PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE

K972793 · Radi Medical Systems AB · DQX · Apr 24, 1998 · Cardiovascular

Device Facts

• Record ID: K972793
• Device Name: PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE
• Applicant: Radi Medical Systems AB
• Product Code: DQX · Cardiovascular
• Decision Date: Apr 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The PressureWire™ System is indicated for the measurement of blood pressure in the coronary vasculature and to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA).

Device Story

PressureWire™ System consists of a guidewire with a near-end mounted pressure sensor, an interface, and monitor cables. Used during PTCA procedures to measure coronary blood pressure and assist in balloon dilatation catheter placement. Operates by connecting the sensor-tipped guidewire to standard pressure-monitoring systems. Provides real-time pressure data to clinicians, aiding in hemodynamic assessment and procedural navigation. Benefits include improved accuracy in pressure monitoring and catheter positioning within the coronary vasculature.

Clinical Evidence

Bench testing only. Safety and performance testing demonstrated substantial equivalence to predicate devices.

Technological Characteristics

Materials include stainless steel and platinum alloy. Sensing principle utilizes a near-end mounted pressure sensor. System includes guidewire, interface, and monitor cables for connection to standard pressure-monitoring equipment.

Indications for Use

Indicated for patients undergoing percutaneous transluminal coronary angioplasty (PTCA) requiring blood pressure measurement within the coronary vasculature and guidance for balloon dilatation catheter placement.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, 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

• ACS Guidewires
• Millar Pressure Measurement System

Submission Summary (Full Text)

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APR 2 4 1998

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

1972793

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

A. Submitter's Information:

| Name: | Radi Medical Systems AB |
|----------------------|---------------------------------------------|
| Address: | Palmbladsgatan 10, S-754 50 Uppsala, Sweden |
| Phone: | 46-18-161000 |
| Fax: | 46-18-161099 |
| Contact Person: | Mats Granlund |
| Date of Preparation: | January 21, 1998 |

B. Device Name:

| Trade Name: | PressureWire™ System including<br>PressureWire™ Sensor,<br>PressureWire™ Interface and<br>PressureWire™ Monitor Cables. |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Transducer, Pressure, Guidewire |
| Classification Names: | Transducer, Pressure, Guidewire |
| Predicate Device Names: | ACS Guidewires<br>Millar Pressure Measurement System |

#### D. Device Description:

C.

The RADI Medical Systems PressureWire™ System consists of a guidewire with a nearend mounted pressure sensor and an interface to facilitate connection to an ordinary pressure-monitoring system.

#### E. Intended Use:

"The PressureWire™ System is indicated for the measurement of blood pressure in the coronary vasculature and to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA).

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F. Technical Characteristics:

The mechanical properties of the PressureWire™ Sensor are similar to ACS Guidewires. Most of the materials used the construction, which will be in contact with blood, are typical for similar devices. These include stainless steel and platinum alloy. The technical properties of PressureWire™ System are similar to the Millar Pressure Measurement System.

G. Performance Data:

Safety and performance testing was performed to demonstrate that the RADI Medical Systems PressureWire™ System is substantially equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 4 1998

Mr. Mats Granlund Quality Manager RADI Medical Systems AB Palmbladsgatan 10 S-754 50 UPPSALA, Sweden

Re: K972793

> Trade Name: Pressure Wire™ System with Pressure Wire™ Sensor, Pressure Wire™ Interface and Pressure Wire™ Monitor Cables Requlatory Class: II Product Code: DQX Dated: January 22, 1998 Received: January 26, 1998

Dear Mr. Granlund:

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 leqally 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 requlations 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 Requlation (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

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Page 2 - Mr. Granlund

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 requlations.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

| 510(k) Number: | K972793 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | PressureWireTM System with PressureWireTM Sensor,<br>PressureWireTM Interface and PressureWireTM Monitor Cables. |
| Indications for Use: | "The PressureWireTM System is indicated for the measurement<br>of blood pressure in the coronary vasculature and to facilitate<br>the placement of balloon dilatation catheters during<br>percutaneous transluminal coronary angioplasty (PTCA). |

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### CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

t

Prescription Use 11 (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1/2/96)

. Ruy
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number _