ZURA TEE SYSTEM

K080223 · Imacor, LLC · IYO · Jun 24, 2008 · Radiology

Device Facts

• Record ID: K080223
• Device Name: ZURA TEE SYSTEM
• Applicant: Imacor, LLC
• Product Code: IYO · Radiology
• Decision Date: Jun 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The ImaCor Zura TEE System is intended for use in the episodic assessment of cardiac function using transesophageal echocardiography. It is indicated for use in clinical settings, including long-term settings such as the ICU, for an indwelling time period not to exceed 72 hours. The ImaCor Zura TEE System is not intended for pediatric use.

Device Story

ImaCor Zura TEE System provides episodic cardiac function assessment via transesophageal echocardiography. System comprises ultrasound machine, miniaturized 'Blue Probe' TEE transducer, and imaging software. Probe designed for extended indwelling (up to 72 hours) in ICU settings. Operator performs imaging; probe tip flexes to obtain standard TEE views. Software controls imaging, recording, and measurement functions. Includes 20-minute software interlock for continuous imaging to prevent mucosal tissue thermal injury. Healthcare providers use output for cardiac monitoring; aids clinical decision-making in critical care. Benefits include extended monitoring capability compared to standard TEE probes.

Clinical Evidence

Evidence includes phantom measurement data, preclinical animal studies, and confirmatory clinical studies. Phantom data demonstrated equivalence to predicate TEE devices regarding effectiveness. Miniaturization of the probe and transducer was shown not to impact safety or effectiveness.

Technological Characteristics

System includes ultrasound machine, miniaturized TEE probe, and imaging software. Probe features transient upward flexion for imaging. Thermal safety managed per IEC 60601-2-37. Software includes 20-minute continuous imaging interlock. Connectivity/platform details not specified.

Indications for Use

Indicated for episodic assessment of cardiac function via transesophageal echocardiography in adult patients in clinical settings, including ICU, for up to 72 hours. Not for pediatric use.

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

• Ultrasonix Modulo (K042326)
• Sonosite Ultrasound Diagnostic System (K043559)
• GE Vivid 7 (K051449)

Submission Summary (Full Text)

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K080223
pg. 1 of 3

# 510(k) SUMMARY

### ImaCor Zura TEE System

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

ImaCor LLC 50 Charles Lindbergh Blvd Suite 200 Uniondale, NY 11553

Phone: [phone] Facsimile: [phone]

Contact Person: Richard C. Lanzillotto

Date Prepared: January 16, 2008

# Name of Device and Name/Address of Sponsor

ImaCor Zura TEE System

ImaCor LLC 50 Charles Lindbergh Blvd Suite 200 Uniondale, NY 11553

### Common or Usual Name

Transesophagcal Echo Imaging System

### Classification Name

Ultrasonic Pulsed Echo Imaging System (892.1560) with a Diagnostic Ultrasonic Transducer (892.1570) or Echocardiograph (870.2330)

### Product Codes

IYO, ITX, DXK

#### Device Class

II

UUN 2 4 7008

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# Predicate Devices

Ultrasonix Modulo (K042326) Sonosite Ultrasound Diagnostic System (K043559) GE Vivid 7 (K051449)

# Intended Use / Indications for Use

The ImaCor Zura TEE System is intended for use in the episodic assessment of cardiac function using transesophageal echocardiography. It is indicated for use in clinical settings, including long-term settings such as the ICU, for an indwelling time period not to exceed 72 hours. The ImaCor Zura TEE System is not intended for pediatric use.

# Technological Characteristics

The ImaCor TEE System consists of three main components:

- 1. Ultrasound Machine:
A TFE predicate device optimized for use with ImaCor miniaturized probe,

- Ultrasound Probe ( The "Blue Probe"): 2.
A miniaturized TEE probe optimized for longer dwell time relative to standard TEE probes enables use in longer term clinical settings such as the ICU. The probe distal tip is flexed upward transiently to obtain standard TEE images.

- 3. Ultrasound Imaging Software:
The software controls standard ultrasound machine functions such as imaging, recording and measuring. Continuous imaging is limited by a 20 minute software interlock should the operator mistakenly leave the machine in continuous imaging mode, thus limiting the potential unintentional exposure of the patient's mucosal tissue to acoustic energy. Maximum probe face temperature is limited according to FDA consensus standard IEC 60601-2-37.

# Performance Data

Performance data demonstrate that the miniaturization of the ImaCor probe and ultrasound transducer. relative to standard size probes does not impact safety or effectivencss. Phantom measurement data shows that the ImaCor Zura TEE device is equivalent to predicate TEE devices with respect to effectiveness.

The ImaCor Zura TEE system was also subject to preclinical (animal) studies and confirmatory clinical studies.

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# Substantial Equivalence

The ImaCor Zura TEE System is as safe and effective as the predicate devices. The ImaCor Zura has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. I The minor technological characterisits, and principles of on predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the ImaCor Zura is as safe and effective as the predicates. Thus, the ImaCor Zura is substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 2 4 2008

ImaCor, LLC % Steven B. Datlof, M.D., J.D. Official Correspondent Hogan & Hartson LLP 1835 Market Street, 28th Floor PHILADELPHIA PA 19103

Re: K080223

Trade/Device Name: ImaCor Zura TEE System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX, and DXK Dated: May 28, 2008 Received: May 28, 2008

Dear Dr. Datlof:

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 ImaCor Zura TEE System, as described in your premarket notification:

#### Transducer Model Number

## Zura TEE

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 forth in the quality systems (QS)

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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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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 [phone]. 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 [phone] or [phone] 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 Lauren Hefner at [phone].

Sincerely yours,

# #

Nancy C. Brogdon

fr

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

Enclosure(s)

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#### Indications for Use Statement

510(k) Number (if known): K080223

Device Name: ImaCor Zura TEE System

Indications for Use:

The ImaCor Zura TEE System is intended for use in the episodic assessment of cardiac function using transesophageal echocardiography. It is indicated for use in clinical settings, including long-term settings such as the ICU, for an indwelling time period not to exceed 72 hours. The ImaCor Zura TEE System is not intended for pediatric use.

Prescription Use V (Part 21 C.F.R. 801 Subpart D)

AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Aruithn Whan

Division Sidr Division of Reproductive. Abdominal, a Radiological Devices 510(k) Number