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 Description

The ImaCor TEE System consists of three main components:

Ultrasound Machine: A TFE predicate device optimized for use with ImaCor miniaturized probe,
Ultrasound Probe (The "Blue Probe"): 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.
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.

AI/ML Overview

The provided text is a 510(k) summary for the ImaCor Zura TEE System, which indicates it's a submission for marketing clearance based on substantial equivalence to existing predicate devices, not a de novo clearance requiring extensive clinical performance studies. As such, the information you're requesting regarding acceptance criteria and detailed study results is largely not present in this type of document.

The document focuses on demonstrating that the new ImaCor Zura TEE System is "as safe and effective as the predicate devices" by having "the same intended uses and similar indications, technological characteristics, and principles of operation." The "minor technological characteristics" are asserted to "raise no new issues of safety or effectiveness."

However, I can extract the available information and highlight what is not present in this specific 510(k) summary regarding performance studies:

Key Takeaways from the document:

Basis for Clearance: Substantial Equivalence to predicate devices (Ultrasonix Modulo, Sonosite Ultrasound Diagnostic System, GE Vivid 7). This means specific, quantitative acceptance criteria for this new device's performance are typically not established and proven in the same way they would be for a novel device.
Performance Data Mentioned: "Phantom measurement data shows that the ImaCor Zura TEE device is equivalent to predicate TEE devices with respect to effectiveness." It also mentions "preclinical (animal) studies and confirmatory clinical studies." However, no details on their design, sample sizes, methodology, or specific acceptance criteria are provided in this summary.

Here's a breakdown of your requested information based on the provided text, indicating where information is absent (as is common for 510(k) summaries relying on substantial equivalence):

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Equivalence to Predicate TEE devices with respect to effectiveness	Phantom measurements showed the ImaCor Zura TEE device is equivalent to predicate TEE devices in effectiveness.
Safety	Performance data demonstrate that the miniaturization of the ImaCor probe (relative to standard size) and ultrasound transducer does not impact safety. Maximum probe face temperature is limited according to FDA consensus standard IEC 60601-2-37. Continuous imaging is limited by a 20-minute software interlock to prevent unintentional patient exposure.
Intended Use / Indications for Use: episodic assessment of cardiac function using transesophageal echocardiography in clinical settings (including ICU) for up to 72 hours, not for pediatric use.	The device meets these stated indications for use (implied through substantial equivalence and confirmed by FDA clearance letter).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size (Test Set): Not specified in the 510(k) summary. The document mentions "phantom measurement data" and "confirmatory clinical studies" but does not provide details on sample sizes for either.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not specified. This information is typically found in detailed study protocols and reports, which are not part of this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/mentioned. The device is an ultrasound imaging system ("algorithm only" in the context of image acquisition and processing), not an AI-assisted diagnostic tool for human readers as described in an MRMC study setup. The summary focuses on the physical device's performance compared to predicates.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, implicitly. The "phantom measurement data" evaluates the device directly, demonstrating its standalone effectiveness in acquiring images and measurements, without human interpretation as part of the primary performance metric for substantial equivalence here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For "phantom measurement data," the ground truth would typically be the known physical characteristics or measurements of the phantom itself.
For "confirmatory clinical studies," the precise ground truth is not specified, but for a TEE system, it would generally involve comparing images and measurements obtained from the device to established diagnostic criteria or other validated imaging modalities.

8. The sample size for the training set

Not applicable/specified. This is not an AI/ML algorithm that undergoes a training phase in the conventional sense for a diagnostic output. The "software" component controls standard ultrasound machine functions.

9. How the ground truth for the training set was established

Not applicable/specified. (See #8)

Summary of Study that Proves the Device Meets Acceptance Criteria:

The document states:

"Performance data demonstrate that the miniaturization of the ImaCor probe and ultrasound transducer relative to standard size probes does not impact safety or effectiveness."
"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."

The "study" that proves the device meets the (implicit) acceptance criteria for substantial equivalence primarily relies on phantom measurement data showing equivalence to predicate devices, supported by preclinical and clinical studies (details not provided in the summary). The FDA's clearance (K080223) indicates they found this evidence sufficient to establish substantial equivalence based on the device having the "same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices."

It's important to understand that 510(k) submissions, particularly for devices relying on "substantial equivalence," often do not include the same level of detailed clinical trial data and statistical analysis that would be present in a PMA (Premarket Approval) application or a de novo clearance pathway for novel technologies that raise new questions of safety and effectiveness.

Summary

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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: (516) 393-0970 Facsimile: (516) 393-0969

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

UUN 2 4 7008

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Image /page/1/Picture/0 description: The image shows handwritten text on a white background. The text includes the alphanumeric string "K080223" on the first line. The second line reads "pg. 2 of 3", indicating it is page 2 of a 3-page document. The handwriting style appears cursive and slightly irregular.

Predicate Devices

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

Intended Use / Indications for 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.
1. 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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Image /page/2/Picture/0 description: The image shows handwritten text that appears to be a document identifier or page number. The text includes "K080223" on the top line, followed by "PG. 3 of 3" on the second line. The handwriting is somewhat stylized, with the numbers and letters clearly distinguishable.

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 (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 Lauren Hefner at (240) 276-3666.

Sincerely yours,

Nancy C. Brogdon

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:

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

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.