(96 days)
No reference devices were used in this submission.
No
The description focuses on the physical components and mechanical function of a delivery system for catheters, with no mention of AI, ML, or data processing for decision making or analysis.
No
The Ventrax Delivery System is described as a "conduit to deliver diagnostic and therapeutic catheters," meaning it aids in the delivery of other devices but does not perform a therapeutic function itself.
No
The device is a delivery system intended to provide a pathway for other devices (both diagnostic and therapeutic) to access the heart, but it does not perform diagnostic functions itself.
No
The device description explicitly lists physical components (sheath, dilators, guidewire) and the performance studies detail bench testing on these physical components.
Based on the provided information, the Ventrax Delivery System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart." This describes a device used in vivo (within the living body) for delivering other devices.
- Device Description: The description details a system of components (sheath, dilators, guidewire) designed to provide a conduit and support for catheters within the heart. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Ventrax Delivery System does not perform any such analysis of bodily specimens.
- Performance Studies: The performance studies listed focus on the physical and mechanical properties of the device, biocompatibility, and simulated use within a body-like environment, not on the analytical performance of testing bodily fluids or tissues.
Therefore, the Ventrax Delivery System is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Ventrax Delivery System is intended to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart
Product codes (comma separated list FDA assigned to the subject device)
DOY
Device Description
The Ventrax™ Delivery System is designed to provide a conduit to deliver diagnostic and therapeutic catheters to specific heart chambers and locations. It provides support for positioning and maintaining the position of catheters at specific locations in the heart. The guiding sheath introducer may be used for percutaneous entry. The System consists of four components: a sheath, a pigtail dilator, a straight dilator and a J-tipped guidewire.
Ventrax™ Delivery System Components
A. 8.5F Guiding Sheath Introducer: provide a conduit to deliver diagnostic and therapeutic catheters within the chambers and coronary vasculature of the heart. The sheath has an integrated valve to restrict blood loss, and a sideport for flushing and withdrawing blood.
B. Mating Pigtail Dilator: designed to conform to the sheath introducer inner diameter, has a tapered tip, has a pigtail at the distal end to assist aortic valve crossing, has an integrated valve to restrict blood loss, and has a sideport for flushing.
C. Mating Straight Dilator: designed to conform to the sheath introducer inner diameter and has a tapered tip. Usage of this straight dilator is optional. This straight dilator is intended to be used only when access is unsuccessful after using the mating pigtail dilator.
D. J- tipped InQwire®Amplatz Guidewire 0.035" X 180cm provides pathway for sheath and dilator advancement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
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)
Performance testing of the Ventrax™ Delivery System was conducted based on the risk analysis and when applicable on the requirements of the following standards: ISO 11135:2014, ASTM D1469-2016, ISO 11070:2014, ISO 594-1:1986, ISO 594-2:1988, ISO 10993-1:2018, ISO 10993-7:2008 (R2016), ISO 2233:2000 (R2016), ASTM D999-08 (R2015), ASTM F 2096-11 (R2019), AAMI TIR 28:2016, IEC 62366-1:2016, AAMI ISO 11607:2019, ASTM F1929:2015, ASTM F 88/F88M 2015, ASTM F 1980 2016, ASTM D 5265 2009 R2016, ISO 10993-3:2014, ISO 10993-4:2017, ISO 10993-5:2009-06 (R2017), ISO10993-10:2010 (R2016), ISO 10993-11:2017, ISO 10993-12:2012, ISO 14971:2019, AAMI ST72:2019, AAMI TIR28:2016.
Biocompatibility testing included: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility Hemolysis Complete, Hemocompatibility Complement Activation, Hemocompatibility Thrombogenicity.
Performance Testing-Bench included: Label Adherence and Condition, Tube OD, Sheath Tip to Dilator Gap, Straight Dilator Radiopacity, Sheath Curve, Pigtail Dilator Curve, Pre-Use, Sheath and Pigtail Dilator Curve Orientation, Dilator Tip ID, Simulated Use – Insertion through Simulated Tissue, Simulated Use Testing- Device Exchange Through Sheath, Dilator and Sheath Assembly, Dilator Protrusion Length, Pigtail Dilator Curve, Post-Use, Guidewire Backloading through Pigtail Dilator Valve, HVA Attachment, Sheath Valve Damage, High Pressure Water Leak Testing, Dilator Joint Strengths, Sheath Free Length, Sheath Marker Band Location, Hemostasis Valve Liquid Leak Test (Short and Long Term), Sheath Joint Strengths, Sheath Hub Thru-Hole ID, Sheath Tip Radiopacity Test, Sheath Tip ID, Sheath Tip Pull Test, Sheath Shaft Tensile Strength.
Based on the indications for use, design, safety and performance testing, the Ventrax™ Delivery System meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device the Amplatzer® TorgVue® Delivery System.
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.
No reference devices were used in this submission.
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
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 14, 2020
Merit Medical Systems, Inc. Elizabeth Lazaro Sr. Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, UT 84095
Re: K202610
Trade/Device Name: Ventrax™ Delivery System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: November 10, 2020 Received: November 12, 2020
Dear Elizabeth Lazaro:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Rachel Neubrander Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202610
Device Name Ventrax Delivery System
Indications for Use (Describe)
The Ventrax Delivery System is intended to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart
| 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
Merit Medical Systems, Inc.
K202610 Ventrax™ Delivery System Premarket Notification 510(k)
510(k) Summary K202610
| General
Provisions | Submitter Name:
Address:
Telephone Number:
Contact Person:
Date Prepared: | Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095
(610) 651 -5093
Elizabeth Lazaro
September 04, 2020 |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Subject
Device | Trade Name:
Common/Usual Name:
Classification Name:
Regulatory Class:
Product Code:
21 CFR §:
Review Panel: | Ventrax™ Delivery System
Delivery System
Percutaneous Catheter
II
DQY
870.1250
Cardiovascular |
| Predicate
Device | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | AMPLATZER® TorqVue® Delivery System
Percutaneous Catheter
K072313
AGA Medical Corporation |
| Reference
Device | | No reference devices were used in this submission. |
| Device
Description | The Ventrax™ Delivery System is designed to provide a conduit to deliver
diagnostic and therapeutic catheters to specific heart chambers and
locations. It provides support for positioning and maintaining the position
of catheters at specific locations in the heart. The guiding sheath
introducer may be used for percutaneous entry. The System consists of
four components: a sheath, a pigtail dilator, a straight dilator and a J-
tipped guidewire.
Ventrax™ Delivery System Components
A. 8.5F Guiding Sheath Introducer: provide a conduit to deliver
diagnostic and therapeutic catheters within the chambers and
coronary vasculature of the heart. The sheath has an integrated
valve to restrict blood loss, and a sideport for flushing and
withdrawing blood.
B. Mating Pigtail Dilator: designed to conform to the sheath
introducer inner diameter, has a tapered tip, has a pigtail at the | |
| | distal end to assist aortic valve crossing, has an integrated valve
to restrict blood loss, and has a sideport for flushing.
C. Mating Straight Dilator: designed to conform to the sheath
introducer inner diameter and has a tapered tip. Usage of this
straight dilator is optional. This straight dilator is intended to be
used only when access is unsuccessful after using the mating
pigtail dilator.
D. J- tipped InQwire®Amplatz Guidewire 0.035" X 180cm provides
pathway for sheath and dilator advancement. | |
| Indications
for Use | The Ventrax™ Delivery System is intended to provide a pathway through
which devices are introduced within the chambers and coronary
vasculature of the heart. | |
| | Summary of the technological characteristics of the Ventrax™ Delivery
System and the AMPLATZER® TorqVue® Delivery System are based on
the following: | |
| Comparison
to Predicate
Device | Similar Indications for Use Similar materials Similar design Same sterilization method Same fundamental technology / principle of operation | |
| | The Ventrax™ Delivery System is substantially equivalent to the
predicate device, Amplatzer ®TorqVue ®Delivery System cleared by
K072313, both delivery systems are designed to facilitate access within
the chambers and coronary vasculature of the heart. | |
| | Performance testing of the Ventrax™ Delivery System was conducted
based on the risk analysis and when applicable on the requirements of
the following standards: | |
| Performance
Data | ISO 11135:2014
Sterilization of Health-care Products - Ethylene Oxide - Requirements for
The Development, Validation and Routine Control of a Sterilization
Process for Medical Devices
ASTM D1469-2016
Standard Practice for Performance Testing of Shipping Containers and
Systems
ISO 11070:2014
Sterile Single-Use Intravascular Introducers, Dilators and Guidewires | |
| | ISO 594-1:1986 | |
| Performance
Data cont. | Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain
of Other Medical Equipment - Part 1: General Requirements | |
| | ISO 594-2:1988
Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and
Certain Other Medical Equipment - Part 2: Lock Fittings | |
| | ISO 10993-1:2018 | |
| | Biological Evaluation of Medical Devices -- Part 1: Evaluation and Testing
Within A Risk Management Process | |
| | ISO 10993-7:2008 (R2016) | |
| | Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide
Sterilization Residuals | |
| | ISO 2233:2000 (R2016) | |
| | Packaging - Complete, Filled Transport Packages and Unit Loads –
Conditioning for Testing | |
| | ASTM D999-08 (R2015) | |
| | Standard Test Methods for Vibration Testing of Shipping Containers | |
| | ASTM F 2096-11 (R2019) | |
| | Standard Test Method for Detecting Gross Leaks in Packaging by
Internal Pressurization (bubble Test) | |
| | AAMI TIR 28:2016 | |
| | Product Adoption and Process Equivalence for Ethylene Oxide
Sterilization | |
| | IEC 62366-1:2016 | |
| | Medical Devices - Part 1: Application of Usability Engineering to Medical
Devices | |
| | AAMI ISO 11607:2019 | |
| | Packaging for Terminally Sterilized Medical Devices- Part 1:
Requirements for Materials, Sterile Barrier Systems and Packaging
Systems | |
| | ASTM F1929:2015 | |
| | Standard Test Method for Detecting Seal Leaks in Porous Medical
Packaging by Dye Penetration | |
| | ASTM F 88/F88M 2015 | |
| | Standard Test Method for Seal Strength of Flexible Barrier Materials | |
| | ASTM F 1980 2016
Standard Guide for Accelerated Aging of Sterile Barrier Systems for
Medical Devices | |
| | ASTM D 5265 2009 R2016 | |
| | Standard Test Method for Bridge Impact Testing | |
| | ISO 10993-3:2014 | |
| | Biological Evaluation of Medical Devices - Part 3: Tests for Genotoxicity,
Carcinogenicity and Reproductive Toxicity | |
| | ISO 10993-4 :2017
Biological Evaluation of Medical Devices – Part 4: Selection of Tests for
Interactions with Blood | |
| | ISO 10993-5:2009-06 (R2017) | |
| Performance
Data cont | Biological Evaluation of Medical Devices - Part 5: Teste for In Vitro
Cytotoxicity
ISO10993-10:2010 (R2016) | |
| | Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and
Skin Sensitization
ISO 10993-11:2017 | |
| | Biological Evaluation of Medical Devices - Part 11: Tests for Systemic
Toxicity
ISO 10993-12:2012 | |
| | Biological Evaluation of Medical Devices - Part 12: Sample Preparation
and Reference Materials
ISO 14971:2019 | |
| | Application of Risk Management to Medical Devices
AAMI ST72 :2019 | |
| | Bacterial Endotoxins-test Methods, Routine Monitoring, And Alternatives
to Batch Testing
AAMI TIR28:2016 | |
| | Product Adoption and Process Equivalence for Ethylene Oxide
Sterilization | |
| | The following performance data was provided in support of the substantial
equivalence determination. | |
| | Biocompatibility testing
The biocompatibility evaluation for the Ventrax™ Delivery System was
conducted in accordance with the FDA Blue Book Memorandum #G95-1
"Use of International Standard ISO-10993, ‘Biological Evaluation of
Medical Devices Part 1: Evaluation and Testing,’" May 1, 1995, and
International Standard ISO 10993-1 “Biological Evaluation of Medical
Devices - Part 1: Evaluation and Testing Within a Risk Management
Process," as recognized by FDA. The battery of testing included the
following tests: | |
| | Cytotoxicity Sensitization Irritation Acute Systemic Toxicity | |
| | Performance Testing-Bench | |
| Performance
Data cont. | • Label Adherence and Condition
• Tube OD
• Sheath Tip to Dilator Gap
• Straight Dilator Radiopacity
• Sheath Curve
• Pigtail Dilator Curve, Pre-Use
• Sheath and Pigtail Dilator Curve Orientation
• Dilator Tip ID
• Simulated Use – Insertion through Simulated Tissue
• Simulated Use Testing- Device Exchange Through Sheath
• Dilator and Sheath Assembly
• Dilator Protrusion Length | |
| Performance
Data cont | • Pigtail Dilator Curve, Post-Use
• Guidewire Backloading through Pigtail Dilator Valve
• HVA Attachment
• Sheath Valve Damage
• High Pressure Water Leak Testing
• Dilator Joint Strengths
• Sheath Free Length
• Sheath Marker Band Location
• Hemostasis Valve Liquid Leak Test (Short and Long Term)
• Sheath Joint Strengths
• Sheath Hub Thru-Hole ID
• Sheath Tip Radiopacity Test
• Sheath Tip ID
• Sheath Tip Pull Test
• Sheath Shaft Tensile Strength | |
| Summary of
Substantial
Equivalence | Based on the indications for use, design, safety and performance testing,
the Ventrax™ Delivery System meets the requirements that are
considered essential for its intended use and is substantially equivalent to
the predicate device the Amplatzer® TorgVue® Delivery System | |
4
5
6
Merit Medical Systems, Inc.
- Pyrogenicity
- Hemocompatibility Hemolysis Complete ●
- Hemocompatibility Complement Activation .
- Hemocompatibility Thrombogenicity ●
The Ventrax™ Delivery System is considered an externally communicating device with circulating blood contact for a limited (