(20 days)
Not Found
No
The summary describes a pressure monitoring system with a syringe, monitor, and printer. There is no mention of AI, ML, or any data processing beyond displaying and storing pressure data.
No
The device is described as a monitor and measuring tool for pressure, not as something that directly provides therapy or treatment. Its intended use is to monitor and measure, which are diagnostic or observational functions.
No
The device description indicates its primary function is to monitor pressure and measure injectate pressures, which are operational functions during a procedure, not diagnostic evaluations of a patient's condition.
No
The device description explicitly lists hardware components including a disposable syringe with a transducer, an electronic monitor, a disposable interface cable, a printer, and mounting accessories.
Based on the provided information, the Merit Medical INTELLISYSTEM II MONITOR is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Intended Use: The intended use of the INTELLISYSTEM II MONITOR is to "monitor the pressure of interventional devices as well as measure injectate pressures in various areas of the body." This involves monitoring pressures within the body during a procedure, not analyzing samples taken from the body.
- Device Description: The device components (syringe, monitor, cable, printer) are designed for pressure monitoring and data display during a procedure, not for laboratory analysis of biological samples.
Therefore, the device's function and intended use clearly fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Merit Medical INTELLISYSTEM II MONITOR is for use only with the disposable INTELLISYSTEM25 Syringe. It may be used to monitor the pressure of interventional devices as well as measure injectate pressures in various areas of the body.
Product codes (comma separated list FDA assigned to the subject device)
MAV
Device Description
The Merit Medical IntelliSystem comprises a disposable inflation/pressurizing syringe with an integral pressure transducer, an electronic monitor for displaying and storing data which is connected to the syringe via a disposable interface cable, a printer for producing a hard copy of data collected during the procedure, and mounting accessories with which the monitor is attached to the procedure table or an IV pole.
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)
Not Found
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
Attachment 4
510(k) Summary
SAFETY AND EFFECTIVENESS SUMMARY
This information of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Submitted by Name/Address: | Chester McCoy
Regulatory Affairs Engineer
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095
(801) 253-1600 ext. 404
(801) 253-1684 fax |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Same as above |
| Date Summary Prepared: | September 15, 1999 |
| Device Name: | IntelliSystem II Angioplasty Inflation
Device |
| Common Name: | Monitor for an Angioplasty Inflation
Device |
| Trade Name: | IntelliSystem II |
| Classification (if known): | Class II, 74 MAV. |
| Predicate Device: | K884913, INTELLIFLATORTM |
1
Performance Standards:
Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act.
Device Description:
The Merit Medical IntelliSystem comprises a disposable inflation/pressurizing syringe with an integral pressure transducer, an electronic monitor for displaying and storing data which is connected to the syringe via a disposable interface cable, a printer for producing a hard copy of data collected during the procedure, and mounting accessories with which the monitor is attached to the procedure table or an IV pole.
Intended Use and Description:
The INTELLISYSTEM II COLOR MONITOR displays pressures created by the INTELLISYSTEM25 Syringe which is used to pressurize the balloon of a dilation catheter during interventional procedures as well as monitor injectate pressures in various areas of the body. The INTELLISYSTEM25 Syringe is connected to the Monitor via two flexible four foot cables.
In addition to displaying pressure parameters in ATM, psi, mmHg, BARS, or kPa. The INTELLISYSTEM II MONITOR displays pressurization number, duration of pressurization in minutes and seconds, time elapsed since last pressurization, and when a negative pressure has been reached. The Monitor also has the capability to display all of the above functions while graphing the pressure cycle on the screen.
Biocompatibility:
The INTELLISYSTEM II COLOR MONITOR does not come into contact with the patient.
Summary of Substantial Equivalence:
The INTELLISYSTEM II COLOR MONITOR is substantially equivalent to the previously cleared INTELLIFLATOR MONITOR.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's seal. The seal features an abstract caduceus-like symbol with three wavy lines emanating from a central point, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 25 1999
Mr. Chester McCoy Regulatory Affairs Engineer Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095
Re: K993341 IntelliSystem II Color Monitor Trade Name: Requlatory Class: II Product Code: MAV Dated: September 27, 1999 Received: October 5, 1999
Dear Mr. McCoy:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation
3
Page 2 - Mr. Chester McCoy
you might have under sections 531 through 542 of the Act for devices you might nave and Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described inis recei will arrow you offication. The FDA finding of substantial in your 510 (n, promote to a legally marketed predicate device equivalence or your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally, 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) dragmostly, process, processions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-Also, please note the regulation entitled, "Misbranding by 4639. reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Christopher
Wolf Sapirstein, M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment 2
| Indications for Use Statement | |
|---|---|
| 510(k) | |
| Number | |
| (if Known) | |
| Device Name | IntelliSystem II Angioplasty Inflation Device |
| Indications forUse | The Merit Medical INTELLISYSTEM II MONITOR is for use only with the disposable INTELLISYSTEM25 Syringe. It may be used to monitor the pressure of interventional devices as well as measure injectate pressures in various areas of the body. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE
IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chitran th for Sapirsteln
(Division Sign-Off)
(Brision Sign-Off) Division of Cardiovascular, Respiratory, Respiratory,
and Neurological Devices K993341
Prescription Use X
Over-The-Cou
Over-The-Counter Use_____________
OR