(30 days)
Not Found
No
The summary describes a mechanical inflation syringe and does not mention any AI or ML components or functionalities.
No.
The device is used to inflate balloons and measure pressure, which are interventional and diagnostic functions, not therapeutic.
No
The device is described as an inflation syringe used to inflate angioplasty balloons and measure pressure within the balloon, which are interventional and monitoring functions, not diagnostic.
No
The device description clearly states it is a "30mL disposable device with a threaded plunger assembly, a flexible high pressure extension tube," indicating it is a physical hardware device, not software only.
Based on the provided information, the basixTOUCH40 Inflation Syringe is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to inflate an angioplasty balloon or other interventional device and measure pressure within the balloon. This is a direct interaction with a medical device used in vivo (within the body), not for testing samples in vitro (outside the body).
- Device Description: The description focuses on the mechanical function of generating and monitoring pressure for inflation, which is consistent with an interventional device accessory.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
The device is clearly intended for use during medical procedures performed on a patient, not for laboratory testing of samples.
N/A
Intended Use / Indications for Use
The basixTOUCH40 Inflation Syringe is used to inflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.
The basixTOUCH40 Inflation Syringe is used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.
Product codes (comma separated list FDA assigned to the subject device)
MAV
Device Description
The basixTOUCH40TM Inflation Syringe by Merit Medical is a 30mL disposable device with a threaded plunger assembly, a flexible high pressure extension tube. The basixTOUCH40TM is designed to generate positive and negative pressure, and monitor positive pressures over a range of zero to +40ATM/BAR (zero to 588 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)
Performance testing of the subject basixTOUCH40 Inflation Syringe was conducted based on the risk analysis. The following performance data were provided in support of the substantial equivalence determination.
Performance Testing
- Fluid Functional Use
- Vertical Gauge Tensile
- Horizontal Gauge Tensile
- Vacuum Capability
- Gauge Accuracy
- Retainer Cap Bond Torque
- Tip Adapter Securement and Tip Securement
The results of the testing demonstrated that the subject basixTOUCH40 Inflation Syringe met the predetermined acceptance criteria applicable to the safety and effectiveness of the device.
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.
Not Found
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.
0
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 top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with a design above them that resembles a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 20, 2016
Merit Medical Systems, Inc. Dan Lindsay Project Manager, Regulatory Affairs 1600 West Merit Pkwy. South Jordan, Utah 84095
Re: K153672
Trade/Device Name: basixTOUCH40 Inflation Syringe Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: MAV Dated: December 18, 2015 Received: December 21, 2015
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. 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.
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
1
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 (OS) 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,
Kenneth J. Cavanaugh -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) K153672
Device Name basixTOUCH40 Inflation Syringe
Indications for Use (Describe)
The basixTOUCH40 Inflation Syringe is used to inflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.
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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| 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
December 18, 2015
1721504 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Trade Name:
Common/Usual Name:
Classification Name:
Regulatory Class:
Product Code:
21 CFR §:
Review Panel: | basixTOUCH40 Inflation Syringe
Inflation Syringe
Angiographic injector and syringe
Class II
MAV
870.1650
74 Cardiovascular |
| Predicate
Device | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | BasixTOUCH Inflation Syringe
Angiographic injector and syringe
K130566
Merit Medical Systems, Inc.
This predicate has not been subject to a design-related recall |
| Device
Description | The basixTOUCH40TM Inflation Syringe by Merit Medical is a 30mL
disposable device with a threaded plunger assembly, a flexible high
pressure extension tube. The basixTOUCH40TM is designed to
generate positive and negative pressure, and monitor positive
pressures over a range of zero to +40ATM/BAR (zero to 588 PSI). | |
| Indications for
Use | The basixTOUCH40 Inflation Syringe is used to inflate and deflate an
angioplasty balloon or other interventional device, and to measure the
pressure within the balloon.
There is no change in the Indications for Use Statement from the
predicate to the subject device. | |
5.0 510(k) Summary
4
The Technological characteristics of the subject basixTOUCH40 inflation syringe are considerably equivalent to those of the predicate, the Merit BasixTOUCH Inflation Syringe. The basixTOUCH40 generates higher pressure than the Predicate. Specifically, the predicate maximum pressure is 35 ATM while the subject maximum Comparison to pressure is 40 ATM. Predicate Device The connection between the gauge and the syringe barrel was modified from a brass-fit connection to a snap-fit connection. The predicate used brass and adhesive to attach the gauge to the syringe barrel; the subject device uses a plastic molded component and o-ring to connect the gauge to the syringe barrel. No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the subject basixTOUCH40 Inflation Syringe was conducted based on the risk analysis. The following performance data were provided in support of the substantial equivalence determination. Biocompatibility testing Based on the categorization of the device with regard to patient contact and duration, biocompatibility testing is not required. Devices that do not have patient contact are not included in the scope of ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process and FDA quidance Required Biocompatibility Training and Toxicology Profiles for Evaluation of Performance Medical Devices, May 1, 1995 (FDA Bluebook Memo G95-1). Data Performance Testing ● Fluid Functional Use Vertical Gauge Tensile ● Horizontal Gauge Tensile ● Vacuum Capability ● Gauge Accuracy ● Retainer Cap Bond Torque ● Tip Adapter Securement and Tip Securement ● The results of the testing demonstrated that the subject basixTOUCH40 Inflation Syringe met the predetermined acceptance criteria applicable to the safety and effectiveness of the device.
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| Summary of
Substantial
Equivalence | Based on the indications for use, design, safety and performance
testing, the subject basixTOUCH40 Inflation Syringe meets the
requirements that are considered essential for its intended use and is
substantially equivalent to the predicate device, the BasixTOUCH
Inflation Syringe, K130566 manufactured by Merit Medical Systems,
Inc. |
| ------------------------------------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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