SCIMED INFORMER PRESSURE WIRE SYSTEM

K974241 · Scimed Life Systems, Inc. · DQX · Nov 12, 1998 · Cardiovascular

Device Facts

• Record ID: K974241
• Device Name: SCIMED INFORMER PRESSURE WIRE SYSTEM
• Applicant: Scimed Life Systems, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Nov 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The SCIMED INFORMER™ Pressure Wire System is intended to monitor the mean intravascular blood pressure and to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The phasic wave signal of the INFORMER Pressure Wire System is intended to facilitate placement of the wire. The INFORMER Pressure Wire System is not intended for use in the cerebral vasculature. The SCIMED INFORMER Pressure Wire System is not intended to be used in combination with any H.F. surgical equipment. The SCIMED INFORMER Pressure Wire System is indicated for use with all physiological monitors that meet IEC 601-1, IEC 601-2-34 standards. These monitors are required to meet electrical isolation for Type CF applied parts.

Device Story

System comprises steerable 0.014-inch coronary guide wire, disposable transducer with cable, and permanent cable. Wire monitors intravascular pressure; transducer converts hemodynamic pressure signals into electrical signals. System interfaces with standard physiological monitors to display phasic waveforms. Used by clinicians during PTCA or interventional procedures to facilitate balloon dilatation catheter placement. Provides real-time pressure data to assist navigation and clinical decision-making during vascular interventions.

Clinical Evidence

In-vitro bench testing included standard guide wire evaluations, ANSI/AAMI BP-22 transducer testing, and mechanical cable testing (tensile, cycling, strain relief). System response and shelf life were validated. In-vivo testing was conducted to compare pressure reading capabilities and guide wire performance against currently marketed devices.

Technological Characteristics

System components: 0.014-inch steerable guide wire, disposable transducer, permanent cable. Guide wire features radiopaque tips (3cm/5cm) and variable flexibility. Transducer converts hemodynamic pressure to electrical signals. Compatible with IEC 601-1 and IEC 601-2-34 compliant physiological monitors requiring Type CF electrical isolation.

Indications for Use

Indicated for patients undergoing PTCA or other intravascular interventional procedures requiring intravascular blood pressure monitoring and guide wire placement. Not for use in cerebral vasculature or with H.F. surgical equipment.

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

• ChoICE Guide Wire (K943192)
• ChoICE Guide Wire (K945129)
• ChoICE Guide Wire (K950141)
• ChoICE Guide Wire (K950113)
• ChoICE Guide Wire (K961015)
• ChoICE Guide Wire (K965063)
• ChoICE Guide Wire (K964551)
• Sceptor Guide Wire (K942333)
• Sceptor Guide Wire (K946240)
• Sceptor Guide Wire (K950534)
• Sceptor Guide Wire (K960563)
• Namic Perceptor DT Disposable Transducer (K910764)
• Medex TranStar Pressure Transducer (K942377)
• Baxter Edwards Reusable PX-1800 (K925638)
• Cardiometrics WaveWire/WaveMap Pressure System (K965140)

Submission Summary (Full Text)

{0}------------------------------------------------

## NOV 1 2 1998

## Summary of Safety and Effectiveness

| General<br>Information | Submitter's Name and Address | SCIMED Life Systems, Inc.<br>One SCIMED Place<br>Maple Grove, MN 55311 |
|------------------------|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person | Jill Munsinger<br>[phone] |
| | Classification Name(s) | Catheter Guide Wire, 21 CFR Part<br>870.1330; Transducer, Blood<br>Pressure, Extra Vascular, 21 CFR<br>Part 870.2850; Patient Transducer<br>and Electrode Cable, 21 CFR Part<br>870.2900 |
| | Common or Usual Name(s) | PTCA Guide Wire<br>Disposable Pressure Transducer<br>Cable, Patient Transducer |
| | Proprietary Name(s) | SCIMED® Informer™ Pressure<br>Wire System |
| | Product Code(s) | 74 DQX (Catheter Guide Wire)<br>74 DRS (Transducer, Blood<br>Pressure, Extra Vascular)<br>74 DRA (Patient Transducer and<br>Electrode Cable |

Predicate Devices

The SCIMED® Informer™ Pressure Wire is substantially equivalent to the products listed on the following page.

{1}------------------------------------------------

.

| Summary of Safety and Effectiveness, continued | |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The SCIMED INFORMER™ Pressure Wire System is intended to<br>monitor the mean intravascular blood pressure and to facilitate the<br>placement of balloon dilatation catheters or other therapeutic devices<br>during PTCA or other intravascular interventional procedures. The<br>phasic wave signal of the INFORMER Pressure Wire System is<br>intended to facilitate placement of the wire. The INFORMER Pressure<br>Wire System is not intended for use in the cerebral vasculature. |
| | The SCIMED INFORMER Pressure Wire System is not intended to be<br>used in combination with any H.F. surgical equipment. |
| | The SCIMED INFORMER Pressure Wire System is indicated for use<br>with all physiological monitors that meet IEC 601-1, IEC 601-2-34<br>standards. These monitors are required to meet electrical isolation for<br>Type CF applied parts. |
| Summary of<br>Technological<br>Characteristics | The Informer™ System is substantially equivalent to the currently<br>marketed SCIMED ChoICE™ and Sceptor PTCA Families of Guide<br>Wires, the Namic Perceptor™ DT Disposable Transducer, the MEDEX<br>TranStar Pressure Transducer, the BAXTER Edwards Permanent Cable<br>Model PX-1800 and the Cardiometrics WaveWire/WaveMap Pressure<br>System. |
| Non-Clinical<br>Test Summary | In-Vitro testing and evaluations were performed on the Informer™ Guide<br>Wire, the Informer™ Disposable Transducer with Attached Cable, the<br>Informer™ Permanent Cable and the complete Informer™ System.<br>Standard guide wire tests were used to evaluate the Informer™ Guide<br>Wire. The Informer™ Disposable Transducer experienced standard<br>ANSI/AAMI BP-22 testing while the cable testing included Cable<br>Connection Cycling, Disposable Transducer Cable Connector Tensile,<br>Transducer Housing/Cable Tensile, Strain Relief and Permanent Cable<br>Connector Tensile. System Response and Shelf Life testing was<br>conducted on complete Informer™ System units. |
| | Additionally, In-Vivo testing was conducted to compare pressure<br>reading capabilities and guide wire performance characteristics to<br>currently marketed devices. |

## Summary of Safety and Effectiveness, continued

{2}------------------------------------------------

| Product | 510(k) | Clearance Date |
|------------------------------------------------------|---------|-------------------|
| ChoICE Guide Wire | K943192 | November 22, 1994 |
| ChoICE Guide Wire | K945129 | March 3, 1995 |
| ChoICE Guide Wire | K950141 | March 3, 1995 |
| ChoICE Guide Wire | K950113 | March 31, 1995 |
| ChoICE Guide Wire | K961015 | May 15, 1996 |
| ChoICE Guide Wire | K965063 | March 4, 1997 |
| ChoICE Guide Wire | K964551 | May 21, 1997 |
| Sceptor Guide Wire | K942333 | August 31, 1994 |
| Sceptor Guide Wire | K946240 | March 31, 1995 |
| Sceptor Guide Wire | K950534 | April 28, 1995 |
| Sceptor Guide Wire | K960563 | April 29, 1996 |
| Namic Perceptor DT<br>Disposable Transducer | K910764 | April 22, 1991 |
| Medex TranStar<br>Pressure Transducer | K942377 | August 16, 1994 |
| Baxter Edwards<br>Reusable PX-1800 | K925638 | October 18, 1993 |
| Cardiometrics<br>WaveWire/WaveMap<br>Pressure System | K965140 | August 18, 1997 |

## Summary of Safety and Effectiveness, continued

Device Description

Predicate Devices, continued

> The SCIMED® Informer™ Pressure Wire System consists of the following components:

- · a guide wire,
- · a disposable transducer with attached cable, and
- · a permanent cable.

The guide wire is a steerable coronary guide wire available in a nominal diameter of 0.014 inches, overall lengths of 185 and 300 centimeters, radiopaque tip lengths of 3 and 5 centimeters, straight and J-tip configurations and one tip flexibility that falls between the ChoICE Floppy and Intermediate models, similar to the ChoICE Extra Support. The guide wire is designed to monitor intravascular pressures and to facilitate the placement of balloon dilatation catheters.

The disposable transducer with attached cable converts hemodynamic pressure signals from the guide wire into electrical signals. This transducer interfaces with standard physiologic monitors to display the electrical signals in phasic waveforms via the permanent cable.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, depicted in a minimalist, abstract design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2 1998

Ms. Jill Munsinger Regulatory Affairs Associate SCIMED Life Systems, Inc. One Scimed Place Maple Grove, MN 55311-1566

Re: K974241 SCIMED® Informer™ Pressure Wire System Trade Name: Requlatory Class: II Product Code: DQX Dated: August 13, 1998 Received: August 14, 1998

Dear Ms. Munsinger:

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 Regulations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 Druq 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

{4}------------------------------------------------

Page 2 - Ms. Jill Munsinger

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]. Also, please note the requlation entitled, "Misbranding by 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,

Thomas J. Callahon

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

Enclosure

{5}------------------------------------------------

| 510(k) Number | K974241 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | SCIMED® Informer™ Pressure Wire System |
| Indications for Use | The SCIMED Informer™ Pressure Wire System is intended to monitor the mean intravascular blood pressure and to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The phasic wave signal of the INFORMER Pressure Wire System is intended to facilitate placement of the wire. The INFORMER Pressure Wire is not intended for use in the cerebral vasculature. The SCIMED INFORMER Pressure Wire System is not intended to be used in combination with any H.F. surgical equipment. The SCIMED INFORMER Pressure Wire System is indicated for use with all physiological monitors that meet IEC 601-1, IEC 601-2-34 standards. These monitors are required to meet electrical isolation for Type CF applied parts. |

fy for Gantf
(Division
Divis
and IVC.
510(k) Number K974241
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)Prescription Use (Per 21 CFR 801.109) OR

Over The Counter Use__________________________________________________________________________________________________________________________________________________________