The IBI Inquiry™ ClearICE™ Intracardiac Echocardiography Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac anatomy and physiology as well as visualization of other devices in the heart.

Device Description

The IBI Inquiry™ ClearICE™ Intracardiac Echocardiography Catheter is comprised of a single-use, disposable ultrasonic phased-array imaging transducer. A Inquiry ClearICE catheter is steerable: catheter, 9 Fr (2.97 mm) in diameter, 90 cm to 110 cm insertable length and available in various curve configuration. The distal portion of the catheter can be deflected in four directions in two orthogonal planes: left-right (in a plane perpendicular to imaging plane) and anterior-posterior (in a plane coincident with the image plane). Bi-directional steering controlled by push/pull handle mechanism and quad-directional steering controlled by a push/pull mechanism and rotating knob. The non-sterile, reusable GE Connector Cable is use to connect IBI InquiryTM ClearICE™ Intracardiac Echocardiography Catheter to the GE Vivid i Ultrasound system. The IBI Inquiry™ ClearICE™ Intracardiac Echocardiography Catheter is used with commercially available GE Connector Cable and Vivid- i Diagnostic Ultrasound System. The IBI Inquiry™ ClearICE™ Intracardiac Echocardiography Catheter is comprised of three major components: (1) the catheter itself; (2) the steering mechanism; and (3) the reusable GE Connector Cable & GE Vivi i Ultrasound System.

AI/ML Overview

This looks like a 510(k) premarket notification for a medical device called the IBI Inquiry™ ClearICE™ Intracardiac Echocardiography Catheter. This document asserts substantial equivalence to previously cleared predicate devices, rather than presenting a de novo study to establish new acceptance criteria or device performance.

Therefore, the document does not contain the information required to answer your prompt. Specifically, it does not include:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods for test sets.
Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
Information on standalone algorithm performance studies.
The type of ground truth used in any performance studies.
Sample size for training sets or how ground truth was established for training sets.

Instead, the submission focuses on demonstrating that the IBI Inquiry™ ClearICE™ catheter is "substantially equivalent" in its technologies and functionality to existing, legally marketed ACUSON AcuNav ultrasound catheters. Substantial equivalence means that the device is as safe and effective as a legally marketed predicate device. This typically involves comparing design, materials, performance specifications, and indications for use against the predicate, rather than conducting new clinical trials to establish de novo performance criteria.

The document lists the following predicate devices:

#K042593 (January 5, 2005) cleared as ACUSON AcuNav 8Fr Ultrasound Catheter.
#K033650 (February 24, 2004) cleared as ACUSON AcuNav 90/10 Diagnostic Ultrasound Catheter.
#K992632 (November 8, 2001) cleared as ACUSON AcuNav Diagnostic Ultrasound Catheter.

The submission confirms that "The IBI Inquiry™ ClearICE Intracardiac Echocardiography Catheter designed and validated in compliance with the following standards," and then lists several ISO, IEC, BS EN, and AAMI standards, along with FDA regulations and guidance documents. Compliance with these standards and regulations is part of the process of demonstrating substantial equivalence for safety and performance, but it does not involve the kind of specific performance study details you requested for AI/algorithm-driven devices.

Summary

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K 070011

SECTION 14

510(k) Summary of Safety and Effectiveness

MAR 2 0 2007

Sponsor: Irvine Biomedical Inc, 2375 Morse Avenue Irvine, CA 92614, USA
Contact Person: Rohit Patel Sr. Regulatory Affairs Specialist Telephone: (949) 271-1127 Fax: (949) 851-3062 E-mail: Rpatel(@sjm.com

Submission date: December 29, 2006

Device Name: IBI Inquiry™ ClearICE™ Intracardiac Echocardiography Catheter

Common Name: Intracardiac/Intravascular Ultrasound Catheter

Classification: Regulatory Class: II Regulatory Category: Tier II

	FR Number	Product Code
Diagnostic Ultrasound Transducer	892.1570	90-ITX
Diagnostic Ultrasound Catheter	870.1200	74-DQO

Predicate Devices:

#K042593 (January 5, 2005) cleared as ACUSON AcuNav 8Fr Ultrasound Catheter.
#K033650 (February 24, 2004) cleared as ACUSON AcuNav 90/10 Diagnostic . Ultrasound Catheter.
#K992632 (November 8, 2001) cleared as ACUSON AcuNav Diagnostic ● Ultrasound Catheter.

Device Description :

The distal portion of the catheter can be deflected in four directions in two orthogonal planes: left-right (in a plane perpendicular to imaging plane) and anterior-posterior (in a plane coincident with the image plane). Bi-directional steering controlled by push/pull

SECTION 14

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handle mechanism and quad-directional steering controlled by a push/pull mechanism and rotating knob.

The non-sterile, reusable GE Connector Cable is use to connect IBI InquiryTM ClearICE™ Intracardiac Echocardiography Catheter to the GE Vivid i Ultrasound system. The IBI Inquiry™ ClearICE™ Intracardiac Echocardiography Catheter is used with commercially available GE Connector Cable and Vivid- i Diagnostic Ultrasound System.

The IBI Inquiry™ ClearICE™ Intracardiac Echocardiography Catheter is comprised of three major components: (1) the catheter itself; (2) the steering mechanism; and (3) the reusable GE Connector Cable & GE Vivi i Ultrasound System.

The IBI Inquiry™ ClearICE™ Intracardiac Echocardiography Catheter is substantially equivalent to ACUSON AvuNav ultrasound catheters that are already cleared for USA distribution under the following 510(k) PreMarket Notification numbers:

#K042593 (January 5, 2005) cleared as ACUSON AcuNav 8Fr Ultrasound . Catheter.
#K033650 (February 24, 2004) cleared as ACUSON AcuNav 90/10 . Diagnostic Ultrasound Catheter.
#K992632 (November 8, 2001) cleared as ACUSON AcuNav Diagnostic . Ultrasound Catheter.

The IBI Inquiry™ ClearICE Intracardiac Echocardiography Catheter designed and validated in compliance with the following standards:

ISO 13485:2003: Medical devices -- Quality management systems --. Requirements for regulatory purposes
21 CFR Section 820: FDA Quality System Regulation .
. Guidance Document -- 9/30/1997: Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers
ISO 14971:2001: Medical devices Application of risk management to medical . devices
. ISO 10555-1:1997: Sterile, single-use Intravascular catheter - Part 1: General requirements
. IEC/EN 60601-1-1:2001: Medical electrical equivment - Part 1: General requirements for basic safety and essential performance
IEC 60601-2-2:1998: Medical Electrical equipment Part 2-2: Particular . requirements for the safety of high frequency surgical equipment
BS EN 60601-1:1990, BS 5724: Part1: 1989: Medical electrical equipment Part . 1 : General requirements for safety
. ISTA 2A: Performance Test for Individual Packaged Products 150 lb or Less
ANSI / AAMI / ISO 11135:1994: Medical devices validation and routine ● control of Ethylene Oxide Sterilization
. BS EN550:1994: Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide sterilization

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BS EN556:2001: Sterilization of Medical Devices Requirements for Terminally . Sterilized Device to be labeled "Sterile"
AAMI TIR28:2001: Product adoption and process equivalency for ethylene oxide . sterilization
ISO 10993-7:1996: Biological evaluation of medical devices Part 7: Ethylene . oxide sterilization residuals
ISO 10993-1:2003: Biological evaluation of medical devices Part 1: Evaluation . and testing

Indication for Use:

Technological Comparison to Predicate Device:

The IBI's Inquiry™ Intracardiac Echocardiography Catheter is substantially equivalent in its technologies and functionality to the ACUSON AcuNav ultrasound catheters that are already cleared for USA distribution under the following 510(k) PreMarket Notification numbers #K042593 (January 5, 2005), #K033650 (February 24, 2004), and #K992632 (November 8, 2001).

The IBI's Inquiry™ Intracardiac Echocardiography Catheter and ACUSON AcuNav ultrasound catheters are ultrasound-tipped catheter devices for ultrasound imaging.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with intertwined snakes and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Rohit Patel Sr. Regulatory Affairs Specialist Irvine Biomedical, Inc. 2375 Morse Avenue IRVINE CA 92614

MAR 2 0 2007

Re: K070011

Trade Name: IBI Inquiry" ClearICE™ Intracardiac Echocardiography Catheter Regulation Number: 21 CFR §892.1570 Regulation Name: Diagnostic ultrasonic transducer Product Code: ITX Regulation Number: 21 CFR §870.1200 Regulation Name: Diagnostic intravascular catheter Produce Code: DOO Regulatory Class: II Dated: December 29, 2006 Received: January 3, 2007

Dear Mr. Patel:

We have reviewed your Section 510(k) premarket 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.

This determination of substantial equivalence applies to the following transducers intended for use with the IBI Inquiry" ClearICE" Intracardiac Echocardiography Catheter, as decriaed in your premarket notification:

Transducer Model Number - Inquiry - ClearICE™

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. Rohit Patel

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 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 market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Andrew Kang, M.D. at (240) 276-1373.

Sincerely yours,

David A. Segerson

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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SECTION 13

Indications for Use

510(k) Number (if known): _K070011

Device Name: IBI Inquiry™ ClearICE™ Intracardiac Echocardiography Catheter

Indications for Use:

1 Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Thind A. Segman

Division Sign-Off) Division of Reproductive, Abdominal, a Radiological Devices 510(k) Number

Page / of /

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Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known): K070011

Device Name: Inquiry™ ClearlCE™ Intracardiac Echocardiography Catheter

Indications for Use: The Inquiry™ ClearlCE™ Intracardiac Echocardiography Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac anatomy and physiology as well as visualization of other devices in the heart.

Transducer: Inquiry™ ClearICE™ Intracardiac Echocardiography Catheter

Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]	N	N	N	N	N	N	N	N	N
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intra-luminar	N	N	N	N	N	N	N	N	N
Peripheral Vascular
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Other (intra-cardiac)	N	N	N	N	N	N	N	N	N

N = new indication; P = previously cleared by FDA; E = added under Appendix E Notes: [*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Amplitude/PWD.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) morn

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

Page ( of 1

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).