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

• K Number: K974457
• Device Name: SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT IMAGING CATHETER PATIENT T
• Manufacturer: HEWLETT-PACKARD CO.
• Date Cleared: 1998-07-14 ( 231 days)
• Product Code: IYO
• Regulation Number: 892.1560

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 Description

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.

Predicate Devices

K942231, K913890, K933517, K921879

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard intravascular ultrasound catheter and pullback device, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.

Therapeutic

No.
The device is solely for diagnostic purposes (intravascular ultrasound examination), not for treating a disease or condition.

Diagnostic

Yes

Explanation: The device is described as an "intravascular ultrasound imaging catheter" intended for "intravascular ultrasound examination of coronary arteries." Its purpose is to perform imaging to assess the condition of coronary arteries, which is a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description explicitly refers to a "catheter" and "PIU" (presumably a Peripheral Interface Unit), which are hardware components. The submission also includes biocompatibility and bench testing results, which are typically associated with hardware devices.

IVD (In Vitro Diagnostic)

Based on the provided information, the Scout catheter is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states "intravascular ultrasound examination of coronary arteries." This is a procedure performed within the body (in vivo) to visualize structures, not a test performed on a sample taken from the body (in vitro).
• Device Description: The description focuses on the catheter's functionality for imaging within the blood vessels.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or performing tests on these samples outside of the body.

IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Scout catheter is an imaging device used directly within the patient's body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

90 ITX, 74 DQO, 90 IYO

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

coronary arteries

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K942231, K913890, K933517, K921879

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
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.(b)
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.

Summary

0

JUL 1 4 1998

K974457

Hewlett-Packard Scout Catheter

510(k) Summary of Safety and Effectiveness

(per 21 CFR 807.92)

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

Trade Name 2)

Model Number

33

Scout 3.2F/45 MHz Coronary Imaging Catheter .014" Compatible M2440A-014 Scout 3.2F/45 MHz Coronary Imaging Catheter .018" Compatible M2440A-018 M240IB Scout Imaging Catheter Patient Interface Unit (PIU)

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

Identification of Predicate Devices: 3)

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

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.

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

Predicate Device Comparison: M2440A is substantially equivalent to the predicate 6) Boston Scientific catheters. The functionality of the motorized pullback integrated into the M2401 B 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.

2

Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is centered on the image and is the only element present.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL

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 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 (OS) 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 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/dsmaldsmamain.html".

Sincerely yours,

William Yin

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa 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

The Scout catheter is intended for the intravascular ultrasound examination of Intended Use: 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 | NA |
| Intra-operative
(specify) | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Intra-Operative
Neurological | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Pediatric | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Small Organ
(prostate) | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Neonatal Cephalic | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Adult Cephalic | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Cardiac Adult | NA | X | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Cardiac Pediatric | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Trans-esophageal | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Trans-rectal | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Trans-vaginal | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Intra-Luminal | NA | X | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Trans-urethral | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Peripheral Vessel | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Laparoscopic | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Musculo-Skeletal
Conv. | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Musculo-Skeletal
Superf. | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Other (specify) | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |

Other Indications or Modes: None

1

David A. Hygum

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(Division Sign-Off)

Hewlett-Packard Confidential

Prescription Use . (Per 21 CFR 801.109) Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number