SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT IMAGING CATHETER PATIENT T

K974457 · Hewlett-Packard Co. · IYO · Jul 14, 1998 · Radiology

Device Facts

• Record ID: K974457
• Device Name: SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT IMAGING CATHETER PATIENT T
• Applicant: Hewlett-Packard Co.
• Product Code: IYO · Radiology
• Decision Date: Jul 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The Scout catheter is intended for the intravascular ultrasound examination of coronary arteries. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

Device Story

Scout 3.2F/45 MHz Coronary Imaging Catheter and M2401B Patient Interface Unit (PIU) provide intravascular ultrasound (IVUS) imaging of coronary arteries. Device inputs ultrasound signals to generate cross-sectional images of vessel walls; system utilizes motorized pullback functionality to acquire longitudinal image data. Used in clinical settings by physicians during transluminal interventional procedures. Output displayed to clinician to visualize coronary anatomy, aiding in procedural decision-making and assessment of vessel morphology. Benefits include enhanced visualization of coronary vasculature to guide interventions.

Clinical Evidence

Bench testing only. Submission includes biocompatibility and bench testing results for all design and material changes to support substantial equivalence.

Technological Characteristics

Intravascular ultrasound imaging catheter (3.2F/45 MHz). Features motorized pullback system integrated into M2401B PIU. Materials: new patient contact materials. Connectivity: operates with M2400A Intravascular Ultrasound System. Energy source: ultrasound transducer. Form factor: catheter-based.

Indications for Use

Indicated for adult patients who are candidates for transluminal interventional procedures requiring intravascular ultrasound examination of the coronary arteries.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• MicroView II/MicroRail II 3.2/30 MHz (K942231)
• Sonicath 3.5F Ultrasound Imaging Catheter (K913890)
• Automatic Pullback Device (K933517)
• CVIS Catheter Pullback Device (K921879)

Submission Summary (Full Text)

{0}

JUL 14 1998
K974457
33

Hewlett-Packard Scout Catheter

510(k) Summary of Safety and Effectiveness

(per 21 CFR 807.92)

1) Submitter's Name / Contact Person: Rob Butler
Address: 3000 Minuteman Road, Andover, MA 01810
Telephone Number: [phone]
Date Summary was prepared: November 17, 1997

2) Trade Name
Model Number
Scout 3.2F/45 MHz Coronary Imaging Catheter .014" Compatible M2440A-014
Scout 3.2F/45 MHz Coronary Imaging Catheter .018" Compatible M2440A-018
Scout Imaging Catheter Patient Interface Unit (PIU) M2401B

Common Name: Ultrasonic Diagnostic Catheter

| Classification Name | CFR Number | Product Code |
| --- | --- | --- |
| Diagnostic Ultrasound Transducer | 21 CFR 892.1570 | 90 ITX |
| Diagnostic Intravascular Catheter | 21 CFR 870.1200 | 74 DQO |

3) Identification of Predicate Devices:

| Manufacturer | Device | 510(k) Number |
| --- | --- | --- |
| Boston Scientific | MicroView II/MicroRail II 3.2/30 MHz | K942231 |
| Boston Scientific | Sonicath 3.5F Ultrasound Imaging Catheter | K913890 |
| Boston Scientific | Automatic Pullback Device | K933517 |
| Boston Scientific | CVIS Catheter Pullback Device | K921879 |

4) Description of the device or modification being submitted for premarket approval.

Functionality: M2440A intravascular ultrasound imaging catheter has equivalent functionality to the predicate Boston Scientific catheters now cleared for use with M2400A; acoustic output for the M2440A operating on the M2400A is within FDA limits. The pullback functionality incorporated into the M2440A catheter and the M2401B PIU are equivalent to the predicate Boston Scientific catheters and pullback devices listed above.

Scientific Concepts: same as existing intravascular ultrasound imaging catheters and pullback devices operating on the M2400A Intravascular Ultrasound System.

Hewlett-Packard Confidential

{1}

34

# Hewlett-Packard Scout Catheter

**Significant Characteristics of the Modification:** new patient contact materials for M2440A Intravascular Ultrasound imaging catheter. New ergonomic configuration for the motorized pullback system.

5) **Statement of Intended Use:** same as intended use for the predicate devices: intravascular ultrasound examination of the coronary arteries.

6) **Predicate Device Comparison:** M2440A is substantially equivalent to the predicate Boston Scientific catheters. The functionality of the motorized pullback integrated into the M2401B patient interface unit when operated with the M2440A catheter is substantially equivalent to the predicate device intended use. Submission includes acceptable biocompatibility and bench testing results for all changes to design and materials.

Hewlett-Packard Confidential

{2}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
JUL 14 1998
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Rob Butler
Regulatory Engineer
Hewlett-Packard Company
Imaging Systems
3000 Minuteman Rd.
Andover, MA 01810

Re: K974457
Scout 3.2/45 MHz Coronary Imaging Catheters
Dated: June 22, 1998
Received: June 23, 1998
Regulatory class: II
21 CFR 892.1560/Procode: 90 IYO
21 CFR 892.1570/Procode: 90 ITX

Dear Mr. Butler:

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 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 895. A substantially equivalent determination assumes compliance with 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 Drug 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 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 regulations.

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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/odrh/dsma/dsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

{3}

# Attachment E: Scout Indications for Use Form

## FDA Diagnostic Ultrasound Device Indications Statement

510(k) Number (if known): K974457

Device Name(s): M2440A-018/M2440A-014 Scout 3.2F/45 MHz Coronary Imaging Catheter(s)

M2401B Patient Interface Unit

Intended Use: The Scout catheter is intended for the intravascular ultrasound examination of coronary arteries. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Ophthalmic | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Fetal | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Abdominal | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Intra-operative (specify) | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Intra-Operative Neurological | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Pediatric | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Small Organ (prostate) | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Neonatal Cephalic | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Adult Cephalic | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Cardiac Adult | NA | X | NA | NA | NA | NA | NA | NA | NA | NA |
| Cardiac Pediatric | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Trans-esophageal | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Trans-rectal | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Trans-vaginal | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Intra-Luminal | NA | X | NA | NA | NA | NA | NA | NA | NA | NA |
| Trans-urethral | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Peripheral Vessel | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Laparoscopic | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Musculo-Skeletal Conv. | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Musculo-Skeletal Superf. | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Other (specify) | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |

Other Indications or Modes: None

Prescription Use ☑
(Per 21 CFR 801.109)

Hewlett-Packard Confidential

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K974457