(192 days)
The DiamondTOUCH Inflation Syringe is used to inflate and deflate balloon angioplasty catheters or other interventional devices and to measure the pressure and time of inflation within the balloon during the procedure. It is also used to dispense fluids into the body and monitor the pressure of that fluid.
The DiamondTOUCH™ Inflation Device and Fluid Dispensing Syringe by Merit Medical is a 30mL disposable device with an integral pressure transducer, microcomputer, back-lit LCD, threaded plunger assembly with lock/release bar, a flexible high pressure extension tube, and a three-way stopcock. The DiamondTOUCH™ is designed to generate positive and negative pressure, and monitor positive pressures over a range of -0.4 ATM/BAR to +35ATM/BAR (-6 PSI to 514 PSI).
The provided text describes acceptance criteria and testing for the DiamondTOUCH Inflation Device and Fluid Dispensing Syringe, but it does not specify performance metrics with numerical acceptance criteria and reported device performance in a table format. Instead, it lists various types of tests conducted.
Here's a breakdown of the information that can be extracted, and what is not available:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in a table with specific numerical thresholds and corresponding results for the DiamondTOUCH device. The document generally states that "The system complies with..." or that tests "were conducted," implying that the device met the requirements of the standards, but does not give quantitative results or specific acceptance criteria values.
2. Sample size used for the test set and the data provenance:
This information is not explicitly provided. The document details types of tests performed (e.g., Biocompatibility Testing, Electrical Safety and EMC, Software V&V, Performance Testing like Vacuum Leak, Accuracy Test), but does not specify the number of units tested for each, nor the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as this device is a physical medical instrument (inflation syringe), not a diagnostic algorithm or AI system that requires expert interpretation to establish ground truth for performance evaluation in the context of diagnoses. The "ground truth" for this device would be its mechanical and electrical specifications and safety compliance.
4. Adjudication method for the test set:
This is not applicable for the same reasons as point 3. Adjudication methods are typically used in studies involving subjective interpretation of data (e.g., imaging studies) where multiple experts might disagree on findings.
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:
This is not applicable as this device is a physical medical instrument, not an AI-assisted diagnostic or interpretive tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable as this device is a physical medical instrument, not an algorithm.
7. The type of ground truth used:
The "ground truth" for this device is effectively established by:
- International Standards: The device was tested against recognized international standards such as AAMI ANSI ES 60601-1, IEC 60601-1-2, IEC 62366, IEC 60601-1-6, ISO 10993-1, ISO 10993-5, and ISO 594-2. Compliance with these standards serves as the ground truth for safety, performance, and biocompatibility.
- Internal Specifications/Risk Analysis: Performance testing was conducted "based on the risk analysis and based on the requirements of the following international standards," indicating that internal specifications derived from these standards define the expected performance.
- Software Verification and Validation Testing: For the software component, the ground truth is established by design specifications and requirements, with "a 'major' level of concern, since a failure or latent flaw in the software could directly result in serious injury or death."
8. The sample size for the training set:
This is not applicable. This document describes a medical device, not a machine learning model, so there is no concept of a "training set" in the context of the described validation.
9. How the ground truth for the training set was established:
This is not applicable for the same reason as point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 29, 2016
Merit Medical Systems, Inc. Dan W. Lindsay Project Manager, Regulatory Affairs 1600 West Merit Parkway South Jordan. Utah 84095
Re: K160107
Trade/Device Name: DiamondTOUCH Inflation Device and Fluid Dispensing Syringe Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT, MAV Dated: June 27, 2016 Received: June 28, 2016
Dear Dan Lindsay:
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. 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.
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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 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,
Brian D. Pullin -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160107
Device Name
DiamondTOUCH™M Inflation Device and Fluid Dispensing Syringe
Indications for Use (Describe)
The DiamondTOUCH Inflation Syringe is used to inflate and deflate balloon angioplasty catheters or other interventional devices and to measure the pressure and time of inflation within the balloon during the procedure. It is also used to dispense fluids into the body and monitor the pressure of that fluid.
| 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) |
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510(k) Summary - K160107
| GeneralProvisions | Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Date Prepared:Registration Number: | Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095801-208-4408801-253-6945Dan W. LindsayJanuary 15, 20161721504 |
|---|---|---|
| Subject Device | Trade Name:Common/Usual Name:Classification Name:Regulatory Class:Product Code:SubsequentProduct Code:21 CFR §:Review Panel: | DiamondTOUCH™ Inflation Device and FluidDispensing SyringeInflation SyringeAngiographic injector and syringeClass IIDXTMAV870.165074 Cardiovascular |
| PredicateDevice | Trade Name:Classification Name:SubsequentClassification Name:Premarket Notification:Manufacturer: | Monarch Inflation Syringe; Universal FluidDispensing SyringeInjector and Syringe, Angiographic (DXT)Syringe, Balloon Inflation (MAV)K011811Merit Medical Systems, Inc.This predicate has not been subject to a design-related recall |
| ReferenceDevices | Trade Name:Classification Name:Premarket Notification:Manufacturer: | basixTOUCHSyringe, Balloon Inflation (MAV)K130566Merit Medical Systems, Inc. |
| Trade Name:Classification Name:Premarket Notification:Manufacturer: | Monarch COMPAK Inflation Syringe andUniversal Fluid Dispensing SyringeInjector and Syringe, Angiographic (DXT)K083523Merit Medical Systems, Inc. | |
| DeviceDescription | The DiamondTOUCH™ Inflation Device and Fluid Dispensing Syringeby Merit Medical is a 30mL disposable device with an integral pressuretransducer, microcomputer, back-lit LCD, threaded plunger assemblywith lock/release bar, a flexible high pressure extension tube, and athree-way stopcock. The DiamondTOUCH™ is designed to generatepositive and negative pressure, and monitor positive pressures over arange of -0.4 ATM/BAR to +35ATM/BAR (-6 PSI to 514 PSI). | |
| Indications forUse | The DiamondTOUCH Inflation Syringe is used to inflate and deflateballoon angioplasty catheters or other interventional devices and tomeasure the pressure and time of inflation within the balloon during theprocedure. It is also used to dispense fluids into the body and monitorthe pressure of that fluid. | |
| Comparison toPredicateDevice | At a high level, the subject and predicate devices are based on thefollowing same technological elements:Same basic design with the same principle of operation. Manual operated by manipulation of a rotating handle. The plunger threads of both syringes can be locked or retractedby using the trigger of the handle. This action allows theplungers to be advanced or withdrawn or locked within thebarrel. When the trigger is released, the syringes both generatepressure by rotating the handle with the same clockwise motion. Digital gauge that presents pressure and time of inflation. The following technological differences exist between the subject andpredicate devices: The subject device has a larger volume (30ml verses 20ml). The subject device has a higher pressure capability (35 ATMverses 30 ATM). The digital display is larger with a visual representation of duringinflation like an analog needle gauge. The handle design was revised to incorporate a one handedpreparation capability. | |
| PerformanceData | No performance standards have been established under Section 514 ofthe Food, Drug and Cosmetic Act for these devices. Performancetesting of the subject DiamondTOUCH Inflation Syringe was conductedbased on the risk analysis and based on the requirements of thefollowing international standards:AAMI ANSI ES 60601-1:2005/(R)2012 and C1:2009/(R)2012 andA2:2010/(R)2012 Medical Electrical Equipment: Part I: General |
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- IEC 60601-1-2 Medical electrical equipment. General requirements . for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests (19-1)
- IEC 62366:2008+A1: 2015 Medical devices Application of . usability engineering to medical devices (5-95)
- IEC 60601-1-6 Edition 3.1:2012 Medical electrical equipment: Part . 1-6: General requirements for basic safety and essential performance Collateral standard: Usability (5-89)
- . ISO 10993-1: 2009 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, and the FDA Modified ISO 10993 Test Profile FDA Memo G95-1. (2-156)
- AAMI / ANSI / ISO 10993-5:2009/(R) 2014, biological evaluation of ● medical devices -- part 5: tests for in vitro cytotoxicity. (2-153)
- ISO 594-2 Second edition 1998-09-01 Conical Fittings with a 6% . (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings (6-129)
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for the DiamondTOUCH Inflation Syringe 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. As a result of the evaluation, a Cytotoxicity test was performed.
The DiamondTOUCH Inflation Syringe is considered an externally communicating device with indirect blood contact for a limited (≤ 24 hours) duration.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on the DiamondTOUCH Inflation Syringe, consisting of the digital gauge, The system complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
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| Performance Testing | ||
|---|---|---|
| PerformanceData cont. | • Vacuum Leak• Syringe Tolerance• Pressure Test• Gauge Housing Integrity• Force | • Accuracy Test• Tubing Tensile Retention• Display Functionality• Battery Life |
| Summary ofSubstantialEquivalence | Based on the indications for use, design, safety and performancetesting, the subject DiamondTOUCH Inflation Syringe meets therequirements that are considered essential for its intended use and issubstantially equivalent to the predicate device, the Monarch InflationSyringe; Universal Fluid Dispensing Syringe, K011811. |
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.