetic tissue, Sheath - dilator assembly - kink & flexibility, Mating dilator to introducer engagement.
Visual Tests: Introducer soft touch pad attachment.
Sterilization validation, Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemolysis, Thrombogenicity, Complement Activation).
The Prelude Pursuit™ Splittable Sheath Introducer has been thoroughly tested through verification of product specifications and user requirements. Key results indicate that the device meets the requirements considered essential for its intended use and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
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
Public Health Service
Image /page/0/Picture/2 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" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 11, 2017
Merit Medical Systems, Inc. Jacquelyn Huyghue Regulatory Affairs Specialist I 65 Great Vallev Parkway Malvern, Pennsylvania 19355
Re: K172117
Trade/Device Name: Prelude Pursuit Splittable Sheath Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: July 11, 2017 Received: July 13, 2017
Dear Jacquelyn Huyghue:
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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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.
1
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 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.
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 (DICE) 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 (DICE) 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.
Nicole G. Ibrahim -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172117
Device Name
Prelude Pursuit™ Splittable Sheath Introducer
Indications for Use (Describe)
The introduction of various types of pacing/defibrillator leads and catheters into the venous vasculature.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary - K172117
| General
Provisions | Submitter Name:
Address:
Telephone Number:
Fax Number:
Contact Person:
Date Prepared:
Registration Number: | Merit Medical Systems, Inc.
65 Great Valley Parkway
Malvern, PA 19355
(610) 651-5090
(801) 545-4285
Jacquelyn Huyghue
July 11, 2017
2529252 | |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Subject Device | Trade Name:
Common/Usual Name:
Classification Name:
Regulatory Class:
Product Code:
21 CFR §:
Review Panel: | Prelude Pursuit™ Splittable Sheath Introducer
Sheath Introducer
Introducer, Catheter
II
DYB
870.1340
Cardiovascular | |
| Predicate
Device | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | St. Jude Medical SJM™ Peel Away Introducer
Introducer, Catheter
K791129
St. Jude Medical (formerly Diag Corp.) | |
| Reference
Device | This predicate has not been subject to a design-related recall
No reference devices were used in this submission. | | |
| Device
Description | The Prelude Pursuit™ Splittable Sheath Introducer is a splittable
introducer system indicated for the introduction of various types of
pacing/defibrillator leads and catheters into the venous vasculature.
The "splittable” function allows the introducer to be withdrawn over a
diagnostic/therapeutic catheter (e.g. peripherally inserted central
catheter, totally implantable venous access device/port, dialysis,
drainage, hemodynamic line, etc.) or pacing/defibrillator lead and from
the vessel while maintaining said device in place. The product is
available in 16 French sizes, from 5 F through 16 F, and in two different
lengths, 13 cm and 25 cm. It is packaged either as a kit with optional
accessory components (introducer needle, syringe, guide wire), or as a
stand-alone (sheath-dilator) set. The device is provided sterile and
intended for single use only. It is for use in hospitals or healthcare
facilities.
The splittable sheath introducer is lubricated with a silicone dispersion
and its hub has a threaded locking mechanism for dilator engagement.
The dilator is designed to conform to the inner diameter of the
introducer and has a tapered tip for ease of insertion. | | |
4
| Prelude Pursuit™ Splittable Sheath Introducer kit consists of: | |
|---|---|
| One (1) Splittable Sheath Introducer | |
| One (1) Dilator | |
| One (1) .038" x 50 cm or .038" x 80 cm guidewire (depending on the introducer length) | |
| One (1) 18 G introducer needle | |
| One (1) 12 cc or 10 cc syringe | |
| Prelude Pursuit™ Splittable Sheath Introducer stand-alone set consists of: | |
| One (1) Splittable Sheath Introducer | |
| One (1) Dilator | |
| The materials of construction are primarily polymers except for the optional guide wire and introducer needle cannula, which are stainless steel. | |
| Indications for Use | The introduction of various types of pacing/defibrillator leads and catheters into the venous vasculature. |
5
Summary of the technological characteristics of the modified device compared to the predicate devices:
| Comparison to
Predicate
Device | Technical
Characteristics | Predicate Device
(K791129) | Subject Device
Prelude Pursuit™
Splittable Sheath
Introducer |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| | Device Dimensions (nominal) | | |
| | Sheath introducer inner
diameter (French) | 5 F through 16 F | 5 F through 16 F |
| | Sheath introducer length
(cm) | 14 & 23 cm | 13 & 25 cm |
| | Dilator outer diameter
(French) | 5 F through 16 F | 5 F through 16 F |
| | Dilator length (in) | 14 cm: 8.67"
and
23 cm: 12.01" | 13 cm: 7.59"
and
25 cm: 12.34" |
| | Dilator tip ID (in) | 0.040" | 0.039" |
| | Introducer needle length
(cm) | 6.6 cm | 7 cm |
| | Introducer needle outer
diameter (gauge) | 18 G | 18 G |
| | Guide wire length &
diameter (in. x cm) | 14 cm: 0.038" x 50
cm J-Tip
and
23 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 | |
Note: All dimensions are nominal.
6
No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the Prelude Pursuit™ Splittable Sheath Introducer was conducted based on the risk analysis and based on the requirements of the following international standards:
- ISO 11070:2014 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 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 10993-4:2002 (Amd.1:2006), Biological Evaluation of Medical Devices - Part 4: Selection of tests for interaction with blood
- ISO 10993-4:2017, Biological Evaluation of Medical Devices Part 4: ● Selection of tests for interactions with blood
- 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
Performance Data
- ISO 10993-10:2010, Biological Evaluation of Medical Devices Part . 10: Tests for irritation and delayed type hypersensitivity
- . ISO 10993-11:2006, Biological Evaluation of Medical Devices -Part 11: Tests for systemic toxicity
- United States Pharmacopeia 40, National Formulary 35, 2017 . Pyrogen Test
- ASTM F756-13:2013, Standard Practice for Hemolytic Properties of ● Materials
- ASTM D4169-16:2016. Standard Practice for Performance Testing . of Shipping Containers and Systems
- ISO 15223-1: 2016. Medical Devices Symbols to be used with . medical device labels, labeling and information to be supplied - Part 1: General Requirements
- ISO 11607-1: 2009 (Amd.1:2014), Packaging for terminally ● sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging Systems
- ISO 2233:2000. Packaging -- Complete, filled transport packages . and unit loads -- Conditioning for testing
- ISO 594-1:1986. Conical fittings with a 6% (Luer) taper for svringes. ● needles and certain other medical equipment - Part 1: General requirements
- ISO 14971:2012, Medical devices Application of risk management ● to medical devices
- . ASTM D999-08: 2008 Standard Test Methods for Vibration Testing of Shipping Container
7
- ASTM F2096-11:2011, Standard Test Method for Detecting Gross ● Leaks in Packaging by Internal pressurization (Bubble Test)
- ASTM F1140-07:2007 Standard Test Methods for internal . Pressurization Failure Resistance of Unrestrained Packages
- ASTM F1980-07:2011 Standard Guide for Accelerated Aging of . Sterile Barrier Systems for Medical Devices
- ASTM F88:2009 Standard Test Method for Seal Strength of Flexible ● Barrier Materials
- ASTM F1929:1998 Standard Test Method for Detecting Leaks in . Porous Medical Packaging by Dye Penetration
The Prelude Pursuit™ Splittable Sheath Introducer has been thoroughly tested through verification of product specifications and user requirements. The following quality assurance and performance measures were applied during the development of the Prelude Pursuit™ Splittable Sheath Introducer:
- Risk Analysis
Performance
Data cont.
- Requirements/Specification Reviews ●
- Design Reviews ●
- Performance Testing (Verification): ●
- o Dimensional Tests
- Introducer sheath tube outer diameter (OD) ■
- . Introducer tip inner diameter (ID)
- . Introducer free lenath
- . Dilator tube outer diameter (OD)
- 트 Dilator tip inner diameter (ID)
- l Dilator protrusion from introducer when assembled
- o Functional Tests
- Introducer hub break force
- Introducer sheath peel force
- Introducer tube to hub joint strength
- . Dilator tube to hub joint strength
- I Mating dilator ISO 594-2 compliance
- o Simulated Use Test
- 트 Introducer sheath / dilator insertion - synthetic tissue
- . Sheath - dilator assemblv - kink & flexibility
- . Mating dilator to introducer engagement
- o Visual Tests
- Introducer soft touch pad attachment I
- o Dimensional Tests
- Sterilization validation ●
- Biocompatibility .
O
- Cytotoxicity o
- Sensitization O
- Irritation O
- Acute Systemic Toxicity O
- Pyrogenicity O
Hemolysis
8
- Thrombogenicity o Complement Activation O
Summary of Substantial Equivalence Based on the indications for use, design, safety and performance testing, the subject Prelude Pursuit™ Splittable Sheath Introducer meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device, the St. Jude Medical SJM™ Peel Away Introducer (K791129).