PRESSURE WIRE SENSOR, MODELS 12004/12304

K031662 · Radi Medical Systems AB · DXO · Jun 6, 2003 · Cardiovascular

Device Facts

• Record ID: K031662
• Device Name: PRESSURE WIRE SENSOR, MODELS 12004/12304
• Applicant: Radi Medical Systems AB
• Product Code: DXO · Cardiovascular
• Decision Date: Jun 6, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2870
• Device Class: Class 2

Intended Use

The PressureWire Sensor is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the coronary and peripheral blood vessels.

Device Story

PressureWire™ Sensor is a 0.014" diameter guidewire (183 or 300 cm length) featuring a distal pressure sensor. Used by physicians to navigate catheters through coronary and peripheral vasculature while simultaneously measuring physiological pressure parameters. Device connects via a detachable cable to a proprietary programmable diagnostic computer. Output provides real-time pressure data to assist clinicians in hemodynamic assessment during interventional procedures. Benefits include combined guidewire functionality and diagnostic pressure monitoring in a single device.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarities to the predicate device.

Technological Characteristics

0.014" diameter guidewire; 183 or 300 cm length; distal pressure transducer; detachable cable interface; connects to external programmable diagnostic computer. Technological characteristics are identical to the predicate device except for internal dimension modifications.

Indications for Use

Indicated for use in coronary and peripheral blood vessels to facilitate catheter navigation and measure physiological parameters. Prescription use only.

Regulatory Classification

Identification

A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.

Predicate Devices

• PressureWire™ Sensor (K022188)

Submission Summary (Full Text)

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JUN - 6 2003

## Attachment 4

## 510(k) Summary

This 510(k) summary is submitted in accordance with the requirements in 21 CFR \$807.92

| Submitted by: | RADI Medical Systems AB<br>Palmbladsgatan 10<br>SE-754 50 Uppsala, Sweden<br>Phone:[phone] |
|----------------------|---------------------------------------------------------------------------------------------------|
| Contact Person: | Mats Granlund |
| Date Prepared: | May 26, 2003 |
| Proprietary Name: | PressureWire™ Sensor |
| Common Name: | Pressure Guide Wire |
| Classification Name: | Catheter Guide Wire (870.1330)<br>Catheter Tip Pressure Transducer (870.2870) |
| Predicate Device: | PressureWire™ Sensor 510(k) # K022188 |

Description of the Device: The PressureWire™ Sensor is a 0.014" diameter, 183 or 300 cm long guidewire with a pressure sensor mounted three cm from the distal end and a detachable cable for connection to a programmable diagnostic computer manufactured by the submitter.

Intended Use of the Device: These devices have the same intended use as the predicate PressureWire™ Sensor.

The PressureWire Sensor is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the coronary and peripheral blood vessels.

Technical Characteristics: With exception of the internal dimension modifications, the subject device has the same technological characteristics as the predicate PressureWire™ Sensor.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 6 2003

Radi Medical Systems AB c/o Mr. Mats Granlund Ouality & Regulatory Affairs Manager Palmbladsgatan 10 SE-754 50 Uppsala Sweden

Re: K031662

Trade Name: Pressure Wire™ Sensor Regulation Number: 21 CFR 870.2870 Regulation Name: Catheter tip pressure transducer Regulatory Class: Class II (two) Product Code: DXO Dated: May 26, 2003 Received: May 28, 2003

Dear Mr. Granlund:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Mats Granlund

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): good manufacturing practice requirements as set 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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bram D. Zuckerman, M.D.
Director

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Attachment 2

## Indication for Use Statement

| 510(k) Number: | K031662 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | PressureWire™ Sensor |
| Indications for Use: | The PressureWire Sensor is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the coronary and peripheral blood vessels. |

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CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

| (Division Sign-Off) | |
|---------------------|--|
|---------------------|--|

Division of Cardiovascular Devices

| 510(k) Number | K031662 |
|---------------|---------|
|---------------|---------|

| Prescription Use | X | OR | Over-The-Counter Use |
|----------------------|---|----|----------------------|
| (Per 21 CFR 801.109) | | | |