The ImaCor Zura Handheld ZHH-010 is a software-based handheld ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging using the ImaCor ClariTEE probe. (Cardiac, TEE)

The system is intended for use in critical care environments where healthcare is provided by trained healthcare professionals.

It is not for pediatric use (Less than 18 years of age) It is not for use in EMS settings.

Device Description

The ImaCor Zura Handheld ZHH-010 is a portable, cardiac, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through a commercial offthe-shelf (COTS) Android™ device. The scanner is Bluetooth and Wi-Fi- based, communicating with a traditional tablet/smartphone via direct Wi-Fi to allow users to export ultrasound images and display in different modes of operation. The ImaCor Zura Handheld ZHH-010 houses a battery and internal power supplies, multichannel beamformer, pre-scan converter and Wi-Fi components. The battery is removable and comes with a separate charger.

The system is a transportable (handheld) ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals. The ImaCor Zura Handheld ZHH-010 is not to be used in a fixed- or rotary-winged air ambulance.

Piezoelectric material in the system's transducer (ClariTEE probe) transmits high frequency, non-ionizing sound waves to the designated cardiac region of the body and converts the subsequent echoes detected into electronic signals to construct an image of the internal structures of an anatomical field. This image is sent wirelessly to an external Android viewing device on which the image can be displayed. Communication between the scanner and the compatible viewing device is performed via Wi-Fi Direct® (Ad-Hoc mode with security) for easy pairing.

The ImaCor Zura Handheld ZHH-010 product components include:

Software: SOUP Imaging App for Android
Transducers/Scanners: ImaCor ClariTEE probe (TEE probe);
Accessories: ImaCor Battery (Li-ion); ImaCor Battery Charger; ImaCor Fan; Medical Power Supply (off-the-shelf power adaptor from GlobTek, Inc.; Model Number WR9QA3200USBNMEDR6B; approved in the US).

AI/ML Overview

The provided document is a 510(k) premarket notification for the ImaCor Zura Handheld ZHH-010, an ultrasound imaging system. It primarily focuses on demonstrating substantial equivalence to a predicate device (Clarius Ultrasound Scanner Model C3HD) and a reference device (ImaCor Zura TEE System with ClariTEE probe).

Crucially, the document states: "The ImaCor Zura Handheld ZHH-010 did not require clinical testing to establish substantial equivalence to the predicate devices indicated." This means that there was no clinical study conducted to prove the device met specific performance acceptance criteria for diagnostic accuracy, as is common for AI/ML-driven devices. Instead, the focus was on demonstrating that the new device, primarily an OEM modification with a tethered probe, performs similarly in terms of safety and technical specifications to existing cleared devices.

Therefore, many of the requested points regarding acceptance criteria and performance studies for an AI/ML device (e.g., effect size of human readers with AI assistance, standalone algorithm performance, ground truth establishment) cannot be answered from this document because such a study was not required or performed for this specific 510(k) clearance.

However, based on the information provided, we can infer the acceptance criteria for this type of submission were related to technical and safety standards compliance and demonstration of substantial equivalence to predicate devices.

Here's an attempt to address the points based on what is available in the document, and explicitly stating what is not available:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence and Standards Compliance)

1. Table of Acceptance Criteria and Reported Device Performance

Since this submission didn't involve a clinical performance study with accuracy metrics, the "acceptance criteria" were primarily about meeting established safety and performance standards for ultrasound devices and demonstrating functional equivalence to predicate devices.

Acceptance Criteria Category	Specific Criterion (Inferred from Document)	Reported Device Performance (Inferred/Stated)
Safety and Essential Performance	Compliance with IEC 60601-1 (General requirements for basic safety and essential performance) and related collateral standards (e.g., usability, EMC).	"Nonclinical performance tests show compliance to the following standards: IEC 60601-1 (2005/(R)2012, A1:2012, C1:2009(R)2012, A2:2010(R)2012), CAN/CSA-C22.2 No. 60601-1-6:11 (2011), CAN/CSA-C22.2 No. 60601-1:14 (2014), IEC 60601-1-2 (2014), IEC 60601-1-6 (2013), IEC 60601-2-37 AMDI (2015)." "The development and testing conducted on the device ascertain that it is safe for use by qualified physicians."
Software Life Cycle Processes	Compliance with ANSI/AAMI/IEC 62304 (Medical device software - Software life cycle processes).	"Nonclinical performance tests show compliance to... ANSI/AAMI/IEC 62304 (2006)."
Functional Equivalence (Core)	The "beamformer" (core imaging engine) is mechanically and electrically identical to the predicate device (Clarius Ultrasound Scanner C3HD).	"The beamformer in the ImaCor Zura Handheld ZHH-010 is mechanically and electrically identical to the predicate device."
Functional Equivalence (Probe)	Device functions with the specified probe (ClariTEE) which was previously cleared (K100989) and is used with a reference device.	The device uses the ImaCor ClariTEE probe, which was cleared under K100989. The device is a "portable, cardiac, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through a commercial off-the-shelf (COTS) Android™ device."
Intended Use & Indications for Use	Matches the predicate device's intended use and indications for use, with minor specificities for this device (e.g. no pediatrics, no EMS).	"The subject device does not introduce any new technology or indications for use; therefore, the system is similar to the predicate device." "All indications for use introduced by the ImaCor Zura Handheld ZHH-010 are similar to the predicate device." Indicates for diagnostic ultrasound imaging using the ImaCor ClariTEE probe (Cardiac, TEE) in critical care environments by trained healthcare professionals. Not for pediatric use (<18 years) or EMS settings.
Cybersecurity	Cybersecurity measures are equivalent to the SOUP (Software Of Unknown Pedigree) software used, which was accepted via the predicate K192107.	"Cybersecurity: Same as SOUP software, Accepted via K192107."
Quality Assurance	Application of quality assurance measures during design and development.	"Quality assurance measures applied to the system design and development include, but were not limited to risk analysis, verification and validation, product specifications, and design reviews."

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

Not applicable / Not provided. The document explicitly states: "The ImaCor Zura Handheld ZHH-010 did not require clinical testing to establish substantial equivalence to the predicate devices indicated." Therefore, there was no clinical "test set" in the sense of patient imaging data used to assess diagnostic performance. Non-clinical performance tests were conducted on the device itself against standards.

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 applicable / Not provided. As no clinical performance study was conducted to establish diagnostic accuracy, there was no need for experts to establish ground truth from patient data.

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

Not applicable / Not provided. No test set was used for diagnostic performance evaluation.

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

No. The document clearly states: "The ImaCor Zura Handheld ZHH-010 did not require clinical testing to establish substantial equivalence to the predicate devices indicated." This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool leveraging machine learning to "improve" human reader performance.

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

No. This is a hardware/software system for direct human use in imaging, not a standalone AI algorithm.

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

Not applicable / Not provided. For the purpose of this 510(k), the "ground truth" was more related to the established specifications and performance of the predicate device and relevant international standards.

8. The sample size for the training set

Not applicable / Not provided. This device is a direct imaging system, and the submission is not for a new AI/ML algorithm that would undergo training on a "training set" of images to learn to perform a diagnostic task. The software is described as "SOUP Imaging App for Android" and "developed by the original manufacturer with no changes made by ImaCor."

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

Not applicable / Not provided. See point 8.

Summary

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April 8, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

ImaCor Inc % Prithul Bom Most Reponsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114

Re: K220490

Trade/Device Name: ImaCor Zura Handheld ZHH-010 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN. IYO. ITX Dated: April 6, 2022 Received: April 7, 2022

Dear Prithul Bom:

We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Jessica Lamb, Ph.D. Assistant Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220490

Device Name ImaCor Zura Handheld ZHH-010

Indications for Use (Describe)

The system is intended for use in critical care environments where healthcare is provided by trained healthcare professionals.

It is not for pediatric use (Less than 18 years of age) It is not for use in EMS settings.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image is a logo for a company called "ImaCor". The logo consists of a gray heart shape on the left side, with blue sound waves inside. To the right of the heart is the company name, "ImaCor", in blue letters. Below the company name is the tagline, "The hemodynamic ultrasound company", in gray letters.

K220490

510(k) Summary

Submitter's name, address, telephone number and contact person: Submitter: Richard Lanzillotto

	Director of Regulatory Affairs
	ImaCor Inc.
	50 Jericho Turnpike Suite 105, Jericho, NY 11753
	Tel: (1)-631-255-7183, rclanzillotto@gmail.com
	Fax: N/A
Date Prepared:	Sept 1, 2021, Modified Nov 1, 2021

1. Name of the device, including the trade or proprietary name, if appliable, the common or usual name, and the classification, if known:

Device Name:	ImaCor Zura Handheld ZHH-010
Common Name:	Diagnostic Ultrasound System and Accessories
Classification:	Class II

Classification Names:

21 CFR Section	Classification Name	Product Code
892.1550	Ultrasonic Pulsed Doppler Imaging System	90 IYN
892.1560	Ultrasonic Pulsed Echo Imaging System	90 IYO
892.1570	Diagnostic Ultrasound Transducer	90 ITX

3. Substantially Equivalent Devices: [Primary Predicate Device]

Device Name	510(k) Number
Clarius Ultrasound Scanner Model C3HD	K192107

Device Description

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removable and comes with a separate charger.

Image /page/4/Figure/2 description: The image shows a medical probe and scanner. The probe, labeled "Probe K100989", is a long, thin, blue tube with a connector at one end. The scanner, labeled "ZHH Scanner", is a handheld device with a gray top and black body, connected to the probe via a white cable.

Fiqure 1: ImaCor Zura Handheld ZHH-010and ClariTEE probe

The ImaCor Zura Handheld ZHH-010 product components include:

1. Software:
- SOUP Imaging App for Android ●
1. Transducers/Scanners:
- ImaCor ClariTEE probe (TEE probe);
1. Accessories:
- ImaCor Battery (Li-ion); ●

ImaCor Battery Charger;

ImaCor Fan
Medical Power Supply (off-the-shelf power adaptor from GlobTek, Inc.; Model Number WR9QA3200USBNMEDR6B; approved in the US).

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The concept of the ImaCor Zura Handheld ZHH-010 transducers and software is to provide an easy to use, high-performance, low-cost ultrasound platform for diagnostic imaging. It is indicated for diagnostic ultrasound imaging in using the ImaCor ClariTEE probe (cardiac, TEE) applications. The lmaCor Zura Handheld ZHH-010 is intended for use in environments where healthcare is provided by trained healthcare professionals.

Regulatory History

The new device submission is similar to a device cleared under – K192107 by the same manufacturer now acting as OEM to ImaCor. The change of this new submission from this manufacturer's own product line is the output probe is tethered to the scanner body as opposed to the transducer being integrated to the scanner body. Otherwise, All electrical and mechanical aspects of thebeamformer are identical to the predicate device. Appropriate changes have been made to mitigate risks and ensure effectiveness of these new features. The software app is developed by the original manufacturer with no changes made by ImaCor. Therefore, it is SOUP by ImaCor's perspective.

Intended Use/IndicationsforUse

The system is intended for use in critical care environments where healthcare is provided by trained healthcare professionals. It is not for pediatric use (Less than 18 years of age). It is not for use in EMS settings.

Primary PredicateDevice

Equivalent devices are referred to as predicate devices in alignment with the FDA's standard terminology for comparable devices. The predicate device selected to demonstrate equivalence is:

1.	Device NameClarius Ultrasound ScannerModel C3HD	FDA 510(k) NumberK192107
----	---------------------------------------------------------	------------------------------

The beamformer in the ImaCor Zura Handheld ZHH-010 is mechanically and electrically identical to the predicate device. However, the output probe for the predicate device is integrated into the scanner body. The ImaCor Zura Handheld ZHH-010 device probe (ClariTEE) is not integrated into the scanner body but is connected to the scanner body by a tether.

Reference Device

A reference device is chosen as it is technologically similar to the new device in terms of its probe output. The reference device selected is:

1.	Device Name	FDA 510(k) Number
	ImaCor Zura TEE System with ClariTEE probe	K100989

The ImaCor Zura Handheld ZHH-010 device is for use with the ClariTEE probe which was cleared in K100989 (06/25/2010). The ImaCor-Zura TEE (reference device) and ImaCor Zura Handheld ZHH-010 are both diagnostic ultrasound systems for cardiac adult applications. They both use the ClariTEE probe; a

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Transesophageal Echo (TEE) transducer.

Determination of Substantial Equivalence

The ImaCor Zura Handheld ZHH-010 employs the same fundamental scientific technology as that cleared with predicate device, Clarius Ultrasound Scanner (K192107). All indications for use introduced by the ImaCor Zura Handheld ZHH-010 are similar to thepredicate device. A comparison table is provided below:

Criteria forComparison	ImaCor Zura Handheld ZHH-010 (SubjectDevice)	Clarius Ultrasound Scanner C3HD(K192107) (Predicate Device)
Portability	Portable ultrasound system	Portable ultrasound system
Power Source	Removable battery (Li-ion)	Removable battery (Li-ion)
Display	Android mobile device	iOS or Android mobile device
WirelessCapability	Communicates wirelessly via Wi-Fi andBluetooth	Communicates wirelessly via Wi-Fi andBluetooth
501(k) Track	Track 3	Track 3
TransducerTypes	- Linear Array	- Linear Array
Intended Use	Diagnostic ultrasound imaging	Diagnostic ultrasound imaging
Indicationsfor Use	-Trans-esophageal (Cardiac)-Cardiac adult	Cardiac adultOther indications not relevant todiscussion
Modes ofOperation	- B-mode	- B-mode- M-mode- Color Doppler- Power Doppler- PWD- CWD- Combined (B+M; B+CD; B+PD;B+PWD)
Cybersecurity	Same as SOUP software	Accepted via K192107

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Equivalency Conclusion

The subject device does not introduce any new technology or indications for use; therefore, the system is similar to the predicate device.

Non-Clinical Performance Data

Nonclinical performance tests show compliance to the following standards:

Reference No.	Year	Title
IEC 60601-1	2005/(R)2012A1:2012C1:2009(R)2012A2:2010(R)2012	Medical electrical equipment-Part 1: General requirements for basicsafety and essential performance (IEC 60601-1:2005, MOD)
ANSI/AAMI/IEC62304	2006	Medical device software - Software life cycle processes.
CAN/CSA-C22.2No. 60601-1-6:11	2011	Medical electrical equipment - Part 1-6: General requirements for basicsafety and essential performance - Collateral standard: Usability (AdoptedIEC 60601-1- 6:2010, third edition, 2010-01)
CAN/CSA-C22.2No. 60601-1:14	2014	Medical electrical equipment - Part 1: General requirements for basicsafety and essential performance (Adopted IEC 60601-1:2005, thirdedition, 2005-12, including amendment 1:2012, with Canadian deviations)
IEC 60601-1-2	2014	Medical electrical equipment - Part 1-2: General requirements for basicsafety and essential performance - Collateral Standard: ElectromagneticCapability - Requirements and tests
IEC 60601-1-6	2013	Medical electrical equipment - Part 1-6: General requirements for basicsafety and essential performance - Collateral Standard: Usability
IEC 60601-2-37AMDI	2015	Medical electrical equipment - Part 2-37: Particular requirements for thebasic safety and essential performance of ultrasonic medical diagnosticand monitoring equipment

Clinical Performance Data

The ImaCor Zura Handheld ZHH-010 did not require clinical testing to establish substantial equivalenceto the predicate devices indicated.

Quality Assurance Measures

Quality assurance measures applied to the system design and development include, but were notlimited to risk analysis, verification and validation, product specifications, and design reviews.

Conclusion

This device is an OEM modification of an existing cleared device using technologies that exist on the market today. The development and testing conducted on the device ascertain that it is safe for use by qualified physicians. The ImaCor Zura Handheld ZHH-010 does not introduce indications for use, technological features, or system characteristics that are not seen in its predicate or reference devices; therefore, the device is similar in safety and effectiveness to these predicate devices.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.