(72 days)
Not Found
No
The device description mentions a "microcomputer" and "monitoring pressures," but there is no indication of AI or ML algorithms being used for analysis, decision-making, or learning from data. The pressure increase is described as a direct result of turning the plunger handle, not an intelligent process.
No
The device is described as a syringe used to inflate and deflate angioplasty catheters, inject fluids, and monitor pressure, which are support functions for a medical procedure rather than directly treating a condition itself.
No
The device is used to inflate and deflate balloon angioplasty catheters, measure pressure within the balloon, inject fluids, and monitor fluid pressure. This is a therapeutic and monitoring function, not a diagnostic one that identifies a disease or condition.
No
The device description clearly outlines multiple hardware components including a syringe, microcomputer, LCD, threaded device, extension tube, and plunger assembly.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device's function in inflating/deflating balloons, measuring pressure within balloons, injecting fluids, and monitoring fluid pressure within the body during a medical procedure (angioplasty).
- Device Description: The description details a syringe with pressure monitoring capabilities used for direct interaction with the patient's body (injecting fluids, inflating balloons within vessels).
- 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) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed for testing samples outside the body to gain diagnostic information. This device is used in vivo (within the body) during a medical procedure.
N/A
Intended Use / Indications for Use
The 30 ATM Monarch™ syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.
Product codes
74 DXT, 74 MAV
Device Description
The 30 ATM Monarch™ is a 20 ml single use balloon inflation and fluid dispensing device with an integral pressure transducer, back-lit LCD, threaded plunger assembly with locking release, a flexible high pressure extension tube and a rotating adaptor. The Monarch™ is capable of generating and monitoring pressures over a range of -7 to +441 PSI (-1 to +30 atmospheres). The internal microprocessor allows monitoring pressure changes with each 360° turn of the syringe plunger handle.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SAFETY AND EFFECTIVENESS SUMMARY AUG 2 2 2001
This information of 510(k) safety and effectiveness information is being submitted in This micrination the requirements of 21 CFR 807.92.
| Submitted by Name / Address: | Dennis (Dan) Reigle
Manager Regulatory Affairs
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095
(801) 208-4349 (direct)
(801) 253-1684 (fax) |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Same as above |
| Date Summary Prepared: | July 24, 2001 |
| Device Name: | 30 ATM Monarch Syringe |
| Common Name: | Balloon Inflation Syringe |
| Trade Name: | Monarch™ Inflation Syringe
Universal Fluid Dispensing Syringe |
| Classification (if known): | Cardiovascular |
| Predicate Device(s): | Monarch™ Inflation Syringe (K943597)
Universal Fluid Dispensing Syringe
(K973230) |
1
SAFETY AND EFFECTIVENESS SUMMARY
Device Description:
The 30 ATM Monarch™ is a 20 ml single use balloon inflation and fluid dispensing I hic 50 ATM Monater - 18 a 20 million of 20 microcomputer, back-lit LCD, threaded device will an intogral problemense bar, a flexible high pressure extension tube and a punger assembly with locas recease our a career of the Monarch™ is capable of generating thice-way incoran pressures over a range of -- 1 to +30 atmospheres (-7 to + 441 PSI). The and montoning pressures over a lange withing the each 360° turn of the syringe plunger handle.
Intended Use:
The 30 ATM Monarch™ syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.
| Modified Device | Predicate Devices | |||
|---|---|---|---|---|
| 30 ATM Monarch | ||||
| (K011811) | 25 ATM Monarch | |||
| (K943597) | Universal Fluid | |||
| Dispensing Syringe | ||||
| (K973230) | ||||
| Materials | Polycarbonate | Polycarbonate | ||
| ● | Barrel | Same as Predicate Devices | Polycarbonate | Polycarbonate |
| ● | Syringe Plunger | Same as Predicate Devices | ABS Plastic | ABS Plastic |
| ● | Syringe Plunger Tip | Same as Predicate Devices | Natural Rubber | Natural Rubber |
| ● | Tubing with | |||
| Rotating Adaptor | Same as Predicate Devices | Polyurethane tubing | Polyurethane tubing | |
| Polycarbonate adaptor | Polycarbonate adaptor | |||
| ● | Pressure Transducer | |||
| Interface | Same as Predicate Devices | Black Silicone Gel | Black Silicone Gel | |
| ● | Microprocessor | Same as Predicate Devices | NEC Electronics, Inc. | |
| µPD75328, 4bit CPU | NEC Electronics, Inc. | |||
| µPD75328, 4bit CPU |
Comparison of 30 ATM Monarch™ to Predicate Devices
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus, with three curved lines representing the staff and a serpent winding around it.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2001
Mr. Dennis Reigle Manager, Regulatory Affairs Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095
K011811 Re:
Trade Name: Monarch™ Syringe Universal Fluid Dispensing Syringe Regulation Number: 870.1650 Regulatory Class: II (two) Product Code: 74 DXT and 74 MAV Dated: July 27, 2001 Received: July 30, 2001
Dear Mr. Reigle:
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 Regulations, 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 you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Dennis Reigle
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for 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) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by 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/dsmamain.html".
Sincerely yours,
James E. Dillard III Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
of_1 Page 1
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:_30 ATM Monarch Syringe
Indications For Use:
The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Device*
510(k) Number K 171811
(Optional Format 3-10-98)