INTELLISYSTEM II COLOR MONITOR

K993341 · Merit Medical Systems, Inc. · MAV · Oct 25, 1999 · Cardiovascular

Device Facts

• Record ID: K993341
• Device Name: INTELLISYSTEM II COLOR MONITOR
• Applicant: Merit Medical Systems, Inc.
• Product Code: MAV · Cardiovascular
• Decision Date: Oct 25, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended 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.

Device Story

IntelliSystem II monitors pressure during interventional procedures; system includes disposable inflation/pressurizing syringe with integral pressure transducer, electronic monitor, disposable interface cable, and printer. Monitor displays pressure parameters (ATM, psi, mmHg, BARS, kPa), pressurization number, duration, elapsed time, and negative pressure status; provides real-time pressure cycle graphing. Used in clinical settings by healthcare providers to monitor balloon dilation catheter inflation and injectate pressures. Output assists clinicians in managing procedural pressure parameters.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System includes disposable inflation syringe with integral pressure transducer, electronic monitor, interface cable, and printer. Displays pressure in multiple units (ATM, psi, mmHg, BARS, kPa). Monitor is non-patient contacting. Connectivity via disposable interface cable to syringe.

Indications for Use

Indicated for monitoring pressure of interventional devices and measuring injectate pressures in various body areas during interventional procedures. For use only with the disposable INTELLISYSTEM25 Syringe.

Regulatory Classification

Special Controls

*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.

Predicate Devices

• INTELLIFLATOR MONITOR (K884913)

Submission Summary (Full Text)

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## 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<br>Regulatory Affairs Engineer<br>Merit Medical Systems, Inc.<br>1600 West Merit Parkway<br>South Jordan, UT 84095<br>[phone] ext. 404<br>[phone] fax |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Same as above |
| Date Summary Prepared: | September 15, 1999 |
| Device Name: | IntelliSystem II Angioplasty Inflation<br>Device |
| Common Name: | Monitor for an Angioplasty Inflation<br>Device |
| Trade Name: | IntelliSystem II |
| Classification (if known): | Class II, 74 MAV. |
| Predicate Device: | K884913, INTELLIFLATORTM |

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#### 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.

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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

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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 [phone] or [phone] 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

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# Attachment 2

| Indications for Use Statement | |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>Number<br>(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