(192 days)
No
The description focuses on the device's mechanical and electronic components for pressure measurement and fluid dispensing, with no mention of AI or ML capabilities. The software is mentioned as "major" level of concern, but this typically refers to the complexity and potential risk of the software controlling the device's basic functions, not necessarily AI/ML.
No
The device is used to inflate/deflate balloons and dispense fluids, but it does not directly treat a condition or disease. It is an accessory used in conjunction with other interventional devices.
No
The device is used to inflate/deflate balloons and dispense fluids, and to measure pressure during these procedures. It does not provide any diagnosis of a medical condition.
No
The device description clearly outlines multiple hardware components (integral pressure transducer, microcomputer, back-lit LCD, threaded plunger assembly, extension tube, stopcock) and performance studies include testing of physical attributes like vacuum leak, syringe tolerance, and force, indicating it is a physical device with embedded software, not a software-only medical device.
Based on the provided information, the DiamondTOUCH Inflation Syringe is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to inflate and deflate balloons within the body, dispense fluids into the body, and monitor pressure within the body during procedures like angioplasty. This involves direct interaction with the patient's body.
- Device Description: The description details a device designed to generate and monitor pressure for use with interventional devices and for dispensing fluids into the body.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens outside of the body (in vitro). IVD devices are specifically designed for testing samples like blood, urine, or tissue in a laboratory setting to diagnose or monitor medical conditions.
The device is clearly intended for use in vivo (within the living body) during medical procedures.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DXT, MAV
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the subject DiamondTOUCH Inflation Syringe was conducted based on the risk analysis and based on the requirements of the following international standards:
AAMI ANSI ES 60601-1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012 Medical Electrical Equipment: Part I: General
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.
Performance Testing
• Vacuum Leak
• Syringe Tolerance
• Pressure Test
• Gauge Housing Integrity
• Force
• Accuracy Test
• Tubing Tensile Retention
• Display Functionality
• Battery Life
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.
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
§ 870.1650 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol featuring a series of overlapping human profiles facing to the right, creating a sense of depth and continuity.
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.
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 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
2
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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3
510(k) Summary - K160107
| General
Provisions | Submitter Name:
Address:
Telephone Number:
Fax Number:
Contact Person:
Date Prepared:
Registration Number: | Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095
801-208-4408
801-253-6945
Dan W. Lindsay
January 15, 2016
1721504 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Trade Name:
Common/Usual Name:
Classification Name:
Regulatory Class:
Product Code:
Subsequent
Product Code:
21 CFR §:
Review Panel: | DiamondTOUCH™ Inflation Device and Fluid
Dispensing Syringe
Inflation Syringe
Angiographic injector and syringe
Class II
DXT
MAV
870.1650
74 Cardiovascular |
| Predicate
Device | Trade Name:
Classification Name:
Subsequent
Classification Name:
Premarket Notification:
Manufacturer: | Monarch Inflation Syringe; Universal Fluid
Dispensing Syringe
Injector and Syringe, Angiographic (DXT)
Syringe, Balloon Inflation (MAV)
K011811
Merit Medical Systems, Inc.
This predicate has not been subject to a design-related recall |
| Reference
Devices | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | basixTOUCH
Syringe, Balloon Inflation (MAV)
K130566
Merit Medical Systems, Inc. |
| | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | Monarch COMPAK Inflation Syringe and
Universal Fluid Dispensing Syringe
Injector and Syringe, Angiographic (DXT)
K083523
Merit Medical Systems, Inc. |
| Device
Description | 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). | |
| Indications for
Use | 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. | |
| Comparison to
Predicate
Device | At a high level, the subject and predicate devices are based on the
following 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 retracted
by using the trigger of the handle. This action allows the
plungers to be advanced or withdrawn or locked within the
barrel. When the trigger is released, the syringes both generate
pressure 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 and
predicate devices: The subject device has a larger volume (30ml verses 20ml). The subject device has a higher pressure capability (35 ATM
verses 30 ATM). The digital display is larger with a visual representation of during
inflation like an analog needle gauge. The handle design was revised to incorporate a one handed
preparation capability. | |
| Performance
Data | No performance standards have been established under Section 514 of
the Food, Drug and Cosmetic Act for these devices. Performance
testing of the subject DiamondTOUCH Inflation Syringe was conducted
based on the risk analysis and based on the requirements of the
following international standards:
AAMI ANSI ES 60601-1:2005/(R)2012 and C1:2009/(R)2012 and
A2:2010/(R)2012 Medical Electrical Equipment: Part I: General | |
4
5
- 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.
6
| Performance Testing | ||
|---|---|---|
| Performance | ||
| Data cont. | • Vacuum Leak | |
| • Syringe Tolerance | ||
| • Pressure Test | ||
| • Gauge Housing Integrity | ||
| • Force | • Accuracy Test | |
| • Tubing Tensile Retention | ||
| • Display Functionality | ||
| • Battery Life | ||
| Summary of | ||
| Substantial | ||
| Equivalence | Based on the indications for use, design, safety and performance | |
| testing, the subject DiamondTOUCH Inflation Syringe meets the | ||
| requirements that are considered essential for its intended use and is | ||
| substantially equivalent to the predicate device, the Monarch Inflation | ||
| Syringe; Universal Fluid Dispensing Syringe, K011811. |