(96 days)
The Ventrax Delivery System is intended to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart
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.
The provided text is a 510(k) Premarket Notification for the Ventrax™ Delivery System. It describes the device, its intended use, comparison to a predicate device, and various performance tests conducted. However, this document does not contain information about an AI-powered device or a study involving human readers or AI assistance.
Therefore, I cannot provide detailed answers to questions 1 through 9, as they are specifically geared towards the evaluation of an AI/ML-based medical device.
Based on the provided text, here's what can be inferred about the device's assessment, focusing on the device rather than an AI component:
- Type of Device: The Ventrax™ Delivery System is a non-AI percutaneous catheter system.
- Purpose of Assessment: The assessment is for substantial equivalence to a legally marketed predicate device (AMPLATZER® TorqVue® Delivery System K072313) to demonstrate safety and effectiveness for its intended use.
- Studies Conducted: The studies are primarily bench testing and biocompatibility testing to ensure the physical and biological properties of the device meet established standards.
Here's an attempt to answer the questions based on the available information, noting the absence of AI/ML specifics:
1. A table of acceptance criteria and the reported device performance
The document lists numerous performance tests, but it does not explicitly state specific acceptance criteria values or detailed reported performance results for each test. Instead, it indicates that "Performance testing of the Ventrax™ Delivery System was conducted based on the risk analysis and when applicable on the requirements of the following standards." The conclusion states that the device "meets the requirements that are considered essential for its intended use."
Without specific numerical acceptance criteria and performance data, a table cannot be fully constructed. The performance data listed are categories of tests, not their outcomes.
| Acceptance Criteria (Implied by Standards & Risk Analysis) | Reported Device Performance (Summary) |
|---|---|
| Adherence to ISO, ASTM, AAMI standards for: | Met the essential requirements for its intended use and demonstrated substantial equivalence to the predicate device. |
| - Sterilization (ISO 11135) | (Details not provided in this summary) |
| - Packaging (ASTM D1469, ISO 2233, ASTM D999, ASTM F2096, AAMI ISO 11607, ASTM F1929, ASTM F88/F88M, ASTM F1980, ASTM D5265) | (Details not provided in this summary) |
| - Intravascular introducers, dilators, guidewires (ISO 11070) | (Details not provided in this summary) |
| - Luer fittings (ISO 594-1, ISO 594-2) | (Details not provided in this summary) |
| - Biocompatibility (ISO 10993-1, -3, -4, -5, -7, -10, -11, -12) | Passed Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility (Hemolysis Complete, Complement Activation, Thrombogenicity). |
| - Risk Management (ISO 14971) | (Details not provided in this summary) |
| - Usability Engineering (IEC 62366-1) | (Details not provided in this summary) |
| - Bacterial Endotoxins (AAMI ST72) | (Details not provided in this summary) |
| Bench Performance Testing for: | (Details not provided in this summary, but the device passed these tests) |
| - Label Adherence and Condition | |
| - Tube OD, Sheath Tip to Dilator Gap, etc. | |
| - Simulated Use (Insertion, Device Exchange) | |
| - Joint Strengths, Leak Testing, Radiopacity, Curve/Orientation, etc. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify exact sample sizes for each bench or biocompatibility test. It lists the types of tests performed.
- Data Provenance: Not specified, but given it's a premarket notification for the US market, the testing would generally align with US regulatory requirements. The studies are prospective in the sense that they are conducted on new device samples specifically for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable as the device is not an AI/ML device requiring expert interpretation for ground truth establishment. The "ground truth" for this type of device is established by objective measurements against engineering specifications and biological standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this refers to expert adjudication in AI/ML performance evaluation studies. The device's performance is objectively measured against standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-powered device, and no MRMC study involving human readers and AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. Its performance is inherent to its physical design and material properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on engineering specifications, material science standards, and established biological safety parameters defined by the listed ISO, ASTM, and AAMI standards. For example, a "Sheath Shaft Tensile Strength" test would have an engineering specification as its ground truth, not an expert consensus.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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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
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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
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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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Merit Medical Systems, Inc.
K202610 Ventrax™ Delivery System Premarket Notification 510(k)
510(k) Summary K202610
| GeneralProvisions | Submitter Name:Address:Telephone Number:Contact Person:Date Prepared: | Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(610) 651 -5093Elizabeth LazaroSeptember 04, 2020 |
|---|---|---|
| SubjectDevice | Trade Name:Common/Usual Name:Classification Name:Regulatory Class:Product Code:21 CFR §:Review Panel: | Ventrax™ Delivery SystemDelivery SystemPercutaneous CatheterIIDQY870.1250Cardiovascular |
| PredicateDevice | Trade Name:Classification Name:Premarket Notification:Manufacturer: | AMPLATZER® TorqVue® Delivery SystemPercutaneous CatheterK072313AGA Medical Corporation |
| ReferenceDevice | No reference devices were used in this submission. | |
| DeviceDescription | The Ventrax™ Delivery System is designed to provide a conduit to deliverdiagnostic and therapeutic catheters to specific heart chambers andlocations. It provides support for positioning and maintaining the positionof catheters at specific locations in the heart. The guiding sheathintroducer may be used for percutaneous entry. The System consists offour components: a sheath, a pigtail dilator, a straight dilator and a J-tipped guidewire.Ventrax™ Delivery System ComponentsA. 8.5F Guiding Sheath Introducer: provide a conduit to deliverdiagnostic and therapeutic catheters within the chambers andcoronary vasculature of the heart. The sheath has an integratedvalve to restrict blood loss, and a sideport for flushing andwithdrawing blood.B. Mating Pigtail Dilator: designed to conform to the sheathintroducer inner diameter, has a tapered tip, has a pigtail at the | |
| distal end to assist aortic valve crossing, has an integrated valveto restrict blood loss, and has a sideport for flushing.C. Mating Straight Dilator: designed to conform to the sheathintroducer inner diameter and has a tapered tip. Usage of thisstraight dilator is optional. This straight dilator is intended to beused only when access is unsuccessful after using the matingpigtail dilator.D. J- tipped InQwire®Amplatz Guidewire 0.035" X 180cm providespathway for sheath and dilator advancement. | ||
| Indicationsfor Use | The Ventrax™ Delivery System is intended to provide a pathway throughwhich devices are introduced within the chambers and coronaryvasculature of the heart. | |
| Summary of the technological characteristics of the Ventrax™ DeliverySystem and the AMPLATZER® TorqVue® Delivery System are based onthe following: | ||
| Comparisonto PredicateDevice | 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 thepredicate device, Amplatzer ®TorqVue ®Delivery System cleared byK072313, both delivery systems are designed to facilitate access withinthe chambers and coronary vasculature of the heart. | ||
| Performance testing of the Ventrax™ Delivery System was conductedbased on the risk analysis and when applicable on the requirements ofthe following standards: | ||
| PerformanceData | ISO 11135:2014Sterilization of Health-care Products - Ethylene Oxide - Requirements forThe Development, Validation and Routine Control of a SterilizationProcess for Medical DevicesASTM D1469-2016Standard Practice for Performance Testing of Shipping Containers andSystemsISO 11070:2014Sterile Single-Use Intravascular Introducers, Dilators and Guidewires | |
| ISO 594-1:1986 | ||
| PerformanceData cont. | Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certainof Other Medical Equipment - Part 1: General Requirements | |
| ISO 594-2:1988Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, andCertain Other Medical Equipment - Part 2: Lock Fittings | ||
| ISO 10993-1:2018 | ||
| Biological Evaluation of Medical Devices -- Part 1: Evaluation and TestingWithin A Risk Management Process | ||
| ISO 10993-7:2008 (R2016) | ||
| Biological Evaluation of Medical Devices - Part 7: Ethylene OxideSterilization 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 byInternal Pressurization (bubble Test) | ||
| AAMI TIR 28:2016 | ||
| Product Adoption and Process Equivalence for Ethylene OxideSterilization | ||
| IEC 62366-1:2016 | ||
| Medical Devices - Part 1: Application of Usability Engineering to MedicalDevices | ||
| AAMI ISO 11607:2019 | ||
| Packaging for Terminally Sterilized Medical Devices- Part 1:Requirements for Materials, Sterile Barrier Systems and PackagingSystems | ||
| ASTM F1929:2015 | ||
| Standard Test Method for Detecting Seal Leaks in Porous MedicalPackaging by Dye Penetration | ||
| ASTM F 88/F88M 2015 | ||
| Standard Test Method for Seal Strength of Flexible Barrier Materials | ||
| ASTM F 1980 2016Standard Guide for Accelerated Aging of Sterile Barrier Systems forMedical 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 :2017Biological Evaluation of Medical Devices – Part 4: Selection of Tests forInteractions with Blood | ||
| ISO 10993-5:2009-06 (R2017) | ||
| PerformanceData cont | Biological Evaluation of Medical Devices - Part 5: Teste for In VitroCytotoxicityISO10993-10:2010 (R2016) | |
| Biological Evaluation of Medical Devices - Part 10: Tests for Irritation andSkin SensitizationISO 10993-11:2017 | ||
| Biological Evaluation of Medical Devices - Part 11: Tests for SystemicToxicityISO 10993-12:2012 | ||
| Biological Evaluation of Medical Devices - Part 12: Sample Preparationand Reference MaterialsISO 14971:2019 | ||
| Application of Risk Management to Medical DevicesAAMI ST72 :2019 | ||
| Bacterial Endotoxins-test Methods, Routine Monitoring, And Alternativesto Batch TestingAAMI TIR28:2016 | ||
| Product Adoption and Process Equivalence for Ethylene OxideSterilization | ||
| The following performance data was provided in support of the substantialequivalence determination. | ||
| Biocompatibility testingThe biocompatibility evaluation for the Ventrax™ Delivery System wasconducted in accordance with the FDA Blue Book Memorandum #G95-1"Use of International Standard ISO-10993, ‘Biological Evaluation ofMedical Devices Part 1: Evaluation and Testing,’" May 1, 1995, andInternational Standard ISO 10993-1 “Biological Evaluation of MedicalDevices - Part 1: Evaluation and Testing Within a Risk ManagementProcess," as recognized by FDA. The battery of testing included thefollowing tests: | ||
| Cytotoxicity Sensitization Irritation Acute Systemic Toxicity | ||
| Performance Testing-Bench | ||
| PerformanceData 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 | |
| PerformanceData 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 ofSubstantialEquivalence | Based on the indications for use, design, safety and performance testing,the Ventrax™ Delivery System meets the requirements that areconsidered essential for its intended use and is substantially equivalent tothe predicate device the Amplatzer® TorgVue® Delivery System |
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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 (< 24 hours) duration
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K202610 Ventrax™ Delivery System Premarket Notification 510(k)
K072313 manufactured by AGA Medical Corporation.
§ 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).