(45 days)
No
The summary describes a standard ultrasound imaging system and does not mention any AI or ML capabilities in the device description, intended use, or performance studies.
No
The device is described as a "diagnostic ultrasound imaging system" and is "intended for diagnostic imaging," which means it is used to identify or analyze a condition, not to treat it.
Yes
The document explicitly states, "The ImaCor Zura Handheld ZHH-010 is a software-based handheld ultrasound imaging system and accessories, intended for diagnostic imaging."
No
The device description explicitly lists hardware components such as the scanner (which houses a battery, internal power supplies, beamformer, pre-scan converter, and Wi-Fi components), the transducer (ClariTEE probe), battery, battery charger, fan, and medical power supply. While it includes software, it is not solely software.
Based on the provided information, the ImaCor Zura Handheld ZHH-010 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- ImaCor Zura Handheld ZHH-010 Function: The description clearly states that this device is an ultrasound imaging system. It uses sound waves to create images of internal structures (specifically the heart) within the body. It does not analyze specimens taken from the body.
Therefore, the ImaCor Zura Handheld ZHH-010 falls under the category of diagnostic imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
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 off-the-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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac
Indicated Patient Age Range
Not for pediatric use (Less than 18 years of age)
Intended User / Care Setting
Trained healthcare professionals. Critical care environments.
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)
Nonclinical performance tests show compliance to the following standards: IEC 60601-1, ANSI/AAMI/IEC 62304, CAN/CSA-C22.2 No. 60601-1-6:11, CAN/CSA-C22.2 No. 60601-1:14, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37 AMDI. The ImaCor Zura Handheld ZHH-010 did not require clinical testing to establish substantial equivalence to the predicate devices indicated.
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.
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.
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
§ 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.
0
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
1
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 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.
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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3
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.
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 |
-
- 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
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
4
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.
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
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).
5
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 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.
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 Name
Clarius Ultrasound Scanner
Model C3HD | FDA 510(k) Number
K192107 |
| ---- | --------------------------------------------------------- | ------------------------------ |
|---|
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
6
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 for
Comparison | ImaCor Zura Handheld ZHH-010 (Subject
Device) | 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 |
| Wireless
Capability | Communicates wirelessly via Wi-Fi and
Bluetooth | Communicates wirelessly via Wi-Fi and
Bluetooth |
| 501(k) Track | Track 3 | Track 3 |
| Transducer
Types | - Linear Array | - Linear Array |
| Intended Use | Diagnostic ultrasound imaging | Diagnostic ultrasound imaging |
| Indications
for Use | -Trans-esophageal (Cardiac)
-Cardiac adult | Cardiac adult
Other indications not relevant to
discussion |
| Modes of
Operation | - 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)2012 | |
| A1:2012 | ||
| C1:2009(R)2012 | ||
| A2:2010(R)2012 | Medical electrical equipment-Part 1: General requirements for basic | |
| safety and essential performance (IEC 60601-1:2005, MOD) | ||
| ANSI/AAMI/IEC | ||
| 62304 | 2006 | Medical device software - Software life cycle processes. |
| CAN/CSA-C22.2 | ||
| No. 60601-1-6:11 | 2011 | Medical electrical equipment - Part 1-6: General requirements for basic |
| safety and essential performance - Collateral standard: Usability (Adopted | ||
| IEC 60601-1- 6:2010, third edition, 2010-01) | ||
| CAN/CSA-C22.2 | ||
| No. 60601-1:14 | 2014 | Medical electrical equipment - Part 1: General requirements for basic |
| safety and essential performance (Adopted IEC 60601-1:2005, third | ||
| edition, 2005-12, including amendment 1:2012, with Canadian deviations) | ||
| IEC 60601-1-2 | 2014 | Medical electrical equipment - Part 1-2: General requirements for basic |
| safety and essential performance - Collateral Standard: Electromagnetic | ||
| Capability - Requirements and tests | ||
| IEC 60601-1-6 | 2013 | Medical electrical equipment - Part 1-6: General requirements for basic |
| safety and essential performance - Collateral Standard: Usability | ||
| IEC 60601-2-37 | ||
| AMDI | 2015 | Medical electrical equipment - Part 2-37: Particular requirements for the |
| basic safety and essential performance of ultrasonic medical diagnostic | ||
| and 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.