SMARTWIRE/SMARTMAP PRESSURE SYSTEM

K021219 · Jomed, Inc. · DQX · May 17, 2002 · Cardiovascular

Device Facts

• Record ID: K021219
• Device Name: SMARTWIRE/SMARTMAP PRESSURE SYSTEM
• Applicant: Jomed, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: May 17, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The SmartWire/SmartMap Pressure System is intended for use in the coronary and peripheral arteries to measure blood pressure during diagnostic and/or interventional procedures. The SmartWire can also be used in replacement of an angioplasty guide wire to facilitate the placement of a balloon dilation catheter, as well as other interventional procedures. Blood pressure measurements are obtained to provide hemodynamic information for the diagnosis and treatment of blood vessel disease.

Device Story

The SmartWire/SmartMap Pressure System is a steerable pressure-monitoring guide wire and interface unit. The SmartWire (189cm or 300cm, 0.014" diameter) features a pressure sensor at the tip; constructed of stainless steel with a platinum-iridium alloy coil. The SmartMap interface unit connects the SmartWire to existing hemodynamic (Physio Monitor) systems, providing an industry-standard 5uV/V/mmHg output. The Patient Cable Model 8000 allows SmartWire compatibility with the legacy WaveMap instrument. Used by clinicians in the cath lab during diagnostic or interventional procedures; the device provides real-time hemodynamic data to assist in the diagnosis and treatment of blood vessel disease. The SmartWire also functions as a standard guide wire to facilitate the delivery of interventional devices like balloon catheters.

Clinical Evidence

Bench testing only. Performance testing evaluated the modified system against the predicate; results were comparable. Biocompatibility testing was conducted per ISO 10993.

Technological Characteristics

Guide wire: 0.014" diameter, 189/300cm lengths. Materials: stainless steel (core, hypotube, proximal coil), platinum-iridium alloy (tip coil). Lubricious coating. Sensing: catheter tip pressure transducer. Connectivity: SmartMap interface provides AAMI BP22-2-1994 compliant 5uV/V/mmHg output to hemodynamic monitors. Power: derived from hemodynamic system.

Indications for Use

Indicated for use in all blood vessels to measure blood pressure during diagnostic angiography and/or interventional procedures. Used in coronary and peripheral arteries; can replace angioplasty guide wires to facilitate balloon dilation 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

• WaveWire/WaveMap Pressure System (K965140)

Submission Summary (Full Text)

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Jomed Inc. April 2002 SmartWire/SmartMa Special 510(k)

# 510K) Summary of Safety and Effectiveness

| Date Prepared: | April 12, 2002 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by: | Jomed Inc.<br>2870 Kilgore Rd.<br>Rancho Cordova, CA 95670 |
| Contact Person: | Terry Schultz<br>Regulatory Affairs Manager |
| Phone Number: | [phone] Ext. 286 |
| Fax Number: | [phone] |
| Device Name: | Jometrics SmartWire/SmartMap Pressure System |
| Classification Name: | Catheter guide wire<br>Cardiovascular blood flow meter<br>Catheter tip pressure transducer<br>Vessel occlusion transducer<br>Patient transducer and electrical cable (including connector) |
| Predicate Device: | WaveWire/WaveMap Pressure System. K965140 |

### Device Description:

The Jometrics SmartWire/SmartMap Pressure System consists of the SmartWire and the SmartMap. Additionally, the SmartWire can be used with the existing WaveMap with the inclusion of the Patient Cable Model 8000.

The SmartWire is a steerable pressure monitoring guide wire used to obtain intracoronary pressure measurements before, during, and after interventional procedures. There are two lengths. 189 cm and 300 cm and the outside diameter is .014". The screw tip, core wire, proximal coil and hypotube are manufactured from stainless steel. The tip coil is composed of a platinum, iridium alloy and coated to provide lubricity. The hypotube and proximal coil are also coated to provide lubricity.

The SmartMap is designed to interface a SmartWire Pressure Wire to the auxiliary input of hemodynamic (Physio Monitor) systems. The SmartMap's power is derived from the hemodynamic system and provides in return an industry standard (AAMI BP22-2-1994) 5uV/V/mmHg output back to the hemodynamic system.

The instrument is intended to measure pressure from a pressure sensor on a guide wire in the coronary and peripheral vasculature during diagnostic and/or interventional procedures.

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Jomed Inc. April 2002

### 510(k) Summary (cont'd)

The Patient Cable Model 8000 is a preamplifier/signal condition unit designed to interface the SmartWire family of wires to an existing WaveMap Instrument. It uses intelligence to set up the circuitry designed to process the SmartWire as done in the SmartMap so that SmartWires may be used with either the SmartMap or the WaveMap.

### Intended Use:

The SmartWire/SmartMap Pressure System is intended for use in the coronary and peripheral arteries to measure blood pressure during diagnostic and/or interventional procedures. The SmartWire can also be used in replacement of an angioplasty guide wire to facilitate the placement of a balloon dilation catheter, as well as other interventional devices. Blood pressure measurements are obtained to provide hemodynamic information for the diagnosis and treatment of blood vessel disease.

# Device Technological Characteristics and Comparison to Predicate Device:

The SmartWire/SmartMap Pressure System uses the same fundamental scientific technology and intended use as that of the predicate device, the WaveWire/WaveMap Pressure System.

### Performance Data:

Applicable testing was performed to evaluate the changes in the SmartWire/SmartMap Pressure System. The testing results were found to be comparable to those of the predicate device, the WaveWire/WaveMap Pressure System. All new materials were tested for biocompatibility according to ISO 10993.

#### Conclusion:

The SmartWire/SmartMap Pressure System utilizes the same fundamental scientific technology as that of the predicate device, the WaveWire/WaveMap Pressure System. The performance data and a declaration of conformity with design controls support a determination of substantial equivalence of the modified device, SmartWire/SmartMap Pressure System to the predicate device, WaveWire/WaveMap Pressure System.

# KO21219

_Premarket Notification [510(k)] Number

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### 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 an abstract symbol that resembles an eagle or bird in flight, composed of three human profiles facing to the right.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 1 7 2002

Mr. Terry Schultz Regulatory Affairs Manager Jomed, Inc. 2870 Kilgore Rd. Rancho Cordova, CA 95670

Re: K021219

> SmartWire/SmartMap Pressure System Regulation Number: 870.1330, 870.2870 Regulation Name: Catheter guide wire, Catheter tip pressure transducer Regulatory Class: II (two) Product Code: 74 DQX, DXD Dated: April 16, 2002 Received: April 17, 2002

Dear Mr. Schultz:

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.

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

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Page 2 - Mr. Terry Schultz

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 your 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,

N.G. Tiller

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Jomed Inc. April 2002 SmartWire/SmartMap Special 510(k)

### 510(k) Number (if known):

Device Name: SmartWire/SmartMap Pressure System

### Indications for Use:

The SmartWire/SmartMap Pressure System is indicated for use in all blood vessels, I he Sinal White Smarthup Fressure Byoss to measures blood pressure during diagnostic angiography and/or interventional procedures. :

K021219

The intended use and indications for use of the modified device as described in its labeling The included use and microations for ientific technology of the modified device has not changed.

# (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Prescription Use (Per 21 CFR 801.19) | <span style="font-size: 2em;">✓</span> |
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OR

| Over-the Counter Use | |
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Division of Carding: 510(k) Number