(140 days)
Not Found
No
The device description and performance studies focus on mechanical and pressure-related functionalities, with no mention of AI or ML terms or concepts.
No.
The device inflates and deflates angioplasty balloons and measures pressure within them; it does not directly treat a disease or condition itself.
No
The device is used to inflate/deflate angioplasty balloons and measure pressure within the balloon, which are interventional functions, not diagnostic ones.
No
The device description explicitly states it is a "single use disposable device" and lists physical components like a "threaded plunger assembly," "flexible high pressure extension tube," and a "three way medium pressure stopcock." This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to inflate and deflate angioplasty balloons or other interventional devices and measure pressure within the balloon. This is a mechanical function performed in vivo (within the body) during a medical procedure.
- Device Description: The description details a syringe, plunger, extension tube, and stopcock – all components used for delivering pressure and fluid in vivo.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to be used in vitro (outside the body) for diagnostic purposes. This device's function is entirely focused on supporting an in vivo interventional procedure.
N/A
Intended Use / Indications for Use
The Merit analog 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 Merit analog inflation syringe is a single use disposable device capable of generating and monitoring pressure in angioplasty or other similar interventional devices. It is fitted with a threaded plunger assembly with lock/release bar, flexible high pressure extension tube. It is provided with a 510(k)-cleared three way medium pressure stopcock.
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 applicable mandatory performance standards or special controls have been established under Section 514 of the Food, Drug and Cosmetic Act for this device. However, a battery of tests was performed according to protocols based on the requirements of industry standards and guidance and the device met the acceptance criteria necessary to demonstrate the safety and efficacy of the device.
The following is a list of all significant testing that has been successfully completed for this device:
Functional Test (Fluid and Air) Torqueability Test Tensile Test Thermal Shock - Leak Test Transportation Simulation Gauge Responsiveness Test Volumetric Comparison Test Greening Effect Vacuum Capability Test Gauge Accuracy and Precision
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
K122321
(pg. 1 of 2
Merit Medical Systems, Inc. Analog Inflation Syringe Premarket Notification 510(k) Section 5
510(k) Summary
DEC 1 9 2012
ಿ
Section 5
510(k) Summary
| General
Provisions | Submitter Name:
Address:
Telephone Number:
Fax Number:
Contact Person:
Registration Number: | Merit Medical Systems, Inc.
1600 West Merit Parkway,
South Jordan, UT 84095
(801) 208-4349
(801) 253-6967
Stephanie Erskine
1721504 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Correspondent Name:
Address:
Telephone Number:
Fax Number:
Contact Person:
Date of Preparation:
Registration Number: | Merit Medical Ireland Ltd.
Parkmore Business Park,
Galway, Ireland
(353) 91 703 761
(353) 91 771 888
Mark Mullaney
December 19th, 2012
9616662 |
| Subject
Device | Trade Name:
Common/Usual Name:
Classification Name: | BasixCOMPAK
Inflation Syringe
74 MAV Balloon Inflation Syringe |
| Predicate
Device | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | Merit Monarch COMPAK Inflation Syringe &
Universal Fluid Dispensing
74 MAV Balloon Inflation Syringe
K083523
Merit Medical Systems, Inc. |
| Classification | Class II
21 CFR § 870.1650, 74 MAV
Division of Cardiovascular Devices | |
| Intended Use | The Merit analog inflation syringe is used to inflate and deflate an
angioplasty balloon or other interventional device, and to measure the
pressure within the balloon | |
| Device
Description | The Merit analog inflation syringe is a single use disposable device capable
of generating and monitoring pressure in angioplasty or other similar
interventional devices. It is fitted with a threaded plunger assembly with
lock/release bar, flexible high pressure extension tube. It is provided with a
510(k)-cleared three way medium pressure stopcock. | |
| | Comparison to
Predicate | The Technological characteristics of the subject Merit analog inflation
device are substantially equivalent to those of the predicate, the Merit
Monarch COMPAK Inflation Syringe & Universal Fluid Dispensing Device.
The significant difference between the devices relate to the pressure gauge
display. The Merit analog inflation device has an analog gauge display. The
predicate device has a digital display. |
| | Safety &
Performance
Tests | No applicable mandatory performance standards or special controls have
been established under Section 514 of the Food, Drug and Cosmetic Act for
this device. However, a battery of tests was performed according to
protocols based on the requirements of industry standards and guidance
and the device met the acceptance criteria necessary to demonstrate the
safety and efficacy of the device. |
| | | Where appropriate, the tests were based on the requirements of the
following documents:
ISO 11135-1:2007 Sterilization of health care products - Ethylene
oxide - Part 1: Requirements for the development, validation, and
routine control of a sterilization process for medical devices. ISO 10993-7:2008 - Biological Evaluation of Medical Devices - Part
7: Ethylene Oxide Sterilization Residuals ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile
Barrier Systems for Medical Devices. ASTM D4169 - 09 Standard Practice for Performance Testing of
Shipping Containers and Systems 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. ISO 594-1:1996 Conical Fittings with a 6% (Luer) taper for syringes,
needles and certain other medical equipment - general
requirements ISO 594-2:1998 Conical fittings with 6% (Luer) taper for syringes,
needles and certain other medical equipment - Part 2: Lock fittings |
| | Safety &
Performance
Tests | The following is a list of all significant testing that has been successfully
completed for this device:
Functional Test (Fluid and Air) Torqueability Test Tensile Test Thermal Shock - Leak Test Transportation Simulation Gauge Responsiveness Test Volumetric Comparison Test Greening Effect Vacuum Capability Test Gauge Accuracy and Precision |
| | Summary of
Substantial
Equivalence | Based on the indications for use, design, safety, and performance testing,
the subject Merit analog inflation device meets the requirements that are
considered essential for its intended use and is substantially equivalent to
the predicate device, the Merit Monarch Inflation Syringe (K083523)
manufactured by Merit Medical Systems, Inc. Differences between the
devices do not raise any different questions of safety or effectiveness. |
1
K122321
(pg. 282)
Merit Medical Systems, Inc.
Analog Inflation Syringe
Premarket Notification 510(k)
Section 5
510(k) Summary
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms reaching upwards, symbolizing growth and development. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Merit Medical Systems, Inc. c/o Stephanie Erskine 1600 West Merit Parkway South Jordan, UT 84095
DEC 1 9 2012
Re: K122321
Trade/Device Name: BasixCOMPAK Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: MAV Dated: November 29, 2012 Received: November 30, 2012
Dear Ms. Erskine:
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. 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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Matthew G. Hillebrenner
for
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Merit Medical Systems, Inc. Analog Inflation Syringe Premarket Notification 510(k)
Section 4
Indications for Use Statement
510(k) Number (if known):
K12232
Device Name: BasixCOMPAK
Indications for Use:
The Merit analog inflation syringe is used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.Y. Hillel
n Sign-C (Division Sign-Oh)
Division of Cardiovascular Devices 510(k) Numbe