PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304

K022187 · Radi Medical Systems AB · DXO · Sep 24, 2002 · Cardiovascular

Device Facts

• Record ID: K022187
• Device Name: PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304
• Applicant: Radi Medical Systems AB
• Product Code: DXO · Cardiovascular
• Decision Date: Sep 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2870
• Device Class: Class 2

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

Device Story

PressureWire™ Sensor: steerable guidewire with integrated piezo-resistive pressure/temperature sensor; 0.014" diameter; 183/300 cm lengths. Used in coronary/peripheral vasculature; operated by physicians. Connects to RADIAnalyzer™ diagnostic computer via detachable cable with identification memory chip. Sensor utilizes Wheatstone bridge for pressure (-30 to 300 mmHg) and temperature (15 to 42°C) sensing. Capacitor added to connector to decrease shield impedance and improve immunity to electrical interference, reducing noise tenfold. System calculates physiological indices including Fractional Flow Reserve (FFR) and Coronary Flow Reserve (CFR). Output presented on RADIAnalyzer™ monitor as real-time graphs/indices; assists clinicians in hemodynamic assessment and clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only. Testing focused on electrical noise reduction and performance verification of the modified connector/capacitor assembly.

Technological Characteristics

0.014" diameter guidewire; Pt coil tip; stainless steel coil/PTFE-coated tube body. Piezo-resistive pressure sensor in Wheatstone bridge configuration. Connectivity via detachable cable to RADIAnalyzer™ computer. Capacitor added to connector for noise reduction. Sterile, single-use.

Indications for Use

Indicated for patients requiring catheter guidance and physiological parameter measurement in coronary and peripheral blood vessels. Contraindicated for use in cerebral vasculature.

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 (K002962)
• FloWire Doppler Guide wire (K972762)

Submission Summary (Full Text)

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K022187

p.1/3

# SEP 2 4 2002

#### 510(K) SUMMARY 9

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and CFR 21 §807.92.

## Submitter's Information:

| Name: | RADI Medical Systems AB |
|-------------------------|----------------------------------------------|
| Address: | Palmbladsgatan 10, SE-754 50 Uppsala, Sweden |
| Phone/Fax: | [phone] / [phone] |
| Contact Person: | Mats Granlund |
| Date of Preparation: | July 2, 2002 |
| Device Name: | |
| Trade Names: | PressureWire™ Sensor |
| Common Name: | Pressure Guidewire |
| Classification Name: | Catheter Guide Wire (870.1330) |
| | Catheter Tip Pressure Transducer (870.2870) |
| | Thermodilution probe (870.1915) |
| Predicate Device Names: | PressureWire™ Sensor (K002962) |
| | FloWire Doppler Guide wire (K972762) |

### Device Description:

The PressureWire™ Sensor consists of a pressure and temperature sensitive sensor mounted on a steerable guidewire to perform real-time invasive physiological measurement in the circulatory system and a detachable cable for connection to a diagnostic computer of the manufacturer's. The detachable cable has an identification memory chip containing the individual calibration parameters for the sensor.

The guidewire has an outer diameter of .014" and comes in two lenghts 183 and 300 cm. The pressure sensor is mounted just proximal of the 3 cm shapeable radiopaque tip.

The signals from the sensor are used for calculation and presentation of any parameters and indices based on temperature and pressure, such as detection of small temperature differences and Fractional Flow Reserve (FFR). By also using the temperature sensitivity in the cables within the device also flow ratios such as Coronary Flow Reserve (CFR) could be derived.

### Indication for Use:

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

# Technical Characteristics Summary:

The technical characteristics of PressureWire™ Sensor are identical with the predicate device (K002962) with the exception of a capacitor.

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#### 10 Description

The device is technically identical with the predicate with exception of the capacitor.

#### 10.1 Intended Use

The signals from the sensor are used for calculation and presentation of any parameters and indices based on temperature and pressure, such as detection of small temperature differences and Fractional Flow Reserve (FFR). By also using the temperature sensitivity in the cables within the device also flow ratios such as Coronary Flow Reserve (CFR) could be derived. The calculation of the signals is made by the manufacturer's RADIAnalyzer™ (See concurrent 510(k) submission)

#### Indications for Use 10.2

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

#### 10.3 Contraindications

Use of the PressureWire™ Sensor is contraindicated for use in the cerebral vasculature.

# 10.4 Principles of Operation

For measurements, the PressureWire™ Sensor is connected to the RADIAnalyzer™, which. After calibration of the sensor in saline solution the system is ready for use.

The mechanical principles of operation are the same as for any ordinary guidewire.

Image /page/1/Picture/11 description: The image shows a medical device called a PressureWire. The PressureWire is a thin, flexible wire with a pressure sensor at the tip. It is used to measure blood pressure inside blood vessels. The image also shows a monitor that displays the pressure readings from the PressureWire. The monitor has a screen that shows a graph of the pressure over time.

Figure 10.1 Pressure Wire Sensor connected to RADIAnalyzer

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#### Composition and Physical Description 10.5

The PressureWire™ Sensor consists of three parts, the sensor, the guidewire, and the torque device. All parts are sterile and for single use only. No changes have been made in the composition apart from the incorporation of the capacitor, which is mounted at the circuit board with in the contact (G), see figure below.

Image /page/2/Figure/3 description: The image shows a diagram of a guidewire with a sensor and a cable. The guidewire has a length of 31 cm, and a sensor with a length of 3 cm. The cable has a length of 200 cm. The diameter of the guidewire is 0.014 inches (0.36mm).

## Figure 10.2: Device parts

The guidewire part is available in two lengths (183, 300 cm). The very tip consists of a 3 cm Pt coil distal of the sensor element, and proximal of the sensor element there is a 28 cm stainless steel coil followed by a PTFE coated stainless steel tube, which ends with the male contact. Within the tube and proximal coil there are mainly a core wire and a triple conductor (Micro Cable) for connection between the sensor element and the male contact. The actual sensor element is a piezo resistive pressure sensor coupled in a Wheatstone bridge. The linear working range for the pressure signals is from -30 to 300 mmHg, and for the temperature signals from 15 to 42℃.

The cable is identical with the predicate device with exception of the capacitor, which is incorporated in the connector (female contact) in parallel with a 100kOhm resistor to decrease the impedance of the shield (proximal tube) at high frequencies as well to increase the immunity of the sensor against disturbing signals from surrounding electrical equipment. To decrease the influence from surrounding electrical equipment has become of more importance when the temperature signals are actively used in the CFR calculations. The noise level has decreased tenfold with the incorporation of the capacitor.

(See Attachment III)

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 2002

RADI Medical Systems AB c/o Mr. Mats Granlund Quality Manager Palmbladsgatan 10 SE-754 50 Uppsala Sweden

Re: K022187

Trade Name: PressureWire Sensor Regulation Number: 21 CFR 870.2870 and 870.1915 Regulation Name: Catheter Tip Pressure Transducer and Thermodilution Probe Regulatory Class: Class II (two) Product Code: DXO and KRB Dated: July 2, 2002 Received: July 5, 2002

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Elias Mallis

Bram D. Zuckernan, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 2 Statement of Indications for Use

| 510(k) Number: | K022187 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | PressureWire ^TM Sensor |
| Indications for Use: | The PressureWire ^TM Sensor is indicated to direct a<br>catheter through a blood vessel and to measure<br>physiological parameters in the coronary and<br>peripheral blood vessels |

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Elier Malls ·············································································································································································· (CFR 801.109)

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

OR Over-The-Counter Use ______________________________________________________________________________________________________________________________________________________ Prescription Use x (Per 21 CFR 801.109)

(Optional Format 1/2/96)